Silicon-gate
CHRONICLE: SILICONE-GATE UNDER THE MICROSCOPE
IN A (DOUBLE) DUTCH CONTEXT
By Frank Eeken, 12 November 2008
--
INTRODUCTION: SYLVIA MILLECAM
-PIC- http://216.25.101.60/imagebank2/sylviamillecam.jpg
Dutch famous actress, comédienne and presentator of Dutch broadcastingorganisation KRO
Sylvia Millecam died on 20 August 2001 at the age of
45 due to sickness. During her road of suffering Sylvia Millecam, who in 1991 had been
declared as most popular woman of the Netherlands, had received treatment from ---seen
Sylvia Millecam's own choice to, after having consulted regular medicine, to reject
regular medicine--- several alternative medicine practitioners (28 in total). Including
Holland's most famous psychic, Jomanda. While these days we can and may rebuild our body
in several ways to a piece of art, the choice of Sylvia Millecam lead to a national and
international critical discussion about (only) alternative medicine, and even to being a
part of the bachelor-education psychology of the Dutch University Maastricht. Regular
medicine believed Sylvia Millecam had breastcancer. Jomanda had mentioned that cancer was
not the case at first: the cause of Sylvia Millecam's illness was an inflammation /
infection. Due to leakage of her sillicone-breasts implanted: "It was the
silicone which eventually caused the cancer". Jomanda mentioned to Sylvia
Millecam that the silicone implants had to be taken out. Regulare medicine refused her
this life-saving operation: "first chemotherapy, that is obligated".
Sylvia did not want chemo and was left to her fate, and (alternative) choice, with death
as a consequence. On saturday 25 August 2001 Sylvia
Millecam was burried at the graveyard Westgaarde in Amsterdam. On the funeral card of
Sylvia Millecam stood: "She knew what she wanted and that she did".
--
NOVA: THE BROTHERS GRIMM
The brothers Grimm of Dutch current affairs Tv programma 'NOVA' ---chiefeditor Gerard
Dielessen (present Director of 'NOS': Dutch Broadcasting Foundation) and finaleditor Piet
van Asseldonk (who in 2001 did advice work for the Dutch Education Inspection for the
Ministry of Education as a side job) created a NOVA-Tv-broadcasting on 1 September 2001: "Useless road Sylvia Millecam along
alternative practitioners", in which Jomanda in an interview disputed the word cancer
"absolutely" and in which Emiel Rutgers, oncological surgeon of the Dutch
'Antoni van Leeuwenhoek' Hospital (AvL/NKI) in Amsterdam, who Sylvia Millecam consulted in
june 2000, was not dirty of taking part in peoples-fairytales and conscienceless said:
"Jomanda's method of dealing, is pure deception and criminal". But
Jomanda's words were cutted, edited and twisted as maybe Jomanda disputed the word
cancer......CUT....."because medium Jomanda comes out on causes" and
........CUT......"In the beginning it was not cancer. In the very end it did
become cancer" and ....CUT...."I always refer people to a doctor".
Jomanda felt strongly misunderstood and unjust attacked: "An interview
about my contact with Sylvia, who then was still alive, was totally edited/cutted by the
Tv-programme NOVA. I had explained everything, nuanced. That Sylvia just had a lot of
support to our conversation. I also said that I have prescibed Sylvia nothing and that I
have advised her to contact a regular doctor. That I always do and for many years ! There
was little left of it" (Dutchnewspaper Telegraaf, 24-12-2001 ). The Dutch
foundation 'Friends of Jomanda' had tried to get hold of the entire recording, the whole
NOVA-interview with Jomanda, not only that which was cutted and edited broadcasted by NOVA
for evidence. NOVA refused to co-operate. One could wunder: Why ? NOVA-reporter
Hetty Nietsch, who interviewed Jomanda: "I never give insight in the rough
material I use". The editorsboard of NOVA of the 1 September 2001 broadcasting
existed out of: Wim van de Pol, Lex Runderkamp (= (former) Dutch Broadcasting
Foundation NOS (Newsjournal) and the report-authors Hetty Nietsch, Aletta Oosten and
Sylvia Pilger. After Jomanda's remarks in NOVA, the editorsboard of NOVA made a phone-call
to the Dutch quackbuster foundation Skepsis / Rob Nanninga with the inciting question:
Could Jomanda on basis of her remarks juridical be tackled ? Skepsis (then) meant
impulsively that this, despite moral resistance, would be unlikely due to a Dutch liberal
law: "punishable by law they are presumable not". The
NOVA-broadcasting resulted in an escalating effect in the social Jomanda-debate. While
some belief that medium Jomanda is living in 'Another World', according to the Dutch
(former) Minister of Justice, Donner, in a speech on 3 May 2004 in reference to the a
study into pressfreedom in the Netherlands, incorrect tales in the media do much damage in
society, to be read as 'bringing harm upon': "Due to the killing
competition between the media the quality of the reporting in the Netherlands
reverses", "often not the facts but what has been published, are seen as
reality. Hard facts will catch on to printed untruths in time, although it can be too
late. With soft facts --reputations, opinions, images, the tone of facts-- that is less
the case. Than reporting creates an own world which can push the real one aside and so can
make or break resputations, destroy lives, can raise people or bring people to a fall, can
determine developments in society and be a source of unrest and war". .
--
WITCH HUNT
Based on the NOVA-broadcasting a (media) witchhunt started on Jomanda under besouled and
inspirating leadership of a few individuals, their views, beliefs and fantasies:
regular thinking highpriests and scribes. After a few medical specialised lawyers
(P.A.M.M. Dingemans, W.G. Verkruisen, J.M. Beer) in the media pressed upon action of the
Public Justice Department against Jomanda, the Dutch Healthinspection IGZ's
inspector-general prof.dr. J. Herre Kingma and inspector Menso Westerouen van Meeteren
started, despite no complaints of relatives of Sylvia Millecam, a criminal-investigation
into a.o. Jomanda. Culpable homicide ? Having kept Sylvia Millecam away from life saving
regular medicine treatment ? Support came from the Dutch political Socialistic Party (SP)
of leader Jan Marijnissen, on who's name the SP-membership of the Dutch quackbusters ass.
VTDK stands, and of SP-member of Parliament Agnes Kant who conscienceless proclaimed lies
about Jomanda in Dutch Parliament, while the same Agnes Kant on 11 December 2005 in Dutch
humoristic Tv-programme 'This was the News' accused Dutch minister Verdonk of lying in
Dutch Parliament and consequently said: "An asylum-seeker who lies, must go
away / leave, thus a minister who......".
--
HERRE KINGMA: CREATIVE WITH INFORMATION
Cardiologist prof.dr. J. Herre Kingma, before his IGZ-period was once the founder and
chairman of the Dutch Order of Medical Specialists. In 1997 Dutch radio-programme 'Radio1
Journaal', and Tv-programmes 'DenHaagVandaag', 'Journaal', (30-01-1997 ) reported about
the revelation of the Dutch Economic Supervision-service (ECD) that medical specialists
had fiddled for at leats 10 million Dutch guilders with declarations. In an interview
chairman Herre Kingma of the Order of Medical Specialists rather spoke of 'creative
declaring' and Herre Kingma minimized, treated as of litle importance, the extent of
the fraud and pointed to the difficult tariff-structure and to the "'ridiculous
low tariffs, for which his professiongroup little by little does not wish to work
anymore".
--
HERRE KINGMA'S IGZ: 'POSITIVE DISCRIMINATION ?
On 16 November 2001 Dutch Healthcare minister Els
Borst ---familymember of convinced quackbusters VTDK-member, anti-alternative-medicine
propagandist and oncologist prof. Piet Borst of the Dutch 'Antoni van Leeuwenhoek'
Hospital (AvL/NKI) in Amsterdam--- got talked about due to an agreement between medical
specialist and medical specialist Herre Kingma's Healthinspection IGZ to keep medical
errors a secret by which patients could not get inspection into the number of medical
errors made in hospitals. And if a judge (Law of Publicness of Government) would force
openness than, according to the agreement between the IGZ and the specialists, medical
files if necessary were allowed to be destroyed. Reason ? Journalists ('media-signals')
and patients would use the information unsubtle and draw the wrong conclusions from it,
thus the justification. By which "social unrest" would arise ? How credible is
an 'zero tolerance' Inspector General for Healthcare of the IGZ, a medical specialist, who
in executing his duty claims to want to react onto signals of alternative-, Jomanda-damage
/ harm but in the media said having no legal possibilities to tackle alternative medicine
and thus thereby indirectly publicly aksing for it, but consequently / in the mean time
approves an agreement between medical specialists and the IGZ to keep signals of
regular-harm (medical errors) a secret and if necessary to let these regular-signals be
bestroyed ? Guilty of 'positive' discrimination ?
--
HERRE KINGMA "JOMANDA IS DANGEROUS"
The (first) 'factual' IGZ-investigation, in which an IGZ-employee had refused during a
Jomanda-healing to take place on a healing-table on invitation of Jomanda, was rather
blocked, blown off by the Dutch Ministry of Health of D'66 party minister Els Borst. While
the same minister Els Borst in Parliament had alleged that "The Dutch
healthinspection (IGZ) must act more actively on signals out of society about practices of
quacks" and that she had "made harsh arrangements about Jomanda with
headinspector Kingma", and while Jomanda was "happy" with an
investigation, as "now the chaff is seperated from the wheat and the truth must
come above the water", the Dutch ministry told Jomanda: "We have
shut down the case, and the how, what and why, that we can not tell you". The
'media-signals' did not report this. What was reported was that Jomanda socalled would be
'acquited' of any blame on 19 December 2001 and that
the IGZ hadn't found any criminal facts. But Inspector-general Herre Kingma was obstinate
in his belief. "Jomanda is dangerous" he stated in Dutch Tv-programme
'NOVA' (19-12-2001 ) and Kingma said that he would do anything tp "tackle these
dangerous quacks". Kingma believed to see sufficient reasons to further
investigate a.o. Jomanda, believing that Jomanda caused damage at her patients (with
emphasis on the plural), and because 'the alarming and disturbing media news kept
coming about Jomanda'', Kingma willingly and knowingly decided personally to continue
the symbolic alternative-crusade, and he started a (second) follow up-investigation, to
again try to let Jomanda be criminally prosecuted. Jomanda again was "happy"
with the new investigation. It could "take away the gap between regular- en
alternative medicine". False hope ?
--
NOVA: PUBLIC AMUSEMENT OR PUBLIC DECEIT ?
Due to the NOVA-Tv-broadcasting many people got confused, as member of Dutch Parliament
Buijs (CDA-party) confirmed in a debate ---in reference to the death of Sylvia Millecam or
more realisticly said in reference to the Tv-broadcasting of gate-keeper NOVA about it---
in the Dutch Second Chamber of Parliament about the lawproposal change Law-BIG of 20 March 2002 in which a proposition by the ministers
D'66-party Els Borst of Healthcare (familymember of VTDK-member, oncologist prof. Piet
Borst) and Korthals of Justice (VVD-party) was handled for change of law which read that
Justice in the future can force alternative practitioners to immediately close their
practice, even though there only exists just a suspicion (belief-conviction) that they
harm the health of patients. This in contradiction with article 6. of the European
Convention for Humanrights, where in member-2 is posed: everyone, who is suspected of a
criminal fact, is presumed innocent until accoring to law his or her guilt has been
established. Seen the things Jomanda would have said in NOVA 'after' the death of Sylvia
Millecam, MP-Buijs said, he just couldn't understand so well, as he stated in the debate,
why Jomanda could not be brought before a judge. On the symposium of the Dutch quackbuster
ass. VTDK on 12-10-2002, in presence of Herre Kingma
who held a speech, homeopaths and their practices were compared to the practices in the
concentration camps of nazi-Germany, afterwhich applaud sounded from the audience.
--
THE NETHERLANDS IS CRITICALLY ILL
In the case Sylvia Millecam some people belief that patients who suffer from a (potential)
life-threathening disease, rather once have the urge to stand open for all that offers
(false) hope and that they do all kinds of nonsense. IGZ inspector-general Herre Kingma:
"We just once have to do with a society in which the sick or those who think they
are, not always think so rational" (Dutch newspaper Trouw, 14-10-2002, 'The
Netherlands paradise for quacks'). Herre Kingma was diagnosed with disseminated
bowelcancer, evenso earlier his brother who visited a 'herb-doctor' which was okay by
Herre Kingma because "we yet all know it does not work", thus Kingma.
After a sickperiod of more than six months, being operated by a former study-fellow who in
a list of Dutch magazine Elsevier glittered as a good surgeon, and according to hearsay an
immunetherapy with Oncovax, a therapy wich is withholded from others, Herre Kingma resumed
his responsibilities as Inspector-General of Healthcare around October 2003. Herre
Kingma's IGZ's Jomanda/Millecam-investigation eventually resulted on 17-02-2004
in the final IGZ-report 'The Care-providing to Sylvia Millecam - an example-case'. Jomanda
is being blamed for negative 'influence' on Sylvia Millecam. The conclusion of the
investigative-IGZ-report was that medium Jomanda "from out of a 'guru-position'
had presented her 'diagnosis' in a semi-religious atmosphere as an 'unimpeachable
judgement' from the Divine world". Jomanda's working method would be "lifeSthreatening"
and Jomanda would be guilty, at first, of culpable homicide (max. imprisonment 2 years).
While Herre Kingma had complaint in Dutch newspaper 'Trouw' (20-06-2002 ) about that he in
the media is being potrayed as 'friend of the pharmaceutical industry', since his
signature stands under contracts with the pharmaceutical industry adding to millions of
Dutch guilders, Jomanda more and more became publicly known as the 'murderer' of Sylvia
Millecam: her friend ! During a period of a half year (29 September 2003, 21:00 -
29 March 2004, 21:00 ) in which Jomanda had been asked by the Spiritual world to be
silent, to not speak at all, only communicate by writing, as a penance for the
Netherlands, Jomanda reacted on this reporting of J.H. Kingma in writing: "The
Netherlands has many storms and evenmore teacups. I can only laugh about this and now know
for even more sure why I was asked to do penance for the Netherlands: The Netherlands is
critically ill". Jomanda a guru in the eyes of Sylvia Millecam ? Sylvia Millecam:
"My parents did not belong to a party or movement, but they did have a motto: Do
not look unnecessary up to people and especially do not look down on people. Can they talk
difficult, do they have no money, funny choice of clothing, that does not matter. You must
look at the heart. The great feeling of equality of all people, lays for me at the
foundation of my life" (Interview SP Tribune 5/97 ). Sylvia Millecam visited a.o.
Jomanda, died and is a stupid cow, "a psychological disorder", according
to VTDK chairman Cees Renckens (Dutch newspaper 'Het Parool', 22-08-2001 ) ? On 11 July
2001 Dutch rockstar Herman Brood committed suicide. He jumped of the Amsterdam
Hilton-hotel. In his pocket one found a letter with the text "yet make a big party
of it". Dutch newspaper 'Trouw' headlined that Herman Brood, for years the 'idol'
of Dutch statesecretary of Education, Culture and Science, Rick van der Ploeg
(PVDA-party), had said goodbye in style: a hero's death ?
--
HERRE KINGMA'S IGZ-REPORT: UNLAWFUL ?
The IGZ-report about Sylvia Millecam ---based according to Herre Kingma's IGZ on
'media-reports/signals' by which "social unrest" would have occured--- was
consequently presented by IGZ-inspector-general Herre Kingma
-PIC- http://www.utwente.nl/%5E%5Econtenttypesdata/17031.jpg
in person on Tuesday 17 February 2004 in the Dutch 20:00 Tv-NOS-newsjournal of
Chief-editor Hans Laroes. Also Herre Kingma and his views, beliefs appeared in many
media-publications: "Jomanda is dangerous". Herre Kingma, with a
book in the hand known as the IGZ-report, made information to the Dutch Public Prosecution
Office (OM) with the aim and the outspoken hope that Jomanda would be be criminally
prosecuted. And the IGZ-report was also put on the internet.
http://www.igz.nl/publicaties/rapporten/rapporten2004/35604
http://www.igz.nl/15451/17876/Rapport_S.M._definitief_17_1.pdf
Dutch lawyer E.J.C. de Jong: "The publication on internet of the IGZ-report
about the medical history of Sylvia Millecam is a huge violation on the personal walk of
life. And did the involved doctors not know that there is an oath of silence towards the
IGZ operative ?..." ('Broken oath of silence', Dutch medical magazine 'Medisch
contact', Nr. 11 - 12 March 2004 ). The former life-partner of Sylvia Millecam, Nol
Willemsen, who had been informed a year earlier about an investigation, had no idea that
the IGZ-report was finished. "Herre Kingma, inspector general for healthcare,
should not have sat in the NOS-journal Tuesday, but with her" found the mother of
Sylvia Millecam in Dutch newspaper 'Trouw', "I find it cowardness that that hasn't
happened. But the report was leaked out, so-called. Well,I belief nothing of that. And
evenso that is no reason to not inform me first", "If someone has to appear in
court, it is not Jomanda, but the Headinspector Herre Kingma. He should be
prosecuted". And further the mother of Sylvia Millecam said in Dutch newspaper
'Algemeen Dagblad' about the handling of the IGZ: "I did not know at all
that they were busy with this. They did not ask me anything. I find it all quit
respectless, for myself but certainly also for Sylvia", "I have witnessed that
Jomanda herself telephoned Sylvia with the question if she was in pain. That was correct
and then when Sylvia put the horn of the telephone on her chest, the pain went away. How
strange that yet may sound, but that are indeed the facts". At one moment Dutch
Health minister Hoogervorst found in Dutch Parliament that concerning the
Jomanda/Millecam-case "a good line had been chosen by the IGZ" and that "carefull
had been acted in the investigation about Sylvia Millecam's death", while in
another moment minister Hoogervorst wrote an apology-letter to the mother of Sylvia
Millecam in which he expressed regret about the (uncarefull?) way of doing concerning the
publication of the IGZ-report. The Dutch Healthinspection IGZ: "Òne of the
most important priciples is the IGZ-principle that a government body must act carefull
towards the peoples". In the Dutch radioprogramme 'Met het oog op morgen' (11
July 2003 ) and the Dutch radioprogramme 'Radio1 Journaal' (12 July 2003 ), about the
question whether doctors are allowed to talk via the media about sickness of famous
Dutchmen, IGZ-inspector-general and cardiologist Herre Kingma found that the psychiatrists
and psychologists who had made public remarks about the case-Volkert van der G., suspect
of the murder of Dutch politician Pim Fortuyn: "unprofessional"
Kingma called their behaviour: "reprehensible" and Kingma was in the
opinion that physicians: "enter publicity too easy about the sickness of
patients". The Dutch Healthinspection (IGZ) in Dutch newspaper 'NRC Handelsblad':
"Psychiatrists and psychologists who in the future make remarks about the clinical
picture of somebody without having seen that person, have to count on disciplinary
measures".
--
IGZ: INFLUENCE BY MEDIA-REPORTS
In the IGZ-report several statements are included from those involved who had been heard
by the IGZ during the investigation. The questions of the IGZ to those involved / heard
are not included in the IGZ-report, by which it is unclear what the IGZ concrete has asked
and with what kind of questions. Open questions ? Closed questions ? Suggestive questions
? It is not unthinkable that the statements of those involved could have been 'influenced'
by the media-reports, media-imageforming (e.g. NOVA) after the death of Sylvia Millecam.
When one but often enough hears and sees for example the message for example "Jomanda
is a dangerous bitch", in line with for example "there are dangerous weapons of
massdestruction in Iraq", than the human urge could exist to, despite reality
(awareness), belief this, and consequently to start proclaiming this belief to third
parties as being truth. In the case of Iraq this 'between the ears' has appeared to have
been a very effective psychological-human-mechanism, with its manipulating and misleading
effect on the psyches of millions of people up to politicians worldwide, who due to this
'influence' did or did not make certain 'alternative' choices.
--
CHRONOLOGICAL: THE FREEDOM OF CHOICE OF SYLVIA MILLECAM
# - Introduction of the IGZ-report: "Although
in the report will not completely go past that, the investigation did not aim at 'the
choices of the patient'. This because 'the freedom of choice of the patient' is not a
matter of discussion and is considered as 'a great asset'".
# - Further in the IGZ-report: Judgement of the
Inspection: "Furthermore the realization of a patientschoice is not
something in which the patient operates autonomous. Choices in healthcare are realized on
basis of the 'informed-consent' principle".
--
UNCLEAR LITTLE KNOB
On 22 September 1999 Sylvia Millecam goes to her
family doctor Joost Kist in Amsterdam with a little knob in her rightbreast, which nobody
of her family or friends knew about. The familydoctor examines her, and refers Sylvia
Millecam the same day to x-ray department of the hospital 'Onze Lieve Vrouwe Gasthuis
(OLVG)' in Amsterdam for a photo of her breast, on which a knob is determined (1-1,5 cm),
but "unclear remains what the lump exactly is", thus Dutch professor in
psychology Rene Diekstra in Dutch newspaper Rotterdams Dagblad (26-02-2004, 'Sylvia's
choice: a regular medical error'). Dutch broadcaster 'NOS' (17-02-2004, 'Guilt Jomanda at
death Millecam'): "The 45-year old Sylvia Millecam died in 2001 to
breastcancer. Although the disease had been determined at her in 1999, she herself did not
belief that it was cancer". Dutch Radio1 Journal (04-10-2006, bco NOS): "In
1999 at Sylvia Millecam a little knob is discovered. For the treatment she seeks her
wellfare in alternative medicine, aomg others at Jomanda".
--
IGZ "IN CONTRADICTION TO NOVA..."
Dutch Tv-programme NOVA (1 september 2001 ) reported that familydoctor Joost Kist on 22 September 1999 found that there was a matter of an
innocent little connective-tissue-knob with the advice to Sylvia Millecam "to
provisional wait and see". A medical-error ? But NOVA had reported wrong,
according to the IGZ-report, which contradicts this data from NOVA: familydoctor
Joost Kist would have confirmed "by means of palpathy the existence of a tumour of
1 à 1½ cm", thus the IGZ-report. Unknown is, not mentioned in the IGZ-report,
how the IGZ came to this conclusion. Has the IGZ called in and examined (e.g. via Dutch
Forensic Institute) the patient-card, the medical-file of Sylvia Millecam at familydoctor
Joost Kist ? Or has the IGZ 'believed' familydoctor Joost Kist on his Hippocratical word ?
It seems like that Herre Kingma's IGZ in the IGZ-report wants to arouse the impression /
wants to emphasize that, "in contradiction to what in the media (NOVA) is
mentioned", that immediately on 22 September 1999 at familydoctor Joost Kist was
clear what the knob was: breastcancer ? A diagnosis which otherwise would be made
months later. One could wunder about the question: Why one at this specific data
should belief the IGZ and not NOVA ? Does the IGZ want to allege that what NOVA has
broadcasted is not the truth ? Or does the IGZ just selectively want to allege that NOVA
has broadcasted untruth in the case it is to the disliking of the IGZ & Co., and at
the same time that NOVA has broadcasted truth in the case it is to the liking of the IGZ
& Co.: "Jomanda has said 'in NOVA' that Sylvia Millecam....." ?
Rather, Sylvia Millecam at that time has communicated the 'innocent' diagnosis of
familydoctor Joost Kist to the partner of doctor Koonen, Tonny Derksen, and to her mother.
Sylvia Millecam discussed everything with her mother. One could ask onezelf whether the
IGZ in het 'carefull' investigation has made inquiries at the mother of Sylvia Millecam
and had heard her ? In case this is not the case, one could ask oneself: why not ?
--
OLVG-PHOTO: NOT IMPRESSIVE
Thus according to the IGZ-report at familydoctor Joost Kist on 22 September 1999 it was
immediately clear what the knov was, while about the photo, made later on the same day of 22 September 1999 in hospital 'Onze Lieve Vrouwe Gasthuis'
(OLVG) in Amsterdam, the IGZ-report sais that "the deviation was not yet
impressive". The OLVG-result a.o.: "this can be normal
gland-tissue, malignacity can rather echographic never be excluded", thus the
IGZ-report. Malignant: "Malicious of a tumour". Wikipedia:
"The medical term 'Maligne' is usual used for several forms of cancer to point out
that the kind of found tumour has the urge to dissemenate. Malicious cells destinguish
themselves by a.o. the fact that at some forms of cancer the cells do change in their
effectiveness, but not in form and shape. Thereby they are in the outer appearance
sometimes not directly recognisable as cancer-cells". Never be excluded ? It could be
this, but it could also be that ? It is no cancer, but it can never be excluded that it
maybe could be cancer ? Thus the OLVG-result gave unclearness about Sylvia Millecam's
little knob. Via her family doctor, the OLVG once again, as advice, refers Sylvia to a
surgeon in hospital 'VU Medisch Centrum' (AZVU) for further examination. Again a referal.
Why ? Because it wasn't clear "what the knob exactly was" ? Because the knob was
"not impressive enough" to make a clear diagnosis, so that further examination
was needed ? Familydoctor Joost Kist did not inform about how it went about for Sylvia
Millecam, who does not show up in the AZVU. Familydoctor Joost Kist took notice of this
after more than a half year afterwards and, according to the IGZ-report, was "shocked"
about this. Sylvia Millecam would have said to familydoctor Joost Kist hebben, as reason
for not showing up on the AZVU-appointment, that according to 'a psychic' the little knob
would not be evil. A 'unknown psychic' ? The IGZ-report, 'Judgement of the Inspection':
"This psychic could possibly be mr. (Anne) Alons". Familydoctor Joost
Kist had voluntary reported to the IGZ to tell the IGZ that his alternative colleagues
Koonen and Broekhuyse according to his belief hadn't granted Sylvia Millecam good care.
Joost Kist declares in the IGZ-report: "Factual it has started with the
psychic (unknown who this has been) who held before that it was not breastcancer".
Or has it factual started with a familydoctor who has held before that it was an unclear
little knob, an "innocent" connective-tissue knob ?
--
SILICONE: MALIGNANT INFLAMMATION
In November 1979 Dr. Charles Vinnik performed explantation of a ruptured breast prosthese
(a 'Silastic': brand silicone in a silicone envelop) of the right breast. The
operative report: "The gel ran down the patient's chest, onto the operating
table and onto the floor. This procedure is performed because of medical necessity as a
ruptured breast implant can produce serious medical problems". In 1981 patient's
right breast "became increasingly fibrotic and dense, raising some concern about
malignancy". The pathology report: "One section demonstrates an
acute necrotizing inflammatory cell reaction".
--
UNJUST REASSURANCE: KEEP AN EYE ON IT ?
Also in September 1999 Sylvia Millecam visits
alternative-doctor J.A.M. Koonen of the healthcenter 'de Grens' in Millingen aan de Rijn
with the request to look at her right-breast. A former-employee of 'de Grens' "remembers
yet very well that Sylvia Millecam was relieved because of the positive result of the
measurement which Koonen had supplied her. There was nothing at hand, so he had
posed", thus the IGZ-report. Sylvia Millecam heard a "complete unjust
reassurance on basis of unsound diagnostic research with a non-scientific method
(electro-acupuncture)", the the IGZ-report.
--
HAARLEM: THE PRESUMPTION OF BREASTCANCER
On 11 May 2000 the family doctor Joost Kist notices
that the knob had become bigger and he refers Sylvia Millecam to hospital 'Kennemer
Gasthuis' in Haarlem. There physical examination, by plastic surgeon mr. J.B.B. van
Tetering who had given Sylvia Millecam her silicone breast implants and at who Sylvia
Millecam since 1992 was under treatment, points to a good feelable tumour (3-4 cm) due to
the underlaying prothesis. General surgeon A.J. is asked to join and a puncture is done.
The result confirms the presumption of breastcancer. Treatmentplan ? Mamma-amputation and
reconstruction (in line with the national protocol: with silicone breast implants
?), eventual followed by chemotherapy, radication and tamoxifentreatment. Sylvia Millecam
resolute prefers an alternative treatment in Switzerland ('cell specific cancer therapy',
CSCT). Because she "doubted the diagnosis breastcancer", thus the
IGZ-report, Sylvia Millecam wants a second opinion: had the doctors made a mistake
? From a study of the Dutch 'Daniël den Hoed' Clinic in Rotterdam in 1999 among 245
cancerpatients it appeared that: 7% of the second opinion's result in a new
prognosis and treatment. In 25% of the cases the treatment is changed. At more than 50%
the second opinion is equal to the first. Patients mostly wanted a second opinion out of
need for more certainty or more information (Mellink WAM, et al., The Second opinion
policlinical Surgery Oncology in the Daniël den Hoed Clinic: analysis of the first 245
patients, Dutch medical magazine 'Nederlands Tijdschrift voor de Geneeskunde 1999; 143:
2471-2474 ).
--
IGZ PROTECTS PERSON OF EVERYTHING IN CAREGRANTING MILLECAM?
The partner of Sylvia Millecam, Nol Willemsen, said in 2008 in the Dutch Tv-programme 'De
Wandeling' (31-10-2008, bco KRO) that he in the Dutch Kennemer Gasthuis hospital in
Haarlem in May 2000 for the very first time was confronted with breastcancer at Sylvia
Millecam: "The very first time I heard of breastcaner was in the hospital
in Haarlem. Although I must thereby say that Sylvia actually already knew it, a year
earlier, at the familydoctor, who had said 'keep an eye on it', out of fear she hadn't
told me. Sylvia became hysterical in the car on the way back home, because a year earlier
it was 'keep an eye on it' and now bang !". In line with the NOVA-broadcasting (1
September 2001 ) which had reported that familydoctor Joost Kist on 22 September 1999
found that there was a matter of an innocent little connective-tissue-knob with the advice
to Sylvia Millecam "to provisional wait and see", which Herre Kingma's
IGZ explicit contradicts by declaring in the IGZ-report that on 22 September 1999 at
familydoctor Joost Kist immediately was clear what the little knob was. Jan Willem
Nienhuys / quackbusters foundation Skepsis (March 2004, 'Millecam (bis)', magazine Skepter
17 (1)): "Immediately already in 1999, when it was yet but a unclear little
knob, Sylvia Millecam did not appear on the appointment to make a puncture, but she
visited Jos Koonen". Dutch Tv-programme 'Netwerk'-journalist Alje Kamphuis
describes in his book 'Sylvia Millecam: on feeling' "among others the road through
regular-medical and alternative-medical the Netherlands since Sylvia Millecam in September
1999 discovers a little knob in her rightbreast and the plastic surgeon on Haarlem
three-quaters-of-a-year later determines: That is cancer" ('Sylvia Millecams
maze', Dutch newspaper Trouw, 2 February 2006 ). For the familydoctor (Joost Kist) ---the "central
person of everything", the person on which everything hinges, thus the
IGZ-report, in the care-granting (to Sylvia Millecam)--- there are on 22 September 1999
thus 2 possibilities:
# - (1) Unclearness about Sylvia Millecam's little
knob (in accordance to Rene Diekstra, NOVA, IGZ-report "the deviation was not yet
impressive", book Alje Kamphuis and Nol Willemsen): medical-error (in the
diagnosis) ?
# - (2) Clearity about Sylvia Millecam's little knob
(in accordance with the IGZ-report "tumour (1-1,5 cm.)" )
In the second / later case (clearity): Familydoctor Joost Kist, thus being aware on
22 September 1999 of a tumour (1-1,5 cm.) at Sylvia Millecam, had refered Sylvia Millecam
on 22 September 1999 to the OLVG, while familydoctor Joost Kist did not inform himself
(informationduty. calling in information) about the result in the OLVG / of his own
reference, while the OLVG, via the same familydoctor Joost Kist, consequently refered
Sylvia Millecam to the AZVU. Familydoctor Joost Kist was not informed (informationduty.
calling in information) about Sylvia Millecam not showing up in the AZVU. Familydoctor
Joost Kist had refered Sylvia Millecam on 11 May 2000, after a delay of 8 months, to the
'Kennemer Gasthuis' hospital in Haarlem, where examination confirms the suspicion of
breastcaner. Judgement IGZ in the IGZ-report: "Familydoctor Joost Kist has
exstremely exerted himself to get to bring about the just treatment for his patient. He
can not be seriously reproached for the arisen delay in the treatment", "The
familydoctor has done what lay in his power to provide his patient of a as good as
possible care...(...)...Yet he should and must have noticed that he had never received
report from the OLVG about the result of the surgical consult. Thus he neglected to follow
the patient, which he also himself regrets. In the light of the total of his meddling with
Sylvia Millecam, this neglect can not serious be blamed on him". In the
Netherlands there are about 7,000 familydoctors compared to about 8,000 registred
alternative practitioners. Dutch Tv-programme 'Netwerk' (19-02-2004; AVRO): "According
to an investigation of the NIPO in the year 2003 tens of thousands medical errors have
been made. A great part of these errors arise because there is bad communication between
hospitaldoctors and familydoctors. Mainly at the maintenance and exchange of patient-files
several serious errors occur". In September 2004 Dutch Institute for Study of
Healthcare (NIVEL) did a study at the Consumer-panel Healthcare into the public trust in
healthcare: "The regular professiongroups enjoys great many faith. In
familydoctors and specialists 91,5 percent and 91,4 percent put many or great many trust
in" (Dutch magazine 'Zorgvisie', 8, August 2005, 'Doctors still enjoy respect').
Remarkable is that the 'media-reports' after the death of Sylvia Millecam does not
anywhere dispute, talk about, the role and dealings --in an evenso equal treatment as
Jomanda-- of familydoctor Joost Kist. Or at least mention something about it. One could
wunder: why not ? Was Sylvia Millecam partial due to familydoctor Joost Kist's
caused delay not anyway just too late for the standard medical treatment with a lesser
chance of survival ?
--
JOMANDA
The IGZ-report states: "After the diagnosis 'breastcancer' was determined,
patient S.M. has also seeked for help at Jomanda", "Jomanda has told Sylvia
Millecam her certain conviction that there was no matter of cancer. Also appeared that
Jomanda has dissuaded chemotherapy". Website Jomanda: "Via Jomanda
the cause of a disease or disorder may be tracked down". Sylvia Millecam visits
Jomanda in May 2000. Medium Jomanda sees no cancer, as
the medium would also not 'see' a cold: consequences of causes. Jomanda's hand
started to shake above a part of Sylvia's right breast and Jomanda received a message that
there would be a relation with something that happened 12 years ago. Sylvia Millecam
answered that she then (= 1988 ?) had gotten silicone breastimplants. According to Jomanda
there lay the cause. "silicone, they had to be taken out". High
percentage ruptured breastprothesis (www.Privekliniek.com, 19-05-2000 ): "Almost
7 out of 10 silicone-gel breastimplants who have been scanned by the researchers appeared
to be leak. According to the FDA, this study can refuel the discussion again about safety
of breastimplants. Many women claim that leaking silicone-gel is the cause of serious
disorders....".
--
AZVU: SECOND OPINION
Sylvia in all kinds of ways starts to inform herself about the disease and treatment
possibilities. On 8 June 2000 Sylvia is in the
Acedemic Hospital Free University (AZVU) hospital in Amsterdam for a second opinion.
Oncologists surgeon prof. dr. S.M. makes the diagnosis breastcancer (tumour minimal 5
cm.). Prof. dr. S.M. suspects on basis of physical examination: local advanced
breast cancer, stage T3. Chemotherapy is the first appointed therapy in the treatment plan
(chemotherapy, operation, radiation). Sylvia Millecam is refered to a specialist for
internal diseases for further examination. On 16 June 2000
specialist for internal diseases oncologist dr. E. van der W., in AZVU hospital in
Amsterdam sees at Sylvia Millecam, after physical examination, a tumour of 7-8 cm without
dissemination. The treatment plan starts with chemotherapy. "The treatment would
offer a chance of 50-60% on longterm survival", thus the IGZ-report, "dr.
van der W. notices that Sylvia Millecam for sure had deepened herself into the matter and
experienced especially resistance against the chemotherapy". According to doctor
for internal diseases and oncologist Dr. van de W. "about 75% of her patients
makes use of alternative medicine". The partner of Sylvia Millecam, Nol
Willemsen, stated in the conversation with dr. van de W., to support Sylvia Millecam in
her choices. A followup appointment is made for 19 june 2000 but Sylvia Millecam lateron
cancels this. Sylvia Millecam alleged not wanting chemotherapy and wanting an alternative
treatment in Switzerland.
--
EMIEL RUTGERS: SYLVIA MILLECAM'S BREAKINGPOINT ?
On 19 June 2000 there is a conversation / consult in
the Antoni van Leeuwenhoek Hospital / National Cancer Institute NKI www.nki.nl
hospital with surgeon oncologist breastcancerspecialist dr. E.TJ.Th. Rutgers:
-PIC- http://static.politiek-digitaal.nl/uploads/images/93/rutgers_groot.png
http://www.nki.nl/Ziekenhuis/Professionals/Medisch+specialisten/Specialisten+A-Z/Rutgers.htm
:
a colleague of anti-alternative medicine propagandist, former-director of the Dutch Royal
Cancer Society 'Koninklijke Wilhelmina Fonds KWF, research director of the Dutch Cancer
Institute NKI and oncologist, prof. Piet Borst, of the Dutch Antoni van Leeuwenhoek
Hospital and Dutch Cancer Institute (AvL/NKI).
The formulation of Dutch journalist Rene Steenhorst in his article 'Jomanda told Sylvia
Millecam that she had no cancer' (3 September 2001, Dutch newspaper Telegraaf): "At
the actrice in September 1999 a little knob in the rightbreast was discovered, that by
doctors of the Kennemer Gasthuis in Haarlem as well as the Antoni van Leeuwenhoek Hospital
in Amsterdam was diagnosed as cancer". A tumour of about 7 à 8 centimeter. Emiel
Rutgers (under the influence of....?) suggests chemotherapy (as only first option):
"the evidence based preference-treatment", thus the IGZ-report, "Beforehand
you can not give guarantees, you can only point out what some-ones statistical chance
is". Sylvia Millecam did not want chemo. The IGZ-report: "In
Sylvia Millecam's experience she was - due to her objections - 'sent away'. She further
expressed herself negatively about the treatment" of Emiel Rutgers (see further).
Emiel Rutgers had the impression that Sylvia Millecam "wanted to hold the
'direction' about her life and the treatment completely in own hand", thus the
IGZ-report. Jomanda in the IGZ-report: "If in the regular care better had
been listened to Sylvia Millecam, with more understanding for her feelings, than she would
have remained in regular care". The IGZ-report: "It has been
determined that in May/June 2000 the regular treatmentsdirection the back had been turned
on and a quest-road started". Former-employees of alternative doctor J.A.M.
Koonen's healthcenter 'de Grens' in Millingen aan de Rijn, according to the IGZ-report, "have
observed that when Sylvia Millecam medio June 2000 in the Antoni van Leeuwenhoek hospital
had heard that she had cancer, she regularly had contact by telephone with alternative
doctor J.A.M. Koonen". Judgement IGZ in the IGZ-report: For the doctors,
plastic surgeon J.B.B. van Tetering, general-surgeon A. J. (Kennemer Gasthuis hospital in
Haarlem), prof. S.M., dr. van der W. (AZVU hospital in Amsterdam) and dr. E.TJ.Th. Rutgers
(Antoni van Leeuwenhoek Hospital) "applies that they have handled in accordance
with the professional applied standards. There is no reason to have criticism on that. It
is also not plausible that the offer out of the regular medicine was the breaking-point
regarding to the choosen therapy-direction" by Sylvia Millecam. A follow-up
consult with Emiel Rutgers Sylvia Millecam refuses. She would want to be treated in
Switzerland.
--
THE EMIEL RUTGERS-EFFECT: IT THREATENS TO GO WRONG
In contrast to earlier, familydoctor Joost Kist, according to the IGZ-report, in the
meantime now did appear to be able to contact the hospital and/or Sylvia Millecam to see
how things worked out for her. After a dealy familydoctor Joost Kist "has taken
care of that Sylvia Millecam received specialistic care. First in the Kennemer Gasthuis in
Haarlem, then in the VU-hospital and next in the Antoni van Leeuwenhoek Hospital. From out
of the hospital the familydoctor heard that patient did not want to start the suggested
treatment. It then became clear to Joost Kist that it threatened to go wrong. He has
called patient several times to urge her to be treated. He estimates that he at leats has
undertaken thirty attempts to get contact with her. At a certain moment Sylvia Millecam
made known do not appreciate his pressure", thus the IGZ-raport, it become more
and more clear to familydoctor Joost Kist "that regular medicine was avoided".
Jan Willem Nienhuys / quackbusters foundation Skepsis (March 2004, 'Millecam (bis)',
magazine Skepter 17 (1)): "Who in traffic is caught on speeding, or driving
under the influence of, gets punished, even if no accident has happened. Why does a doctor
caught with an electro-acupuncturemachine go scotfree ?".
# - Dutch quackbuster foundation Skepsis "No
cancer but a bacterium" (Skepter 14 (3 ), September 2001 ): "Soon
appeared that she already in september 1999 had a lump in her chest, and that she in the
spring of 2000 in the Kennemer Gasthuis hospital, and then after that in may in the Antoni
van Leeuwenhoek hospital had gotten the news that the tumour was already so big that
operating without previous chemotherapry was not possible. She rejected that..".
# - In the IGZ-report a transcript is stated from the
Dutch Tv-programme 'Rondom 10' (6 september 2001, bco NCRV) in which salttherapist Cees
Boegem declares: "Sylvia Millecam has unfortunately run into the wrong
doctor at the Anthoni van Leeuwenhoek Hospital. That is not due to the doctor, that is not
due to Sylvia, those two absolutely didn't suit each other. Yes but he said chemotherapy
and only then I will operate you. If he would have said I operate you, I try to win your
trust and aftter that chemo....".
# - The IGZ-report: On 3 October 2000 Sylvia
Millecam told oncological surgeon Prof. dr. R.I.C. W. in Amsterdam: "that
she has been in the Antoni van Leeuwenhoek hospital, which had resulted in the
treatment-proposal: first chemotherapy, than amputation and after-radiation".
Sylvia Millecam wanted by all means no chemotherapy and consequently ended up in the
alternative circles.
# - The IGZ-report: The alternative-doctor
C.J.M. Broekhuyse in Haarzuilens, who Sylvia Millecam for the first time visited on 12
December 2000, "describes to have heard from Sylvia Millecam that the diagnose
breastcancer was determined and that the regular practitiones did not allow any other
therapy than 'first chemotherapy, followed by operation'. As patient did not wish
chemotherapy, she seeked alternative solutions", "Broekhuyse descibes
that Sylvia Millecam regarding a regular treatment (operation) was in stalemate position.
Broekhuyse: 'Operation on which I repeatedly pressed upon was not possible, because the
surgeon found that according to protocol first chemo had to be applied. Patient did
absolutely not want chemo...". Broekhuyse found the policy of the oncologist in
the AvL hospital, dr. E.TJ.Th. Rutgers, very arbitrary. According to Broekhuyse did Sylvia
Millecam indeed want an operation, but provided without previous chemotherapy.
# - A friend of Sylvia Millecam, Aart Staartjes in the
Dutch Tv-programme 'Barend en Van Dorp' (14-11-2001 ): "Yes, but it went
wrong at another point, look, Sylvia had gone to the hospital, a friend of het, whom she
had told, thus determined cancer and he said go for a second opinion to the Antoni van
Leeuwen hospital, those boys know everything, she went there, they said 'we can operate
it, but than you first must get radiation, otherwise we will not do that', so she found
that a problem, and unnecessary, that ofcourse also happens, that went into her head, that
got into her head and she went on a search, like must radiation really take place".
# - Marlou Boots of Dutch Silicone Supportgroup SVS,
who a small year before her death had a good contact with Sylvia Millecam, in Dutch
magazine 'Party': "Sylvia. was very wrathful about the attitude of the
oncologist, who treated her as a toddler. He refused to operate her. First she had to and
would have to follow chemotherapy, but Sylvia did not want this". and Marlou
Boots in a reaction by telephone (2004 ): "Dr. E.J.Th. Rutgers, an
oncologist and breastcancerspecialist at the Dutch 'Antoni van Leeuwenhoek' hospital / NKI
refused Sylvia Millecam an operation to remove her breastimplant, he wanted chemotherapy
first, which Sylvia did not want, he treated Sylvia as a toddler, Sylvia was furious about
that".
--
THE CERTAINTY OF EMIEL RUTGERS: CHEMOTHERAPY
The refusal of cancerspecialist Emiel Rutgers to remove Sylvia Millecam's breast implants,
by which according to Jomanda "a healing-process" would have started, is
not metioned in the IGZ-report which tries to create a smokescreen around the dealings /
negligence of dr. E.TJ.Th. Rutgers. The IGZ-report: "Dr. Rutgers is an
expert in the area of breastcancer in the Netherlands. He is part of the 'Early Breast
Cancer Trialists Collaborative Group', an authoritative international collaboration of
scientists in the area of breastcancer that does studies since 1987", "Out of
the alternative field there has been criticism about the attitude in the hospitals in this
crucial stage. This attitude / act would have been too stiff and impesonal by which one
would have more or less driven Sylvia Millecam 'out of the hospital' and thus cut of the
road to a regular treatment. This criticism is contradicted by the facts",
"Further there is criticism, which aims mainly at dr. Rutgers, as he would have had a
(too) stiff attitude concerning the to be followed treatment ('first chemotherapy and only
then surgery'). Not has appeared that dr. Rutgers has given patient Millecam exclusively
this choice".
In case of the appeal of the Dutch quackbusters ass. VTDK / foundation Skepsis against the
decision (October 2006 - see further) of the Dutch Public Prosecution Office (OM) to not
prosecute Jomanda, the Dutch Court of Appeal (Gerechtshof Amsterdam) judged (9 April 2008
) that Jomanda still yet had to be prosecuted by the Dutch Public Prosecution Office (OM),
because Jomanda and two alternative doctors (Broekhuyse and Koonen) "fell
seriously short in meeting their care-duty". The Three would have said to Sylvia
Millecam she had no cancer but just only an 'bacterial infection', misleading Sylvia
Millecam, and they would have held back Sylvia Millecam from regular care. According to
the Court of Justice this applied regarding medium Jomanda for "the certainty by
which announcements were made" by which Millecam would have been held back from
regular care. The partner at that time of Sylvia Millecam, Nol Willemsen, pointed out in
the book of journalist Alje Kamphuis about Sylvia Millecam ('Sylvia Millecam: op gevoel',
2006, pg. 149 ) that oncological surgeon Emiel Rutgers "for sure and certain
advised chemotherapy as only option". Nol Willemsen: "It was
immediately clear for Sylvia that she did not want that" (Dutch newspaper
Volkskrant, 'Syl made this choice aware', 29-12-2001 ). The IGZ-report: "Yet
Dr. Rutgers finds sure and certain that it always is useful to undergo chemotherapy".
According to Sylvia's mother Sylvia Millecam, her only daughter, had visited all hospitals
in Amsterdam. In all hospitals Sylvia was told that the only chance on healing was
chemotherapy.
--
CHEMOTHERAPY ? SYLVIA MILLECAM "NO" !
Nol Willemsen in 2008 stated in Dutch Tv-programme 'De Wandeling' (31-10-2008, bco KRO)
about Sylvia Millecam choice not wanting chemotherapy: "That was clear from
day 1 that she did not want that". No doubt about it. Sylvia Millecam did not
want chemo due to great fear for an early menopause, fear of being chronicly tired
afterwards and because she doubted is this would extend her life, and because her father
had died in 1997 of an inflammation which regular medicine by accident thought was cancer,
and he died of the treatment. There were also other bad experience with regular medicine
with friends and in the family. Mother of Sylvia: "No, because Sylvia
herself did not want chemotherapy. That she already knew for certain from the beginning.
She had experienced good friends whom did get chemo but still after three months died, and
yet also then having lost their voice and their hair and their appetite. She found it
terrible if she would die like that, she still had many plans, but was also very
religious. She did not have the feeling that death really meant the end" (Dutch
newspaper 'Trouw', Interview, by Eveline Brandt, 21-02-2004 ). Dutch newspaper 'NRC
Handelsblad': "That Sylvia Millecam knocked on the door of alternative
healers, come forward out of a fear for chemotherapy. The actrice saw chemotherapy as a
disease on its own. Millecam's grandmother and the grandmother's sister also had
breastcancer. The sister underwent chemotherapy and died two years later. Her grandmother
refused this and lived another ten years" (NRC, by Anneke Polak, 7 February 2006
).
--
SYLVIA MILLECAM: EXPLANTATION
Thus in May 2000 Jomanda advised Sylvia Millecam to let her silicone breast implants be
taken out. Oncological surgeon Emiel Rutgers refused, he first wanted chemotherapy.
JOMANDA: "if that mess was to be taken out, a healing process owould have
started. Sylvia did want to, but one of the doctors in the hospital said: `no, first
chemotherapy, that is obliged.' Sylvia thought then: Just like at my fathers certainly?!
With him they also thought that he had cancer, but that proved to be later an
inflammation. And that became his death. Because they did not want operate Sylvia, she has
angrily walked away. Thus, who has been in neglect ? The regular doctors have withholded
her an operation. They have put her in her bare shirt. I have never said to her that she
had not to take the chemo. Personally I am against chemo, but much more people are"
(Dutch newspaper Algemeen Dagblad, 24 december 2004, 'Jomanda and the death of Sylvia, by
Alard Besse)
REMOVAL BREASTIMPLANTS IMPROVES HEALTH DRAMATICALLY
(Aziz NM, Vasey FB, et al. Comparison of clinical status among women retaining or removing
gel breast implants, Presented at the annual meeting of the American College of
Epidemiology,1998 )
http://www.center4research.org/qna12.html
http://www.breastimplantinfo.org/what_know/if_implant_breaks.html
EXPLANT STORY: SYMPTOMS IMMEDIATELY DISAPPEAR
http://www.toxicbreastimplants.org/explant.htm
BREASTIMPLANT-STUDIES: ELIMINATING DATA EXPLANTS
http://www.humanticsfoundation.com/implantdilemma.htm
LEAKING IMPLANT / BREASTCANCER: COMPLETE RECOVERY
Unless the implants are removed from the body, such patients will have a continuing
downhill course: "An overall body detoxification process developed by Lee
Cowden, M.D. of Dallas, TX of Texas has brought about complete recovery from at least one
lady who suffered from a combination of breast cancer and silicone tetramer leakage",
as interviewed by Stephen B. Edelson, M.D. http://www.freewebs.com/implants/siliconearthritis.htm
IMPLANT INCREASE, EXPLANT DECREASE CANCER RISK
(Campbell A, Brautbar N, Vojdani A., Toxicol Ind Health. 1994 May-Jun;10(3 ):149-54
) "Our findings show a marked significant increase in previously suppressed
natural killer (NK) cell activity in 50% of the patients. In the other 50%, no change or
suppressed NK activity was observed. These findings are compatible with recent studies in
experimental animals, which show that administration of silicone reduces natural killer
cell activity, and that this is reversible upon removal of the silicone. Since NK cells
are important in the control of tumour cell growth, we propose here that patients with
reduced NK cell activity are at a higher risk of developing cancer, a concept recently
described in experimental animals (Potter et al., 1994; Salhon et al., 1994 )" http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=7855864&dopt=Abstract
REMOVAL IMPLANTS: IMPROVEMENT
In 1994 a study found that 72% of 33 women who underwent implant removal
experienced significant improvement in numerous silicone-associated symptoms within 22
months (Seminars in Arthritis and Rheumatology 24:1 Suppl 1, August 1994, 22-28. )
REMOVAL: DRAMATIC IMPROVEMENT
In 1994 Doctors (University of California, Davis School of Medicine) reported that
for a woman with debilitating multisystem sarcoidosis (multiorgan granulomas ) "her
clinical condition dramatically improved," after her silicone implants were removed.
(International Archives of Allergy and Immunology 105:4, December 1994, 404-407 ).
REMOVAL: SCLERODERMA RESOLVED
Dermatologists (Medical University of South Carolina at Charleston) reported that when a
woman with scleroderma had her implants removed "the scleroderma gradually
resolved." (Archives of Dermatology 126:9, September 199 , 1198-1202 )
REMOVAL: IMPROVEMENT HEALTH
In January 1995 Doctors (University of Alabama) found that 72% of 142 women said
their implants caused a variety of symptoms. 50% of the women reported improvement in
their health problems when the implants were removed (Annals of Plastic Surgery 34:1, Jan.
1995, 1-6. ).
REMOVAL: REVERSING SYMPTOMS
In 1995 a study concluded: "In vivo and in vitro studies, case
reports and population studies show that: Silicone is immunogenic, biodegradable and
transported to distant location. Silicone brast implants leak and in turn silicone
migrates outside the breast tissue. These immunological abnormalities and symptoms are
reversible upon removal of the breast implants in 50-70% of cases". (Brautbar,
Campbell, Vojdani, University of Southrn California, Journal Biomater Sci Polym Ed 1995;
7(2 ):133-45 ).
EXPLANTATION: IMPROVEMENT
End 1995 a study found that 70% of 300 woman with implants and musculoskeletal complaints
who had explantation reported "improvement in their systemic symptomatology"
(Clinical Rheumatology 14:6, November 1995, 667-672 ).
WOMEN GETTING BETTER AFTER EXPLANTATION
"A recently released medical study conducted by some renowned plastic surgeons
gives further evidence of a link between silicone breast implants and autoimmune
disease...(...)...Systemic symptoms were eliminated or improved in 79% of 39 women who
underwent explantation plus capsulectomy. In contrast, 88% of 16 Observation group
patients remained unchanged or worsened. Our data suggests that explantation may be more
effective in relieving connective tissue disease-like symptoms in women who are younger.
Furthermore, a longer duration of implantation may result in a poorer outcome after
explantation" (Woodbridge, N.J., 29 Dec. 1995, PRNewswire). http://www.nnseek.com/e/alt.support.breast-implant/women_getting_better_after_explantation_9865816m.html
REMOVAL: SYMPTOMS DISAPPEAR
"Silicone-associated symptoms go away when implants are removed. Once the implants
are removed, you still need to detoxify the body of silicone residue" (1996,
The Light Party, 'Scientific evidence proves that').
OUTCOME ANALYSIS: 100 WOMEN AFTER EXPLANTATION
"A prospective outcome analysis was conducted on 100 consecutive women who
requested explantation of their silicone gel breast implants...The mean reasons for
explantation were suspected silicone-related health problems, 76%; suspected rupture.
Before explantation 75% of the questionnaire respondees had lost some sensitivity in their
nipples following their breast augmentation. Following explantation there was significant
improvement in nipple sensitivity in 38% of breasts in the 75 respondees... In total of
186 implants were removed. 57% had failed by rupturing or leaking. 42% were colonized by
bacteria...." (Ann Plast Surg. 1997 Jul, 39(1 ):9-19, Peters W, et al.)
http://www.freewebs.com/implants/silicone100.htm
http://p102.ezboard.com/fimplantinformationnetworkfrm7.showMessage?topicID=22.topic
In 1997 Canadian researchers polled 100 women for health changes they experienced
after having their silicone implants removed, after having had the implants for a mean of
12 years. After an average of 2.7 years, 45% of 75 women in this group (those who had lost
nipple sensitivity ) believed, in retrospect, their implants had caused permanent health
problems and 43% were suing the implant manufacturers. Those women who had no previous
signs of autoimmune symptoms responded "most favorably to explantation" as 80%
reported "major improvement" in their symptoms and 93% said they had a
"significantly improved psychological well-being" (Annals of Plastic Surgery
39:1, 1997, 9-19 ).
NEW SYSTEMIC DISEASE "SILICONOSIS"
"A critical review of literature was performed and our case seems to be the first
one reported in Italy. The internist should become familiar with the immunological
disorders related to silicone breast implants, often so marked to require the explantation
of the prostheses to improve symptomatology. However, perhaps due to the leak and
spreading of silicone, the progression to a severe systemic involvement may remain despite
the implant removal". (Iannello S; Belfiore Istituto di Medicina, Minerva Med,
89:117-30, 1998 Apr..) http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=9676177&dopt=Abstract
POST EXPLANTATION: IMPROVEMENT
"In this cohort of symptomatic breast implant recipients, disease amelioration
following explantation provides additional supportive evidence for the existence of a
novel illness triggered by silicone gel-filled devices. The demonstrated improvement of
systemic phenomena following implant removal was more likely to occur if these devices
were in place for less than 12 years..." {Arthur E. Brawer, 1 June 2000,
Journal of Nutri. & Environm. Medicine, Vol.10, Nr.2 ).
--
SYLVIA MILLECAM: THE MOVIE
# - In a women with silicone breastimplants a 13 cm
long uncommon tumour was found, centered within the breast and protruded into the lung,
thorax and ribs: "tumours centered primarily within the breast tissue may
arise from the fibrous capsule that develops around silicone implants". This was
reported in the November 1995 publication of the American College of Chest Physicians. Dr.
R.C.W. Vermeulen and Prof. H.R. Scholte: "Women with silicone
breastprothesis often have complaints of serious pain and chronic fatique. At leaking of
the prothesis, an increase of the symptoms of pain and fatique are found"
(Silicone Implant Complaints, Journal of Rheumatology 2003: 30: l O, Rupture of Silicone
Gel Breast Implants and Symptoms of Pain and Fatigue).
On 23 November 2000 the tumour of Sylvia Millecam was greater than 10 cm. On 5 December
2000 the tumour from the muscle had a size of 15x10cm. In March/April 2001 Sylvia Millecam
swollowed 12 tablets paracetamol a day due to serious pain. In May 2001 (Millingen a/d
Rijn) there was a matter of leaking skin and fluid came out of the swollen rightbreast of
Sylvia Millecam. In the summer of 2001 the rightbreast was three times as big as the left.
Sylvia Millecam had serious pain day and night and didn't sleep anymore of the pain. The
breast was so painful that she had to support it when walking. Sylvia Millecam at a
certain moment couldn't go to the toilet on her own anymore and when talking she had to
gasp for breath after every second sentence. The family doctor J.K. visited Sylvia
Millecam in Millingen a/d Rijn on 14 August 2001 and J.K. declared in the IGZ-report dat
when he saw Sylvia Millecam it seemed: "as if I stepped into a movie".
At Sylvia Millecam a fast pulse was observed and at percussion, to hear whether internal
organs are healthy, there was a robust dim of the right-thoraxhalf. Familydoctor J.K. told
Sylvia Millecam she did not have long to live. On Friday 17 August 2001 Sylvia Millecam
was admitted in the hospital and the doctors who examined her told Sylvia Millecam:
"You have just yet a few weeks to live". A few days later Sylvia Millecam
died.
--
EMIEL RUTGERS: HERO IN HEALTHCARE
The ghost Emiel Rutgers ? In September 2004 Dutch Institute for Study of Healthcare
(NIVEL) did a study at the Consumer-panel Healthcare into the public trust in healthcare:
"The regular professiongroups enjoys great many faith. In familydoctors and
specialists 91,5 percent and 91,4 percent put many or great many trust in" (Dutch
magazine 'Zorgvisie', 8, August 2005, 'Doctors still enjoy respect'). Remarkable is that
the 'media-signals' after the death of Sylvia Millecam does not anywhere dispute, talk
about, the role and dealings --in an evenso equal treatment as Jomanda-- of oncological
surgeon breastcancerspecialist dr. E.TJ.Th. Rutgers of the Antoni van Leeuwenhoek
Hospital. Or at least mention something about it, because going towards the media-reports
about the case Sylvia Millecam the millions peoples could almost start to 'belief' that
Emiel Rutgers doesn't even exist at all. A ghost surrounded by a smoke-screen ? And if the
Antoni van Leeuwenhoek Hospital did come into the news in the case Millecam, it was then
the alternative-critical-words of e.g. Dutch quackbusters ass. VTDK-boardmember Frits van
Dam and/or -supporter prof. Piet Borst, or:
# - ""I do not want to call myself a
hero", sais Emiel Rutgers. Yet he himself points out that the succesful innovations
as the mammateam that he put up together with colleages , in important degree are
dependent on his involvement, the knowledge and the capability to work together...."
(Source: 'Politiek-digitaal', May 2004, Interview with Emiel Rutgers http://www.politiek-digitaal.nl/belgen/held_in_de_zorg-_interview_met_emiel_rutgers
)
# - and (29-08-2007 ): "Dr. E.J.Th.
Rutgers (1955 ) is appointed to remarkable professor surgery oncology, especially the
diagnosis and the treatment of the mastectomies, to the faculty of Medicine of the
University of Amsterdam (AMC-UvA). The chair has been established due to the Netherlands
Cancerinstitute 'Antoni van Leeuwenhoek' Hospital (NKI-AvL)....". http://www.nki.nl/Ziekenhuis/Nieuws/Archief/2007/Emiel+Rutgers+bijzonder+hoogleraar.htm
--
IGZ-REPORT: MISLEADING THE PEOPLES ?
In the IGZ-investigation, during an inquiry conversation between Jomanda and the IGZ, a
Jomanda conducted miracle had come to word. About a patient with serious back-problems
(lesion) who after a Jomanda-treatment had stood up out of the wheelchair. A during that
Jomanda-IGZ-hearing present doctor replied: "I know you are telling the
truth, because that was my patient" (Dutch newspaper 'Algemeen Dagblad', Jomanda
and the death of Sylvia, 24 December 2004, Allard Besse http://www.gatago.org/nl/politiek/5571900.html
). According to Jomanda's former partner Paul van Loon the lesion-patient was someone out
of the circle of friends of IGZ Inspector general Herre Kingma or of his familymembers and
hence Kingma's personal rancour, thus Jomanda's Belgium support and shield. This
Jomanda-miracle, which would have shined a complete different daylight on Jomanda's
treatment of Sylvia Millecam, is also Hippocratical not mentioned in the IGZ-report. In
negligence of duty, bringing harm upon (the psyches of) millions of people ?
--
DUTCH MINISTER OF HEALTHCARE: HANS HOOGERVORST
Formally the Dutch Minister of Health is responsible for the activities of the Dutch
Healthinspection IGZ. Dutch Parliament can call the Minister on this. Dutch Minister (from
2003-2007 ) of Health VWS Drs. J.F. Hans Hoogervorst (VVD-party) has done very little in
the Millecam / Jomanda-case, besides stating in the media that homeopathy is just
non-working water: "courageous" remarks for which Hoogervorst in
2004 received an award from the Dutch quackbuster foundation Skepsis, while Director
Innovation, Profession and Ethics drs. Nico C. Oudendijk (the present replacing
Inspector-general of the IGZ) on behalf of Dutch Health minister Hoogervorst stated and
wrote in a letter(02-02-2004 ): "The Dutch Healthministry VWS doesn't want
to encourage nor promote the use of alternative medicine and holds about that a neutral
point of view". Drs. Nico C. Oudendijk on behalf of the Health-minister also
stated in the letter that a request for hearing the other side in the case of Jomanda
could not be honoured: "It is not the task of the Ministry of Healthcare to
mix in such discussions". While the previous minister of Healthcare Els Borst,
after the Millecam/Jomanda-debate in 2001 in the Dutch Second Chamber of Parliament, had
said in reference to a new approach of the Dutch Healthinspection IGZ that she had made
harsh agreements with Inspector-general Herre Kingma about Jomanda, and Minister
Hoogervorst in his speech for the Royal Dutch Medical Association (KNMG) during the
KNMG-conference 'Arts and Openness' on 11 March 2004 at Rotterdam about the theme
'openness' remarked: "I think that you agree with me when I say that
openness is an indispensable instrument for increasing the quality of healthcare".
With in mind the priciples of decent Government, Article 22 of the Dutch Constitution, and
with what was stated in the IGZ-report towards the alternative practitioners: "according
to the manual Mr. D.Hazewinkel-Surenga's study of Dutch criminal law, a life-offence, or
agression-offence, can also be perpetrated by negligence, dereliction of duty, when there
is a certain care-duty", a future-question in mind could be for the (potential)
Jomanda-visitors who decided in the past around the Sylvia Millecam/Jomanda case on basis
of negative media (NOVA) / IGZ-report Jomanda-imageforming not to visit Jomanda (anymore):
How much does a missed (change on) healing and/or (public)health-improvement cost, and who
had been responsible and liable ? Drs. Nico C. Oudendijk on behalf of Dutch Health
Minister Hoogervorst stated in another letter (15 july 2004, reference: IBE/BO-2500197 )
with reference, in answer to a registred letter (18 April 2004 ) that he "saw no
ground for a damageclaim" because he "never prohibited the Dutch peoples
to visit Jomanda nor did he withold the peoples information about Jomanda". The
truth about Jomanda and her miracles must not have crossed his mind, which could save
millions in euro's and in suffering in healthcare by a much cheaper and safer
treatment-method ?
--
COMPLAINT-LETTER TO HERRE KINGMA
In August 2004 a '(com)plaint Jomanda'-letter was
written to Inspecteur-general prof. dr. J.H. (Herre) Kingma, with copies send to the Dutch
Second Chamber of Parliament party Green Left / Femke Halsema, the Dutch National
Ombudsman / mr. M.M.S. Mekel and the Dutch Ministry of Health, Minister Hoogervorst / drs.
Nico C. Oudendijk. A (com)plaint because of Kingma's handlings concerning Jomanda. On the
complant-letter no single reaction came from the IGZ. Consequently an orientation
complaint was send, by means of a registred letter, to the Dutch Ministry of Justice (3
September 2004 ) again concerning Herre Kingma's Jomanda/Millecam IGZ-report with a
request for elucidation from the ministry on the complaint. As appeared from a letter
(27-09-2004 ) of the Minister of Justice, on behalf of him, head Bureau Legal and
Policysupporting Matters H.Ph.M., the complaint was, without any critical comments
regarding content, put aside and passed and send on to the Dutch Ministry of Health. On
behalf of the Dutch minister of Health, director Innovation, Profession and Ethics, drs.
Nico C. Oudendijk (the present replacing Inspector-general of the IGZ) on his turn passed
the complaint-letter on, as appeared from a Health-ministry-letter (16-11-2004 ) again
back to the Dutch healthinspection IGZ, where it all had started to begin with, for
'handling regarding the content'. On 23-12-2004 a letter was received from J.R.J. Mineur,
employee legal matters of the Dutch Healthinspection IGZ, with the announcement of receipt
of the complaint-letter to the Ministry of Justice, which, so was written, via the
Ministry had been send to P.A.W. Edgar (IGZ Headinspector curative somatic care) for
handling 'regarding content'. With in the back of the mind the sharp criticism of the
Dutch Commission Hans Pont (2004 ) on the Dutch Health inspectorate IGZ ---an IGZ
workingatmosphere of distrust, threats and intimidation--- eventually another Dutch
Healthinspection IGZ legal-employee, mr. Barbara A. Prins stated by letter (4 February
2005 ) among others: "The Dutch healthinspection does not have a prejudiced
view about non-regular(alternative medicine", "Asfar
non-regular(alternative)medicine and regular medicine are not incompatible they can to the
judgement of the IGZ offer complementary possibilities which the patient seeks", "The
IGZ finds the allegation as would the Inspector-general incite to hate, discrimination and
verbal violence very serious", "Might you express yourself further
publicly about Inspector-General Herre Kingma, than the Dutch Healthinspection has every
right to consider further legal measures". The justification for publication of
personal (medical) information in detail in the IGZ-report about Sylvia Millecam was
according to the IGZ found in a 'higher' cause: the general interest of the case.
The justification for the (com)plaint-letter, based on reality, to Inspecteur-general
prof. dr. J.H. (Herre) Kingma was rather also found in a 'higher' cause: the
general public interest of the case-Jomanda/Millecam:
# - Unreal fear for alternative-, Jomanda-medicine
(Jomanda-phobia) must not be encouraged.
# - Not turning account to all the posibilities which
the present standard of alternative- / Jomanda-medicine offers is reproachable,
blame-able.
# - It seems that the choice for not choosing
Jomanda-medicine to a great extent was / is influenced by wrong recommendations and
unfounded judgements about Jomanda.
# - In 2003 Herre Kingma was the most influential
person (a guru?) in Dutch healthcare according to magazine Medical Today. Herre Kingma
found Jomanda "dangerous" and her treatment-method "perilous"
for patientS (with emphasis on the plural). Dutch study (1995 ) of the bureau for
marketresearch Trendbox: 46% of the Dutch find Jomanda 'appealling'. Study
(05-01-2006 ) of Dutch 'De Vos en Jansen' Marketresearch: 13,6% of the Dutch
believe in medium Jomanda (Mediacourant). "Once she was the most popular woman of
the Netherlands. But anno 2006 we think at the name of Sylvia Millecam mainly about
quacks" (Dutch newspaper Parool, 04-02-2006, 'For Sylvia this was not necessary',
Bart van Zoelen ). Dutch Foundation for innovative study and education complementair
medicine (IOCOB http://www.iocob.nl ) in 2007: "Our
thinking in the Netherlands about alternative medicine and cancer is fairly influenced by
one case, Sylvia M.. Again and again mentioned and used to point out how terrible and
dangerous alternative treatments can be at cancer". Besides NOVA, the IGZ-report
resulted in an even more escalating effect in the social Jomanda-debate. It was obvious
that it was Herre Kingma & Co.'s intention ---due to / under the influence of the
Dutch quackbuster ass. VTDK / a regular beliefconviction--- to punish Jomanda, to change
her behaviour, to silence / suppress her / her liveconviction and treatment-method. It is
thereby clear that NOVA / IGZ-report was meant to cultivate the public at which also in
reasonableness could be expected that the denounced negative imageforming Jomanda-remarks,
aimed against issues of ideological nature, would be considered for further spreading.
Awarely, as in reasonableness and fairess could be presumed seen the position NOVA /
Kingma holds in society, this considerable chance has been accepted by NOVA / Kingma which
point to conditional intention: well-conscious taking a great risk on errors /
consequences, also those which one primary would not have wanted. Whether or not errors /
consequences are the result, are not at issue. This judgement is strengthened by the
circumstance that Herre Kingma ---who personally presented the IGZ-report to the
Netherlands in the newsprogramme NOS journal and to the world on the internet--- had to
have been aware of the effect of 'media-signals' since the IGZ-report was just put
together, according to Herre Kingma himself, based on 'media-signals / news'. Thus knowing
(knowledge-part), being informed that behaviour (choices) could lead to victims and taking
this knowledge into bargain at publication / broadcasting. And this judgement of
conditional intention is also strengthened by the circumstance that NOVA / Kingma in no
way at all has taken distanced from the Jomanda-remarks or rectify on the moment that
complete different conclusions became known at NOVA / IGZ. The Dutch Minister of Health
Hans Hoogervorst recognised that many people use alternative medicine, and found (Dutch
Parliament, 12 August 2004 ) the percentage of Dutch people who have visited Jomanda "considerable":
a population group. Did Herre Kingma & Co. withhold Dutch public health a cheaper and
safer treatment-method (Jomanda) ? Are the peoples of the Netherlands financial and
physical disadvantaged by Herre Kingma & Co. ? Have they been brought harm upon ? "The
arguments to not acknowledge non-conventional medicine on scientific grounds are
oversimplified, partially rendered out of date and paradigm-determined. Withholding this
acknowledgment leads to damage to patients" (Dutch magazine for Healthlaw
'Tijdschrift voor Gezondheidsrecht', 2003, Nr. 8: p. 539-541, by A.L.B. Rutten,
'Alternative Medicine and the evaluation of Law-BIG').
As in contradiction to Herre Kingma's IGZ belief / report:
# - Jomanda's way of acting, method is not perilous.
# - Jomanda does not know (most of her) her visitors
(full halls, mass healings).
# - Diagnosis proposition by Jomanda is unrealistic.
# - Jomanda interferes herself with 'Cause-Nosis'.
# - Jomanda recommends to fight causes, and as a
result prevents consequences (diagnoses).
# - Jomanda has no 'guru position' and does not want
that also.
# - Jomanda does not interfere intrusively with
visitors.
# - Jomanda's judgement is not unimpeachable. people
have their own will and choice freedom.
# - Jomanda leaves visitors in that/their choice and
as a result in their value.
# - Jomanda does not play for doctor. Jomanda is a
psychic healing medium.
# - Jomanda's provided care is experienced by
thousands as healing: physically and mentally, which saves euro's and suffering in regular
medicine.
# - Dutch Alternative medicine: "ROLE
OF THE GOVERNMENT: Back to the basic, article 22 of Dutch constitution, can be posed that
the Dutch government within the available financial possiblities has an task to take
measures which protect the health and has an effort-obligation for the quality for what is
offered, and for the attainableness and accessibility of healthcareprovisions in
geographic and financial manner. This in global terms described government-responsibility
reaches out to the entire field of healthcare, regular and non-regular, proven or
unproven" (Source: Letter from Dutch Statesecretary of Health ministry, H. J.
Simons (labour PVDA-party) to the Chairman of the Dutch Second Chamber, 1992-1993, 23 158,
nr. 1, 17 May 1993 ).
# - Dr. Jessica Utts (University Californie), who
worked on the US-government sponsered Stargate-project, after research (1973, 1989,
between 1992 en 1994 ) concluded about gifts of mediums (anomalous cognition), that "It
is clear to this author that anomalous cognition is possible and has been demonstrated.
This conclusion is not based on belief, but rather on commonly accepted scientific
criteria".
# - Princeton University's Princeton Engineering
Anomalies Research (PEAR) laboratory Manager Brenda Dunne: "The collective
scientific evidence supporting phenomena such as those demonstrated by Jomanda and others
is sufficiently robust that the term "paranormal" is now inappropriate. Only
when we ourselves accept them as "normal" will we succeed in communicating their
relevance to others who are more skeptical".
# - Rick van der Ploeg, professor economics at the
Robert Schuman Centre of the European University Institute in Florence, former financial
spokesman for the Dutch Second Chamber-party PVDA and former statesecretary Ministry of
Education, Culture and Science OCW: "The death of Sylvia Millecam lead on
the other hand to a call for discrimination of non-qualified 'doctors'" (Bert
Bakker, 2004, http://www.iue.it/Personal/RickvanderPloeg/Agenda%20for%20Europe.PDF
).
# - In a column ('First believing, than seeing', 2004
) of professor Sander Bais ---a commissionmember of the Dutch newspaper 'de Volkskrant'
bèta-canoncommission of which also the present Dutch minister of Education, Culture and
Science and supporter and member of the Advice-Council of the Dutch quackbuster ass. VTDK,
Ronald Plasterk, is a commissionmember of--- Sander Bais writes a.o. the following:
"And it happened in those days in Valkenburg (ZL) that Jomanda spoke again
!...(...)...She does not do business with the Public Prosecution Mystery. She cannot be
blamed, she just passes through messages. The medium as a soul-saving transfer-point.
Befehl ist befehl. Ich habe es nicht gewusst. Indeed, she cannot be blamed...(...)...About
her plans exist little doubt. In Valkenburg she first takes pity over the famous object of
interest "Little Lourdes" once the alternative healingresort for the less
fortuned who weren't given it to be transported in long Lourdes-trains to the true resort
to there see the miracles with own eyes, and not seldom cause of the hardships too find a
blessed death..." http://staff.science.uva.nl/~bais/bres/Jomanda.pdf
--
HERRE KINGMA: FLEEING ?
Cardiologist Herre Kingma was appointed Inspector General of the Dutch Healthcare
Inspection IGZ in 2000. Herre Kingma is for many years member of the Dutch quackbusters
ass. VTDK while Dutch Minister Remkes of Home Affairs in 2004 in the Dutch First Chamber
of Parliament proclaimed about the IGZ and the Jomanda/Millecam case: "The
Inspections each heave a legal task, I underline that thereby the independency of the
Inspections is important". Herre Kingma, who in this function refused for 5 years
to investigate socalled medical errors, resigned at the Dutch Healthinspection IGZ in January 2006 to become the new chairman of the management
board of one of the largest non-acedemic hospitals in the Netherlands, the 'Medisch
Spectrum Twente' (MST), after praising words about his IGZ-functioning, -deeds in a
goodbye-speech of Dutch Health minister Hans Hoogervorst who also presented Herre Kingma
with a Royal decoration, Officer of the Order of Orange-Nassau for his deeds as Inspector
General of the Dutch Healthcare Inspection.
--
NO PROSECUTION JOMANDA
On 03-10-2006 the Dutch Public Justice Department
decided not to prosecute Jomanda and 4 other alternative practitioners for the death of
Sylvia Millecam. They all went scot-free. According to the Public Prosecution Office (OM)
there were insufficient / no indications found in her extensive investigation, in which
among others it had heard several witnesses and consulted different experts, that the 5
alternative practitioners: -(1 )- had kept Sylvia Millecam away from regular
medicine, -(2 )- had acted with intent or in neglect, by which Sylvia Millecam's
health damaged or harmed, -(3 )- had influenced / directed Sylvia Millecam's choice
(no chemotherapy, sceptical towards regular medicine, treatment by alternative
practitioners). The OM posed that it was not proven that "Jomanda has said that
Sylvia Millecam had no cancer" and thus that there was no matter of disadvantaged
/ negative influence. The blame of the suffering and the early death lay pure at the own
choice of Sylvia Millecam. IGZ (former) inspector Menso Westerouen van Meeteren, who at
that time investigated the case Millecam, called the decision of the Dutch
justicedepartment (OM) non satisfactory and "botch-work".
--
CRITICISM ON IGZ
HOSPITAL SCANDAL: MEDICAL ERRORS
The Dutch national Ombudsman once had fierce criticism on the Dutch Inspection IGZ
concerning a scandal around the hospital Eemland in Dutch city Amersfoort where since 1994
due to medical error possible seven infants and three adults had died. The IGZ reacted /
acted too late, despite several 'disturbing signals' about very serious problems on the
departments midwifery and gynaecology of the hospital. Laxness. The National Ombudsman:
"Thereby the inspection-service has insufficiently given meaning to her role as
independent supervisor on the quality of healthcare" http://www.ombudsman.nl/rapporten_db/rapport.asp?rapportnummer=19970580
IGZ NOT WORKING CORRECT
The General Chamber of Auditors / Netherlands Court of Audit found in their report
(04-02-1999 ), after a study into the supervision at the Dutch Healthinspection IGZ on
public health, that the Dutch Healthinspection IGZ did not do her work properly. http://www.rekenkamer.nl/cgi-bin/as.cgi/0282000/c/start/file=/9282301/modules/glln63zd?layout=print
IGZ: FAILING MANAGEMENT, DISRESPECT
Also the appointment of prof.dr. J. Herre Kingma at the Dutch Healthinspection IGZ in 2000
did not make the criticism go away. A Dutch Commission Pont (2004, Hans Pont) had scharp
criticism on the Dutch Inspection of Health IGZ: The internal organisation of the
IGZ was characterised by failing management, bad internal communication, little respect of
higher placed employees for the lower employees, and a workingatmosphere of distrust,
threats and intimidation. An IGZ-workscouncil was instituted, which asked the highest
official of the Ministry of healthcare (VWS) for a IGZ-crisismanager who "had to
do what Herre Kingma neglected to do", thus the Dutch radio-programme 'De
Ochtenden' on 16 December 2005 reported looking back at the inheritance of Herre Kingma as
he was about to depart the IGZ. End 2004 the director Innovation, Profession and Ethics of
the Dutch Ministry of Healthcare, drs. Nico C. Oudendijk, became the new crisismanager and
Headinspector Product safety at the Dutch Healthinspection IGZ. On 1 July 2005 the IGZ
Inspector Advertisement-Supervision, Astrid Meij, resigned because, according to her, the
IGZ-supervision on the farmaceutical industry falls short, is lacking. The renewed Dutch
Health inspection IGZ, after the departure of Herre Kingma in January 2006, mentioned (17-10-2006 ) not to appeal the decision of Public Justice
Department (OM) to not prosecute the alternative practitioners and Jomanda.
--
QUACKBUSTERS APPEAL DECISION JOMANDA
While the Dutch quackbuster ass. 'Vereniging tegen de Kwakzalverij' (VTDK) in 2001 had
seen a light by stating "adopting a reserved position" about the tragic
death of Sylvia Millecam, on 4 December 2006 they
suddenly experienced another light. VTDK, together with former IGZ-inspector Menso
Westerouen van Meeteren who's aspiration was publicly supported by Herre Kingma, decided
to appeal at, write a letter of complaint to the Amsterdam Court of Justice against the
decision of the Public Prosecution Office (OM). With a so-called article-12-procedure VTDK
wanted to enforce and make the Public Prosecution Office to afterall prosecute a.o.
Jomanda. VTDK: "There was no talk of a resolute and consistent choice for
non-regular treatment, up to and including June 2000 Sylvia Millecam choose just for
regular treatment". Rather, in reality in September 1999 Sylvia Millecam visited
alternative-doctor J.A.M. Koonen in Millingen aan de Rijn and in May 2000 Sylvia Millecam
consulted Jomanda. The friend of Jomanda and Sylvia Millecam, Dutch actrice Wieteke van
Dort, said in Dutch newspaper 'de Volkskrant' ('Choice', 24-09-2001 ): "Sylvia
Millecam was an intelligent woman who knew very well what she wanted. 'If necessary I want
to die of a sickness, but not from the treatment of it', were her own words. Cancer or no
cancer, that questions is not the issue. Sylvia wanted no regular treatment. And that I
have heard out of her own mouth, a month before she died".
--
QUACKBUSTERS.....BIG PHARMA APPEAL DECISION JOMANDA ?
Frits van Dam, psychologist of the Dutch Antoni van Leeuwenhoek hospital / Dutch Cancer
Institute (AvL/NKI) and secretary of VTDK (21-10-2008 ): "VTDK is often
suspected of receiving money from the farmaceutical industry. That is not true. We are an
independent association of concerned but unpaid volunteers...(...)...Thus I can assure
everyone, VTDK does not receive a cent from the farmaceutical industry or from which
commercial organisation what so ever. She does not also want that. VTDK attaches so very
strongly to her independency that she in a matter of speech rather go bankrupt that loose
her independency. The problem is mainly that the alternative practitioners and their
supporters can not imagine that VTDK exists out of people who sincerely are worried about
what quacks cause and who unpaid want to do something about that".
--
PHARMACY DE GREIDEN
The present domain-name of Dutch quackbusters VTDK http://www.kwakzalverij.nl
stands on name of chairman C.N.M. Renckens at adres Jister 17 -19 in Dutch city
Heerenveen. This is the same adres as of the one-man business, pharmacy 'de Greiden' in
Heerenveen http://www.apotheek-degreiden.nl
, established in 1997, which was driven and prolonged by Harry de Vries, chemist and
druggist and the former secretary of VTDK, into managementcompany 'H. de Vries Beheer BV'
(BV = private company) founded in 1989 with as a companydescription "the investing of
capital, buying, selling, renting and letting and exploiting of real estate". Under
'H. de Vries Beheer BV' fell / fall: (A) Hairanalyses Netherlands BV (making
hairanalyses, advising of patients / clients and delevering vitamins and/or
mineral-preparations), (B) Happy Trading BV (im- and export trade-goods, trade-activities
national and international), (C) Happy Air BV (exploiting and letting aircrafts), (D)
Happy Yachting BV (chartering of sailyachts, buying and selling of yachts and parts,
requirements, im- and export of yachts and belongings) and (E) pharmacy 'De Greiden B.V'
(the practising of the pharmacology-art / pharmacy).
--
MEDIVEEN GROUP
The correspondence-adress of Pharmacy 'De Greiden' (Postbus 2450, 3500GL) is also the
adres of headbusiness Mediveen Group Netherlands BV: a chain of 223 pharmacies
spread over the Netherlands http://www.mediveen.nl
'Mediveen Groep Netherlands BV' is part of 'Mediveen Group BV'. Under Mediveen Group BV is
a.o. mentioned the Coöperative Servicepharmacy Midden-Brabant UA with as a
correspondenceadres: 'Jan Heijnsstraat 10A' and adres 'Lage Witsiebaan 2A' in Dutch
city Tilburg. On the adres 'Lage Witsiebaan 2A' was to be found / is to be found a.o.
Foundation Homecare-shop Midden-Brabant, Coöperative Careunion South U.A, Foundation
Caregroup West- and Midden-Brabant, Coöperation Familydoctorposts Midden Brabant U.A.,
Foundation Supporting ANW Familydoctorcare Midden-Brabant. The neighbours of these
organizations (at 'Lage Witsiebaan 2B') were / are: Foundation Careinterest
Brabant, the Provincal Patient/Consumer Platform North-Brabant (PPCP-NB) and the Regional
Patient/Consumer Platform Middle-Brabant (RPCP-MB).
--
IATROSOPHY: DOES (THE) HISTORY REPEAT ITSSELF ?
On 5 August 1993 Dutch Tv-programme NOVA made a report about the disputed naturopathy
iatrosofie with interviews with I.A. van der Graaff of VTDK and with H. Plokker, inspector
Dutch Public-healthcare IGZ, about the number of victims and the legal problems which
stand a prohibitation of the alternative medicine iatrosophy in the way. Also in reference
to the death of a girl from Tilburg after treatment, the iatrosophy came accordingly
negatively big in the media: Blameable death ? Obsessed looking for healing ?
Lawgiver lets medical charlatans be ? Dangerous pseudo-science practices ? Money-swindle ?
A sect-like movement under leadership of a guru ? Family doctor and employee of the
healthservice of the Dutch political Socialistic Party, Henk van Gerven, in Dutch
newspaper Trouw (17-08-1993 ): "It is a shame that alternative medicine in
contrast to normal medicine can be put on the market without registration and judgement on
effectiveness and safety. Such a screening would be very benefitial to the quality of our
healthcare and save a lot of money". As in the Sylvia Millecam case, due to
'disturbing and alarming news in the media' about complaints about iatrosophy there were
questions asked in the Dutch Second Chamber of Parliament on 17 August 1993. On 20 August
1993 the Dutch Foundation Victims of Non-recognised Alternative Medicine (SNAG) in Dutch
city Tilburg was founded. SNAG was founded in reference to the death of the girl from
Tilburg. The telephone number at that time of SNAG, as registered at the Dutch Chamber of
Commerce, was in january 2002 the same phonenumber as that of the Regional
Patient/Consumer Platform (RPCP-MB): the neighbours of the Mediveen Group BV.
Questions and complaints RPCP discusses with a.o. the Dutch Inspection for Healthcare IGZ.
--
OPG GROUP
On the postal adres of the Mediveen Group BV (Europalaan 2, 3526KS Utrecht) one also finds
--besides several pharmacies BV's and e.g. Pharma Medical International BV, Foundation
Cooperation Tabletsproduction-- the OPG Group http://www.opggroep.nl
a (whole)saler in manufacturer of medicine, pharmaceutical prepparations, bandagematerial,
medical instruments and devices for pharmacies. Part of OPG Group is Mediveen with as
Operations & Store Director for Mediveen Elmer Meurs.
# - Chairman board of directors OPG: Marc C. van Gelder (President of the
Supervisory Board ACP Pharma),
# - Member board of directors OPG: F.E. Eelkman Rooda (Vice-President of the
Supervisory Board ACP Pharma),
# - Groupdirector OPG: Marcel L.N. van den Broek (Medeco AS Norway),
# - Plenipotentiary OPG: Mohammed N. Bagherpour (Medizinische Fakultät),
# - Chairman board of commissioners OPG: Jan F. van Duijne (Board of
Commissioner of company TenneT, electricitymarket in the Netherlands and in
North-west-Europe, daughtercompanies: APX Spotmarket bv APX UK Shareholder: The Dutch
State),
# - Commissioner OPG: Sibrandus C. Huibers (Director 'Intergamma BV',
President commissioner Euroteco),
# - Commissioner OPG: Willem M. van den Goorbergh (Board(member) Association
AEGON, deputy chairman Board of Directors Dutch bank Rabobank Netherlands, Bank Dutch
Communities (Nederlandse Gemeenten), Welten, Radboud University Nijmegen and the 'Nexus
Instituut' -> Chairman Dutch quackbuster foundation Skepsis (1998 - 2004 ) Simon J.
Doorman, Participant Nexus-institute),
# - Commissioner OPG: Paula Swenker (member of Dutch VVD-party of the First
Chamber of Parliament, independent chairman of the Ambulance-care Netherlands, independent
chairman of N.V.A. (Dutch Association for brokers in Insurances and Insurance-advisers),
hospitaldirector, director Care of 'Careinsurers Netherlands' (Zorgverzekeraars Nederland:
a association which serves the interests of all care-insurers with as chairman former
VVD-party politician Hans Wiegel http://www.zn.nl ).
--
ORTHOMOLECULAR THERAPY
Orthomolecular therapy, also called orthomolecular medicine, is an alternative medicine.
'AOV Orthomoleculare Nutritionsupplements BV' is in the business of developing and
distributing nutrition-supplements http://www.aov.nl Prof.
Willem Betz is considered to be an international authority concerning the critical
approach of alternative medicine. He is Head of the Education for general practitioner to
the Free University Brussels (VUB) and is president and general secretary of Quackbuster
organization SKEPP in Belgium. Prof. Willem Betz: "Paying yourself bleu on
nutritionsuplements is what really hurts. Claiming that nutritionsuplements an sich could
be useful and would decrease all kinds of pain, does not only do violence to the truth but
it also misleads the consumer. And that contains risks". Willem Betz speaks of
quackery and "the supplement-mafia". Wholesalers to which AOV delivers
are among others the OPG Group: at the adres of Mediveen Group c.q. pharmacy 'De
Greiden' c.q. Harry de Vries, the former secretary of Dutch quackbusters ass. VTDK.
VTDK-chairman Cees Renckens against quackery ? "Criticism VTDK also has on the
unbridled advertisment for medicine and therapies on the internet. Chairman Cees Renckens:
'That is against the professional code. Take for example the orthomolecular wholesale.
They earn a lot of money with the sale of complete unneeded vitamins. On their site you
find a list of recommended doctors who use the socalled non-toxic tumour-therapy. It is
about half failed persons, but how must the patient know that'..." (Dutch
newspaper 'Provinciale Zeeuwse Courant', 12-10-2000, by Rens Koldenhof, 'Every fool can
quack anything on the internet' http://rparticles.kobala.nl/aproxy.php?id=419105
).
--
DUTCH MINISTRY OF HEALTHCARE
In 2005 medicine-seller OPG Group brought out an offer to the shares Orfe S.A.: a
pharmaceutical distribution-organization which also exploits pharmacies in Poland. The
pharmaceutical license-holder (d.d. 01-10-2007 ) for O.P.G. Wholesale B.V.
(registry-number 2948 B/G , 2949 C , 2947 A/D) is the Dutch Ministry of Healthcare. On
European level OPG is part of the International Pharmaceutical Service Organisation.
--
QUACKBUSTERS SKEPSIS "LEGALISED MURDER"
Also Dutch quackbuster foundation Skepsis filed a letter of complaint, received by the
Court of Justice in Amsterdam on 5 December 2006, and
which was supplemented on 12/13 March 2007: "Skepsis finds the doctors Jos
Koonen, René Broekhuijse (in the meantime suspended) and the medium Joke Damman
('Jomanda') rather are responsible for Millecams death....The judge must be able to speak
out about the errors of Koonen and Broekhuijse and Jomanda - otherwise in the Netherlands
there is a matter of legalised murder".
--
INFORMATION AGAINST INSPECTOR MILLECAM-CASE
On 22-12-2006 the renewed Dutch Healthinspection (IGZ)
made information against its own (former) inspector, Menso Westerouen van Meeteren, who
investigated the Millecam case and hooked up with VTDK, for 'possible violation of
official secrecy'. Current Dutch health Headinspector Gerrit Van der Wal would have 'great
objections' against VTDK's and Skepsis's article 12-procedure. A legal battle followed.
Menso Westerouen van Meeteren, who in the Millecam-case had spoken to all involved, was
angry, and he saw the handling of the inspection (IGZ) and the Dutch justice department
(OM) as an attempt to eliminate him as a trial-party. In his written-defence he spoke of "Stasi-methods':
an underground deal between governmentbodies against a critical loner". He didn't
understand the way things were going: "Was the inspection not for many
years in the opinion that Jomanda and associates had to be prosecuted ?".
Westerouen van Meeteren: "The absolutism of which alternative practitioners
sometimes make use of, is shocking. Jomanda hides behind the voice of God". Dutch
NOS Text-tv (7 October 2005 ) and Dutch Tv-programme 'NOVA' (11 October 2005 ): "Bush
acts under instruction of God": President Bush had to attack Afghanistan and Iraq by
order of God. Also God had told him that he must help at the foundation of a state for the
Palestinians Bush would have said that during a meeting with the Palestinian president
Abbas in 2003....
--
MINISTER: MOTIVE ARTICLE-12-PROCEDURE MISSING
Again some political pressure and support followed. Member of the Second Chamber of Dutch
parliament Agnes Kant of the Socialistic Party (SP) decided to ask questions in the Second
Chamber (18 July 2007 ) to the (new) Minister of
Healthcare Klink about the case Sylvia Millecam: Why didn't the Dutch Public
Justice department (OM) institute prosecution against among others Jomanda ? Why does the
(present / new) IGZ co-operate in the decision in the past from the Public Justice
department not to among others prosecute Jomanda ? Dutch Minister Klink answered: "Not
the question into the dislike of mrs. Millecam for regular care has been the central issue
in the legal investigation, but the question whether a causal link could be shown between
the handlings or negligence of the practitioners and eventual negative consequences from
that...(...)...Furthermore in criminal law there are heavy demands operative concerning
evidence". In short: 'Evidence-Based'. Minister Klink found the decision not to
prosecute and the decision of the IGZ to not appeal that decision just: "The
IGZ does not have any reason to presume that the decisive proces of the Public Justice
department (OM) would not have been careful. Every motive for a article 12 procedure was
missing". On 6 September 2001 already was known that: "The Public
Justice Department (OM) sais in a reaction not to see sufficient motive for an
investigation. Accoring to a spokesman of the Justice Department alone the statement of
Jomanda that Sylvia Millecam did not have cancer, is unsufficient reason for
prosecution" (Dutch newspaper 'NRC Handelsblad', ''Medical lawyer P.A.M.M.
Dingemans wants that Justice Department prosecutes Jomanda').
--
ARTICLE-12 COURT MILLECAM-HEARING
But not everyone could find themselves and accept the decisions of, ánd the Public
Justice department (OM), ánd the (present / new) IGZ, ánd Dutch Minister Klink of
Healthcare, to find it not necessary to prosecute Jomanda. With (again) a tsunami of
docile 'disturbing and alarming' media-news as a consequence, two days before a
court-hearing concerning the Article-12 procedure would take place: "Judge
must give a judgement about Jomanda: former inspector wants prosecution practitioners of
Sylvia Millecam", "Prosecute Jomanda afterall", "Prosecution demanded
for death Millecam", "Skepsis wants to prosecute Jomanda for death
Millecam".
--
THE STAR-STATUS OF WESTEROUEN VAN MEETEREN
On 30 November 2007 a court-session took place. The
court heared the involved parties about the written-complaints of quackbusters VTDK and
Skepsis. While Dutch newspaper 'Volkskrant' on 26 September 2007 had reported "The
Dutch Public Justice department (OM) will not prosecute former-inspector Menso Westerouen
van Meeteren for violation of his office-secrecy in the case- Sylvia Millecam....That
battle is in the past: the former-inspector has after a conversation with the Inspection
withdrawn his complaints" and Dutch broadcast organisation 'Omroep Brabant' on 29
November 2007 stated: "Westerouen van Meeteren has himself sat in the
accused bench, but in september became known that justice department has dismissed this
case", odd and wierd that IGZ (former) inspector Westerouen van Meeteren
consequently was presented at this Millecam-hearing as a star ---according to Skepsis's
Jan Willem Nienhuys--- to after all give way to his complaints. Had there been something
or somebody in Westerouen van Meeteren's surroundings which had talked him over /
influenced him ? Like something or somebody in Westerouen van Meeteren's surroundings had
talked him over to publish the IGZ-report on the internet since this had been socalled
against Westerouen van Meeteren own liking, willing and choice ? The IGZ-report: "In
Dutch Tv-programme 'NOVA' (dd 1 September 2001 ) dr. Emiel Rutgers calls it criminal that
patient was presented that there was no case of cancer. He himself means that he is quoted
too close by NOVA. The suggestion is aroused that patient had 90% chance on complete
healing, when she would have been treated by regular medicine. He has expressed himself
much more differentiated, but the NOVA recording has not been broadcasted integral /
completely. If his suggested treatment would have taken place immediately, the chance on
local-healing hould have been 80-90%". Jomanda's legal adviser proclaimed in the
Millecam-hearing that the wrong impression was aroused by the cutting and editing in NOVA.
Jomanda had expressed herself "much more differentiated, but the NOVA recording
has not been broadcasted integral / completely". Thus a consistent IGZ / surgeon
oncologist Dr. E. Rutgers ?
--
JOMANDA YET PROSECUTED IN CASE-MILLECAM
On 9 April 2008 the Dutch Court of Justice in
Amsterdam spoke out its verdict concerning the Article-12 appeal-procedure of VTDK and
Skepsis. http://zoeken.rechtspraak.nl/resultpage.aspx?snelzoeken=true&searchtype=ljn&ljn=BC9170&u_ljn=BC9170
The Dutch Public Prosecution Office (OM), which in October 2006 had decided to not
proscute, had according to the Court of Justice to still yet prosecute medium Jomanda and
two alternative doctors (J.A.M. Koonen from Millingen and C.J.M. Broekhuyse) afterall in
reference to the death of Sylvia Millecam. Since the (lighter) offence of culpable
homicide becomes barred after 6 years, the Court now spoke of 'serious abuse' which barres
less quick. The two doctors and Jomanda according to the Court would be guilty of
(intentionally) bringing serious harm upon Sylvia Millecam (max. imprisonment 10 years)
and of having mislead (false hope) individual Sylvia Millecam: "No cancer, but
an bacterial infection" (NOVA). This while the two alternative doctors earlier had
received letters from the IGZ. To Jos Koonen the IGZ wrote: "In the opinion
of the Inspection you have not been uncarefull concerning the treatment of Sylvia
Millecam, in the sense that you have aroused false expectations. In case of treatment of
patient I consider my meddling with you ended". And to Dr. Broekhuyse the IGZ
wrote: "The direct reference for the visit formed the question whether you
have kept away mrs. Millecam, who has been under your treatment, from contacts with
regular practitioners or that you have supported her in the view that she did not need to
seek help for her disease at regular practitioners. For none of the two matters the
Inspection has been able to find indications. The above means that the Inspection on this
moment does not find further meddling with your functioning really necessary".
--
CONTRADICTING REGULAR DIAGNOSIS: PUNISHABLE BY LAW ?
Ina M. from Dutch city Vlissingen in 1987 visited a doctor because of a little knob in her
breast. Photo's were made. The doctor assured her that it was good-natured. In 1991 Ina M.
noticed that one breast changed. After reference to the Dutch Dijkzigt-hospital in
Rotterdam an operation followed to an evil tumour and treatment with chemotherapy based on
the exact same photo's, as the first good-natured diagnosis. The Dutch inspector of
Healthcare IGZ adviced Ina M. to file a complaint to the Medical Board. This was denied.
Eventually Ina M.'s presence in Tv-programmes ('alarming-media-signals') had lead to an
agreement between the parties (source: Dutch 'Dossier weerwerk', 03-03-1993; bco RVU,
Harmke Pijpers).
--
OFFERING FALSE HOPE: PUNISHABLE BY LAW ?
The Court of Justice also argued in the verdict that patients who suffer a (potential)
life-threathening disease would be fairly urged to stand open for anything that offers
(false) hope and to trust those who poses healing in prospect. Oncological surgeon Emiel
Rutgers said in the NOVA-broadcasting of 1 September 2001 concerning Sylvia Millecam:
"Doing nothing: 100% wrong, only an operation: 50% wrong, operation and radiation:
20% wrong, operation, radiation and chemotherapy: less than 10%". In Dutch
Tv-programme 'I miss you' (28-08-2007, bco EO) attention for the story of the 1-year old
baby Fleur Hobers at whom after medical examination a tumour is discovered. Fleur received
chemotherapy in the Dutch hospital UMCG in Groningen. The mother: "It was
as if she thought, when I co-operate, than it will soon be over". The treatments
stopped before the last chemo, because on the scans everything seemed clean. Fleur was
allowed to go home and the family experienced a great time together. But in June 2005 a
little know is discovered on Fleurs forehead: the cancer is back and Fleur dies. The
Oncology Times (Vol. XXVIII, No. 17, 10 September 2006, Charlene Laino) reported: "Patients
facing death from cancer are willing to undergo chemotherapy for much smaller improvements
in outcome than would health care providers, a systematic review of the literature
spanning two decades and multiple continents has found....", another article
states "...Gofman (from the Manhattan Project that developed the first nuclear
bomb) has shown that over 70% of the cases of breast cancer are due to 'medical x-rays'.
Small wonder that over 70% of the Oncologists that were polled said that they would not
use chemo therapy on themselves or their own family...", and in another article
becomes clear that '75% of physicians would refuse chemotherapy themselves': "The
great lack of trust is evident even amongst doctors. Polls and questionnaires show that
three doctors out of four (75 per cent) would refuse any chemotherapy because of its
ineffectiveness against the disease and its devastating effects on the entire human
organism. This is what many doctors and scientists have to say about
chemotherapy:"The majority of the cancer patients in this country die because of
chemotherapy, which does not cure breast, colon or lung cancer. This has been documented
for over a decade and nevertheless doctors still utilize chemotherapy to fight these
tumours." (Allen Levin, MD, UCSF, "The Healing of Cancer", Marcus Books,
1990 )....".
http://www.curenaturalicancro.nl/artsen-zelf-geen-chemotherapie.html
http://www.niburu.nl/index.php?showarticle.php?articleID=16490
--
NOT GIVING FULL INFORMATION: PUNISHABLE BY LAW ?
Also Jomanda according to the verdict of the Court of Justice on 9 April 2008 Jomanda
would not have "full and complete informed" Sylvia Millecam. Cancer
patients, lost in a maze of uneven care: "The first doctor gave her six
months to live. The second and third said chemotherapy would buy more time, but surgery
would not. A fourth offered to operate. Karen Pasqualetto had just given birth to her
first child last July when doctors discovered she had colon cancer. She was only 35, and
the disease had already spread to her liver. The months she had hoped to spend getting to
know her new daughter were hijacked by illness, fear and a desperate quest to survive. For
the past year, she and her relatives have felt lost, fending for themselves in a daunting
medical landscape in which they struggle to make sense of conflicting advice as they race
against time in hopes of saving her life..." (By Denise Grady, The New York
Times, 29 July 2007, http://www.nytimes.com/2007/07/29/health/29Cancer.html
)
--
JAN WILLEM NIENHUYS CONCERNED FOR THE LIVING
Quackbusters Skepsis's Jan Willem Nienhuys: "A great deal of people have a
extreme lively fantasy. They can very well tell stories on parties or they become
novelwriter. Some people just have their hands on the keyboard and the sentences come
rolling out. If you then also yet loose the difference between reality and fantasy, you
become Jomanda" (magazine Online, opinion E-zine, 3rd yr., nr3, 1999 ). Jan
Willem Nienhuys ---who describes Jomanda as a "fantasy-inclined personality" and
who believes that nobody "is psychological so strong that he is unsensitive
for" 'influential' appreciation--- said in Dutch current affairs Tv-programme
'Een Vandaag' (bco TROS, 10 April 2008 ) regarding the verdict of the Court of Justice on
9 April 2008, while not being able to keep his grin of his face, being as happy as a
little child to hear that a.o Jomanda would possibly be prosecuted: "It is
for us not about that single patient that has died, it is for us about the violation of
the legal-order, that any quack just can treat people with the death as consequence, and
that nobody is doing something about that, we are concerned for the living so that that
same will not happen to them".
# - Dutch Tv-programme 'Brandpunt' (29-08-1993; bco
KRO): "Report from van Peter Tetteroo about a pathologist in Birmingham,
who several times wrongly established bone-cancer by which several patients, among who
many children, unjustly underwent radio- and chemotherapy or were operated. Interview with
a.o. the Dutch Inspectorate of Public Health".
# - Falsely diagnosed with cancer and died of chemo:
"A recent article in the Miami Herald reports that a jury awarded the family of a
women who was diagnosed with and treated for cancer when she never had the disease. The
woman died from the side effects of her chemotherapy treatment..." http://www.newstarget.com/008836.html
# - I was given chemo for cancer I never had: "I
was given chemo for cancer I never had": sound like a nightmare? For one woman, it
was a terrifying reality. Here's how she and three other women got their bodies and their
health back after being misdiagnosed...(...)...From my hospital bed one night, I watched a
woman named Jennifer Rufer on ABC Primetime talking about how she had been falsely
diagnosed with cancer--and she'd been given the same blood test I had! My doctors argued
with me when I asked to stop treatment four weeks later, but I knew my gut that I didn't
have cancer. A few weeks after I stopped--about nine months after the whole ordeal
started--I was strong enough to drive a from my home in Pennsylvania to Memorial
Sloan-Kettering in New York City, one of the best cancer hospitals in the country. I got
thoroughly tested and found out that there was no cancer in my body, and there probably
never had been...." (Marie Claire, 1 October 2003, Shanti Sosienski http://www.accessmylibrary.com/coms2/summary_0286-24465527_ITM
)
# - Forcing chemo-therapy on 12 year old children:
"We didn't know that when we took our child to the hospital that that we would
lose our right to decide what is best for our child", Parker Jensen: "They're
trying to kill me with chemicals"
http://www.patriotsaints.com/MyChildMyChoice/cases/ParkerJensen/
http://www.cbsnews.com/stories/2003/08/27/health/main570305.shtml
# - Forcing chemo on child: child dies: "Dominik:
The True Story" http://www4.dr-rath-foundation.org/THE_FOUNDATION/true_story_dominik.html
# - State-sponsered medical terrorism: ""Kidnapping
13-Year old and forcing chemotherapy against her will" http://www.newstarget.com/016387.html
--
KEEPING PEOPLE AWAY FROM MEDICINE: PUNISHABLE BY LAW ?
Also according to the Court of Justice Jomanda would have kept Sylvia Millecam away from
regular care. This while Jomanda refered Sylvia Millecam in first instance to have her
silicone breast implants taken out by regular medicine and there being witnesses who have
heard Jomanda lateron refering Sylvia Millecam to regular doctors, and while it is
publicly known, as thousands of Jomanda visitors could testify (anecdotes) and as noted
down in past Jomanda-publications ('media-signals'), that Jomanda on her healings always
sais to "not exclude doctors": logical and rational reasoning
since Jomanda for 30 years has been calling out (also in the media) for co-operation
between alternative- and regular medicine. Since Sylvia Millecam had visited Jomanda long
before 1999 and seen the girlfriend link with Jomanda, it can be assumed that Sylvia
Millecam in 2000 was aware, informed and knowledgable of the Jomanda-vision,
lifeconviction a.o.: "co-operating with doctors / regular medicine".
Dutch parliament, Second Chamber: "Furthermore out of several studies
---Realizable-research substitution-effects alternative medicine, Netherlands Institute
for Health Care Research, NIVEL http://www.nivel.nl
1991. pg. 22 and CBS, monthly report, Healthstatistics May 1992--- it comes forward that
patients who use alternative medicine in general certainly do not turn their back on
regular medicine; they appear to make use of regular care at least as often as those who
do not use alternative medicine" ((Questions of parliamentmembers Laning-Boersema
(CDA-party) and Van Otterloo (PVDA-party) about iatrosofic healers, with on that answers
by the government by minister Hirsch Ballin (Justice), also on behalf of the
statesecretary of Healthcare 4 October 1993 )). Moreover seen the Jomanda rule, guiding
principle in the Jomanda-vision, lifeconviction "what you sow, you shall yourself
harvests" ---as spoken out by Jomanda to thousands of Jomanda-visitors and as
documented in media-publications and Jomanda books--- Jomanda therefore, however,
realistic and rationally seen, would be crazy, very stupid or ill in the head to use,
apply her paranormal gifts in a wrong manner. For example for personal use, (financial)
advantage, misleading people, disadvantageous-, aproachable influence or causing damage to
other peoples health.
--
MODERN CRUSADE ON JOMANDA BASED ON BELIEF-CONVICTION
The secretary of the Dutch quackbusters ass. VTDK, Frits van Dam, pledged for a
profession-prohibition. When not possible, the law had to be changed, thus Frits van Dam.
In the case of Jomanda which profession ? Jomanda has a 'free profession' for which there
is (inter)nationally no unambiguous defenition. But if a judge would pose a future
profession-prohibition on Jomanda, would that mean that the profession 'healing medium'
receives a (legal) status of recognition ? Jomanda is being stamped as the person who
so-called had played thé crucial role in the choice of Sylvia Millecam to not be treated
(by regular medicine) and thus Jomanda would be jointly responsible for Sylvia Millecam's
death. If medium Jomanda had made an (medical) error about Sylvia Millecam's diagnosis
than that would imply that medium Jomanda's paranormal gifts are not-working correctly.
Reverse burden of proof: Where is the scientific research from which can be
concluded that Jomanda's paranormal gifts do not function correctly ? If one does not have
such a research, than at first one can never make judgement that Jomanda made an error,
because one does not know at all whether or not Jomanda's paranormal gifts work correctly,
because one has nothing concrete in hand only in the fantasy. Was the IGZ-report careful
prepared and sufficiently motivated ? Did one have the possesion during the
decisionmaking-proces over sufficient knowledge regarding to content of Jomanda and her
medicine, her healings, her life-conviction and did one put this to the test as regard to
scientific sources ? Or were the socalled 'criminal facts' between the ears of the IGZ ?
Without study into Jomanda's paranormal gifts, without walking around discovering of her
world, claiming that Jomanda's paranormal gifts have made a mistake, points to a ('earth
is flat') prejudice, a presumed belief-conviction. By having no research in hand about
Jomanda's paranormal gifts that implies secondly that one (Herre Kingma & Co.) in the
Netherlands wants to prosecute people based on a believeconviction. A crusade against
Jomanda ! Was Herre Kingma 'negative influenced' by the media ? Would Herre Kingma &
Co. have had no notion and awareness of reality, that 'the' media often help some
half-truths and lies into the world ? Did Herre Kingma belief blind wat others (the media)
put in front of him ? Or did Herre Kingma, as a true IGZ-employee in exercising his duty
and as a Hippocratical physician ('evidence-based'), just because he indeed realised this,
started the Jomanda investigation to get the truth on the table of the Netherlands about
Jomanda, in line with Jomanda's strong wish for 30 years ?
--
PRO-FORMA MILLECAM HEARING SESSIONS
The Sylvia Millecam saga, the pro-claimed belief of the wanted prosecution of Jomanda
---not wanted and not at all to the liking of the mother of Sylvia Millecam to whom Sylvia
Millecam told everything and shared everything with but who hasn't been heard in the IGZ
investigation--- continues to this present day with lawsuit-hearings (pro-forma) about the
Millecam/Jomanda-case on 30 October and 13 November 2008. With as a consequence, the media again
obstinate bleeting that Jomanda would have advised Sylvia Millecam to socalled avoid /
ignore regular medical care and would have dissuaded chemotherapy, while the former
partner of Sylvia Millecam, Nol Willemsen, several times, has stated: "It
was immediately clear for Sylvia that she did not want that".
--
CEES RECNKENS: UNBELIEVABLE IMPUDENCE
The Dutch current affairs Tv-programme 'Netwerk' (29-10-2008, bco NCRV) paid attention,
the evening before the first pro-forma-court-session in Amsterdam, to the case Sylvia
Millecam, again repeating parts of the NOVA-broadcasting of 1 September 2001. In 'Netwerk'
Dutch quackbusters ass. VTDK-chairman Cees Renckens said: "Sylvia Millecam
is dead and now Jomanda must explain why she has done that, on which grounds she has meant
to be able to say that it was no breastcancer for example, is yet of an unbelievable
impudence". Can Cees Reckens explain what his colleague oncological surgeon Emiel
Rutgers has done ? According to Cees Renckens in 'Netwerk' Jomanda would have known
somebody with a magnetfield-therapy. But rather in reality the adress of the clinic in
Swiss, where Sylvia Millecam underwent magnetfieldtherapy in summer 2000, Sylvia Millecam
had gotten from a Dutch doctor. Not from Jomanda. Cees Renckens further believed in
'Netwerk' that Jomanda would have said to Sylvia Millecam it would be aright. Jomanda said
in NOVA (1 September 2001 ) as included in the IGZ-report): "At a certain
moment I did get alarm-situations. That I have also mentioned. With that something clearly
was done. But at a certain moment I did get yet the feeling there is fluid, something is
not okay. That I have also mentioned" (to Sylvia Millecam). In June or July 2001
Jomanda had a conversation with the partner of Sylvia Millecam, Nol Willemsen. Jomanda had
a restless 'feeling' and was worried. Sylvia looked bad and Jomanda dit not trust Sylvia's
cough. Jomanda said to Sylvia Millecam that it was not going well with her. Jomanda was
afraid that it would go wrong, and Jomanda thought of cancer. And also according to Cees
Renckens in 'Netwerk' Jomanda would have said that Sylvia Millecam didn't need
chemotherapy in a phase that "that Millecam" would have doubts about
treatment-choice......... Cees Renckens further in 'Netwerk' stated to belief that a good
care-provider must advise someone so that his chance of survival is the best. In the case
of Sylvia Millecam:
# - -90%- Belgium quackbusters SKEPP.be:
"Was Sylvia Millecam healed if she had been treated professional ? The
survival-rates for the treatment of not yet disseninated breastcancer are continuesly
getting better and according to the surgeon of the Dutch 'Antoni van Leeuwenhoek' hospital
her chances for healing were more than 90 percent at a combination of operation, radiation
and chemotherapy...." ('The quacks have not been acquited', 2006, By prof.
Wim Betz).
# - -69%- Dutch Cancersociety KWF (2005
): "The survival figures for breastcancer......At the moment the 5-year
survival is 80% and the 10-year survival 69%".
# - -90%- On 6-7-2004 the Dutch Council for
Journalism took a decision about a complaint from the Dutch 'Workinggroup Jomanda to
North-Netherlands' and Jomanda against an article of the chiefeditor of the Dutch
newspaper 'Dagblad van het Noorden' (defender). On 19 February 2004 in the newspaper
'Dagblad van het Noorden' a chief-editoririal comment was published under the title
'Quacks'. The first sentence of the article was: "The actrice Sylvia
Millecam had died from breastcancer because she had too much faith in alternative medicine
and the faithhealer Jomanda". The article ended with the following phrase:
"Who makes a nonsense diagnosis and with that by fact rides patient to the death,
makes itsself guilty of quackery..". Thus, according to the Council for
Journalism in their judgement of the complaint, "the impression is being aroused
at the reader that Jomanda has by fact driven Millecam to death". The direct
cause, the crank up, the incitement for this insulting phrase, according to the Council, "Jomanda
became again subject of discussion after the appearance of the report of the Dutch
healthinspection" The report made up by initiator Herre Kingma. The view of the
defending chief-editor, as justification for his article, as mentioned in the Council's
verdict, was a.o.: "According to defender the Dutch Healthinspection had
the view tha Millecam would still be alive, or at least would have had a fair chance, if
she had not turned away from regular care", "Defender points out a quote
of H. Kingma of the inspection in Dutch newspaper 'De Volkskrant' of 21-02-2004: 'She
(Millecam) surely in the early beginning had more than 90 percent chance on healing. That
road has been cut off by complete unjust comforting words out of the alternative corner'.
Kingma has according to the defender after the appearance of the report about the
case-Millecam consistently spoken out in this sense and thereby he has joined the
article". http://www.rvdj.nl/2004/58
# - -70%- Dutch quackbusters ass. boardmember
Frits van Dam: "Alternative cancertreatments fight the fear, not the
cancer...(...)...On average more than 50% of the cancerpatients die to their disease. That
is on average, because the course of the disease differs strongly, dependent of the
specific diagnosis and the stage of the tumour. Woman with breastcancer have a chance of
70% to become just as old as their genderfellows who have no cancer..." (Dutch
newspaper 'NRC Handelsblad', 3 July 1999, and quackbusters ass. VTDK, 17-02-2002,
'Cancertherapies').
# - -90%- Dutch quackbusters Skepsis, Jan
Willem Nienhuys: "...When Sylvia Millecam quickly went downhill in the last
three weeks and of closeness, pain and oedema could noy lay, sit, swollow, sleep or stand
she was friday brought to the Radboud hospital in Nijmegen. There the doctors could just
only determine that she had at most two more weeks to live. Who chooses a certain early
death above chemotherapy and a fairly certain healing (more than 90 percent certain for
the combination of operation, radiation and chemo) had that freedom....AvL-surgeon E.
Rutgers in Nova of 1 september about inflammations and Jomanda's nonsense-story..."
('No cancer but a inflammation', Magazine Skepter 14(3 ), September 2001 )
# - -50%- Dutch newspaper 'De Gelderlander' (23-08-2001,
'Sylvia refused regular medication'): "Sylvia Millecam did not want regular
treatment, despite the 50 percent chance on healing which the doctors had calculated for
her". Dutch newspaper 'Brabants Dagblad' (23-08-2001, 'Sylvia knew exactly how
sick she was'): "Chemotherapy and/or an operation would offer 50 percent
chance on healing. The actrice choose emphatic for an alternative treatment".
--
A BUNCH OF QUACKS
In Dutch newspaper 'Algemeen Dagblad' (31-08-2001 ) Dutch psychiatrist Rigo van Meer asked
himself how an intelligent sparkling woman, as Sylvia Millecam, could have let herself be
fooled by a bunch of quacks. But put in a more realistic perspective: How an
intelligent sparkling Netherlands were and are fooled by a bunch of quacks ? Herre Kingma,
at that time director R&D Cardiology of the Dutch 'St. Antonius' hospital in
Nieuwegein, was in the beginning of the years '90 Dutch research-leader concerning the
medicine Captopril (Capoten): "suitable to offer patients with heartattack a
greater survivalchance" for which the venom of a snake, the Brazilian arrowhead
Amazonian viper (jararaca), is used (bio-piracy?). In 2006 was reported that "The
drugs, including captopril and lisinopril, can cause bone abnormalities in the skull,
inhibition of growth and kidney damage that can kill the fetus or newborn",
"Even though captopril came on the market 25 years ago, until now there was hardly
any information on the effect of taking ACE inhibitors in the first trimester, and they
were thought to be safe" (New York Defective Drugs Lawyer, 09 June 2006, Denise
A. Rubin) http://www.citizen.org/documents/rdmyths.pdf
, http://newyorkcity.injuryboard.com/defective-drugs/
On Herre Kingma's name there are several Captopril publications and studies (CATS) among
others financed by Bristol-Myers Squibb: a big manufacturer of breastimplants. A
Dutch practice for Alternative Medicine (23-08-2004, 9:43:49 ): "The case
Millecam --the true background of her death (silicone-implants) is known by the
physicians-- is intentionally by the media and the involved Ministry ripped out of context
c.q. placed in a negative daylight. This because there are large financial interests c.q.
relative balance of power at stake". The Millecam-case will be contential dealt
with in the summer of 2009. A question that could rise
is whether for example VTDK-chairman Cees Renckens, oncologist Dr. E.J.Th. Rutgers,
Inspector-general Herre Kingma, inspector Menso Westerouen van Meeteren would put a
product into their own bodies which has never been tested on humans, and of which the
safety has never been shown by the manufacturers and studies have shown that this product
or medicine causes cancer in mice and dogs ? In the Sylvia Millecam-case, the Dutch
Healthinspection IGZ's inspector-general prof.dr. J. Herre Kingma, inspector Menso
Westerouen van Meeteren, the Dutch quackbusters ass. VTDK (Cees Renckens, Frits van Dam)
and foundation Skepsis (Jan Willem Nienhuys), Dutch media and politicians, seemed and seem
only tunnel-visioned interested in the crucifiction of medium Jomanda, while they
Hippocratical and peoples-representing passive and silent ignored and still ignore
SILICONE-GATE.
(To be completed and continued.......)
--
SILICONE-GATE
DOW CORNING: SILICONE
Silicone are not found in nature. End 1800 by
Professor F.S. Kipping (Nottingham University) silicone was invented: a long, flexable
polymer of silicon, oxygen, and carbon, made of itsself repeating molecules. One does not
know exactly what to practical do with it, so it remains many years a
laboratorium-curiousity. Since the late 1800's,
individuals have injected or implanted foreign substances into a woman's body to augment
or reconstruct their breasts. "Upon the medicinal properties of silica in cancer,
fibroid tumours and diabetes" (Battye, R. F., 1874, Edinburgh Medical Journal. 20:
420-435 ). The eat known augmentative implant was in 1895
attempted in Germany by Dr. Vincenz Czerny, using a woman's own adipose tissue. But the
body tends to quickly reabsorb the fat. The procedure falls out of favor by the 1940s.
Around 1900 a number of other substances were tried,
including ivory, glass balls, ground rubber, ox cartilage and Terylene wool.
Experimentation with paraffin injections began in 1889,
developed by Austrian surgeon Dr. Robert O. Gersuny ('Ueber eine Subcutane Prothese', Z
Heilkunde, 9:1, 1900 ) who injected it into the scrotum of a young man to replace resected
testicles. Gersuny' procedure was extended to injections for breast enlargement. Paraffin
injections were very popular during 1900-1914. In 1902, H. Eckstein ('Ueber Subcutane und
Submukose Harkparaffinprothesen', Dtsch Med Wochenschr 28:573, 190223 ) made report of the
disadvantages and complications: infection, hardening of the breast and tumour-like lumps.
The technique is abandoned by the 1920s. In 1930
silicone is commercially developed by Frank Hyde (Coming Glass Works in a workrelation
with the Dow Chemical Company (Dow-Corning Corporation)). On 26 February 1971 James Hyde
of Dow Corning received one of chemistry's highest awards for his major (research) role in
developing a versatile family of synthetic substances: the silicones, used in airplanes
and kitchens, delicate surgery and astronauts' spacesuits and a wide variety of other
products. Begin 1940's silicone is being used as
lubricant and refrigerant in the industry. The largest manufacturer of silicone prothesis
is the Amercian company Dow Corning, a world leader in the area of silicone-based
materials: and a joint venture during WOII in 1943
of Corning Glass Works and Dow Chemical Company (mothercompany), where the much talked
about pharmacologist and chemist Alexander Shulgin in 1960 begun his career with human
experiments / research into many chemical substances on its psycho-active efficacy. Goal
of the joint venture ? Development and production of silicone (silicone polymers) for
military use. Plastic surgery arose during WWII cause of the many warcasualties in a.o.
England. At the end of World War II, when the military contracts expired, silicone was a
product without a market. Dow Chemical did human toxicological research on silicone for
biomedical applications on behalf of Dow Corning in 1948, and continued this to at least
1959. Dow Corning brought silicone prothesis from 1962-1963
onto the market. Dow Corning Wright is also part of the joint venture between the Dow
Chemical Company and Corning Inc. since 1977. DC Wright --manufacturer of medical devices
(e.g. hip prothesis) and surgery instruments-- was also the marketing arm for the silicone
breast implants (SBI).
HIDDEN HISTORY OF US GERM TESTING
(BBC, 13-02-2006 ) "Fifty years ago, American scientists were in a frantic race to
counter what they saw as the Soviet threat from germ warfare. Biological pathogens they
developed were tested on volunteers from a pacifist church and were also released in
public places. The remarkable story is told in a BBC Radio 4 documentary, Hotel Anthrax...".
http://news.bbc.co.uk/1/hi/programmes/file_on_4/4701196.stm
--
DOW CHEMICAL
Dow Chemical, established in 1897, is the largest international chemical concern in the
world (156 countries) with it's main office in US Midland, Michigan. The vision of the
present Chief Executive Officer (CEO), Mr. Andrew Liveris: "to contribute
to create a better world". http://www.nationmaster.com/encyclopedia/Dow-Chemicals
In 1965 in the Netherlands, in province Zeeland, in
Terneuzen a factory of Dow Chemical was opened by Prins Bernhard. Dow became talked about
during the Vietnam war (1961-1971 ) due to its
production for the US military of chemical weapons: Agent Orange (defoliant) and
napalm (firebombs), with which many (children) were terribly mutilated. Agent Orange
caused chlorine-acne, Hodgkin disease, different kinds of cancer, defamation of the
nerve-system. Agent Orange: "The Chemical Terror of Vietnam". Agent Orange, on
itsself poison, was heavily poluted with dioxin, one of the most poisonous chemicals ever
studied, and dumped above, sprayed out over Vietnam. Millions of liters. Dow and other
manufacturers were aware of the polution, but kept in a secret for the US government. In 1971 Dow Terneuzen in the Netherlands became talked about
because of dumping of substances in and poluting of the Dutch river Westerschelde.
Defoliant by dioxine (agent orange) of Dow Chemical resulted in 1983
in Brasil about 40 deaths and dead cattle. In 1984 a
trial of Vietnam veterans against companies who produced agent orange lead to a
damagecompensation of 180 million dollars. In 1987 the
Dutch Tv-newsjournal 'NOS-Journaal' and Dutch Tv-programme 'Brandpunt' reported that
poison, barrels with chemical waste, was discovered in Dutch town Terneuzen and that Dow
Chemical had admitted to have dumped the poison which lead in 1989
to a National Environment Policy-plan. In 1992 it was
mentioned in the Netherlands that the town Boerengat in the muncipal Terneuzen had to
disappear due to expansion of a factory of Dow Benelux. Als Dutch Tv-programme 'Hier en
Nu' (July 1994; bco NCRV) payed attention to this. In 1996 Dow Chemical the Netherlands received a, by the Dutch
government handed out, certificate for Dow's "modern company-philosofy":
renewel, cleaner prodcution and environmental reporting (Dutch Tv-programme 'Kenmerk', bco
IKON). Greenpeace demostrated in 2003 at the Dow
Chemical in Dutch town Terneuzen regarding the chemical waste, the toxic-disaster in
Bhopal India in 1984 at the Union Carbide Company of owner Dow. In 2003
begins the cleaning of the soil in the Dutch polder at Zaamslag in the province Zeeland:
leaking barrels with chemical waste of Dow Benelux. In the beginning of June 2008 there is a raid by the Dutch Justice Department at
the American chemicalcompany Dow Benelux in Dutch town Terneuzen due to e number of
incidences at which dangerous substances would be exposed.
--
SILICONE TIME LINE
--
SILICON VALLEY & BREAST IMPLANTS
The high-tech region Silicon Valley in Californië is named after the chemical basic
element Silicon (Si). Silica, or the chemical formula SiO 2, is how it is mined from the
earth. Silica is 45% silicon. Silicone gel, used for breast implants, is a synthetic
material containing 38% silicon. Silicon is used as a raw material in the production of
silicone. Silicone is a bond of oxygen and the element Silicon, the basic material for
computerchips. Silicon is in silicone computer chips as in breastimplants.
--
JAPAN
Silicone rubbers were invented in 1945 and used in
airplanes. Despite the lack approval of the Food and Drug Administration (FDA), which must
approve products before coming onto the market, however, doctors experimented with liquid
silicone injections for breast augmentation. American researchers discovered in 1945 that
in Japan free silicone was injected in the breasts of bargirls en pleasure-girls in an
attempt to look more Western and to keep the Americans, stationed in Japan, satisfied
(Hilts and Foreman). The breasts of Japanese women were too small, in American eyes and
belief.
--
DIRTY DOW (VINYL CHLORIDE): DR. VERALD K. ROWE
In 1948 an article 'Toxicological Studies on Certain
Commercial Silicones' (Journal of Industrial Hygiene and Toxicology) about toxicological
research on various silicones, described the dangers surrounding the workplace handling of
silicones. The conclusion was that commercial silicones as a group were physically
"inert" (non-working in the body) and were very low in toxicity. The article
also warned that some types of silicones had certain potential hazards, a risk of physical
harm: irritation, inflammation, edema, necrosis, slowed growth, increase in weight
of certain internal organs, respiratory failure, and death. The article was co-authored by
Dow Chemical, besides H. C. Spencer and S. L. Bass, toxicologist Dr. Verald K. Rowe:
member of the National Academy of Science, National Research Council (1964-1972 ),
assistant Director (1965 ) of the Biochemical Research Laboratory / Chemical Biology
Research, president of the Society of Toxicology SOT (1966-1967 ), member of many
professional societies (e.g. American Chemical Society) and committees (sponsored by the
Environmental Protection Agency and the National Cancer Institute), president of the
American Industrial Hygiene Association (1973-1974 ). Dow Corning had instituted a newly
formed research group, headed by Don Bennett, which housed down the road at Dow Chemical,
called the Biomedical Research Laboratory: "to probe the potential utility
of such silicon chemicals across the broad disciplines of biology, i.e., plant sciences,
microbiology and animal science". Verland K. Rowe had accepted in 1937 a position
in the Biochemical Research Laboratory of the Dow Chemical Company (testing methodologies):
consultant to the Vice President for the Health and Environmental Sciences / Research at
the Dow Chemical Company. Dow Chemical was informed by V.K. Rowe in 1955
that silicone spreads throughout the body, and causes organ damage. In 1973 V.K. Rowe was
Director of Toxicological Affairs of the Health and Environmental Sciences / Research at
the Dow Chemical Company. V.K. Rowe in 1968 had recommened that Dow Corning established a
toxicological laboratory in-house so that they would be able to "know and
understand the physiological properties of all such materials". V.K. Rowe was
(co)author of over 80 scientific publications:
# - '20 percutaneous applications of all silicone
fluids for one month produced no adverse effects' (Rowe, V. K., Spencer, H. C. & Bass,
S. L., 1948, J. industr. Hyg., 30, 332 )
# - Long-term study: rats were kept on a diet of
silicone fluid for two years. "No difference between tests and controls" (Rowe,
V. K. Spencer, H. C. & Bass, S. L., 1950, Arch. industr.Hyg., 1, 539 ) http://www.inchem.org/documents/jecfa/jecmono/v46aje63.htm
VINYL CHLORIDE CONSPIRACIES
According to their own documents http://www.chemicalindustryarchives.org
Dow Chemical and other corporations conspired since the early
1960's to conceal the grave danger that vinyl chloride exposure posed to their
own workers. Testing conducted in 1959 on rats, rabbits, guinea pigs and dogs at Dow
Chemical's Biochemical Research Laboratory revealed the danger. Adverse effects on the
liver were seen in animals that had inhaled only 100 parts per million of vinyl chloride,
a fraction of the concentration to which many workers were exposed. In a letter to the
B.F. Goodrich (Chemical Co.'s industrial hygiene director) on 12 May 1959, one of the Dow
scientists, V.K. Rowe, outlined the experimental findings and concluded that vinyl
chloride could produce "rather appreciable injury" among workers routinely
exposed to 500 parts per million. V.K. Rowe ended his letter by stating: 'As you
can appreciate, this opinion is not ready for dissemination yet and I would appreciate it
if you would hold it in confidence but use it as you see fit in your own operations'".
http://www.pbs.org/tradesecrets/docs/pdf/BOB_20010215_155937.pdf
V.K. Rowe's plea for confidentiality was hardly needed. According to Jim Morris of the
Houston Chronicle (in 'For years, makers and users of vinyl chloride concealed the
terrible truth: The chemical can cause cancer' http://www.chron.com/content/chronicle/special/vinyl/index.html
) the industry's own documents "depict a framework of dubious science and
painstaking public relations, coordinated by the industry's main trade association with
two dominant themes: Avoid disclosure and deny liability". The chemical companies
were hiding the fact that they had "subjected at least two generations of workers
to excessive levels of a potent carcinogen that targets the liver, brain, lungs and
blood-forming organs". And while the documents show that the industry freely
shared health information among themselves, "the companies were evasive with their
own employees and the government", wrote Jim Morris. "They were unwilling
to disrupt the growing market for polyvinyl chloride (PVC) plastic, used in everything
from pipe to garden hoses". However it wasn't until 2001 that a 90-minute
Tv-special by PBS and Bill Moyers, "Trade Secrets" http://www.pbs.org/tradesecrets/program/vinyl.html
brought the culpability of the chemical industry to the attention of the public at large."It's
all about money", Ray Reynolds, the Vista chairman of Oil, Chemical and Atomic
Workers Local 4-555, concluded. "All these years, I believe, they've been killing
people, but they've put a dollar figure on it".
http://www.studentsforbhopal.org/DirtyDow.htm
# Timeline / Chronology Vinyl chloride
Markowitz and Rosner http://www.deceitanddenial.org/docs/timeline.pdf
# Vinyl chloride: a case study of data suppression and misrepresentation
- Early Suppression of Evidence of Liver Damage
- Evidence of Nonliver Cancer
http://www.thefreelibrary.com/Vinyl+chloride:+a+case+study+of+
data+suppression+and+misrepresentation-a0135379029
DIRTY DOW: COMPLICITY IN MASS MURDER ?
Environmental Protection Agency (EPA)'s cover-up activities - In 1965/1966 under direction
of Dow Chemical's V.K. Rowe and Dr. Albert Kligman (professor of Dermatology at the
University of Pennsylvania), prisoners, locked up in Holmsberg Prison, were used as guinea
pigs for experiments: pure dioxin was applied to their skin. The prisoners got sick:
cancer. Rather, according to Dow, without availability of healthrecords, the prisoners
developed: "Chloracne but no other health problems". The prisoners
seeked help at EPA but EPA rejected their claims and 'lost' their files.
# - In 1978 the US Department of Defense disposed of
its remaining stockpiles of Agent Orange. It was burned at sea at Johnson Island. The EPA
1978 safety manual for the crew of the incinerator ship Vulcanus read: "The
highly toxic contaminant present in Herbicide Orange is
2,3,7,8-tetrachlorodibenzo-p-dioxin. The US Air Force has analyzed Herbicide Orange stocks
and found TCDD concentrations ranging from 0.05 to 47 ppm (parts per million). Times Beach
was evacuated at 2 ppb (parts per billion)". The EPA 1978 safety manual was put
together with the cooperation of Dow Chemical's V.K. Rowe, who: "had been
Dow's point man in telling customers that there were no problems with their herbicides
while he secretly wrote to Dow management that TCDD is 'the most toxic material we've ever
studied'".
(David Kay, 'The Big Lie: 9/11 and the Government's Complicity in Mass Murder', 2005 ) # - In 1979 EPA's Mike Dellargo wrote a report, as a
rebuttal to Dow Chemical's lies, identifying most of what the 1994 official version
finally admitted. Among others: "'TCDD is 10 times more potent than the
potent human carcinogen aflatoxin', 'TCDD is a complete carcinogen when applied to the
skin', 'Milk and beef are a serious source of TCDD contamination. By 1991, the entire food
supply, especially animal products, contained so much dioxin that the average American
ingests from 150 to 500 times EPA's 'acceptable' dose on a daily basis'".
# - EPA held suspension/cancellation hearings. Dr.
V.K. Rowe gave direct Testimony before the US Environmental Protection Agency (EPA) on
13-11-1980: "Dow began the manufacture of 2,4,5-T in
1950...(...)...Moreover, the results of the laboratory testsshowed that each of the
clinical parameters tested fell within the normal range, and 'was not harmful to the
subjects'...(...)...In January of 1968, I was surprised to receive a letter from Dr.
Kligman reporting new results....The results of all these tests were within the normal
range and there was no evidence of toxicity or illness, other than the chloracne, among
any of the subjects......" (In Re: The Dow Chemical Company, et al., FIFRA Docket
Nos. 415, etal. Date Served: 30 October 1980 http://www.nal.usda.gov/speccoll/findaids/agentorange/text/01025.pdf
)
# - "Major testimony about these experiments
came to light in 1980 EPA hearings. Mr. Rowe testified about them. No moral outrage here.
Rowe refused to follow up on the state of these prisoners, would not conduct anything
close to a medical exam, and the matter was dropped. The result ? Dow Chemical could
continue to claim that 'Beyond a case of chloracne, there is nothing wrong with anyone
exposed to Agent Orange'. The EPA blew a powerful opportunity to check on a controlled
body of men with known exposure, and didn't" (EPA Collusion with Industry: A Very
Brief Overview, Editor Liane C. Casten, Environmental Task Force Chair of Chicago Media
Watch, testimony to EPA), hearing of December 14, 1994 http://www.greens.org/s-r/078/07-47.html
).
# - Study by Columbia University: estimated
that "at least 2.1 million but perhaps as many as 4.8 million people would have
been present during the spraying" of Agent Orange over Vietnam (JM Stellman, Et
al., 'The extent and patterns of usage of Agent Orange and other herbicides in Vietnam',
Nature, Vol. 422, 17-04-2003 ) "A study by The Journal of Occupational and
Environmental Medicine found elevated levels of TCDD (the most toxic chemical in the
dioxin family) in 95% of blood samples taken from residents living in Bien Hoa City, more
than 30 years after spraying was stopped" (Tran, Tini, 'Study: Agent Orange Still
in Vietnam', AP, 11-08-2003 ). In 2004 the Vietnam Association for Victims of Agent Orange
filed the first-ever lawsuit in the United States seeking compensation, from Dow among 36
others companies, for the Vietnamese victims of Agent Orange. In 2005 the lawsuit was
dismissed.
CORPORATE CRIMES
The need for an international instrument on corporate accountability and liability
(Greenpeace International, June 2002 )
# DOW BRAZIL S.A......
# DOW (formerly Union Carbide) (BHOPAL, INDIA)
On 3 December, 1984, the world witnessed the worst chemical disaster ever when a gas leak
in the Union Carbide plant in Bhopal, India, killed at least 8,000 workers and residents
in the first three days after the disaster and caused permanent and debilitating injuries
to more than 150,000.... Greenpeace: "The most basic principles of justice have
been denied. Misinformation and lying has been the norm. Profits are pursued irrespective
of the costs to humans and environment"
# DOW CHEMICALS (India).........
# DOW AGROSCIENCES Ltd, (NEW ZEALAND)
The primary location of damage is New Plymouth, however Ivon Watkins Dow(IWD) products
containing 2,4,5-T were sprayed extensively around New Zealand's agricultural and forestry
land to control weeds. IWD imported trichlorophenol (TCP) from the USA and Germany until
1969, when they started manufacturing TCP in New Plymouth. In 1987, this plant was the
last in the world still producing 2,4,5-T. 2,4,5-T was one of the ingredients in the
infamous chemical substances, agent orange, which was used as a defoliant in the Vietnam
war. In 1985 the company was reported as saying that in no instance has it been proven
that dioxin is responsible for any permanent damage either to people or the environment.
Ironically according to a 1965 internal memo written by Dow's toxicology director, Dr.
V.K. Rowe: "As you well know, we had a serious situation in our operating plants
because of contamination with 2,4,5-trichlorophenol with impurities, the most active of
which is 2,3,7,8-tetrachlorodibenzo-p-dioxin. The material is exceptionally toxic; it has
tremendous potential for producing chloracne and systemic injury." Furthermore,
according to a recent Reuters report, the US Air Force has found strong links between
adult onset diabetes and Agent Orange.........
http://archive.greenpeace.org/earthsummit/docs/corpcrimes_1of3.pdf
FAIR AND PROPER CONCLUSIONS
Understudy and colleague of V.K. Rowe at the Dow Chemical Company (Laboratory Health and
Environmental Research) was research pathologist-toxicology Prof. Richard J. Kociba,
principal reviewer Cornel University. Prof. Richard J. Kociba was part of the Society of
Toxicology SOT (Program Committee 1979-1982, Liaison with American College of Veterinary
Pathology) and published a.o. "Three-generation reproduction study of rats given
2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD) in the diet" (Murray, F.J., F.A. Smith,
K.D. Nitschke, C.G. Humiston, R.J. Kociba and B.A. Schwetz, Toxicology and Applied
Pharmacology, 50:241-252, 1979 ). Prof. Richard J. Kociba testified as a witness at the
EPA Dow Prehearing No. 4 (295 ) about 2,4,5-Trichlorophenoxyacetic Acid (the toxicity of
2,4,5-T and TCDD based on 90 day studies of repeated oral doses on rats) held on 20
February 1974 which concluded that: "Finally, no party will 'win' or 'lose'
if 2,4,5-T is approved or banned. Even were Dow to bow out (which it has no intention of
doing), the public is entitled to a fair and proper conclusion as to whether it may use
the product". Years later the 'Vinyl Chloride Conspiracies' were exposed:
"for years, makers and users of vinyl chloride concealed the terrible truth: the
chemical can cause cancer".
# - Dow Chemical's chief toxicologist Dr. Verald K.
Rowe retired in 1979 when he was 1 of 4 Dow Scientists with the highest Dow title for
researcher: Research Fellow. Verald Rowe died on 28 February 2004. Colleague Richard J.
Kociba concluded that V.K. Rowe: "was truly a major contributor to both the
formation and advancement of toxicology leading to the important and respected scientific
discipline that it is today. We all owe a deep sense of gratitude to V. K. Rowe for not
only his role in the initial chartering of the Society of Toxicology SOT, but also for his
major contributions to the entire science of toxicology" (Toxicological Sciences
79, 209-210, 2004 ).
--
SILICONE TIME LINE
--
FIRST IMPLANT
In 1950 RR de Nicola made report ('Permanent
artificial (silicone) urethra', J Urol 63:168, 1950 ) on the first implantation of
silicone rubber to replace a urethra. The first silicone implant in a human being. In 1950
Dow Chemical and Dow Corning performed studies whch demostrated toxic hazards associated
with Dow Corning silicone.
--
VIVA LAS VEGAS
In 1950 - 1960, the years with Jane Russell and
Marilyn Monroe pointing a way, the use of silicone injected directly into the breasts
becomes popular. Ondanks problemen: inflammatory reactions. First in Japan and later
spread to the United States, popular among topless dancers in San Fransico and Las Vegas.
Famous topless dancer Carol Doda: "Science has invented all these new
wonderful things, Why shouldn't we use them?". In Japan silicone injections are
banned because of dangerous side effects, migration to other parts of the body, causing
infections, severe cases of inflammation, formation of hard lumps, immune system disease,
cancer and death. Hereby silicone injections were never approved in the US.
--
ANIMALS SILICONE DIET
A short-term study was conducted: rats were fed diets containing silicone. Result ?
"No adverse effects". Dogs were fed diets containing silicone: "No abnormal
findings", "The liver of all dogs fed silicone fluid, but not of controls,
presented brown/black deposits, similar deposits were also found in the interlobular bile
ducts" (G.P. Child, H.O. Paquin & W.B. Deichmann, 1951,
Arch. industr. Hyg., 3, 479 ).
--
ELI LILLY
In early 1952, a program was agreed upon with
manufacturer (a.o. DES) Eli Lilly for the pharmacological examination of assorted
organofunctional silicon compounds: "The screening of these compounds has
shown that a great many organofunctional silicon compounds and polymers have totally
unexpected activities. Certain ones proved to be acutely toxic, even though closely
similar structures were not especially toxic".
--
CONSUMER PRODUCTS
The chemical division of the General Electric Company, Waterford, N. Y announced end March 1954 three new applications of silicones to
consumer products and the development of a new family of silicone fluids. The new product
had "value for textiles, bottles and leather". (New York Times, 1 April
1954, pg. 51 )
--
SILICONE: HIGH TOXICITY
In 1954 a Dow Coming Chemical study finds that a chemical in silicone, called silica, has
"quite a high order of toxicity," but this study is not released publicly. Dow
Chemical was informed by scientist H.C. Spencer in 1954
that silicone causes health problems. Testing showed a "high order of toxicity
from dust inhalation". And Dow Chemical was informed by Dow Chemical scientist,
V.K. Rowe in 1955 that silicone spreads throughout the
body, and causes organ damage.
--
THE CHENOWETH STUDY
A short-term study: rats maintained diets containing silicone emulsion. Result ? "No
adverse effects" (J. Frodsham, 1956, Unpublished
report No. 1HR/63, Imperial Chemical Industries Ltd., Industrial Hygiene Research
Laboratories). In 1956 again a Dow Corning Chemical study calls into question the safety
of silicone, and again it is concealed from the public. Silicone fluid fed to laboratory
dogs is found to migrate throughout their bodies and lodge in vital organs. In 1956 in the
introduction paragraph of a Dow Corning study ('The Physiological Assimilation of Dow
Corning 200 Fluid': the Chenoweth study), co-authored by Dow Chemical's M. B. Chenoweth,
was noted that earlier Dow Chemical experiments had shown that many silicones were inert
and that the increasing use of silicones for medicinal purposes had triggered a need for
information on their biological ramifications. The study further revealed that, when
injected intramuscularly in rats and administered orally in dogs, Dow Corning 200 fluid
('DC 200') had migrated to all major organs of the body: "A lactating dog
fed with the material has siloxane in the skin and hair, brain, bile, liver, kidney,
heart, milk, urine, skeletal muscle, lung, adrenal, and blood". The study was not
published to the medical or scientific community. DC 200 fluid is chemically equivalent to
the Dow Corning 360 fluid ('DC 360') which is used in breast implants.
--
THE MIAMI STUDY: ALTERED REPORT
Dow Chemical's dr. V. K. Rowe was in 1957 asked by Dow
Corning to make study on six Dow Corning silicone materials. Dr. Rowe designed the testing
protocol for the silicone toxicology research. The study ('the Miami study'), testing was
performed by Dr. William Deichmann at the University of Miami School of Medicine. The
original report, prepared by Dr. W. Deichmann (5 October 1957 ), was a report on 6
silicone materials, but altered to delete one compound and to delete all adverse effects
identified in Dr. Deichmann's original report. The altered version (on 5 Dow Corning
silicones), produced by Dow, concluded that none of the Dow Corning 200 Fluids caused any
harmful effects. The unaltered version of Dr. Deichmann's report produced by Dow Chemical:
"Only 1 rat died and there was an apparent decrease in the number of leukocytes.
This is not statistically significant" while really "2 rats died during
experiment and there was a marked decreased in the number of leukocytes. This difference
is considered statissignitically significant".
--
SARANAC LAKE LAB. STUDY
In 1957 Dow Chemical and Dow Corning jointly
commissioned the 1957 Saranac Lake Laboratories study. Conclusions, reviewed by V.K. Rowe,
et al. ? "High levels of Dow Corning's silica dust severely damage the breathing
apparatus of test rats" and "If fibrotic changes of the lungs develop in
man, they will probably be diffuse in character. If exposure is stopped, a measure of
recovery is quite possible".
--
CENTER FOR AID TO MEDICAL RESEARCH
In 1959 the non-profit Center for Aid to Medical
Research was established by Dow Corning, as a response to questions from the medical
community about medical application of silicones. The Center provided the medical
community with medical products and research regarding the uses of silicone for medical
applications. A long-term study: rats were fed a diet containing silicone fluid and
observed for two years. Result ? "No consistent adverse effects", "The
consistent slight weight increase of the small gut was not statistically significant. No
silica was found in the gut wall or any undue rise in other organs. tumouric incidence was
not abnormal" (Frazer, A.C., 1959, Unpublished report dated November).
--
AGELESS BARBIE: 'LIFE IN PLASTIC, IT'S FANTASTIC'
The doll Barbie, symbol of Western toys, the ideal image of the American woman with an
erotic look, of the American toy-manufacturer Mattel was born in 1959.
The year in which the mass production of Barbie began. During the racial riots in the
United States and the Vietnam-war end '60 a marketing-strategy dilemma arose how to
position Barbie. Barbie was a.o. made in low-wages countries. In the Dutch radio-programme
'The benefit of the doubt' ('Het voordeel van de twijfel', 1996; bco HOS) workers from
Thailand told about sick-making and deadly labour circumstances for a few dollars a day.
Barbie's male partner (1961 ) was named Ken..Barbie
has gotten through the years several 'makeovers' in line with developments in society e.g.:
Afro-American, urban-look, in a wheelchair, shorter skirt and smaller breasts. From notes
from a brainstorming session of Mattel's 'Future of Barbie': "- Concept:
Super Malleable Barbie. - Description: Produce Barbie dolls using the Dow Corning
3179 dilatant compound (a mixture containing silicone oil and boric acid, commonly known
as Silly Putty). -Pro: Barbie can bounce. - Con: When Barbie pretend-falls
asleep whilst pretend-reading a newspaper, the newsprint will show up on her face. -
Potential slogan: 'Ken will thank you.'".
--
DR. THOMAS CRONIN
In the early 1960's plastic surgeon and researcher Dr.
Thomas Cronin (Baylor University http://www.baylor.edu
) approached Dow Corning about the possibility of using silicones in breast implants. A
short-term study: rats received silicone fluid. Result ? "No significant adverse
effects" (W.E. MacDonald, G.E. Lainer, W.B. Deichmann, 1960,
Arch. industr. Hyg., 21, 514 ). Franklin L. Ashley, T.D. Rees, and surgeon Dick Goulian
(Professor of Surgery, director of training for plastic surgery, longtime Director of the
Division of Plastic Surgery at the New York Hospital-Cornell University Medical Center)
had began studies in 1960 in laboratory animals. Eventually more than 1000 test animals
were injected with a PMS, purified medical-grade silicone. Note: Botox is a purified
medical grade. In the 1960's a 40 year-old woman died after breast injections when some of
the silicone fluid traveled to her lungs. Later in 1960 in California and Nevada laws are
passed against silicone injections. They were classified as being criminal (offence).
Women sometimes seek medical treatment for complications up to 30 years after receiving
this type of injection. The practice continues to pop up in underground circles.
--
FIRST (TEST) SILICONE BREAST IMPLANT
A short-term study: rats were fed a mixture of liquid dimethylpolysiloxane and silica.
Result ? "No significant differences were found between the test and the control
animals" (Carson et al., 1961 ). In 1961 as Dow
Corning prepares to market the first silicone breast implant (SBI) the company is advised
by Dow's own Center for Aid to Medical Research that silicone will bleed through a
silicone bag and be absorbed into human tissue. In stead of making this information
publicly known Dow Corning begins developing an own version of siliconegel implants.
Silicone leaking from implants can be equivalent to injections of silicone into the body. http://cti.itc.virginia.edu/~meg3c/ethics/cases/dcc/dccpart1.html
Ethel Mullison (Dow Corning Center for Aid to Medical Research, 1961 ): "If
enclosed within a silicone bag, the fluids would tend to diffuse the walls of the silicone
rubber and be absorbed into the tissues". The FDA, alarmed by the dangers of
silicone for health, poses in 1962 strict rules concerning silicone injections. In 1962
the first silicone breast implant operation occured in clinical trials.
--
INFLAMMATIONS / INFECTIONS
In 1962 from a letter by Dr. Ken J. Olson (Dow
Chemical Biochemical Research) to McHard, Dow Corning on the toxicity by subcutaneous
injection of Dow Corning 200, 555, 550 Fluids it appears that Dow Corning 200 fluid 10 cs.
resulted in a moderate inflammatory response in the subcutis as indicated by the presence
of polymorphonuclear cells and a very large mononuclear cells. "This type of
inflammatory reactions is interpreted as due to infection". With DC 555 and 550
Fluid, all injection sites showed evidence of inflammatory reaction indicated by the
presence by mononuclear cells and polymorphonnuclear cells.
--
SILAS A. BRALEY / FRANK GEROW
In 1962 Silas A. Braley, Dow Corning's director Center
for Aid to Medical Research, reports on a telephone call with Texas plastic surgeon Dr.
Frank Gerow regarding his findings from the use of the saline silastic prosthesis. A leak
was discovered during implantation. Dr. Gerow "sealed it with cement on the
operating table....". Dr. Gerow reports that the saline he has been using in some
of the silastic sacs has been in animals for 9 months and that the body sets up a chemical
balance. Gerow has analyzed the fluid inside the sacs after this 9 months and found
protein, SO4 ions and also indications that the body had set up a balance of magnesium and
other ions. Finally, Dr. Gerow stated that the "direct injection technique has
worked out beautifully". Lateron in 1962 S.Braley notes on a telephonecall to Dr.
Thomas D. Cronin about the difficulties which could be caused due to problems with
uncatalyzed breast material with measuring and the variability of both the base material
and the mixing techniques necessitates different amounts of cross-link resulting. Cronin
said that he is not concerned about leakage if he were to use the thin material because a
film forms around the implant retaining the material in place.
--
SALE OF BREAST IMPLANTS
In 1962-1963 Dow Corning starts, without long term
studies, without noting the health dangers and without monitoring the women who get them,
with the sale of breast implants ("Silastic": brand silicone a trademark of the
Dow Corning Corporation) in a silicone envelop, developed in 1962 bij Dow Corning
researchers, two plastic surgeons from Texas: Thomas Cronin and Frank Gerow (TD
Cronin, FJ Gerow, "Augmentation mammaplasty: a new 'natural feel' prosthesis.
Transactions of the Third International Congress of Plastic Surgery. Amsterdam",
Excerpta Medica Foundation; 1964:41-9 ) http://www.info-implants.com/BC/0016.html
--
SILICONES (INJECTIONS): HUMAN ENGINEERING
After the first Gerow-implant in 1962, A.C. Speirs and Ralph Blocksma ('New implantable
silicone rubbers', Plast Reconstr Surg 31:166 ) in 1963 reported on use of multiplicity of
silicone forms, silicone sponges and room temperature vulcanizing silicone fluid (RTV),
for underskin implantation in rats and patients to determine the tissue response to a
variety of silicones. Dick Goulian, working with Herb Conway and Dow Corning, presented in
1965 their 1963 "Experimental Studies on a New
Silicone" (injection of RTV-silicone into the breast and face) at the 10th Meeting in
Philadelphia, Pennsylvania of the in 1955 founded (American Society of Plastic and
Reconstructive Surgeons) http://www.ps-rc.org Plastic
Surgery Research Council: "The only drawback was a moderate exothermic
reaction with the necessary catalyst which caused some of the animals to have a temporary
alopecia. Unfortunately, Dow Corning withdrew this as it was extremely difficult to
prepare, and they were having their problems with the FDA anyway" (Conway H,
Goulian D: Experience with an injectable Silastic RTV as a subcutaneous prosthetic
material. Plast Reconstr Surg, 32(3 ):294-302, 1963 ) Dick Goulian (an FDA recognized,
Dow-Corning sponsored investigator) was interested in "Producing an
Immunologically Incompetent System" and at the 16th PS-RC meeting in 1971 "Dick
Goulian spoke on 'The Possible Applications of a Highly Purified Collagen in
Reconstructive Surgery' a precursor paper on collagen injection therapy".
--
SILICONE SPREADS
In 1963 Dr. Walter Berman had written to Silas Braley
(Dow Corning's director Center for Aid to Medical Research) reporting on his injection of
silicone fluid in mice. Two days after injection, silicone was found in most organs
including the brain, liver, spleen, intestinal wall, adrenal and kidney. He also found "evidence
of at least radio activity and most probably silicone in the brain and all of the various
other organs....".
--
FDA NO AUTHORITY
Dow Corning continued to receive silicone toxicology research from Dow Chemical, after
beginning to market breast implants. Approval of the FDA was not necessary because the
FDA, because the FDA then had no authority regarding medical devices, because the breast
implants were inside a 'protective' envelop. Under the '1906 Federal Food and Drugs Act',
the FDA had only authority regarding food and drugs and under the '1938 Food, Drug and
Cosmetics Act (the 1938 Act)' the FDA had only limited authority over medical devices.
--
TIMMIE LINDSEY: FIRST SILICONE BREAST IMPLANT
(In 1964 ?) The first woman to receive silicone breast
implants form Frank Gerow was Timmie Jean Lindsey: "I had the world's first
breast job, and endured years of misery", "was persuaded to become a guinea pig
for a new operation", "in one of the most contentious - and, many would say,
dangerous - experiments in medical history", ""If Dr Gerow told me there
were any risks, I didn't listen", "Dr Gerow assured other patients that the
implants were 'as harmless as water'", "'Silicone does not make you sick', Dr
Gerow said", "And 45 years after going unhesitatingly under the knife, Timmie
Jean is no longer so trusting of medical science". (Daily Mail, by Sharon
Churcher, 29-09- 2007, 'I had the world's first breast job - and endured years of Misery,
sais Texan greatgrandmother') http://www.dailymail.co.uk/pages/live/femail/article.html?in_article_id=484674&in_page_id=1879
--
MISLEAD PUBLIC AS MUCH AS POSSIBLE
On 28-05-1964 Silas A. Braley (Dow Corning's director
Center for Aid to Medical Research) wrote a memo to among others Dick Goulian, in
reference to an article in the 'The Insider's Newsletter' (25 May 1964 ) about
"Unknown factors with silicone injections include absorption, migration and
hardening". Silas A. Braley wrote: "We have no knowledge where the
reporter obtained this information. If anyone knows anything about this, we'd appreciate
hearing from him. We are trying to keep such articles as this out of the public eye as
much as possible".
--
DOW CORNING 200 / 360 FLUID
After the publication of a paper (Frank J. Gerow, Mel Spira, S.Baron Hardy, S. Law,
'Silicone immersion treatment of the severely burned patient', In Transactions of the
Third International Congress of Plastic Surgery, Amsterdam: Excerpta Medica), Dow Corning
developed a more purified medical grade 360 silicone. A confidential report entitled
'Chronology of Silicone Injection' Dow Corning provided a historical account from Dow
Corning's perspective of the use of liquid silicone injections, and it notes that Dow
Corning 200 fluid was used for industrial applications. After Dow Corning in 1964 established its own medical products division to market
breast implants and other medical devices using silicone technology, which worked with
more than 35,000 doctors from all over the world and developed an extensive medical
library, the 200 fluid was designated Dow Corning 360 Medical Fluid. The report notes that
"The original label on the new product carried the inscription 'formerly Dow
Corning 200 Fluid'".
# - Complications, tissue reactions in humans, were
reported in 1964: in the breast: injected in Japan, and in the cheek area:
injected with Silicone 360 (Sternberg TH, Ashley FL, Winer LH, Lehman R, 'Gewebereaktionen
auf injizierte Fltissige Silicium-verbindungen', Hautarzt 15:281, 1964 / 'Tissue reactions
to injected silicone liquids: A report of 3 cases" by Winer, L.H.; Sternberg, Thomas
H.; Lehman, Robert; and Ashley, Franklin L., published in Archives of Dermatology, Vol.
90, No. 6, pages 588-593, December, 1964 ).
# - In 1964 Harry Dingman, Dow Corning's Legal
Counsel, wrote to Ban Smart of the FDA (7 November 1964, M35009-012, 'The Physiological
Assimilation of Dow Coming 200 Fluid') and informed him of a reported fatality following
injection of a silicone. Dr. Crenshaw, California, had injected a woman with silicone
mixed with a vegetable oil. She "then went into a coma in a matter of a few hours,
and died within a few days".
# - In 1964, in a letter to the FDA, Dow Corning
lawyers represent that liquid silicone, a major component of the silicone-gel implant, is
not absorbed by the body. However internal Dow Corning testing had already conclusively
demonstrated the exact opposite.
--
VIVA LAS VEGAS
In 1964 Dr. Franklin Ashley (UCLA Center for the
Health Sciences) wrote to Silas Braley (Dow Corning's director Center for Aid to Medical
Research) regarding a "girl in Las Vegas who received injections". The 28
year old had received 30 injections into the breast. 10 - 15 minutes following her final
injection she had onset of nausea followed by dizziness and almost complete loss of
vision. At the same time she developed severe left anterior chest pains without dyspnea or
tachypnea.
--
AUTO-IMMUNE DISEASE / 'HUMAN ADJUVANT DISEASE'
# Miyoshi K, Miyamura T, Kobayashi Y, et al: Hypergammaglobulinemia by prolonged
adjuvanticity in man. disorders developed after augmentation mammoplasty. Jpn Med J 1964; 2122:9-14:
"Although medical literature on the subject of foreign materials introduced into
the human body dates far back, Miyoshi et al in 1964 first formulated the concept that
such reactions could cause a human disease that was specifically related to the immune
reaction to foreign materials. They called the resulting condition 'human adjuvant
disease' because the disease resembled the illness produced in animals by injection of
Freund's adjuvant into tissue. Miyoshi et al also formulated a genus and a divisional
definition of the condition. The genus definition states that human adjuvant disease is
that autoimmune condition of humans caused by the presence of a foreign material in
contact with human body. The divisional definition encompasses six criteria. Of great
interest, all of the cases Miyoshi et al reported were due to foreign materials introduced
for cosmetic augmentation into the human female breast" (source: 'Human adjuvant
disease: presentation as a multiple sclerosis-like syndrome', Britta Ostermeyer Shoaib,
MD, and Bernard M. Patten, MD, Houston, Tex Southern Medical Journal, February 1996, Vol.
89 No. 2, p179-188 ).
--
INVESTIGATIONAL NEW DRUG
Biomaterial: all non-bodynatural materials which keep the human body or
bodyfunctions going, when the body can not longer do that itsself. The FDA approved the
injection of medical-grade silicone for soft-tissue (excluding breast) augmentation for
experimental use in the United States under a FDA investigational new drug (IND) 10-year
exemption for Dow Corning in 1965. "In 1965
the FDA determined that the clinical use of injectable silicone fluid was a "drug
use" and authorized 7 investigators to inject silicone fluid. Dow Coming developed a
more highly purified form of liquid silicone, containing fewer heavy metals and other
impurities, labeled it MDX 4.4011, and made the material available only to the authorized
investigators" ('The history of injectable biomaterials and the biology of
collagen, Aesthetic Plastic Surgery, 9:133-140, Nr 2, June 1985, G. Matton, A. Anseeuw, F.
De Keyser, Akademisch Ziekenhuis de Pintelaan, Gent, Belgium) http://www.info-implants.com/Walt/169.html
# - Dr. N. Ben-Hur and Z. Neuman in 1965 injected Silicone 360 in a rat which resulted in a
tumour-like formation 'siliconoma' ( 'Siliconoma. Another cutaneous response to
dimethylpolysiloxane', Plast Reconstr Surg, 36:629, 1965 ). Dr. Ben-Hur reported in a
letter (24 February 1965 ) to the Dow Corning Center for the Dow Corning Center for Aid to
Medical Research. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=5845695&dopt=Citation
# - Drs. Hur and Neuman observed malignant epithelial
tumours that were believed to be of sweat gland origin. The conclusion drawn from the test
data was that "there seems to be sufficient evidence at this time that
complications of this nature are to be expected".
--
DEATH OF A PATIENT: BREASTCANCER
In 1965 Franklin Ashley to Silas A Braley (Dow
Corning's director Center for Aid to Medical Research) reported the death of a patient
after various injections of silicone around the face. In a letter to the Dow Corning
Centre for Aid to Medical Research, a woman injected with silicone is claimed to have
developed breast cancer. On 24-06-1965 Dr. T. Rees
wrote a letter to Dr. Silas Braley and Fred Dennett, Dow Corning Center for Aid to Medical
Research. Dr. Rees stated "The inevitable has happened. We found a case of
carcinoma of the breast in a 37 year old woman who has had both breast heavily injected
with pure silicone material", "Also...there is evidence of silicone deposits in
the lymph nodes of the axilla (armpit) ... it appears that the silicone is drained to a
certain extent by the lymphatic system", "We are hesitant to report it because
undoubtedly it will create quite a stir but feel that the case must be reported for the
sake of thoroughness and completeness. We are open to counsel as to just what manner this
should be done".
--
LUMPS AND CANCER
In 1965 a study finds that lumps develop under the
skin when silicone enters human tissue, but Dow Corning continues to insist that silicone
is an inert (=non-working) substance. In 1965 testresults show that polyurethane foam,
inserted by operation into rats, caused cancer in 15% of the animals.
--
SALINE IMPLANTS
In 1965 by Dr. H.G. Arion of France the saline implant
is introduced: a silicone rubber sac filled with a sterile salt water solution after
implantation. The saline's dominate the U.S. breast implant market in the 1990s.
--
BREAST IMPLANT: A DEVICE
In 1966 the Dutch broadcasting organisation (bco)
VARA, with its left / democratic and socialistic character, aired a Tv-programme
'Womanlinesses' about plastic surgery. The U.S. patent office approved the first silicone
breast implant in 1966. Implants were seen as a 'device'. Not a drug. Although both are
absorbed into the human body, no testing was legally required for implants, as with
pharmaceutical products, to satisfy the FDA. A short-term study: rats were fed diets
containing silicone. Result ? "No adverse effects". (S. Carson, M.S. Weinberg,
B.L. Oser, 1966, Proceedings of the Scientific Section of the Toilet Goods Association,
No. 45, 8-19 )
--
CAUTION USING SILICONE
In 1967 T D Rees, F L Ashley, D Goulian, D L
Ballantyne, S A. Braley published 'The present status of silicone fluid in soft tissue
augmentation': the clinical use of silicone liquids in man preceded any responsible and
controlled experiment in animals. The unresolved problem related to silicone is migration
to distant organs, cautioning against its use for mammary augmentation. The authors
caution against using silicone fluid with any additives such as olive oil (Plast Reconstr
Surg. 1967 Apr ;39 (4 ):411-20 ).
--
DOW'S CRIMINAL MANAGERS
In 1967 Dow Corning and three of its top executives
are criminally indicted by a federal grandjury in Bay City, Michigan, for permitting
deliveries of silicone without FDA approval. In 1968,
according to a secret study for Dow Corning, when silicone bags are implanted into dogs
the silicone leaks out and is dispersed throughout their systems. In a Dow Corning letter
from E.J. Hobbs (Toxicologist, 1968 ): "...distribution (of silicone implant fluid
in dogs) occurs throughout the entire body...". In 1968 it was found bij
Gorzinski of Dow Corning that: "Cockroaches went into the silicone fluid
only...and...never got more than a few inches from the dish before dying...".
These study results indicated "some type of activity existed in the Dow Corning
360 fluid". (Texaco and Shell studies obtained from Dow Corning).
--
SILICONE TEXAS-STYLE
In 1966 Mel Spira had impregnated a mitten with silicone, used for a burned hand dressing
to help in maintaining motion. The adding saline or silver nitrate resulted in more pain.
On the 14th (1969 ) and 16th (1971 ) Meeting Plastic
Surgery Research Council, Chicago, Illinois one discussed: "Frank Gerow,
Mel Spira, and Baron Hardy in 1969 were injecting 'Cured Silastic Gel as an Implanted Soft
Tissue Substitute'. They were taking the gel from inside breast implants and putting it in
the darnedest screw type syringe of monstrous size with a colossal needle --which looked
more like a bicycle pump than anything else-- and were injecting the material
subcutaneously. It really did fairly well, but had some tendency to 'ball up', losing its
original shape", "This 'Texas style' injector was being used to augment breasts.
The patient had to be under general anesthesia, because one look at Frank's bicycle pump
syringe would have had them running for the hills" In 1969 Frank Gerow became an
active member of the Plastic Surgery Research Council.
--
SILICONE IN RACE HORSES
In 1969 silicone fluid was used inside the sheath in
flexor tendon healing studies in dogs. Jerry E. Adamson and his friends from Norfolk noted
that this was used a great deal in the veterinary work with race horses, and that even
podiatrists were using this in the plantar surface (Southeastern Society of Plastic and
Reconstructive Surgeons, Annual Meeting, 25 April 1977, Hot Springs, Virginia:
Jerome E. Adamson, M.D., President Invocation).
--
WORLD HEALTH ORGANISATION
13th report of the joint Food and Agriculture Organization of the United Nations (FAO) and
World Health Organization (WHO) Expert Committee on Food Additives, Rome, 27 May - 4 June 1969: "Studies have been carried out on
silicone fluids with and without the addition of silica. The presence of silica did not
raise any toxicological problems nor did it affect the results of the experiments in a
significant way. No bio-chemical studies are available. Short-term studies have been
carried out in several species but only one adequate long-term study of
dimethylpolysiloxane fluid has been carried out in the rat. None of them has revealed any
significant toxicity" (Chemical safety, Toxicological evaluation of among others
some food colours and certain substances, FAO Nutrition meeting report No. 46A, WHO, Food
add. 70.36 )
--
BIOLOGICALLY ACTIVE COMPOUNDS OF SILICON
(Mikhail G Voronkov et al, 1969, Russ. Chem. Rev., 38
975-986 ) The literature data and the studies by the authors of the review on biologically
active organosilicon compounds are reviewed. The role of silicon in living organisms, the
toxicity and biological activity of its organic derivatives, and the therapeutic
applications of its compounds are discussed. http://www.iop.org/EJ/article/0036-021X/38/12/R03/RCR_38_12_R03.pdf
Professor Mikhail Grigorievich Voronkov is known ('the Voronkov reaction') in the science
world as a distinguished specialist in the field of chemistry. He presented a lecture at
the 40th Nobel Symposium 'Biochemistry of Silicon and Related Problems' (Stockholm, 1977
). Voronkov was the second most frequently cited Soviet chemist in 1981-1985 and the third
most prolific scientist in the world as reported The Scientist in 1990. Voronkov was the
first in the world to start the investigation of heterolytic cleavage reaction of the
Si-O-Si group. His pioneering investigation of biologically active silicon compounds lead
to the discovery of substances with unique effect on living organism. He created a new
branch of silicon chemistry, namely bioorganosilicon chemistry: "Silicon and
Life", "Silicon in Animated Nature", "A wonderful element of
life". Wide-world recognition: 'Silatranes' (a tricyclic molecule with the central
element silicon (and oxygen)) turned out to be a new class of physiologically active
substances already found many uses in agriculture and medicine. http://content.arkat-usa.org/ARKIVOC/JOURNAL_CONTENT/
manuscripts/2001/MV-457FT%20as%20published%20mainmanuscript.pdf
--
IMPLANTS DECREASE BRAIN WEIGHT ?
In 1970 Dow Chemical's pathologist Gary Sparschu found
that experiments performed on rats injected with Dow Corning 360 fluid showed that the
fluid had migrated to different parts of the body, including the bone marrow. The female
test animals also showed decreased brain weights. While there was exchange of key
personnel to and from Dow Corning, Dow Chemical knew, was aware that liquid silicone was
being developed for medicinal uses, and knew at the time of Sparschu's tests that Dow
Corning was using liquid silicone in its breast implants.
--
PSYCHIC VIEW "DOW WILL BE SUED"
Forrest Stark in 1957 had studied 'The physiological activity of Dow Corning 200 Fluid'
and found that by a mechanism unknown a small amount of Dow Corning 200 Fluid was absorbed
through the skin by the adrenal and kidneys of a rabbit. In 1970
J.K. Boone (Dow Corning) wrote a handwritten note to Forrest Stark regarding inflatable
mammary development assurance (rupture shell strength - thickness): "The
device now marketed (gel filled) has certainly not been complication free but to date it
has not caused us severe liability problems. Over the long haul, I would guess that we
might be sued about as often for hard, painful breasts as for 'shrinking' ones".
--
LYING DOW CORNING
In 1970 Dow Corning reports to the scientific
community that implants caused no adverse health consequences in four laboratory dogs.
Later, because of the discovery process in court, it will be revealed that one of the dogs
died and the other three suffered chronic inflammation. ('Two-year study with Silastic
Memory Implants', TX-202A and TX202B in Dogs, 20 April 1970, http://caselaw.lp.findlaw.com/scripts/getcase.pl?court=nv&vol=114nvadvopno155&invol=2
)
--
DOW'S REDESIGNED IMPLANTS: 95% RUPTURE
Center for Media and Democracy: "Contrary to Dow's projections that
implants last a lifetime, one study of implant recipients found that 35.7% of the women
had experienced a rupture within the first 9 years after implantation. By year 17, the
rupture rate had increased to 95.7%. The rupture problem apparently increased after Dow
redesigned its implants in the 1970s" (1996, Vol.3, No.1, by John C. Stauber and
Sheldon Rampton).
--
CHEMICAL CHANGE IN SILICONE: INFECTION
In 1971 Morgan (Dow Corning) wrote a memo to Wayne
Koning (Dow Corning) regarding a complaint made by Dr. Condie concerning the composition
of the silicone gel in a ruptured implant. The patient developed a reoccurring infection
and a staph infection four months post-op with fluid "oozing from the wound".
The memo states that "the prosthesis was practically empty of gel and what gel was
there was extremely fluid and oozed out of the prosthesis and the surrounding tissue....
It appears to me that we have had a gel breakdown but I did not discuss this in any way
with Dr. Condie". Three month later Dr. Condie wrote to Wayne Koning regarding a
patient with breast implants who developed an "allergic reaction in the skin over
the right breast, or an infection in the skin of the right breast. There was slight
itching associated with the condition. This was also associated with some swelling of the
upper lip and it was felt that she might have angioneurotic edema, however, with
antibiotic therapy the cellulitis cleared up. This was approximately 16 days after she was
first seen for the condition". Six months later, the right breast again became
red and swollen. The implant was removed and Dr. Condie noted that "it was
extremely difficult to remove all of the silicone which was flowing and not gel like in
consistency". Dr. Condie also stated that the silicone in this case was "extremely
watery and flowed very easily". Dr. Condie: "I cannot help but
feel in my own mind that there was something which caused chemical change in the silicone,
making it liquid instead of a gel".
--
ECONOMIC CONSIDERATIONS
In 1972 Dow Corning pharmacologist, Don Bennett, notes
in an internal memo that economic considerations are constraining research into the
biological applications of silicone. In 1972 Mc Ghan Corp brought the first implant onto
the market with liquid silicone-gel, thinner than the rubber-like version which were sold
in the '60s.
--
U.S. AIRFORCE
Plastisch chirurg Robert L. Cucin of the New York Hospital-Cornell was a Major in the US
Airforce from 1967-1977, and once Chief of Surgery in Misawa, Japan. R.L. Cucin did and
published several studies with colleague Dick Goulian: 'The effect of reconstituted
collagen gels on the healing of experimental bony defects: a preliminary report' (J Surg
Res. 1972 Apr;12(4 ):318-21 ), 'Transplantation of the
cryopreserved nipple-areolar complex' (Ann Plast Surg. 1980 May ;4 (5 ):391-5 ) and
'Screening the nipple for involvement in breast cancer' (Ann Plast Surg. 1980 Dec ;5 (6
):477-9 ).
--
DOW'S TESTING: FRAUD /MISREPRESENTATION
In 1973 Silas A. Braley, Dow Corning's director Center
for Aid to Medical Research, and Gordon Robertson of Dow Corning publish an article
'Toxicological Studies, quality control, and efficacy of the Silastic mammary prosthesis'
(journal Medical Instrumentation, 1973, 7, (2 ): 100-103 ). The article cites and
discusses the Food & Drug Research Laboratory (FDRL) report on '2-Year Studies With
Miniature Silastic Mammary Implants'. Robertson and Braley reprint the 6 month test
results in Medical Instrumentation and claim that these are the results after 2 years of
implantation.
--
CRIME LAB
In 1973 S. Braley (Dow Corning) made report of a
telephone conversation with Mrs. Herman D. Jones of the Georgia Crime Lab regarding a
death caused by a breast injection of silicones. Pathologist reported large amounts of
silicone emboli in the brain and lungs. In the case of the breast tissue, the silicone was
dripping out.
--
IMPLANTATION: A SERIOUS SITUATION
In 1973 Silas A. Braley made a telephone call report
with Dr. F. McDowell regarding Bromley Freeman's paper on the use of free gel
implantation. "I explained Dow Corning's great concern with this situation and
that we had finally gone to outside counsel in Washington for advice. The situation is
serious enough that we are going to considerable length to notify all persons that the
breast implant is not to be cut open. The outside counsel has felt that the FDA could
interpret this used as a drug being furnished in a very elaborate package, and could thus
eliminate all beast implants of any kind".
--
DOW'S PORNOGRAPHIC PICTURES
In 1973 Art H. Rathjen, senior clinical research
specialist from Dow Corning, informed numerous Dow Corning employees by memo of an 'Album
for Clinical Photographs, Silastic Mammary Prostheses'. The album is later used by sales
persons. Maurice Popple (Dow Corning) replied to Art Rathjen eleven days later: "Art,
I am in receipt of your pornographic picture album and think it's a great idea. As you are
aware, salesmen spend long weeks away from home and such an album is a comfort to take
along. I am awaiting with adrenalized anticipation the next batch of photos .... Anyhow, I
have always considered myself a leg man so I don't claim any special expertise in the
subject area".
--
IMPLANTS CAUSING SICKNESS
The Dutch broadcastingorg. KRO aired in 1973 a short documentary about plastic surgey (dr.
J.W. Best). In October 1973 Dr. Ben T. Gregory wrote a
letter to Art Rathjen (Dow Corning). Gregory had ruptured an implant unknowingly during
surgery. The patient, 3 months after implantation, experienced redness on her breast and
perforation of the skin. The implant protruding outside and "gel dripping out of
the hole". In 1977, as reported to Art H. Rathjen of Dow Corning, with two other
incidents of ruptured mammaries, upon explantation, Dr. Gregory found a quantity of loose
gel. Other Dr. Gregory patient follow-up's showed:
- 1983 patient no. 29: rheumatoid arthritis.
- 1984 patient no. 08: arthritis in 1978, 6 years post-implantation.
- 1984 patient no. 48: idiopathic thrombocytopenia purpura, 5 years post-implantation.
- 1984 patient no. 26. arthritis in her fingers.
- 1984 patient no. 47. urinary bladder papiloma and a palpable node in the left axilla.
- 1984 patient no. 36: rheumatoid arthritis in the upper extremities.
- 1984 patient no. 31: discoid lupus in 1982.
- 1984 patient no. 50: minor arthritic changes in her hands.
- 1984 Operative report of a Gregory patient: "tingling numbness which radiates up
and down both legs". Diagnosis: Aortofemoral stenosis.
--
SILICONE KILLS
From a memo in 1974 from E.J. Hobbs (Dow Corning
toxicologist) to Needleman about a study of Dow Corning 200 fluid injected intravenously
in rabbits it appeared that 17 of the 28 rabbits tested died during the study probably due
to lung, liver and kidney congestion. Eldon Frisch, an employee of Dow Corning, wrote a
letter to James McDonough, Department of the Army, regarding his letter of 12 September 1974. Frisch stated: "I want to
emphasize that we do not recommend implantation of the gel except when fabricated in
devices with intact silicone elastomer capsule".
--
PROTEST AGAINST FDA INVESTIGATIONAL NEW DRUG
In Silas Braley's (Dow Corning's director Center for Aid to Medical Research) telephone
call report (November 1974 ) of his conversation with
Dr. Charles Vinnik is noted: "Dr. Vinnik then launched into a very extended
discussion of how terrible he thinks the silicone fluid injections are and the fact that
it is going to mean the financial ruin of Dow Corning if we ever get it approved by the
FDA. He said that he had just treated the wife of a doctor from Saginaw who had obtained
pure #360 medical fluid directly from a friend at Dow Corning in the days before it was
restricted. She had exactly the same typical inflammatory and foreign body reaction that
the patients he had seen from Kleifgen and Dr. Haines in Las Vegas. He said he has seen
some good results in the face and thinks this is put in tiny amounts and in a highly
vascular area, but to put it into other areas of the body, he feels is catastrophic. He
said he is going to do everything he can to prevent this from ever becoming cleared until
further work has been done. He has gone to Senator Cannon and to the FDA commissioner to
protest the clearance of the FDA investigational new drug (IND). He states that he will
offer himself as an expert witness against anybody who chooses to use it in the
future".
--
DOW'S FATAL DECISION: AN AWARE CHOICE ?
In 1974 / 1975 researchers from Dow Corning reveal
tumour-development in test-animals. At 80% of the testanimals malignant. In 1974 Dow Corning made a fateful decision. Dow Corning worked
with two closely related teams of scientists, housed at Dow Chemical, on the nature of
silicones. One first group (pharmacologist Dr. Don Bennett's) found that some forms of
silicone -- including a type used in breast implants -- were biologically active and
changed the immune system. Dr. Bennett: "We learned there was a lot of
biological activity with silicone compounds. We were looking for active materials and we
had them. We were almost an embarrassment". to Dow Corning. The second other
group (chemists and toxicologists, Dr. Robert S. Lake, expert on viruses) established that
silicones were inert and were safe to use in implants. "Dow Corning choose to
continue it's commercial breast implant business based on the findings of the second group
scientists", former employees said in 1994 (New York Times, 9 May 1994, Sandra
Blakeslee, 'Dow Corning had conflicting findings on silicone'). A decision based on
profits (at the benefit of a few), and not based on the safety of the materials (at the
benefit of millions of people) ? Dr. Bennett said in 1994 in order to understand this
decision from Dow Corning "one has to recall the climate of the mid-1970's, the
days of mechanical medical devices, mostly made from silicone, that were going to
revolutionize medicine". Dr. Bennett later in 1974 quits in a falling-out with
Dow Corning over the lack of research. In 1994 Bennett was director of the division of
drugs and toxicology at the American Medical Association in Chicago. Dr. Lake left Dow
Corning in 1975. The former employees also said Dow Corning in 1975 decided to stop
research into the immunological activity of silicone. Dow's decision: a 'diagnosis' from
out of a profitable atmosphere presented as an 'unpeachable judgement' ?
--
IMPLANTS: 'STRINGY GOOEY SUSTANCE
In January 1975 Brashier (Dow Corning) wrote a memo to
T. Salisbury and VerVoort regarding a patient of Dr. Goldwyn's who reported a "stringy
gooey substance" that was coming out of a woman's breast who had just been
implanted. The patient snipped the substance with a scissors. The implants were removed
and replaced and the same thing happened.
--
DOW'S TASK FORCE: SALES RESULTS
Dow Corning organised a 'Mammary Prosthesis Task Force' to further development of the
Silastic Mammary prosthesis, Low Profile Round and Contour, with 'flo gel'. The deadline
for product introduction is 1 June 1975. Hoyt (Dow Corning) wrote in January
1975 in an internal memo to among others members of the Task Force: "I
can't emphasize enough the urgency and importance of this project for the business in
1975.The basic assignment is to insure rapid commercialization of a new mammary prosthesis
product line....How this assignment is handled in detail is up to the Task Group. We are
primarily interested in the final result.... Because of our market position and tight
corporate business situation as we progress into 1975 we really cannot accept any delays
in getting the product onto the market. The big mammary prosthesis sales months will be
May, June, and July in which approximately 36% of our total business sales will be made.
Missing one of those months would have a dramatic impact". Dow Corning senior
clinical research specialist Art Rathjen wrote end of January 1975 a memo to numerous Dow
Corning employees regarding 'Gel Bleed - New Gel In Mammary Prostheses Scheduled For June
1 Introduction': "There is only a two week period before the new 'flo-gel'
is scheduled to be formulated and filling begins. A question has not yet been answered is,
whether or not there is an excessive bleed of the gel through the envelope.... We must
address ourselves to this question immediately.... The stakes are too high if a wrong
decision is made", "I would like to emphasize that this task and the assignment
of all members, has received total Business and Product Marketing Group (PMG)'s
support". In February 1975 Dow Corning's
Mammary Task Force meets. Dow Corning is "15 weeks, 170 days, 2,568 hours (and )
154,080 minutes" from the 1 June 1975 deadline. Will Larson reported gel
migration in monkeys with the new gel. A "major point of contention" was
that "No specification exists on the acceptable thickness for the low profile
round envelope". End May 1975, a meeting of
the Dow Corning Mammary Task Force. Countdown to product introduction "1 week, 8
days, 192 hours, 11,520 minutes" from the 1 June 1975 deadline. The Task Force
decides on "aggressive marketing tactics" including rebates, consignment,
back-up units-singles for immediate rupture-replacement, and price breaks for big users.
In 1975 Dr. K.J. Olson, a Dow Corning scientist newly transferred from Dow Chemical,
reported that "if there is any leakage of the breast implant, by diffusion,
rupture, or by any means, some frequency of allergic reactions of patients will occur. In
some cases, the problems posed are likely to be serious". Thomas D. Talcott, a
senior Dow Corning materials engineer, responsible for the testing of implantparts, and
William D. Larson write in an internal Dow memo from 1975: "We are
concerned about possible bleed situation as we are about safety test results". In
1975 a Dow Corning animalstudy had shown that the new silicone breastimplants leak and the
silicone spread. Dow kept this information secret because they had brought their first
silicone-gel filled implants onto the market.
--
SILICONE BOOTLEGGED
In 1975 on the 20th Meeting Plastic Surgery Research
Council in New Haven, Connecticut: "there was a panel on 'Injectable
Silicone' with Art H. Rathjen, Charlie Vinnik, Milt Edgerton, and Kel Cohen. Art Rathjen
had stressed the importance of the liaison between the Dow Corning teams and clinicians
using the material. He noted that there were cases popping up everywhere where silicone
was being injected which was really not medical grade. This bootlegged material often led
to massive areas of irritation and slough, occasionally blindness, and death"
(20th, 1975 Meeting Plastic Surgery Research Council, New Haven, Connecticut).
--
DOW' SALESMEN: OILY IMPLANTS
In 1975 numerous plastic surgeons complain by letter
to Dow Coming that its newly redesigned silicone implants appear oily, like being soaked
in Mazola oil, and seem to be leaking even before they are surgically inserted. They
groused about Dow's implants rupturing in the operating room as they were being inserted
in women's breasts. From internal Dow documents (memo from Dow Corning' J.K. Boone 'Oily
Effect on New Mammaries', memo from Tom Salisbury to Dow Corning sales force 'Oily
phenomenon with New Mammary Prostheses') it appears that salesmen of Dow Corning were
given the instruction by an executive to wash, wipe off and towel-dry the implants before
displaying them to surgeons, thus concealing the oily- and leakage problem. Sales
executive Tom Salisbury advised salespeople to "change demonstration samples
often". In 1975 Dow Corning employees are compelled to edit a training video for
plastic surgeons when implants rupture during the filming of the video. Bob Schnabel (Dow
Salesman, in a letter to his boss, 1975 ) schrijft: "I do not know who is
responsible for the decision (to put faulty implants on the market) but it has to rank
right up there with the Pinto gas tank".
PINTO GAS TANK
Wikipedia: "In early production of the Ford Motor Company's car model Pinto it became
a focus of a major scandal when it was alleged that the car's design allowed it's fuel
tank to be easily damaged in the event of a rear-end collision which sometimes resulted in
deadly fires and explosion. Critics argued that the lack in design made the car a
potential deathtrap. Ford was aware of this design flaw but allededly refused to pay what
was characterized as the minimal expense of a re-design. Instead, it was argued, Ford
decided it would be cheaper to pay off possible lawsuits for resulting deaths. Mother
Jones Magazine obtained the cost-benefit analysis that it said Ford had used to compare
the cost of an $11 dollar repair against the cost of paying off potential law suits, in
what became known as the 'Ford Pinto Memo'. The characterization of Ford's design-decision
as gross disregard for human lives in favor of profits led to major lawsuits, criminal
charges, and a costly recall of all affected Pintos. While Ford was acquited of criminal
charges, it lost several million dollars and gained a reputation for manufacturing 'the
barbecue that seats four'". # Pinto Madness For seven years the Ford Motor
Company sold cars in which it knew hundreds of people would needlessly burn to death (By
Mark Dowie). http://www.motherjones.com/news/feature/1977/09/dowie.html
--
INFLAMMATORY REACTIONS
In August 1975 Dr. Upton (Dr. Thomas Cronin's
associate) wrote a letter to Dow Corning senior clinical research specialist Art Rathjen
regarding capsular contracture: a condition that develops when the body naturally forms a
wall of scar tissue as a defense around the implant. This buildup of scar tissue can
contract and distort the shape of the implants, resulting in the breast feeling hard and
becoming misshapen. This can be an extremely painful condition. Dr. Wilflingseder and Dr.
Laub had been able to demonstrate small particles of free silicone inciting inflammatory
reactions in adjacent soft tissue. They noted the same phenomenon "Although the
etiology of the problem is multifaceted, I am sure, we still wonder if the surface of the
silicone polymer plays a significant role".
--
INJECTIONS: DOW REQUESTING FDA APPROVAL
In September 1975, Dow Corning's 'News Release -
Silicone Fluid Injection' stated that Dow Corning had filed a New Drug Application with
the FDA requesting approval to market silicone fluid for injections. In an internal memo
from Art Rathjen, a senior clinical research specialist of Dow Corning: "Because
of legal complications, any inquiries from the media should be referred to Silas Braley or
Joseph Radzius at Dow Corning". In response to the press release Silas Braley in
a internal document summarized a phone call with Dr. Charles Vinnik: "Dr.
Vinnik wanted to know what we were doing about preventing this use so that all of the
incapable people don't get a hold of it for this kind of use".
--
HORRORS OF INJECTIONS -Vs- IMPLANTS
On 10 December 1975 Dow Corning's director of the
Center for Aid to Medical Research Silas Braley made a telephone call report concerning a
call with Richard Samuels about a grand jury investigation being done on Hal Ellison for
doing injections of silicone fluid. Braley states: "I told Mr. Samuels that
we had been fighting the breast injections since we had heard about them and were trying
to get the information across to people. We find now that people are very confused about
breast injections vs. breast implants and I explained that the latter are both ethical and
legal and that the problems of injections do not apply. I asked for his help in
differentiating between these two procedures so that those women who have had surgical
augmentation will not worry when they read about the horrors of injections".
--
EMBARRASSING DOW CORNING
In March 1976 Dr. Edward Terino presented a paper on
"Technique and results of 50 Breast capsule releases" at the California Society
of Plastic Surgeons. A (not torn or ruptured) Dow Corning implant was removed 10 years
post-op: "Upon opening the capsule bilaterally there was a thick sticky
layer of silicone outside the envelope. On taking the implants out bilaterally there was
no perforation from the envelope whatsoever, but there was clearly silicone on the
outside. And pathology showed extensive foreign body giant cell granulomas". Dr.
Donald E. Barker --who presented a paper 'Reactions to Silicone Implants in the Guinea
Pig' to the Scientific session of the American Society of Plastic and Reconstructive
Nurses in October 1976 (Aesthetic Plastic Surgery, 1978, Barker and Sherrill Lee Schultz,
R.N.)-- approached Art Rathjen (Dow Corning) after Dr. Terino's presentation and stated he
was also studying capsular contracture. Dr. Baker subscribed to the possibility that the
migration of fluid or low moleculars through the envelope, which causes the greasy feel to
the envelope, may be contributing to the contracture. The question remained in Baker's
mind, Art Rathjen reported in an internal memo, as it does in a number of other plastic
surgeons around the country. Dr. Baker wanted to take Dow Corning's Silastic implants in a
centrifuge to collect what was forced through the envelope. The quantity of what comes
through should then be implanted in animals in a very small quantity to see what kind of
tissue reaction develops. Art Rathjen thought that it would be in the best interest of Dow
Corning if they were to "take the initiative" and attempt to do something of a
similar basis first. Rathjen stated in the internal memo: "I think it would
be embarrassing for Dow Corning and for any of our research expertise, if we find that
this type of testing has to be left to a doctor in this field. If he were to come up with
something detrimental, I think we ought to be prepared for it". Despite Rathjen's
knowledge that gel bleeds through the envelope, Rathjen told Dr. Terino in a following
letter that this "is physically impossible" from a polymer chemistry
standpoint. Rathjen suggested to dr. Terino not to publish his paper: "I truly
think it would be to the best interest of all concerned, if we try to get some answers
before there is any further dissemination of information which might be erroneous".
--
FAILURE DEMOSTRATION IMPLANTS
In 1976 a Dow Coming internal study reveals that the lining of silicone implants loses
strength even when sitting on a shelf. In April 1976
Milt Hinsch (Dow Corning) wrote a memo to Brodhagen concerning demonstration implants used
at the April 11-15 Aesthetic Show in Atlanta: "Of these 23 (demonstration
implants), 5 had large bubbles in the gel, 1 broke when picked up, and 3 others developed
bubbles in the gel around the patch area during the show. We were unable to show the
entire line as planned".
--
90% IMPLANTS RUPTURE AND LEAK: INFLAMMATIONS
In 1976 Dow Chemical received complaints from doctors who report different serious
inflammationreactions and spreading of silicone at women with implants. End June 1976 John Gallagher (Dow Corning) stated in an internal
memo ('large increase in rupture returns in the past month') to Bob Becker that: "All
the doctors claim that the ruptures are happening from 90% of the prosthesis with the
creases and large air bubbles", "an excessive amount of ruptures", "I
wanted to bring this to your attention because I have one customer that has had a return
of 30 ruptures in the last 3 months.... We have enough problems with competition without
worrying about ruptures constantly". In 1976 Art Rathjen complains in an internal
Dow memo to his superiors about the lack of any scientific evidence proving the safety of
silicone breasts: "I have proposed again and again that we must begin
in-depth study of our gel, envelope, and bleed phenomenon".
--
DESPERATE DOCTOR SEEKS ADVISE AND STRAW-BLADE
In June 1976 Silas A. Braley (Dow Corning's Director
of the Center for Aid to Medical Research) made a telephone report concerning a
conversation with Dr. Nicholas Georgiade who's patient had developed a mediastinal node
enlargement and lung lesions and suspected gel migration from a ruptured implant. Dr.
Georgiade noted in theconversation that the patient's husband is a "smart
ass" trial lawyer and he wanted to know how to handle this. Dr. Georgiade wanted
a letter from Dow Corning so that he had "enough information to counteract any
feelers that this lawyer may put out". Art Rathjen (Dow Corning) replied (July
1976 ) to Dr. Nicholas Georgiade by letter: "The first silicone gel-filled
mammary prosthesis was implanted in a patient of Dr. Tom Cronin's in 1962, and as of July
1976, she still has them, and her course during the past 14 years has been uneventful.
Since that time, mammary implants numbering in the hundreds of thousands have been used
for augmentation and reconstruction of the breast. The percentage of complications has
been minimal, and very frankly, gel migration due to breakage of the silicone envelope has
not been a problem nor can I recall when a surgeon has questioned us about this, relative
to a Dow Corning Product. We also have test data on the implantation of our materials; and
there is, to my knowledge, no indication or proof that phagocytes (white bloodcells that
absorbe microben) pick up the material and carry it off through the body". That
was not "feasible".
--
DOCTORS HIPPOCRATICAL ALTERING BREAST IMPLANTS
On 23 July 1976 a hearing, regarding breast implants,
was held by the FDA Panel on Review of General and Plastic Surgery Devices. J. Radqius of
Dow Corning stated that he has evidence that doctors might be altering the breast implants
by injecting an antibiotic into the prosthesis which is gradually released through the
membrane of the implant.
--
BREAST IMPLANT CAUSES BREASTCANCER
On 12 August 1976 Dr. John Wolfe (Detroit Medical
Center) wrote to Milt Hinsch (Dow Corning). Dr. Wolfe had concerns about the silicone
mammary prostheses: "I would like to stress to you that the present
prostheses composed of silicone are more than an inconvenience but a very serious problem.
Very often women who have an augmentation have severe mammary dysplasia. Severe mammary
dysplasia is related to a high incidence of developing breast cancer. Prostheses
effectively block from view a great amount of the breast tissue on radiographic
examination.... We have the situation where implants are being put into breast which are
at high risk for developing breast carcinoma and we are seriously impairing our ability to
recognize the carcinoma in its early and curable stage".
--
IMPLANT: LUMP IN THE BREAST
On 20 September 1976 Dr. C. Vinnik wrote a letter to
Art Rathjen (Dow Corning), copying Dr. Brody of the American Society of Plastic and
Reconstructive Surgeons (ASPRS). Dr. Vinnik reports on a patient with a Heyer-Schulte
breast implant who developed a lump in her left breast. Dr. Vinnik noted that the implant
was intact and the pathologist's report showed: "Extensive fibrosis and
granuloma formation that I have seen previously with silicone injections. I do not know
what the implications of this problem are, however, one consideration must be that there
was extensive reaction within the tissue to the silicone gel with which it was in contact.
I believe this is a serious matter and is something that the Standards Committee of the
American Society of Plastic and Reconstructive Surgeons (ASPRS) should ultimately
consider. I might add that the type of reaction described in this case is similar to that
of injected silicone gel as reported several years ago by Dr. Boo-Chai of Singapore. You
will recall that Dr. Boo-Chai ran a series of breast injections with silicone gel through
a dissection subcutaneous pocket with disastrous results".
--
DOW CORNING: CONSCIOUS (OF GEL-MIGRATION)
Dow Corning senior clinical research specialist Art Rathjen in October
1976 wrote to Kurt Wagner, M.D. regarding a problem with gel migration: "Obviously,
whether it is a Dow Corning implant or a competitors' the fact that this phenomenon would
exist is disturbing enough. We have always been conscious of this possibility: therefore,
you certainly caught me off guard when you first reported that the gel from one of our
implants had indeed migrated to the groin". In November
1976 Dr. Charles Vinnik wrote to Art Rathjen regarding a histologic response to
a patient whose breast implant ruptured: "Microscopically it appeared to
resemble the reaction seen around silicone injected breasts" Dr. Vinnik also
remarks that the response to silicone materials in humans is "a very variable
thing....". In December 1976 Guillermo
Colocho. M.D. (New Mexico) enclosed tissue specimens of patients who experienced problems
with implants in a letter to Art Rathjen (Dow Corning). Patient 1 had a small nodule in
the right breast 3 years post-op. Following biopsy, pathological diagnosis revealed
lymphoid hyperplasia. Patient 2 developed multiple tender nodules and lumps in her breast
5 months post-op. Following bilateral biopsies, pathological diagnosis revealed bilateral
lymphoid hyperplasia.
--
DOW'S PATIENT BROCHURE
From 1963-1973 Dow Corning had only 'warned' of fluid accumulation and foreign body
reactions in its product inserts. From 10/1974 - 09/1976 Dow Corning added to its product
inserts for the Silastic implant: capsular contracture/firmness, pain or discomfort from
surgery, ptotic breasts, additional surgeries/implantations, and the risks associated with
surgery. In 1976 Dow Coming represents in a patient
brochure ('Facts You Should Know About Your New Look') distributed to potential breast
implant patients that "Based on laboratory findings and human experiences to date,
a gel-filled breast implant should last for a lifetime". In the pamphlet Dow
Corning did not mention information about side effects, the possibility of silicone
leakage, that the implants could rupture, or that some patients would experience enlarged
lymph nodes, scar formation or inflammation as a result of leakage. This while Dow Corning
was receiving numerous complaints of spontaneous rupture from surgeons and sales
representatives.
# - Dow Corning News for July/August 1981 contained an
article on product liability. The article recommended that Sales, Marketing and TS&D
among others avoid making erroneous verbal representations about a product's performance
and avoid promising to take care of any problems in the use of the products.
--
DOW'S MASSIVE EXPERIMENT ON WOMEN
Thomas Talcott, a senior Dow Corning / Chemical engineer since 24 years, had begin 1976
written to his superiors about implants regarding shell strength / thickness: "When
will we learn at Dow Corning that making a product 'just good enough' almost always leads
to products that are 'not quite good enough'?". Later in 1976
Thomas Talcott, responsible for the testing of implantparts, quits as head Technical
Service and Development in a dispute over the safety of silicone implants. Talcot said to
a news reporter: "Dow Corning and surgeons have been performing a massive
experiment on women, under the motto of selling a commercial product" (Business
Week, 1991 ).
--
THE MEDIA: PLAYING THE OSTRICH
Mainstream media (a few individuals) continued to ignore the serious health concerns, like
for example documented in a 1976 issue of Ms.
Magazine. Harriet Trudell then working for Nevada Governor Mike O'Callaghan: "We
knew that silicone was no good back in the 1970s. Showgirls and cocktail waitresses in Las
Vegas were coming under enormous pressure from the casinos to have their breasts enlarged.
We wouldn't hear about their cases until they started having problems and came to us for
help. The silicone would just rot their breasts away. It was horrible, and of course there
went their livelihood" (Center for Media and Democracy, 1996, 3(1 ), J.Stauber,
S. Rampton).
--
FDA: MEDICAL DEVICES AMENDMENT
Eventually in 1976 the FDA begins with regulating,
enacts the Medical Devices Amendment to the Federal Food, Drug and Cosmetic Act. The FDA
now has the authority to review and approve the safety and effectiveness data of new
medical devices. But since silicone breast implants have been on the market for almost 15
years, they are "grandfathered." Manufacturers of the implants, when called to
do so by the FDA, will be required to provide safety and effectiveness data.
--
IMPLANTS: CANCER IN THE BREAST
In March 1977 a complaint report from Dr. Tony Emmett
filed by Green. The report stated that Dr. Emmett in a case had removed implants after a
cancer was found in the breasts. This was one of several such cases sighted by Dr. Emmett.
The cancer cells had seemed to follow the capsule.
--
DOW'S MANIPULATION OF THE PUBLIC
In March 1977 Del Petraitis, a Dow Corning employee
who later worked for McGhan Medical, writes a memo regarding bleed studies for Dr. D.E.
Barker. There seems serious concern whether any gel bleed data should be released to the
public because: "any general release of this data could be misinterpreted
or misconstrued, and could result in severe repercussions in the public sector",
"The bleed measurement may not be representative of actual in vivo results.... I
still believe that Dow Corning should convey the impression that we are indeed working in
this area". Journalists ('media-signals') and patients would use the information
unsubtle and draw the wrong conclusions from it ? By which "social unrest" would
arise ?
--
DOW CORNING: 'FINGERS CROSSED'
In 1977, the year 3M (Minnesota Mining and
Manufacturing) Corporation enters the breast implant business, a Dow Corning sales,
purchasing, marketing executive, Chuck Leach, tells a gathering of the International
Society of Plastic Surgeons, concerned doctors, that Dow Coming has a study underway on
the possible seepage of silicone from breast implants. Mr. Leach says later, according to
an Associated Press report, he had his fingers "crossed" at the time because in
fact, in reality no such study existed. In an internal Dow Corning memo he admitted to
have lied (at the benefit of...?). Leach wrote: "I assured them, with
crossed fingers, that Dow Corning too had an active 'contracture/gel migration' study
underway. This apparently satisfied them for the moment, but one of these days, they will
be asking us for the results of our studies. . . . It is very likely just a matter of time
until the orthopedic community will be aggressively asking similar questions to those we
are now hearing from the plastic surgeons". The Associated Press had issued a
correction stating that Chuck Leach "was referring not to safety studies on the
implants, but specifically to whether bleeding from the implant could be responsible for a
phenomenon known as capsule contracture, 'crossed fingers' meant only that he hoped the
company would continue to build on research into capsule contracture of silicones".
In 1996 Leach, after 33 years of service, retired. Charles 'Chuck' Leach, former president
of the Rotary Club and an involved member of Memorial Presbyterian Church for many years,
died 'peacefully' on 29 June 2005 at age 70, surrounded by his loved ones among who his
wife Marcia Leach whom he met at Dow Corning. Chuck Leach "a dedicated, loving man
of faith, with a good sense of humor, a positive attitude, and a strong faith in God"
( http://www.waresmithwoolever.com ).
--
DOW CORNING'S MORAL VALUES
End September 1977, as appears from internal Dow
memos, Dow Corning' Implant Product Marketing Group (PMG) made a risky decision to
introduce the inflatable mammary implant at the Plastic Surgery Show on 30 October l977.
The product would be put on the market without clinical tests and without all of the data
having been collected. A 1972 study had showed a deficiency in the envelope. The PMG had
more fear for the risk of losing market share, than for the risk of the product not
performing. Dow Corning was concerned with a permanent loss in market share unless Dow
Corning moved quickly. Dow Corning senior clinical research specialist Art Rathjen
objected. He found that the product's efficacy should be determined after clinical trials
and not merely "on the bench". "A moral issue", "An
ethical matter is involved here", Art Rathjen believed, and he wundered. "Was
Dow Corning really, truly being honest and straightforward with its customers?".
But Rathjen' suggestion was turned down. Rathjen stated that he was prepared to resign
because his "reputation was on the line as it relates to the silicone injection
fluid". But memos from Art Rathjen appeared inconsistent with memos from others
within Dow Corning.
--
INCREASE IN RUPTURES
While in 1977 in the Dutch Tv-consumerprogramme 'King Customer' (Koning Klant) of Dutch
bco VARA one spoke about 'bust-embellishment' with victims and experts, Dow Corning in
half December 1977 received complaints from 4 doctors
about "abnormal percentage(s) of ruptures" occurring with mammary implants (14%,
32%, 12% and 11%) while implanting what was then a new kind of silicone implant. Numerous
doctors report an increase in ruptures. Dow Corning salesman, Frank Lewis said: "I
am sure some of these were the fault of the doctor, but that alone could not account for
such a high percentage of ruptures. These doctors have on the average 10 years of
experience in this procedure".
--
FIRST LAWSUIT IN SILENCE
In 1977 Richard Mithoff, a Houston attorney, wins the
first individual lawsuit for a Cleveland woman who claims that her ruptured implants and
subsequent operations had caused pain and suffering. She receives a $170,000 settlement
from Dow Corning. The case receives little publicity.
--
LEAKING IMPLANT: INFLAMMATION
At the 23rd Meeting Plastic Surgery Research Council in May 1978
spoken about was the study of Mark Mandel (Beverly Hills) 'Free Silicone in Breast
Capsules: Electron Probe Analysis', showing that: "a number of breast
prothesis envelopes were indeed broken and that free silicone in minute amounts could be
detected in the breast capsule". In 1978 Donald E. Barker, M.D., Marvin I Retsky,
M.D. and Sherill Schultz, R.N., report in the Plastic and Reconstructive Surgery Journal:
"Modern silicone bag-gel breast implants leak silicone gel through the bag, the
amount leaked varies from one implant to another and is not constant for any type or
brand, and the silicone will be found in fibrous thickening and various degrees of
inflammation will be found in capsules surrounding the implants".
--
IMPLANT-VICTIM DIANE FJELSTAD
In 1978 the FDA had the plan to categorize breast
implants in another (higher) category so that higher safety-tests were required. This plan
is being obstructed by the industry and plastic surgeons. Implant-victim Diane Fjelstad:
"In 1978, I was encouraged by a team of doctors, including an obstetrician, a
plastic surgeon and radiologist, to have bilateral mastectomies to prevent breast cancer.
I believed these doctors when they told me that the implants were perfectly safe, would
last as lifetime" and "wouldn't have any side effects" and "that
the Dow Corning implants were guaranteed not to move and I could breast-feed naturally
with no problems". Diane Fjelstad further: "I was told that I
would look like a 21 year old when I was 75. That was in 1978 and I was 22 years old"
('The Broken Promise: Healing your Body after Breast Implants', Healing the Body with
Soul, Jaclyn Henderson, RC, Spring, 2005 ). About a year after the implants Diane Fjelstad
gets all kinds of symptoms: Difficulty running and breathing, hurting chest (which
doctors named "a bad virus"), became allergic, developed rashes and skin
sensitivities, hand, wrist and arm began to go numb, she couldn't stir pots, comb her hair
or use a hair dryer, blurry vision, uncontrollable rapid heart movements, headaches,
diarrhea, muscle and joint aches. Eventually a mammogram was taken which showed clearly
that one of the implants (for a long time) had ruptured.
--
DOW CORNING NOT INTERESTED
Dow Corning's internal documents shows that Dow Corning thought that silicone had some
kind of immune reaction. Dow Corning tested silicone compounds, used as a booster to
vaccines, to increase the immune reaction apart from the vaccine itself. For more than a
decade the efforts of a scientist, who found some of the first direct links between
silicone in breast implants and immune system disorders, to get Dow Corning to do such
studies, were rejected. Studies from Dr. John Paul Heggers (University of Texas) in the
1970's concluded that the human immune system reacted to silicone in breast implants by
making antibodies against it which attacked the silicone. As of 1978
Dr. Heggers got in contact with Dow Corning, with the question whether they were
interested in the possibility implants caused immune problems. "They just weren't
interested", Dr. Heggers said. As confirmed by Dr. Robert LeVier, technical chief
of the Dow Corning Corporation's Health Care Businesses in February 1992: "We
disagree with Dr. Heggers on the scientific approach to the problem". While
product-liability lawyers saying there are more than enough studies and experts supporting
the link, Dow Corning's obstinate preached dogma remained, that while silicone can leak
from implants, there is no scientific evidence that it causes autoimmune disease.
--
"LIQUID SILICONE, A DANGEROUS NARCOTIC"
In December 1978 (Journal Aesthetic Plastic Surgery,
Vol 2, Nr 1, 247-250 ) Dicran Goulian Jr. (Department of Surgery (Plastic), New York
Hospital-Cornell University Medical Center) published 'The Current status of liquid
injectable silicone'. Goulian repeats a quote from a summary from his last report
presented at an annual meeting of the American Society of Plastic and Reconstructive
Surgeons (ASPRS) several years earlier: "Medical grade injectable liquid
silicone is an extremely inert material...(...)...Its safety, in our current state of
knowledge, is directly related to the intelligence, caution, and knowledgeable judgment of
the operator". Goulian adds: "Those intimately involved in the
former study agree that, used properly, liquid injectable silicone appears to have
redeeming value in at least a limited group of problem situations". Seen "the
original research protocol lacked sufficient detail and was broad and vague in scope",
a new research protocol was set up in cooperation with the American Society of Plastic and
Reconstructive Surgeons (ASPRS), submitted and approved by the FDA. Another "much
more detailed, and restrictive" 7-year study "confined to major tissue
defects of the head and neck" had been resumed on 1 March 1978. Goulian further
states: "In short, we are dealing with a new commodity in medicine which is
not unlike a dangerous narcotic. It is a potentially lethal or disfiguring agent which is
readily available and easily administered, but, unlike a dangerous narcotic, there is no
existing legal mechanism for its proper control. Until such control is available, liquid
silicone should not be released for general use". D. Goulian spoke out the hope
that this all would "ultimately bring the true status of liquid injectable
silicone into proper and generally acceptable perspective". http://www.springerlink.com/content/k446887118530681/fulltext.pdf
--
DEFECT IN SILICONE GEL: MALIGNANT INFLAMMATION
In November 1979 Dr. Charles Vinnik performed
explantation of a ruptured (Silastic) prosthese (right breast) due to patient' accident
while playing with her child in a playground. Dr. Vinnik's cover letter to G. Jakubczak
(Dow Corning): "The implant was definitely defective and decidedly not up
to the proper standards. I am very distressed about this apparent breakdown in quality
control, as I have removed many broken Dow Corning products.... (Dow Corning) should have
a recall ... of some sort to the physician", " I think it may be wise to at
least alert physicians that there may be a problem with this particular lot number".
The operative report: "The gel ran down the patient's chest, onto the
operating table and onto the floor. This procedure is performed because of medical
necessity as a ruptured breast implant can produce serious medical problems". In
1981 patient's right breast "became increasingly fibrotic and dense, raising some
concern about malignancy". The pathology report: "One section
demonstrates an acute necrotizing inflammatory cell reaction". Dr. Vinnik wrote
in a second letter to the President of Dow Corning Wright Bob Rylee: "(T
)here is suspicion in my mind that we are dealing once again, with a shell failure. You
will see from the enclosed Pathology Report that this patient had considerable silicone
reaction to the extruded material. Review of the sections, by the same pathologist who has
reviewed all of the silicone injection material with me over the past 12 years, shows this
reaction to be as marked a reaction as we ever saw with the silicone injections. I believe
this proves the point that 'pure silicone' can cause severe foreign body reactions in
susceptible individuals". In 1983 Dr. Vinnik wrote to Robert Rylee, Vice
President of Dow Corning Wright, the health care business: "Various
theories were postulated as to why this gel was not cohesive and thus reacted as migratory
gel within this patient's body producing considerable inflammation, foreign body reaction
and discomfort", "I will not assume liability along with Dow Corning for a
defect in the silicone gel".
--
PUBLIC CITIZEN: IMPLANTS CAUSE CANCER
In the '70s and '80s implant manufacturers and plastic
surgeons assured women that breast enlargement was a simple, safe procedure. In the years '80 in the US and Canada the concern about the
healthrisks of silicone breast implants came to light. The pressure on the manufacturers
increased: several lawsuits. In 1980s Ralph Nader's consumer advocacy organization
Public Citizen Health Research Group, Washington, D.C. http://www.citizen.org
, with head Dr. Sidney Wolfe, sends out warning signals that silicone breast implants
cause cancer.
--
DOW "IMPLANTS ARE SAFE, AFTER 'EXTENSIVE' TESTING"
A patient (of Joseph Connelly, M.D.) had a ruptured implant (Silastic) due to a car
accident. The patient's family doctor stated that tests suggested "chronic lupus
erythematosus". Connelly wants to know if Dow Corning has any information whether
the silicone implants can cause lupus. In April 1980
the chief of biomaterial safety for Dow Corning / senior Group Leader for the Health Care
Group Research, William Boley, answered to Joseph Connelly that it is highly improbable a
woman's onset of lupus is connected to her silicone breasts. William Boley claimed
conscienceless the implants have been proven safe in "extensive testing",
although three years later in 1983 he admitted the opposite, saying there is "no
valid long-term implant data to substantiate the safety".
--
POLYURETHANE FOAM
In 1980 polyurethane foam is introduced by Cooper
Surgical as a coating for the brand Meme silicone-gel implants. Scotfoam, the supplier of
polyurethan, assumed that the foam was used for industrial means, "When
polyurethane-covered implants were observed to have a lowered capsular contraction rate,
their use became frequent " (RT Hester, F. Nahai, J. Bostwick, et al., '5 year
experience with polyurethane covered mammary prostheses for treatment of capsular
contracture, primary augumentation, and breast reconstruction', Clin Plast Surg
15:569-585, 1988 ).
--
FDA RECLASSIFICATION BREAST IMLANTS ?
Dutch magazine 'Privé' (De Telegraaf) journalist Henk van der Meyden spoke on Dutch
television in 'Tv-Prive' (bco Tros, 1981 ) with a plastic surgeon about among others
bungling. In 1981 Dr. Frank Gerow requested an
injectable gel (commercialization) for soft tissue augmentation (face and breast). In January 1982 the FDA, after findings of 'a possible unkown
risk for damage', made another attempt, a proposal to reclassify breastimplants in a
stricter category (Class III) which would require manufacturers to prove the safety of
their products in order to keep it on the market. The FDA gave specific details about what
safety data would be asked for. The FDA rather waited about another 6 years to legalize
the reclassification.
--
DUTCH PROMOTION BREAST IMPLANTS
Dutch Tv-presentator Ria Bremer handled in the Dutch medical consumer tv-programme 'Vinger
aan de pols' in 1982 a.o. the advantages and disadvantages of breastprothesis. In March 1982 in the Dutch educational (school) Tv-programme
'Open Schooltijd' (bco NOS/Teleac) the Dutch cancersociety Queen Wilhelmina Fund (M.
Heshusius) came to word in a report about breast amputation: the production of
breastprothesis, how a breastreconstruction takes place with images of women swimming in a
pool and a shop for breastprothesis. In August 1982
Dutch docter Menno Sluyter in a Dutch Tv-programme 'Survival' (Dutch bco TROS) facilitated
a Dutch co-production of a medical programme of the BBC ('Your life is in Their hands: The
Body Beautiful') about plastic surgery of commentary.
--
"SMALL BREASTS ARE DEFORMITIES, A DISEASE"
90% of plastic surgeons practicing in the US see themselves as American Society of Plastic
and Reconstructive Surgery (ASPRS) member. The ASPRS in 1982
declared that small breasts are: "deformities.....a disease which in most
patients result in feelings of inadequacy, lack of self-confidence, distortion of body
image, and total lack of well-being due to a lack of self-perceived femininity".
ASPRS continued "The enlargement of the underdeveloped female breast is,
therefore, often very necessary to ensure an improved quality of life for the
patient". Breast enlargement is a profitable operation. For a set of implants
doctors paid $200 to $300. They charged $4,000 for the one-hour surgery needed to put them
in. Cosmetic surgery (therefore) became the fastest-growing specialty in American
medicine. Doctors started aggressively marketing their services. The ASPRS launched a
costly marketing campaign: news releases, 'patient education' brochures, videotapes etc
(Center for Media and Democracy, 1996, 3(1 ), J.Stauber, S. Rampton). In 1983 ASPRS invested $4 million in an advertising campaign to
publicize breast implants as "essential to women's mental health". ASPRS
promoted breast augmentation procedures suggesting that an increase in breast size would
also increase a woman's self-esteem. ASPRS did little to correct the created illusion, the
fairytale, that breast augmentation procedures had few risks ('Reforms in Medical Device
Regulation: An Examination of the Silicone Gel Breast Implant Debacle', Rebecca Weisman,
Golden Gate U.L).
--
DOW'S LACK OF SAFETY DATA
In a memo a Dow Corning researcher in 1983 made known
that the company could not show solid data which proof the safety concerning long term use
of silicone gel-filled implants.
--
FUNGAL COLONIZATION OF IMPLANT
In February 1983 a case is reported of (heavy growth)
fungal colonization associated with bilateral inflatable silicone mammary implants.
Operative findings included a cheesy-white exudate that surrounded the implants (Walton,
Bunkis, Plast.Reconstr.Surg. 71(2 ):260-1 )
--
CHANGING DOW'S PRODUCT LITERATURE
In November 1983 Dow Corning' Jerry Marlar wrote a
memo about "plans to change the silicone gel product literature to indicate some
degree of sensitization". Charles Lentz of Dow Corning answered: "I
would like you to delay a final action on this plan until a group representing a broader
product responsibility in the corporation has had a chance to discuss the subject and
reach a conclusion. I believe this is essential because the major component of gel is
polydimethylsiloxane. This material is used in a very broad spectrum of products and
consequently a variety of human exposure does occur. For example, PDMS is used in a
variety of personal care products, such as skin lotions. If your literature suggests
silicone gel causes some degree of sensitization, there is significant potential for
implicating other PDMS products". Delaying the plan because journalists
('media-signals') and patients would use the information unsubtle and draw the wrong
conclusions from it ? By which "social unrest" would arise ?
--
PROPLAST TMJ IMPLANTS: DUPONT'S TEFLON
DuPont De Nemours & Co. produces a substance called Teflon. Teflon is used in many
products like e.g. nonstick frying pans. Teflon also is used as an ingredient, sometimes
the primary ingredient, in various medical implant devices. In 1976 dr. Charles Homsy, a
former (1959-1966 ) DuPont scientist, developed at the Research Laboratory of Methodist
Hospital, Houston a commercial product called Proplast: a new patented material
combining a.o. DuPont's Teflon polytetrafluoroethylene (PTFE), but altering its physical
composition, used to make medical implants. In 1983
the Proplast TMJ Implant --after FDA approval for use in medical treatments late 1970's,
subject only to 'general controls' because the implant was 'substantially equivalent' to a
predicate device-- was sold by Vitek Inc. founded in 1969 by Dr. Charles Homsy. The
Proplast TMJ Implant: an implant used in replacing e.g. the meniscus in the
temporomandibular joint (TMJ), a joint in the jaw in front of the ear. Vitek sold the
Implant despite warning from DuPont to Vitek of failed experiments in the past using
Teflon in implants. An English surgeon, Sir John Charnley, concluded (published in
December 1963 ), after using Teflon to replace worn cartilage in the hip joints of dogs,
that Telfon abraded or disintegrated causing serious harm. The Proplast ligament showed
poor results. It was removed in numerous cases because of rupturing and causing
inflammatory reactions in the joints where they had been implanted. Experimental data had
revealed insufficient mechanical properties (Grood ES, Noyes FR: Cruciate ligament
prosthesis: strength, creep, and fatigue properties, J Bone Joint Surg Am 1976,
58:1083-1088 ).
# - At the 1986 American Association of Oral and
Maxillofacial Surgeons (AAOMS) meeting surgeons reported catastrophic biomechanical
failure of the Proplast-Teflon implant. It caused a giant cell reaction leading to bone
resorption and pain (Cowley, 1994 ).
# - By 1988 Vitek Inc. had manufactured thousands of
Proplast TMJ Implants but Vitek withdrew the Proplast TMJ Implant from the market.
# - The FDA issued a Class I recall in 1990 on the
Vitek Proplast-Teflon implant due to reports of serious problems (1999, TMJ Implants: a
Consumer Information Update booklet http://www.fda.gov/cdrh/consumer/tmjupdate.html
)
# - In 1992 Congress held a hearing "Are FDA and
National Institute of Health (NIH) ignoring the dangers of TMJ Implants ?". Because
there was no viable registry of Proplast-Teflon patients, one could only relate to
testimonials from implant patients who reported a.o. systemic problem, fevers, infections,
visual disturbances, memory loss, confusion, seizures, dementia, abnormal thyroid
function, allergies, sensitivities to chemicals and medications, rashes, chronic
hoarseness, intolerance to heat or cold, atypical multiple sclerosis.
# - In 1994 the FDA took all TMJ implants, regardless
of composition and design, off the market and announced that "similar risks and
similar safety and effectiveness concerns are associated with all TMJ implants"
(Fed. Reg. 65475, 65476, 20 December 1994 ).
# - In 2000 TMJ disorders affected approximately 30
million people, most of whom are women. The TMJ Association: "There are reports of
broken marriages, torn families, lost careers, and bankruptcy which, combined with the
physical problems, may have been ultimately responsible for over 50 suicides".
# - According to the TMJ Association in a letter
(16-05-2003 ) to the Office of Pollution Prevention and Toxics: "To date,
the FDA, the Centers for Disease Control and Prevention, the Agency for Healthcare
Research and Quality and the National Institutes of Health have not taken the medical
problems these patients manifest sufficiently seriously to investigate the link between
implanted materials and subsequent health status of the recipients", "The
Environmental Protection Agency (EPA) and the Environmental Working Group have stated that
no one has found that the chemicals have a toxic effect on humans, though animal research
does indicate potential toxicity. Without scientific study but information from thousands
of implant patients, we can definitively say that most we have heard from developed a
worsening health condition following implantation" (Terrie Cowley, President of
The TMJ Association, 1994, October 23-25, 'Technology Gone Awry' Presented to the
Conference on Biomaterials and Medical Devices).
--
SILICONE TIME LINE
--
THE USE OF PLASTIC SURGERY
In 1984 in Dutch discussion Tv-programme 'Around Ten'
(Rondom Tien, bco NCRV) of presentator Henk Mochel the goal, use and succes of plastic
surgery came to word. In the Dutch radio-programme 'With the eye on Tomorrow' (Met het oog
op morgen, bco NOS, 1984 ) Prof. H.Musaph, at his departure, expected many progress in
plastic surgery: prothesis for the male penis.
--
HUMAN ADJUVANT AND CONNECTIVE TISSUE DISEASE
Among others in the '80 several case-reports with
implications about the role of breastimplantations in the development of connective tissue
disorders appeared. Some reports handled about confirmed diagnosises of known disorders as
e.g. systemic sclerosis. Other reports handled the less known human adjuvant (auto-immune)
disease. It was about the following procedures:
(1 ) - SILICONE INJECTION
(2 ) - COMBINED SILICONE AND PARAFFIN INJECTIONS
(3 ) - SILICONE GEL IMPLANTS,
(4 ) - SALINE-FILLED IMPLANTS
# - A Vargas, 'Shedding of silicone particles from
inflated breast implants, letter', Plast Reconstr Surg 64:252-253, 1979
# - CM Baldwin EN Kaplan, 'Silicone induced human
adjuvant disease', Ann Plastic Surg 1983; 10: 270-3
# - MA Byron, VA Venning, AG Mowatt, 'Post mammoplasty
human adjuvant disease', Br J Rheumatol 23:227-229, 1984:
"With the growing use of silicone in a variety of implants, the now rare
occurrence of human adjuvant disease may become increasingly common" http://yukonmom47.tripod.com/id36.html
# - KM Fock, PH Feng, BH Tey, 'Autoimmune disease
developing after augmentation mammaplasty: report of 3 cases', J Rheumatol 11:98-100, 1984
# - Y. Kumangai, Y. Shiokawa, TA Medsger, Et al,
'Clinical spectrum of connective tissue disease after cosmetic surgery. Observations on
eighteen patients and a review of the Japanese literature', Arthritis Rheum 27:1-12, 1984
# - TJ Sergotti, JP Limoli, CM Baldwin, Et al, 'Human
adjuvant disease, possible autoimmune disease after silicone implantation: a review of the
literature, case studies, and speculation for the future', Plast Reconstr Surg 78:104-114,
1986
# - MH Weisman, TR Vecchione, D. Albert, LT Moore, MR
Mueller, 'Connective-tissue disease following breast augmentation: a preliminary test of
the human adjuvant disease hypothesis', Plast Reconstr Surg. 1988; 82:626-30.
--
SILICONE INERT ?
In 1963, Professor Thomas Cronin, one of the two inventors of the silicone breast implant,
introduced the Dow Corning silicone gel-filled breast implant to the international Society
of Plastics Surgeons. He called the silicone a totally inert material and stated that in
case of implant rupture, the silicone gel would not migrate and that free gel would not be
harmful to tissue. Cronin added "as scientifically, proven by Dow Corning".
Consequently, it was also believed by most plastic surgeons that silicone breast implants
were inert and would last for ever. At the 29th Meeting Plastic Surgery Research Council
in Detroit, Michigan in April 1984: Frank Gerow, the
other of the two inventors of the silicone breast implant, "had been working for
years with Organosilicones and whereas it had been felt that these were inert, safe, and
stable, he showed that in the presence of certain infections, they were indeed
biodegradable".
--
THE MARIA STERN-CASE
In 1984 the lawsuit Maria Stern-vs-Dow Corning, San
Francisco. A Federal Court concluded that Dow Corning was fraudulent by bringing implants
on the market as being safe and having misrepresented animal studies. US districtjudge
Patel found in an appealcase that the evidence showed that the evidence showed that Dow
Corning's implants were remarkable weak and confirmed the verdict of the jury that Dow
Corning had commited fraud. Maria Stern's systemic autoimmune disease is found by a jury
to be caused by her silicone breast implants. Stern was awarded $211,000 in compensatory
damages and $1.5 million in punitive damages (to punish a company for its actions and
serve as a deterrent). The judge noted that Dow's own studies "cast considerable
doubt on the safety of the product". Results which were not disclosed to patients
and dotors. The judge called Dow's actions "highly reprehensible". The
case was won on basis of many internal Dow Corning documents that had been discovered in a
Dow storage area by attorney Dan Bolton. Bolton introduces the silicone-induced problems
for the first time in court, with "experts" that theorize the silicone-immune
system connection. The evidence is rather sealed by a court order (confidential
settlements, Federal Rule of Civil Procedure 26-c). Dow's lawyers had negotiated to pay in
exchange for a "protective order" blocking public access to embarrassing
internal documents, memo's and testimony which had emerged during the trial. Also in other
(following) cases Dow used this strategy. As a consequence of the lawsuit Dow Corning in
1985 changed it's product-literature and added a warning with the expectation that doctors
would give them to their patients. That appendix mentioned the possibility of immunesystem
sensitivity and the possibility of spreading of silicone after rupture of implant, in line
with an internal report by William Boley and other Dow Corning scientists in which was
concluded that the preponderance of available data suggests that silicone can produce
immune-mediated diseases. The Stern case received slight media coverage. One wasn't
interested.
--
SILICONE: IMMUNOTOXICITV REACTION
On 9 May 1984 Eldon Frisch, an employee of Dow
Corning, wrote a memo to the chief of biomaterial safety for Dow Coming, William Boley.
Frisch informed Boley in reference to Dow Corning's competitor Baxter's presence at a
recent biomaterials meeting that Baxter: "..tested a number of materials,
including silicones, and have found that many, if not most, plastics and elastomers elicit
an immunotoxicitv reaction" (Gmo. Frisch to Boley re "lmmunotoxicity Assay
Method," May 9, 1984. Bates No. DCCK MM 037828, Exhibit 7, Record No. 73951 ).
William F. Boley (coauthor 1974 Dow Study of silicone's effects on the immune system, 1985
): " I think we probably should start at least acknowledging the potential
for sensitization (of the immune system by silicone). I think we have excessive personal -
and corporate liability exposure". Rather in 1987 Dow Corning publishes a
'position statement' in which immuunsystem problems with implants are denied.
--
SILICONE CAUSES FATAL tumourS
In 1985 Dow Corning lead a study on rats, injected
with silicone gel. The findings showed that de presence of silicone cause tumours in 25%
of the tested animals. The arisen cancer was fatal in 85% of the infected animals. Dow
Corning tries to leave the testresults out of consideration under the mask of "that
this cancer-form does not occur in humans".
--
PLASTIC SURGERY: PHYSICAL EVOLUTION ?
At the 30th Meeting Plastic Surgery Research Council in Portland, Oregon in 1985: "Joseph Rosen, working at Stanford, suggested
that 'nerve repair should ideally be done at the axon level' and he described a silicone
chip with axon tubes which could be implanted so the axons literally regenerated through
the tubes. He used a one mm square chip which had a grid of 2,500 such tubes cut by laser.
This was still in the developmental process". Dutch Tv-presentator Tineke Verburg
presentated in 1986 in Dutch Tv-programme 'Aktua' (bco
TROS) a way for figure-correction: liposuction.
--
POLYURETHANE FOAM
Scotfoam, the supplier of polyurethane foam discovered in 1986
for the first time that it's industrial chemical product was implanted in the
cancer-sensitive tissue of the female breast. Scotfoam informs the firm Cooper Surgical
that 2-toluene diamine (TDA), the degradation product in foam, is not recommened for use
in human implants. If substantial amounts of TDA were produced by the chemical breakup of
the polyurethane covering of the breast implant and then released into the blood the
result might be an increased risk of cancer for women with implants.
--
DOW'S KNOWLEDGE OF GEL BLEED, SYSTEMIC DISEASE
On 29 April 1986 in an Infor-Med, Jackie Markham,
Natural Y Surgical Specialties, claims that there is overwhelming agreement among ASAPSs
members, that the less exposure of silicone to the lymphatic system the better, because it
means less of a load on the immune system. Surgitek (a subsidiary of Bristol-Meyers Squibb
Co and manufacturer of polyurethane coated implants) and Dow Corning are accused of
dumping and "fire-saleing" high-bleed mammary implants, which they had advocated
for years, on the market (Dow Corning Trial Exhibit List Abstracts, document #439 ).
--
SILICONE IMPLANTS CAUSE CANCER ?
At the 32nd Meeting Plastic Surgery Research Council in Boston, Massachusetts in 1987: "David Dreyfuss, sponsored by Tom Krizek, had an
interesting study on 'Silicone Implants as an Anticarcinogen'. He quoted figures on the
low instance of breast cancer in patients who had had silicone implants and then studied 2
cm implants in 300 rats which he followed for 200 days with various types of implants. A
mammary cancer stimulating agent was injected and a high instance of a mixed
adenocarcinoma with a low benign tumour incidence occurred in the controls. The animals
with polyurethane sheet, free silicone gel, and silicone sheet implants, had similar
tumour instances to the controls, but those with silicone implants had a statistically
significant lower tumour incidence as compared with the controls. That left a great deal
of food for thought".
--
DOW CORNING' MISLEADING ADVERTISEMENT ?
In 1987 a Dow Corning advertisement 'Silastic Mammary
Prostheses' states: "When you use the Silastic Mammary Prosthesis, you know
all possible precautions have been taken", "At least 207 tests -from raw
materials to finished product- all for your professional protection", "19 years
of clinical experience", "A half of a million mammary implants since 1962",
"FDA registered and inspected manufacturing facilities", "And, if our
prosthesis costs a few dollars more, think of it as your malproduct insurance". A
Dow Corning document (#446 ) titled "Driving force: Profitability and consolidation
major objective: Profitability - Everything currently being done or being proposed is
designed to impact this objective" described the key objectives being to increase
sales in 1987 for the Silastic II by 25%. To accomplish this, Dow Corning Wright plans to
use the Battelle study and P.R.E.P. program and focus its sales efforts to "targeted
key accounts for conversion to Silastic II." Also recommended was to: "Continue
close working relationship with Plastic Surgery Educational Foundation (PSEF), the
American Society of Plastic and Reconstructive Surgeons (ASPRS), and ASAPS for obvious
political benefits".
--
MEDTOX-REPORT: SILCIONE CAUSES INFLAMMATION
In April 1987 Robert LeVier (Dow Corning) presented
the results of the 'Medtox Project Final Report' at Dow's Health Care Businesses Board
Meeting. The purpose of the Medtox project was to formulate a consolidated understanding
of all internally funded safety studies of silicone material relevant to the Health Care
Business, and to relate the findings to current safety issues as presented in the
literature, by the physician community and in litigation. Robert Levier / the Medtox final
report concluded that there can be acute inflammation progressing to chronic inflammation
characteristic of a mild foreign body from silicone breast implants. The Health Care Board
reported that legal counsel had recommended that Dow Corning settle the Maria Stern case
because of "incomplete information on our implant package inserts".
--
DOW CORNING FAIRYTALE "RUPTURE RATE 1%"
In 1987 Gene Jakubczak of Dow Corning answers in a
letter to Dr. Muller's questions about implant rupture. Jakubczak sais, in contradiction
with the truth, that Dow Corning had been tracking the rate of ruptures since the
gel-filled implants were introduced to the market. He also states: "The
rate (of rupture) is less than 1% for gel filled product"
--
ABC'S 20/20: CAPSULAR CONTRACTURE 40%
On 4 January 1988, ABC's "20/20" aired a
segment on breast implants, about women suffering 'capsular contracture' after the
insertion of their implants. Capsular contracture is a condition that develops when the
body naturally forms a wall of scar tissue as a defense around the implant. This buildup
of scar tissue can contract and distort the shape of the implants, resulting in the breast
feeling hard and becoming misshapen. This can be an extremely painful condition. Although
doctors interviewed on the Tv-show claimed the incidence of capsular contracture was very
low, the Head of the American Plastic Surgeons Association admitted it might be as high as
40%.
--
COMMAND TRUST NETWORK
To provide women with adequate information about the risks and benefits of breast
implants, in 1988 the National Breast Implant
Information Clearinghouse, Command Trust Network (CTN), was founded by Kathleen Anneken
and Sybil Niden Goldrich. The Command Trust quickly discovered that "for
thousands of people, simple and successful plastic surgical solutions are being promised
but not delivered by the medical community and by medical device manufacturers":
hippocratical negligence with the head in the sand / 'another world'. Silicone breast
implants became the focus of the Command Trust Network. Sybil Goldrich was one of the
first women to speak publicly about problems with silicone gel breast implants when she
published her story "Restoration Drama" in Ms. Magazine in June 1988. Breast
cancer, and after mastectomy, Goldrich received silicone gel-filled breast implants. The
nightmare began. Goldrich underwent seven operations and received a total of 4 sets of
implants within 2 years when she finally decided to have her implants removed for good.
Surgery had found silicone in her liver, uterus and ovaries. Goldrich has been one of the
leading consumer advocates involved in the fight for women's health in relation to breast
implants. She worked closely with Congressman Ted Weiss: a New York democrat, and chairman
of the House Goverment Operations subcommittee on human resources and intergovernmental
relations which oversees the FDA. The activism of Command Trust Network led to the
landmark 1992 FDA Congressional hearings, before which Goldrich testified countless times,
that resulted in the restriction of the sale of the then-unregulated devices. A 1997
Lifetime movie told Goldrich story and chronicled her participation in what was at that
time the largest class action (where cases were heard together in stead of individually)
lawsuit in U.S. history. The suit which eventually put Dow Corning out of the breast
implant business and bankrupt. In 2005 the National Organization for Women (NOW) awarded
Goldrich the Woman of Courage Award. http://commandtrust.com/aboutct.html
--
TEXTURED IMPLANTS: INFLAMMATORY RESPONSE
At the 33rd Meeting Plastic Surgery Research Council in San Francisco, California in 1988: "J.D. Stuart, from Charlottesville, studied
'Traditional and Textured Surface Silicone Implants' and the resulting capsule. The
textured implants actually had a thicker capsule with a marked inflammatory response which
was absent in the smooth textured surfaces".
--
PUBLIC CITIZEN
In 1988 thousands of women are believed to be
experiencing complications with silicone implants, according to the Public Citizen Health
Research Group. The complaints include rocklike deformities and chronic inflammation of
the breasts, plus more serious diseases such as lupus, systemic sclerosis and neurologic
dysfunction.
--
DOW "MAY THE FORCE / GOD BE WITH YOU"
In February 1988 the Senior Managing attorney at Dow
Corning, Greg Thiess, stated in a letter ---concerning Dow Corning studies on the force
(e.g. by external squeezing, love making, hugging, physical medical examination,
breastcancer screening, by accident running into someone / an object etc.) that a mammary
implant could withstand once placed inside a female's breast--- in regard to implant
rupture: "Dow Corning has done no such studies".
--
DOW CORNING SURVEY: DOW NOT INTERESTED
In May 1988 a Dow Corning Organizational Survey, among
Dow employees, reveals --while an exceptionally high rating of more than 90% of Dow
Corning employees considered the company 'highly ethical': a beliefconviction--
that managers don't show any interest for improvement of quality: "They
need to walk the talk". With suggestions for fixing problems nothing is being
done. "Dow Corning does not accept the fact that quality costs money", "Over-emphasis
on profitability", "Too much short-term thinking", "Bureaucratic,
with blurred responsibilities, CYA ('cover your ass' ) effect, politics, game-playing,
'good old boy' network". "This detracts from long-term, fundamental
research". Patricia Lang, a consulting toxicologist, writes in 1989: "The
Dow Corning management style is not conducive to running even an adequate toxicology
laboratory", "At the present time, the WRONG people are making decisions (in
some cases the WRONG decisions ) which impact upon the science being performed".
--
FDA RE-CLASSIFICATION IMPLANTS: CLASS III
On 24 June 1988, Six years after the 1982 proposal,
FDA classifies the implants into Class III. Premarket Approval Applications from silicone
breast implant manufacturers are due by July 1991. The PMA's must prove affirmatively,
with valid scientific data (other than 'anecdotes') that their devices are safe and
effective. After the PMA's are submitted by the manufacturers, the FDA has 180 days to
evaluate the safety data. In 1988 the FDA acknowledged that siliconegel implants all
slowly began to sweat gel through the envelope to the surrounding tissue. A FDA
staffemployee concluded that there was sufficient evidence to suspect silicone of causing
cancer in humans.
--
BREAST IMPLANT LINK TO SERIOUS SKIN DISEASE
The Chicago Sun-Times reported on 8 July 1988 about a
7-year-study (Journal of the American Medical Association) of Dr. Harry Spiera, a
rheumatologist at Mount Sinai School of Medicine, which showed that breast implants may be
linked with scleroderma, a potentially deadly disease. Of the 113 new female patients Dr.
Harry Spiera treated who suffered from scleroderma, 5 had undergone silicone breast
implants following breast-cancer surgery or for cosmetic reasons. The incidence of
scleroderma, which itself is very rare, would appear to be more than would occur by
chance. Scleroderma is an arthritic disease affecting the skin that can attack vital
organs. The Nutrition Health Review (22-06-1989 ): "'In some patients,
breast enlargement with silicone implants may precipitate scleroderma, a serious
auto-immune disorder whose most prominent feature is severe skin-thickening that can
restrict hand movement and facial expression', reports Harry Spiera. Dr. Spiera:
'The difference was statistically significant and suggests a relationship between silicone
[breast implants] and scleroderman'".
# - Scleroderma (systemic sclerosis:
"scleros"/"derma": "hard"/"skin"): a
systemic disease at which inflammations can occur in the entire body, also in the limbs,
and therefore can be accounted as a rheumatic disease at which the body continuesly makes
more connective tissue. Connective tissue can be found in the entire body. It takes care
off that the cells of our skin, joints, muscles and organs are kept together. An increase
of connective tissue can thus occur in any part of the body where connectve tissue is:
the patient gets a hardened, more tight skin and joint-inflammations and also internal
organs, like stomach, intestines, lungs, kidneys, can stiffen.
--
SILICONE GEL CAUSES CANCER
# - "The silicone gel used in breast implants
has been found by its manufacturer, Dow Corning Corp., to cause cancer in laboratory
animals, according to internal documents from Dow and the Food and Drug Administration
that were obtained by the consumer advocacy group Public Citizen. Citing the documents,
Sidney M. Wolfe, director of Public Citizen's Health Research Group, yesterday called on
FDA Commissioner Frank Young to ban silicone gel implants immediately. According to FDA
estimates, about 2 million women have had silicone gel breast implants and about 130,000
more receive them each year. Each implant consists of a closed, breast-shaped bag filled
with silicone gel..." ('FDA ban urged on gel for breast implants', The Washington
Post, 10 November 1988, Boyce Rensberger)
# - W.D. Galloway had reported on the 'Analysis of
Lifetime Carcinogenicity Study of Silicone Gels' conducted by Dow Corning using rats
injected with gels (Q7-2159A and MDF-0193 ). Galloway stated: "Both of the
gel-implanted groups showed a large number of cancers compared to the control group",
"According to Dow Corning, ... the tumours were peculiar to rats, the so called
foreign body tumours", "Absent epidemiologic data, and without waiting for
results of additional lifetime studies, knowledge of the mechanism by which these tumours
was induced is critical to estimating human risks. It is possible that the tumours were
chemically induced, rather than being induced by a physical mechanism, as Dow suggests. If
this is the case, then the argument that such tumours do not occur in man is untenable. If
the tumours were chemically induced, the active agent is more likely to be one of the
several chemicals which make up the gel, rather than a metabolically produced reactive
intermediate, since the tumours which did occur, did not occur selectively in
metabolically active organs such as the liver".
# - Dow Corning' toxicology consultant Gerry Schoenig
in 1981 reviewed the data from the 2 year implant study of Q7-2159A and MDF-0193 gels at
Industrial Bio-Test Laboratories (IBT ): "fibrosarcoma around implant and
malignant lymphoma in rat colony said we had a problem with cancer".
# Despite Cancer report, Doctors Defend implants
"In the wake of a study showing a silicone gel used in breast implants causes
cancer in rats, doctors stood by the implants, noting that the operations have never been
known to cause cancer in women. Thousands of women who had undergone the breast operations
called plastic surgeons on Thursday to ask about the risks involved in the implants
following the release of data from a study in rats showing implants caused fibrosarcoma, a
cancer of the muscle lining. Susan Cox, 47, education director for Y Me Breast Cancer
Support Program, who herself underwent breast implants following surgery, said a dozen
concerned women call her group's hotline....." (Chicago Sun-Times, 11 November 1988, Howard Wolinsky)
# Silicone breast implants on Trial
10 December 1988 - After the Public Citizen Health
Research Group (HRG) urged to ban the implants, a FDA panel of advisers, after a hearing,
voted to collect more data on breast implants. The danger data on breast implants was
being kept secret by court order following settlement of malpractice lawsuits. The
advisory panel voted against banning silicone breast implants. http://www.thefreelibrary.com/Silicone+breast+implants+on+trial.-a06924580
# - IMPLANTS: CANCER
At medication-studies (situation A) on testanimals it is common that the results are
extrapolated to a human targetgroup. What a mouse has overcome in the study, will for
certain also overcome a human. Situation B: breastimplants ? In March 1988 Dow
Corning submitted pathology results of a 1985-1987 2-year rat study of two kinds of
silicone gel implants. Dow claimed in their report that the study showed that silicone gel
did not cause cancer. However, the FDA reviewer, Hoan My Do Luu, expressed concerns about
the malignant tumours found in approximately 25% of the rats. She stated that: "more
than 50% of these tumours are fatal". In addition, the silicone gel was found to
have "spread into surrounding tissue" and "migrated to distant
sites". The FDA reviewer quoted scientists who reported that such tumours had
been detected in humans. The reviewer concluded "It would be irresponsible to
disregard the possibility of malignant development of permanent implants in humans".
The Acting Chief of FDA's Health, Sciences Branch, Melvin Stratmeyer, reviewed the
information and summarized that "The conclusion of this report is that silicone
can cause cancers in rats; there is no direct proof that silicone causes cancers in
humans; however, there is considerable reason to suspect that silicone can do so".
Despite the concerns about this research expressed within the FDA, at the public FDA
advisory committee meeting in November 1988, FDA officials minimized their concerns about
the cancer findings, and emphasized that the results were inconclusive. At the 1988
meeting, the presentation by the Director of the Office of Device Evaluation, Robert
Sheridan, concluding: "the types of tumours seen in rats would be unlikely
to occur in humans, and that, if a human cancer risk does exist, it would be small,
therefore FDA does not believe that regulatory action is currently warranted"
(Source: United Silicone Survivors of the World, October 1996 ). At the 1988 FDA Advisory
committe meeting, the Director of Public Citizin's Health Research Group, Dr. Sidney Wolfe
expressed concern about the cancer risks indicated by the Dow Corning rat study. For more
than 2 years after the advisory committee meeting, FDA and Dow Corning repeatedly fought
efforts by the Public Citizin's Health Research Group to have the study documents made
public under the Freedom of Information Act. Most of those who spoke in defense of
silicone implants at the 1988 FDA advisory committee meeting claimed that the Dow Corning
rat study did not provide evidence that implant would cause cancer in humans. In addition,
Dow Corning and other implant supporters cited an epidemiological study: conducted
by Dr. Dennis Deapen and his colleagues (Pike, Casagrande, and Brody), funded by 3 implant
manufacturers, to determine if breast implants increase the chance of developing cancer.
This 'Deapen study' was of 3.000 women in California and indicated no increased risk of
breast cancer. However, an internal FDA review of the Deapen study that had been conducted
during the summer of 1988 "found numerous sources of errors, biases, and
methodological limitations" in the study. Most notably, the FDA reviewers
critized the fact that the patients were studied for an average of 6,2 years, which is "probably
too short to detect breast cancer.... considering that the latency period for foreign body
carcinogenesis in humans appears to be in the range of 20-30 years", "Even
with all the biases inherent in the study design, the authors did note a higher number of
observed cases of cancers at other sites than expected. Based on these results and the
fact that silicone can migrate to other sites, the authors should have addressed this
issue by including cancers at other sites, instead of limiting their study to only breast
cancer". By 1989 the plastic surgeons had reported on the same data again, this
time reporting "increased frequencies of lung and vulvar cancers" among
breast implant patients.
http://yukonmom47.tripod.com/id2.html
http://www.info-implants.com/BC/0028.html
http://gyxe.com/breast-implant/6-691-1992-congressional-report-
on-silicone-breast-implants-part-6-read.shtml
--
STARS SEEKING BALANCE
Dutch Tv-presentator Sonja Barend had in Dutch Tv-programme 'Sonja on Sunday' (1988, bco
VARA) a conversation about changing looks with an owner of a plastic surgery clinic. On
Dutch radio in the programme 'How long is Eternal' (bco RVU, 1988 ) was spoken with
plastic surgeon Dr.Kleinschmidt about "Eternal youth" and
"Life-lengthening". In April 1989 became
known that talk-show host David Letterman had liposuction to deflate his "spare
tire" and that actress Mariel Hemingway had undergone breast-augmentation surgery to
land a starring role in 'Star '80': "It really wasn't done for 'Star 80.' I
did it at 19 years old for me. Yes, I wouldn't have gotten the part had I not had breasts,
because I was playing a Playmate who was voluptuous", Hemingway said on 13
January 2003 on Entertainment Tonight. The implants ruptured and she finally had them
removed. She underwent the controversial hyper-beric oxygen treatment to get rid of all
the silicon in her body. And a book appeared: 'Mariel Hemingway finds her balance'.
http://www.intheknow.org/news11303.shtml
--
SILICONE BREASTAUGMENTATION: SYSTEMIC SCLEROSIS
(Ann Intern Med., 1 September 1989, 111(5 ):377-83,
Varga J, Schumacher HR, Jimenez SA.)
"Our demonstration that silicone escapes from elastomer-silicone-gel breast
implants and appears to be closely associated with a chronic inflammatory reaction,
suggests that silicone plays a role in the development of certain cases of systemic
sclerosis (tissue hardening)". http://www.ncbi.nlm.nih.gov/pubmed/2669593
# Breast implant Silicone can cause Trouble elsewhere
"Silicone used in breast implants can escape from the implant and cause severe
inflammation and hardening of tissue elsewhere in the body, a study reports. The
condition, known as systemic sclerosis, continues even after the implant is removed,
because the silicone already has leaked into surrounding lymph tissue and blood vessels.
From there, it can affect the skin and other connective tissue, the immune system and
internal organs. In extreme cases, it can lead to potentially fatal lung or heart
complications. The study was conducted by researchers at Thomas Jefferson University, the
University of Pennsylvania School of Medicine and the Veterans Administration Medical
Center.. " (The Washington Post, 5 September 1989
)
--
DR. PIERRE BLAIS "IMPLANTS DOUBLE CANCER"
Research chemist Dr. J.J.B. Pierre Blais, working for Canada's Health Protection Branch of
the Department of National Health and Welfare determined that polyurethane foam, used in
Même-implants, were not suitable for implantation. Women with such implants can expect
'double' cancer. One by the silicone gel and another by this foam. Blais was ordered to
destroy his original notes and documents in which he noted that polyurethan foam is not
suitable for implants. Blais was fired because he continued to urge getting the
polyurethane foam-coated implants off the market.
# Chemist Dr. Pierre Blais fired after calling Breastimplant Unsafe
(The Scientist 1989, 3(17 ):7, 4 September 1989, by
David Spurgeon)
Canadian scientist / research chemist J.J.B. Pierre Blais appeals his dismissal,
charges the agency that employed him with trying to stifle his criticism of the
product....
http://groups.google.co.jp/group/alt.support.breast-implant/msg/d935de8d0971cec0
http://www.pahealthsystems.com/printthread.php?threadid=122698
# Health and Welfare's National Disgrace
Canadian Science Writers' Association: 1991 Science journalism award
(Saturday Night Magazine, by Nicholas Regush - April 1991 )
In the past two decades medical devices - from heart valves, infant incubators, and
dialysis machines, to tampons and surgical gloves - have killed, mutilated, electrocuted,
blinded, burned, and injured hundreds, if not thousands, of Canadians. And if you think
the federal government's watchdog agency is serious about policing them, you probably
believe in the tooth fairy. Dr. Pierre Blais is a wiry, cerebral Montreal-born physical
chemist with a solid international reputation for his work on the properties and behaviour
of the various plastics, metals, gels, rubbers, and synthetics being used ever more widely
to repair or enhance the human body........
http://www.redflagsweekly.com/medevices.html
http://www.breastimplantsupport.org/view_topic.php?id=159&forum_id=15&jump_to=330
--
MONKEY BUSINESS: POLYURETHANE
At the 34th Meeting Plastic Surgery Research Council in Atlanta, Georgia in 1989: "T.R.
Hester studied the 'Histology Around the Capsules of Smooth, Textured, and Polyurethane
Covered Implants in Monkeys'. There had been no reports of any adverse reactions from the
polyurethane, but it was still unclear whether the improved results with polyurethane were
primarily due to the texture of the surface or to 'nuances of its chemical
structure'".
--
SILICONE GEL: INERT ?
Also at the 34th Meeting Plastic Surgery Research Council in Atlanta, Georgia in 1989: "J.R. Sanger wondered if 'Silicone Gel is Really
Biologically Inert ?'. When injected into nerves, it did elicit a perincural inflammatory
reaction, but no axonal degeneration".
# Silicone gel infiltration of a peripheral nerve and constrictive neuropathy following
rupture of a breast prosthesis
(J R Sanger, H S Matloub, N J Yousif, R Komorowski, Reconstr Surg. 1992, vol. 89, no5, pp.
949-952 ) "Following rupture of a subpectoral breast prosthesis, massive amounts
of silicone gel migrated into the arm of a patient...(...)...This is the first reported
case of silicone gel infiltration of a nerve and constrictive neuropathy associated with a
prosthesis". http://cat.inist.fr/?aModele=afficheN&cpsidt=5436495
--
SILICONE HYPERSENSITIVITY
Further at the 34th Meeting Plastic Surgery Research Council in Atlanta, Georgia in 1989: "J.P. Heggers, working with Marty Robson, studied
the possibility of 'Silicone Hypersensitivity'. Hydrocephalic patients who had a
malfunction of their shunts not due to infection, had an immunoglobulin band which was
diffused. In excessively high concentrations, when compared with controls, this suggested
an immunologically mediated inflammatory reaction" ('Silicone Hypersensitivity:
An Update', Visiting Professor John P. Heggers, Ph.D. Division of Plastic Surgery, South
Florida University, Tampa Florida, 11 May 1994, http://www.bio-germ.com/Resources/ArtistDetail.asp?ID=64
)
# Silicon-Induced Contracture Syndrome
(The Truth Campaign Magazine, Issue 33, by Ivan Fraser, November 2005 )
"Do additives in health food supplement and pharmaceutical tablets make us Ill ?
The following article explores the theory that silicon dioxide - a chemical excipient in
most nutritional supplement pills and many pharmaceutical drug tablets - may be the cause
of a range of symptoms, including forms of Chronic Fatigue Syndrome...." http://www.ivanfraser.com/articles/health/sics.html
# Silicone Hypersensitivity
Elisa / Act Biotechnologies Clinical Update #11
http://www.elisaact.com/pdfs/CLUD-11-Silicone.pdf
# - FDA AWARE OF PROBLEMS:
Silicone-victim L. (02 January 2007 ): "Myself and my two sons -born after
implants- became very sick from the silicon in our medications. After learning that we
were hypersensitive to silicon, I found that it was in all of their medications. Once we
removed and or switched all of their meds to silicon free meds, their health improved
dramatically in a matter of a couple of weeks. They were both very ill with numerous
unexplainable medical problems. My eldest child -born of implants- tested positive for
Lupus and I was told that youngest had JRA- arthritis, due to the swelling in his joints.
The FDA has an interesting section about silicone hypersensitivity in the 2004 consumer
handbook on breast implants. I have been trying to get them to insist on a silicon
hypersensitivity analysis but they refuse. As far as the breast implant issue, I have
"proof" that the FDA knows that the MRI's (magnetic resonance imaging), that
they are using for the current safety studies, do not work. After pushing the issue and
challenging them they admitted that, "the MRI's don't even show chunks of migrated
silicone gel"..." http://www.opposingdigits.com/forums/viewtopic.php?t=4345
--
GROWING IMPLANTS UNREST: LAST A LIFETIME
The unrest, in a.o. US Congres, about the dangers of silicone breast implants for health
grew: 'The silicone implant scare', critics called it. Sowing panic while
charlatans promised salvation through exotic therapies, claiming silicone could be sweated
out at a clinic in Mexico. The growing unrest spread to Europe arond 1990. Many years Dow
Corning promised that implants would "last a lifetime". In the beginning of 1990, after many years of profit, Dow Corning changed its
package inserts to warn that most implants are unlikely to last more than 10 years. This
meant that the majority of women with implants needed surgery to take them out. Despite
the impact of implants on auto-immune and other diseases.
--
SURGEON "IT'S FOR WOMEN ALL ABOUT THE MONEY"
Belgium plastic surgeon Dr Wim de Maerteleire (graduated at the Catholic University
Leuven, founder of Mediplast http://www.mediplast.be
) wrote in an article 'Why America chooses salt and Europe silicone': "....the
medical legal system in America....no cure no pay principle....Therefore in America many
patients see 'big money' in going to trial against their doctors...Beginning
1990 a great number of patients saw big money in their silicone prothesis. They
namely claimed that you get cancer, joint-disorders, skin-disorders etc from
them...Silicone is in present than yet about the most studied product for medical use. No
study could find a link with cancer or any other disorder. The medical world is than yet
convinced that silicone are completely safe..." http://www.borstenforum.nl/index.php?name=News&file=article&sid=3
# - Reaction from the Dutch Foundation Support for
Women with Silicone Implants (Stichting Steunpunt voor Vrouwen Siliconen implantaten, SVS)
/ founder Marlou Boots on the article of Dr Wim de Maerteleire (to the Dutch Ministry of
Health VWS): "Under which denominator shall this article fall ? Objective
information, Creative deception, Twisting and turning of facts or plain lies ? Can and may
a doctor just publish such ?".
--
CANADA COVER-UP: BREAST IMPLANTS
Linda Wilson suffered serious infections after having had Meme implants. She had
both implants removed. On 6 February 1990 she wrote a
letter to the then-commissioner Norman Inkster asking for an investigation into why Health
Canada exempted Bristol-Myers Squibb's Meme implants distributor (Real Lapperière Inc.)
from having, in line with regulations, to register the devices and ensure their safety. No
action was undertaken, said Robert Chartrand of the Royal Canadian Mounted Police 8 years
later to the Toronto Star who reported the case. Robert Chartrand started an investigation
looking at Health Canada's regulation of the Meme breast implant and of all silicone gel
implants, including Dow Corning's devices. (Network, http://www.cwhn.ca
, Volume 1 No.3 )
A WOMAN IN MY POSITION: THE POLITICS OF BREAST IMPLANT SAFETY
Book by Linda Wilson in which she discusses her own case and how she (almost single
handedly) uncovered the huge 'big business practice' cover-up of the underhanded deeds of
companies (e.g. breast implant manufacturers) and deception in Canada and the American FDA
involvement: " Dr. Blais said that once inside the body, the polyurethane covering
begins to disintegrate almost immediately. It could become entwined with breast tissues
rendering its complete removal virtually impossible and it could make the treatment of
infection prolonged and difficult. ". http://www.cwhn.ca/search/pubRecord.htm?ObjectId=106622&category=Breast%20Implants
--
TEXTURED SILICONE IMPLANTS
At the 35th Meeting Plastic Surgery Research Council in Washington, D.C in 1990:
# - "Robert Brohim, working with George
Rodeheaver from Charlottesville, reports on 'A Histological Evaluation of the Early Tissue
Reaction to Textured Silicone Surfaces' studying a number of commercially available
materials and suggesting that implants with significant surface texturing disrupt and thus
delay the formation of a continuous collagen capsule around the implant. The degree and
maturity of tissue reaction was proportional to the magnitude of surface texturing".
# - "David Ruebeck, from Indianapolis, reports
on 'Fibrous Capsules Formed Around Smooth Versus Textured Silicone Implants'. He felt that
in their rabbit model, there was not a significant difference in contracture pattern or
collagen makeup of two types of implants although there was evidence of a gross structural
difference with the textured implant producing a thicker, more opaque, and more vascular
heterogeneous capsule. This suggested that the textured implants do not prevent capsular
contracture when compared to smooth silicone implants".
# - "Mimis Cohen, from the University of
Illinois, also studied 'Capsular Contracture Around Various Types of Silicone Breast
Implants' and with a tensiometer, showed significantly thicker capsules around
smooth-walled implants in pigs. Some of their implants were filled with saline and some
with silicone and they did not see that this played any significant role in capsule
formation".
--
BELIEF: FDA - MOST IMPOTENT AGENCY IN WASHINGTON
A US district court orders the FDA to make public hundreds of animal studies as from the
'60s which Dow Corning had given to the FDA. The FDA got hold of these studies under a
'strict confidential' procedure. Dow Corning gave 329 studies to FDA. On 27 November 1990 Federal District Court judge, Stanley
Sporkin, ruled in a suit brought by consumer advocacy organization Public Citizen Health
Research Group --whom had been attempting since 1972 to get the courts to say that data on
safety and effectiveness of drugs and medical devices should be public-- that under the
Freedom of Information Act the FDA had to release more safety data on silicon breast
implants voluntarily submitted by manufacturers. "A major, major victory",
said Dr. Sidney Wolfe of Public Citizen. Judge Stanley Sporkin: "The FDA
would have this court believe that it is the most impotent agency in Washington, and that
the only way it can protect the public's health and welfare is by begging manufacturers of
possibly lethal devices to submit information voluntarily". Health care advocates
welcomed the ruling since rheumatologists, epidemiologists and cancer specialists for many
years heard horror stories from implant patients and had to deal with the consequences of
their surgery. Despite written documentation, the general public was not been made aware
of possible health hazards of breast implants.
--
DOW CORNING: DESTROYING MEMOS
Researcher Mary Ann Woodbury wrote in a 1990 Dow
Corning memo that her analysis of government survey data showed only 250,000 to 800,000
-while Dow officials had claimed 2 million-- women had implants. Showing that implants
were sold to women already having (defected) implants ? Dow Corning argued (The Houston
Chronicle, 4 December 1993, Andrea D. Greene ) that defect-rate could not be established
by simply comparing the number of women who actually have implants to the number of
implants sold. Misleading incorrect information to physicians and the FDA ? And Greg
Theiss (Dow attorney) ordered Woodbury and Chuck Dillon (Dow's medical director) to
destroy all copies of Woodbury's memo. The memo mentioned: "25.9 percent of
the devices have had some type of problem associated with them. This translates to 30.3
percent of the women with some type of problem" http://www.freewebs.com/implants/memos.htm
--
CONGRESSIONAL HEARING
While in September 1990 W.L. Miller (Dow Corning Wright Marketing) in a telex stated:
"The FDA continues to exert tremendous influence on the ways in which we manage
our business", end of 1990 a U.S. Congressional hearing headed by New York
Representative Ted Weiss deals with the safety of, and health problems associated with
silicone breast implants. Breast implants were risky. The FDA had received 2,017 reports
of adverse reactions from silicone implants. The hearing also discusses the fact that not
all the information that the manufacturers have are available for public scrutiny due to a
court order from the Stern-verdict. The concern resulted the Safe Devices Act:
health care providers must report complications or fatalities with medical devices to the
Department of Health and Human Services and to the device manufacturer who must notify the
FDA. Representative James A. Traficant, Jr. (OH): "At hearings in December 1990, Dow Corning misled the House Committee on
Government Operations by testifying that silicone posed no safety problems or health
risks. In addition, Dow Corning also refused to provide key documents requested by the
committee"
--
DUTCH QUEER WORLD OF PLASTIC SURGERY
Barbara van Beukering spoke in Dutch Tv-programme 'Pauze Tv' (bco AVRO, 1990 ) with Dutch
plastic surgeon Martin Koopman about breasts and plastic surgery and their influence on
the life of women. A later episode was about the effect of plastic surgery on daily life.
Dutch Tv-programme 'Around Ten' (Rondom Tien', October 1990; bco NCRV) tuned into this by
making a broadcasting about function and meaning of the breasts of women: women
about breast-reduction, -enlargement and Prof. Bouma (surgeon VU Amsterdam hospital) tells
about operations. In December 1990 the Dutch
news-journal 'NOS-journaal' mentions that Dutch hospitals for competitor-reasons wanted to
start own commercial clinics. And just before new year 1990 Dutch Tv-presentator Ivo Niehe
(bco TROS) came with a Tv-broadcasting, besides about the story of 40 years of plastic
surgery in the Netherlands, about "how much more the plastic surgery does than
cosmetic intervention": 'The Queer World of the Plastic Surgery'.
--
SURGEON "IT'S ONLY ABOUT THE MONEY"
In the US, a successful surgeon could hope to earn as much as $3 million a year. Houston
plastic surgeon Franklin Rose said advertising had created "a breast-implant
free-for-all, Twins would come in, sisters would come in, and I'd go from room to
room". Another Houston doctor, Gerald Johnson, said "The most surgeries
we did in one day was 17". Gerald Johnson celebrated his success by building a
breast-shaped pool at his home with a nipple-shaped hot tub. By 1990, over a million women
had gotten "boob jobs". (Center for Media and Democracy, 1996, 3(1 ), J.Stauber,
S. Rampton).
--
CONNIE CHUNG: FACE TO FACE
In the US sick women started to appear on television in december
1990: manufacturers earned money from implants while knowing that women got
sick from them. The CBS Tv-programme 'Eye / Face to Eye / Face' with met Connie Chung
(Emmy nomination) started to report about the dangers of breast implants. Connie Chung
interviewed women, among who Sybil Goldrich, who claimed that their breast implants gave
them autoimmune disorders and conveyed the message that implants were dangerous devices.
Connie Chung called silicone gel "an ooze of slimy gelatin that could be poisoning
women". After the broadcast aired, physicians reported an "avalanche"
of calls from women who were concerned about the safety of their implants. The show,
viewed by millions of Americans, "unleashed a torrent of protests and
investigations around the country". Plastic surgeon (Annapolis, Maryland) Marcia
Ormsbsy: "The implant crisis started with Connie Chung and it quickly
became headline news". Also Marcia Angell, M.D. --the Executive Editor of the New
England Journal of Medicine and, some say, one of the most influential doctors in the US--
criticized Connie Chung for "implicitly [blaming] the FDA for permitting such
risky products to be sold". Angell argued that Chung terrified thousands of women
into believing that their implants were walking time bombs. Agreeing with Marcia Angell,
Columbia University law professor David E. Bernstein also had criticism: Connie "Chung's
tendentious coverage favoring the plaintiffs claims set the tone for media coverage of
breast implants for the next five years" A more balanced report would have been
more useful for all, Bernstein found. But these judgements made in Connie Chung's show,
the kick off of the implant scare as some called it, put the FDA under additional public
pressure: to act in a different way than they would had done uptill this moment
without these judgements ?
--
STUDIES: DOW CORNING WANTING DIRECT CONTROL
In January 1991 Dr. Cherup had send a letter to ASAPS
returning a research grant. She did not get any cooperation from Dow Corning and Mentor.
They "more or less told that they did not want their textured silicone implants
involved in any studies over which they were unable to have direct control".
Cherup stated that she did not want to add to the "the mound of already existing
information wrought by studies which are biased as being supported by one company or
product or another" (Dow Corning Trial Exhibit, #516 ).
--
DOW CORING'S MORAL VALUES: MISLEADING FDA
End February 1991 Eldon Frisch (an employee of Dow
Corning) wrote a memo to Garry Brody, M.D. about letters from the FDA on the use of
silicone fluid on hypodermic needles: "I have found the letters from FDA
that have served as a basis for the use of silicone fluid on hypodermic needles and
syringes for many years. I have removed all references to Dow Corning just in case these
letters somehow find their way back to FDA. I have been asked by some of the individuals
at FDA about the basis for silicone fluid being used on syringes and needles, and have
never produced these letters. There are some who believe that if FDA cannot identify how
it came about that fluids were allowed on syringes and needles, then it is difficult for
them to rescind the approval".
--
DUTCH ACTRICE SYLVIA MILLECAM: IMPLANTS
The IGZ-report does not mention whether the Dutch Healthinspection IGZ has demanded
information for examination and 'inspection', as the Dutch Law on Medical Devices offers
the IGZ that possibility, about information of the breastimplants of Sylvia Millecam. "Doctor
for internal diseases dr. H.F. Dankmeyer has called in information at the Dutch Kennemer
Gasthuis Hospital but has never received this", thus the IGZ-report. The Dutch
Kennemer Gasthuis Hospital in Haarlem earlier did not want to give information about the
nature and origin of Sylvia Millecam's implants to the editorsboard of the Dutch magazine
'Aktueel' (article Marlou Boots / Dutch Supportgroup SVS). But for the book of reporter
Alje Kamphuis ('Sylvia Millecam op gevoel', 2006 ) Dutch plastic surgeon Joost B.B. van
Tetering of the 'Kennemer Gasthuis' hospital in Haarlem, whom placed Sylvia Millecam's
breastimplants, 'suddenly' in 2005 did give insight in the medical records of Sylvia
Millecam. According to Alje Kamphuis / Joost B.B. van Tetering Sylvia Millecam had
breastimplants in 1991 From Sylvia Millecam's medical
records it appears, as described in Alje Kamphuis's book (pg. 162 ), that:
# - (A) Joost B.B. van Tetering: "All
our surgeons put in a written report (e.g. operation-report) which implants are used. This
was also in 1991 already obligated and also far before that time" and which kind
of implants of which big American company had used at Sylvia Millecam in 1991:
# - (B) "Informed is at the
mothercompany in America" and they appeared to have been 'silicone-implants'
and not the perilous 'polyurethan prothesis'.
On the patient-card of Sylvia Millecam there would be a sticker of McGhan Medical
Corporation. One could asks oneself: if this sticker has always been on there, or
if the sticker was placed on it áfter the death of Sylvia Millecam ?
--
(A) VAN TETERING "REGISTRATION BREASTIMPLANTS SINCE 1991"
# - MP Mrs.Beckers-de Bruijn (Green Left-party) in
Dutch Parliament ( 17-12-1991 ): "Chairman ! I have had an answer
last week on my question about siliconebreast prothesis and I make up out of that that
there is no systematic registration of harmful side effects taking place". Mrs.
Kamp (VVD-party): "Also my party has great appreciation for the plan of the
council to together with the plastic surgeons to create a national information system for
guarding quality of implants, too begin with silicone breastprothesis".
# - IGZ Headinspection medicine drs. P.H. Vree in
Dutch Parliament ( 1 Februari 1994 ): "Also the inspection is
involved at the reports of problems with medical devices", "Everything what is
on the market in the Netherlands, must be seen by the Dutch government, thus by the
inspection", "the Netherlands has had not so terribly much legislation in
reference to medical devices", "Maybe the Netherlands has been the
test-territory for medical devices".
# - Dutch Health Minister Els Borst in a letter to
Dutch Parliament ( 31-01-2000 ): "The Commission Silicone-implants
of the Dutch Healthcarecouncil attaches great value to registration of an implant. In this
registration should be recorded the data of the woman as well as from the implant",
and (10 April 2002 ), Minister Borst: "Yes, the Dutch Normalisation
Institute has executed an attainable-study into the putting up and maintaining a general
implants register".
# - MedWeb/ANP ( 5 July 2002 ): "The
registration of implants is bad", thus prof. J. Nicolai, head of the department
plastic surgery of the Dutch Academic Hospital Groningen (AZG)..In the Netherlands upto
1998 there was a limited databank, but it is not prolonged anymore. The government did not
see much in it, sais Nicolai...
# - Dutch newspaper 'Volkskrant' ( 31-12-2002 ):
"Hospitals do not comply to the obligated registration of breastimplants.
Therefore is is difficult to call back women if it seems that the filling of the implants
are unsafe...".
# - Dutch Newsagency ANP ( 31-12-2002 ):
"Since 2001 all European countries are obligated to keep a national
plastic-implantregister. But the Netherlands does not comply to that. The registration of
silicone breastimplants is in the Netherlands even since August 2002 completely stopped,
because there is no money for it...".
# - Missing prothesis: Implants unsufficient
registrated: "Hospitals only make note of a fraction of silicone breast
implantations. If afterwards it seems that filling are not safe and leak, it is almost
impossible te recall all women in short time to the hospital. That writes professor
Chantal van der Horst, plastic surgeon in the Amsterdam AMC, and Steven Klein, medical
student in Dutch medical magazine 'Medisch Contact' (jrg. 58, nr1, 03-01-2003
)......Since 1995 plastic surgeons are asked to send in a standard-form after the placing
of silicone breastimplants....In practice it appears that the number of reports do not
agree with the number of sold implants. In 1999 1,354 implants were registered, towards
11,966 sold silicone breastimplants to private-clinics and hospitals..."
(Nieuwsbank).
# - Road of suffering with breastimplants: "She
has just got back from hospital. Outof her previous operation she held over a stoma and a
great infection in her leftbreast. 12 years ago Gonda Buurken (57 ) got new
breastimplants...(...)...the legal battle against the maufacturer of her breastimplants,
Dow Corning, took 10 years. Is was a great fuss. Just only showing which implants the
doctors all those times had used, for example. It was not in the
operation-reports..." (Dutch newspaper 'Algemeen Dagblad', 8 November 2006
).
# - News from the Council for National healthcare, RVZ
( 15-02-2007 ): "The Dutch Orthopaedy Association pleas for a
national register for prothesis. With such a register the insight in the effectiveness and
quality of prothesis increases. That is good for the patient and it also saves money.
Registration rather seems to get difficult of the ground in the Netherlands...".
--
(B) VAN TETERING "SILICONE-, NO POLYRETHANE PROTHESIS"
# - Chemist gets fired after calling breastimplant
unsafe: "Canadian scientist / research chemist J.J.B. Pierre Blais appeals
his dismissal, charges the agency that employed him with trying to stifle his criticism of
the product...(...)...That product is a polyurethane-coated breast implant known as Même.
Blais first became interested in it in 1979, and the more he learned about M~me, the more
concerned he became about its potential harmful effects on the women who had received it
as part of reconstructive or cosmetic surgery. Blais is not the only scientist to hold
such views. All silicone gel-filled breast implants are unsafe, says Douglas Teisch of the
Health Research Group, a Washington, D.C.-based consumer advisory body, and
polyurethane-covered types are "a particularly noxious" variety...."
(The Scientist 1989, 3(17 ):7, 4 September 1989, by David Spurgeon).
# - Diana Zuckerman (President, National Research
Center for Women & Families) in a reaction (27-06-2006 ) to the findings of Dutch
reporter Alje Kamphuis and doctor surgeon Van Tetering: "Breast implants
can be silicone without polyurethane or silicone with polyurethan. Polyurethane covered
breast implants have silicone on the inside, and polyurethane covering the silicone
envelope. The reporter and doctor are both mistaken if they think that polyurethane
covered implants were not also silicone implants. Most (if not all) polyurethane covered
implants were silicone gel inside, and all had a silicone shell under the polyurethane.
The polyurethane covering was determined to break down to a known carcinogen, TDA, and
were taken off the market in the US in 1991, not 1992. I believe that they are still sold
in some countries, which is terrible - they are the most dangerous breast implant ever
made. According to the website, McGhan sells a Style 40 that has a smooth shell, NOT
polyurethane. I don't know if they used to be different years ago, but usually they would
change the style number if they changed the material".
--
MARLOU BOOTS Sylvia Millecam canceled a follow-up appointment in the Dutch AZVU
Hospital for 19 June 2000. She prefered an alternative treatment, and Sylvia Millecam
seeked contact with Marlou Boots of the Dutch Silicone-Support Group SVS for Women with
Silicone Implants. Sylvia Millecam and Marlou Boots sincethen had a good contact and they
started to investigate because "Sylvia didn't trust it all", thus Marlou
Boots. Marlou Boots and Sylvia Millecam discovered that the silicone implants were the
cause of Sylvia Millecam' sickeness (Silicone Associated Disease). Marlou Boots: "In
the literature we soon found out what kind of implants Sylvia had: Polyurethane
silicone".
--
POLYURETHANE IMPLANTS CAUSES CANCER
In April 1991 the New York Times reported that a type
(Meme and Replicon) of breast implant (polyurethane coated), made by Surgitek, a
subsidiary of Bristol-Meyers Squibb Co.--the type Canadian scientist Pierre Blais
questioned years earlier-- breaks down in the body and produces a chemical (2-toluene
diamine: TDA) that has been shown to cause cancer. Pierre Blais also had a TDA-concern
about the risks for fetuses and breast-feeding infants of women with implants. According
to the American Society of Plastic and Reconstructive Surgeons, since the 1960s, about 2
million (according to FDA scientists and the House panel, the Government Operations
Subcommittee on Human Resources and Intergovernmental Relations: 3 million, and according
to member of FDA's public affairs staff Marian Segal an estimated 1 million) American
women had breast implant surgery. Many women complained of problems, among them infection
and pain. 25% of all implants were the kind tied to the cancer risk. But FDA-spokeswoman
Sharon Snider said: "the implants pose no imminent danger to women who have them
right now". While Surgitek studies showed that the number of cancers caused by
release of TDA into the body would be "one in several million implants",
the FDA reassured the public and plastic surgeons: "low cancer risks": a
lifetime cancer risk from 1 in 10,000 (a "unrealistically high" estimate)
to 1 in a million. The FDA based themselves upon a risk assessment method that treats the
implanted material as if it were ingested (not implanted). Comparing an apple with a pear
? Dr. Pierre Blais: "Women do not eat implants". New York Congressman Ted
Weiss, chair of a committee of the House of Representatives which oversees the actions of
the FDA, accused the FDA of misleading the public. Internal FDA documents seen by the
committee: "revealed that the most recent public FDA statements on these
implants do not accurately reflect the conclusions of the FDA's own scientists".
These internal documents from FDA scientists showed a different FDA believeconviction,
than the one the FDA had made public: "the cancer risks may be more than 100 times
the levels reported by FDA and by Surgitek": 1 in 50 to 1 in 500, on basis of
experiments of Dr. John Autian, researcher at the University of Tennessee, who tested 17
different (implanted) polyurethane foams in animals: "Feeding studies are O.K. for
something taken by mouth, but not for something that will be in the body's environment,
sloshing around for months and years". Also National Cancer Institute studies
from the early 1960's showed that TDA caused cancer in 1 on 6 animals. Ted Weiss also said
the FDA failed to mention the 'risks of birth defects' in its public statements. While non
of the implanted women were in anyway warned or called back, Bristol-Myers Squibb Co.
quickly (temporarily) halted shipments of the breast implant devices, took the implants
off the market and claimed to have stopped selling them. After April 1991
polyurethane-covered implants were no longer marketed. While the FDA had reported that the
foam instantly, after placing in the body, due to bodytemperature, dissolves, Bristol
Myers (Surgitek spokeswoman, Karen Garoukian Ferraro) publicly maintained it's obstinate
belief that polyurethane foam coating remains intact after implantation, and Boston
surgeon Susan Love said: "The uproar over implants has needlessly scared women to
death". Social unrest ? Dr. Susan B. Love is mentioned in Dow Corning's public
relations efforts strategy regarding the FDA hearings end November 1991.
http://www.newscientist.com/article.ns?id=mg13017682.100
http://query.nytimes.com/gst/fullpage.html?res=9D0CE6DA1E3AF93BA25757C0A967958260
http://query.nytimes.com/gst/fullpage.html?sec=health&res=9D0CE1DE1F3AF935A25756
C0A967958260
http://query.nytimes.com/gst/fullpage.html?res=9D0CE3D8103BF932A3575BC0A967958260
http://query.nytimes.com/gst/fullpage.html?sec=health&res=9D0CEEDC1338F937A25757C0
A967958260&n=Top%2fNews%2fHealth%2fDiseases%2c%20Conditions%2c%20and%20
Health%20Topics%2fPlastic%20Surgery
http://query.nytimes.com/gst/fullpage.html?res=9D0CE1DE1F3AF935A25756C0A967958260
# Time Bombs in the Breast ?
(29 April 1991, By Andrew Purvis, Time Magazine)
"Susan Cox, 49, was horrified. After a death-defying battle with breast cancer and
a prolonged recovery that included reconstructive surgery, the Chicago nurse learned last
week that the very implant used to repair her breast could raise her risk of developing
cancer once again..." http://www.time.com/time/magazine/article/0,9171,972846-1,00.html
--
SILICONE TIME LINE
--
FDA "PROVE WHAT YOU CLAIM"
In April 1991 as a consequence of the
re-classification to Class III in June 1988 and under pressure of media-reports
('signals') about sickneses, complaints of women, the FDA requested the manufacturers to
deliver proof, studies for judgement, that silicone prothesis (saline-filled implants
would be evaluated in the future) were safe and effective. Dr. Diana Zuckerman, as
investigator of Congress, had access to al these studies and to the internal FDA documents
involved in this. The FDA had given the manufacturers an ultimatum: prove within 90 days
(deadline 9 July) implants are safe and effective or take them off the market. The FDA
then had 180 days to study the evidence. The FDA had ordered manufactures to give doctors
easy-to-read information (de-coding doctor' language) because the unaware women
considering and/or receiving (150,000 a year) breast implants had to be told (post
'pre-marketing surveillance') about the health risks, potential dangers from implants:
hardening of breast tissue, shielding possible tumours (mammograms), and ("based on
less conclusive evidence") linking leakage of silicone implants to autoimmune
diseases and cancer. FDA hearings would follow. By the deadline, 9 July, only Mentor
Corporation, McGhan Medical Corporation, Dow Corning and Bioplasty, Inc. had submitted
pre-market approval applications to the FDA.
DOW "THE ISSUE OF COVER-UP IS GOING WELL"
"The issue of cover-up is going well", Dow Corning CEO Dan Hayes wrote in a
1991 internal memo * (provided to Mediawatch group FAIR by anti-Dow breast implant
activists). "Obviously, this is the largest single issue on our platter because it
affects not only the next 2-3 years profitability of Dow Corning Company, but also
ultimately has a big impact on the long-term ethics and believability issues.... What is
at risk here is somewhere between $50 million and $500 million'" (Extra Magazine,
July/August 1996, By Laura Flanders, "PR Firm Finds 'Grassroots' Support for Breast
Implants" http://www.fair.org/extra/9608/breast-implants.html
) [ * Note: 24 June 1991 - Hall (Dow Corning) memo to Gary Anderson, Campbell, Carmichael,
Biggs, LeVier, and Jenkins regarding the 'DCC Committee' ]
--
THE NETHERLANDS: "PLASTIC SURGERY POPULAR"
Dutch Tv-presentators Mart Smeets and Maartje van Weegen presentated Dutch Tv-programme
'NOS-laat' from Dutch broadcasting organisation NOS in june 1991:
body-corrections by plastic surgery had become very popular and very common. In an
interview the editor of the American fashion magazine 'Vogue' told that plastic surgery in
the United States was an enormous growth-market, but plastic surgeon Andries Molenaar, the
first cosmetic surgeon of the Netherlands, found the American eagerness for
body-corrections not desirable. In the Netherlands, he found, surgeons handled patients
responsible. They did not perform operations if one had a psychological problem.
--
DOW CORNING'S ETHICS
On 10 June 1991 in Business Week magazine an article
was published accusing Dow Corning of concealing documents for a decade about product's
safety. Implants could deteriorate and leak (not "lasting a lifetime") effecting
the immune system and cause cancer. The first time Dow's ethics were questioned, said John
E. Swanson, guardian / creator of Dow Corning's much-admired ethics program, manager of
internal communications and the sole permanent member of Dow's top Business Conduct
Committee, which dated back to the years 1970s and was considered an industry model. On 4
June 1991 Swanson had send a warning note to the Business Conduct Committee' chairman
about the Business Week article which was hurting Dow's "hard-earned
reputation" and asking: "If there is a growing body of anecdotal
evidence of health problems (even in the absence of studies), should a responsible
manufacturer stay in the market ?". Swanson found that "it was time to
re-examine our position". Swanson discussed with the Business Conduct Committee
(including Dow Corning's influential Director of Sales and Marketing, its Vice President
and General Manager) about suspending sale and manufacture of implants. And Swanson spoke
with an executive. A fictional press release was made up for use in a Corporate Board of
Directors meeting on 10 June 1991, where the issue would also be discussed: "Dow
Corning Wright will suspend the manufacture and sale of breast implants until research on
certain bio-safety issues has been concluded...." (Andrew Singer, May/June 1994
). But eventually it was no wake-up call, the Board of Directors decided to stay in
business believing that production suspension would be admitting implants were dangerous
which would invite more legal actions. Swanson spoke of an "insulated
organizational syndrome", an "attitude of invincibility", "What
Dow Corning needed was a leader with a sixth sense".
DOW CORNING: THE 'SICK' SENSE
(By: Kathy L. Keithley Johnston, R.N., Legal Nurse Consultant, Breast Implant Specialist,
Medical Director Toxic Discovery Network http://nweb.plastikos.com/PlainTxtNL.htm
) On 18 september 1991 John E. Swanson, guardian of Dow Corning's much-admired ethics
program, tells Dow Corning that he can no longer accept its decision to continue selling
silicone breast implants and submits his refusal. A refusal means he would have nothing
more to do with the product - he would not discuss it or help the company defend itself
against criticism: "I approached top management. I told them that I had an
ethical conflict of interest with the company's breast implant position". This
conflict came after, among other things, Swanson's wife endured one debilitating illness
after another for 17 years - illnesses she believed to be caused by the silicone breast
implants manufactured by her husband's company. Several doctors had examined her but
couldn'td find an explanation. No diagnosis by the M.D.s. Eventually a surgeon had to work
3 hours to remove the silicone breast implants that had been in her chest for 17 years.
Swanson left Dow Corning where he worked for 26 years, moved from Michigan to Indiana,
starts his own company Applied Business Ethics, considering to write a book on the breast
implant controversy: "The ethics process worked while the company had no
problems. But when the company's feet were put to the fire, the process failed"
(Andrew Singer, May/June 1994, 'In breast implant scandal, where was Dow Corning's concern
for women ?' http://www.singerpubs.com/ethikos/html/dowcorning.html
)
--
LAWSUIT: BRENDA TOOLE -Vs- BAXTER
In July 1991 Toole-vs-Baxter Healthcare Corporation,
Alabama. A Jury decides against Baxter/Heyer-Shulte Corporation and awards Brenda Toole
the largest settlement so far, $5.4 million, which the judge later reduced to $2.27
million. Toole, who shows only preliminary symptoms of systemic autoimmune problems,
nevertheless had silicone in her lymphatic system according to plaintiffs' witnesses and
thus an increased risk of developing an autoimmune disease, as a consequence of her
ruptured silicone implants.
DOUGLAS R. SHANKLIN
Earth is flat: when the majority, or a few determining individuals, who influence
the thinking of the mass, do not belief it, it is not true ? The verdict in the
Toole-vs-Baxter case was appealed: "The only evidence that Brenda Toole is
at increased risk for cancer and immune system diseases is the testimony of Dr. Shanklin.
Baxter, on the other hand, produced evidence which tended to show that the overwhelming
majority of the medical establishment disagrees with Dr. Shanklin. It is clear that today,
in 1991, the scientific basis for Dr. Shanklin's views is not generally accepted; in 1981,
there was even less basis for a belief that a ruptured implant could cause cancer"
http://cases.justia.com/us-court-of-appeals/F2/999/1430
http://caselaw.lp.findlaw.com/cgi-bin/getcase.pl?court=11th&
navby=case&no=9915019OPN
--
IMPLANT-MAKER: FALSE UNPROVEN CLAIMS
End July 1991 Bioplasty Inc., manufacturer of 'Misti
Gold' inflatable breast implants, was accused by the FDA of making false unproven
misleading claims and selling an unapproved illegal product. The device would not obscure
mammograms and thus allowe for easier detection of breast tumours. The implants were
seized.
--
FDA: DATA MANUFACTURERS NOT SUFFICIENT
In September 1991 the FDA concludes that the silicone
breast implant manufacturers' safety data does not prove the devices are safe or harmful.
Manufacturers are told to submit further data.
--
DOW'S 'GRASSROOTS' PR-STRATEGY: BURSON-MARSTELLER
In 1990 Dow Corning billed it's PR-firm Burson-Marsteller $6,000 in PR fees. From May 1991
through February 1992 Dow's billings to Burson-Marsteller increased to $3,776,000 with
gross income of $1,384,000. 'Grassroots' is a corporate buzzword for a PR strategy. It
uses corporate wealth to subsidize orchestrated mass campaigns that put seemingly
independent citizens on the front lines as activists for corporate causes.
DOW CORNING: MANIPULATION PUBLIC OPINION AND MEDIA
Dow Corning's Media Plan - The following document was obtained in discovery in the breast
implant litigation. It contains a detailed proposal by Dow's PR-firm Burson-Marsteller
Public Relations of 14 October 1991 outlining Dow's
public relations efforts prior to anticipated FDA hearings on the saftey of Breast
Implants: Objectives, Audiences, Strategies, Activities, Trained patient
spokespersons, Trained physician spokespersons, Contacting top medial columnists, top
national issues columnists, Story ideas, Putting together a team of oncologist or other
doctor, two patients and a Dow Corning spokesperson, Dow Corning Wright's targeted
Media-list an Medium-contacts. http://consumerlawpage.com/article/mediamanipulate.shtml
PR PLAN BREAST IMPLANTS: MANIPULATION SCIENCE
"Once reviled as corporate villains, the manufacturers of silicone breast implants
have made a stunning comeback recently in the court of public opinion. A series of
scientific studies and news stories have emerged, arguing that breast implants are in fact
harmless, and that companies such as Dow Corning and Bristol-Myers are hapless victims of
misguided women, greedy attorneys and manipulated juries. This turnaround is no accident.
PR Watch had obtained internal documents from Burson-Marsteller, the PR firm which
engineered Dow Corning's PR strategy in the early 1990s. The documents provide an
intriguing peek into a massive, expensive, and carefully orchestrated campaign that
integrates state-of-the-art grassroots PR with subtle manipulations of science and the
legal process: The Internal Burson-Marsteller PR documents state (among others):
- "Utilize spokespeople, drawn from women's cancer support groups in major markets,
to defend mplants by writing letters to the editor and participating in media
interviews".
- "These women (including celebrities) will be trained and testimony will be written
for them to deliver before Congressional committees".
Burson-Marsteller advised that cancer specialists should be recruited as
"spokesdoctors" to defend the company in the top 15 media markets in the United
States, because "an oncologist obviously has more credibility than a plastic
surgeon"". http://www.prwatch.org/prwissues/1996Q1/silicone10.html
Cancerspecialists / oncologists not as independent thinking individual, but as ('between
the ears') 'influenced' pawns in the great breastimplant risk-game in the backyard of the
peoples ?
--
SURGEONS DEFEND BREAST IMPLANTS: MEDIA-BLITZ
As the FDA prepared to rule on 4 January 1992 on whether silicone breast implants can be
used, the Boston Globe (Carol Stocker) reported on 31 October
1991 that Plastic surgeons, some of whom earn up to 50% of their incomes from
breast surgery, were countering the accusations that women face serious dangers from
silicone implants. Countering how ? By unleashing their 'secret weapon': satisfied
customers ('anecdotes'). The surgeons launched a million-dollar lobbying and media blitz
featuring newspaper ads with the names, photos and testimonials of women who had had
breast surgery, and the headline: "Millions of women have chosen implants. You may
never have that option". Anne Gorman, spokeswoman for the American Society of
Plastic and Reconstructive Surgeons (ASPRS): "We feel the women are our
best spokespeople". An ASPRS-statement based on feeling / emotion pointing
towards what certain people in certain situations call: "anecdotical evidence" ?
In an article (12 November 1991 ) 'FDA begins breast
implant hearings - safe enough to stay on market ?', Marlene Cimons (Los Angeles Times)
--mentioned on Dow Corning's targeted media list-- lets implanted women come to word:
"Silicone gel implant has given me back my life".
--
FDA HEARING / ADVISORY PANEL: IMPLANTS NOT-OKAYED
On 12 november 1991 head FDA commisioner David Kessler
brings together, for three days, its General and Plastic Surgery Devices Panel to review
all of the safety data from the manufacturers' Premarket Approval Applications (PMA). The
purpose of the panel is to advise FDA as to what they could tell the public about the
safety and effectiveness of the silicone breast implants based on the PMA's. The panel is
composed of a broad range of experts, including representatives from the fields of plastic
surgery (some plastic surgeons earn up to half their incomes from breast surgery),
oncology, epidemiology, internal medicine, immunology, radiology, pathology, gynecology,
toxicology, sociology, biomaterials and psychology, as well as industry and consumer
groups. The American Society of Plastic and Reconstructive Surgery (ASPRS) also made known
its position: in favor of leaving the implants on the market. Also the American
Medical Association (AMA) and the American Cancer Society (ACS) favored leaving the
implants on the market. Consumer representative Vivian Snyder: "It would
really be wonderful if the FDA could address such attitude-impacting mental health issues
as what is really healthy and normal and maybe even beautiful". Dow's PR firm
Burson-Marsteller among others organized a massive partly funded by Dow Corning
"Washington fly-in" --in which National breast cancer organization Y-ME
participated-- to bring up to 1,000 women to Washington to plea in favor of implants. Paid
spokespersons for Dow Corning. One of the women who went to Washington said: "You
know, it means so much for a woman not to be small, not to feel disfigured because God
didn't make her enormous". Some women calling the breast implants a "ray
of hope" for cancer victims: a way to feel "whole again". Others
saying they are dangerous to health. A Burson-Marsteller document: "We will
be paying for Timmie Jean Lindsey to testify--based on the fact that she could not take on
the financial responsibility". But Lindsey's complete true story supported
implants causing connective-tissue disorders. Her daughter claiming implants gave her
lupus. Implant-victim Terry Davis: "My doctor told me to lobby the FDA to
keep implants". But instead she told the FDA panel of her implant-complications.
Eventually the panel hearing rejects the data from Dow Corning, Mentor, McGhan, and
Bioplasty, concluding there is not sufficient data about the risks and benefits of the
devices, and for FDA approval. The manufacturers could not provide the asked evidence. The
panel found a lack of data regarding: "the chemical properties of implant
materials, mechanical and physical properties of the implants, frequency of adverse
effects such as rupture and contracture, the extent to which implants mask tumour
detection in mammography, and risks of cancer or immune disorders" (Frank B.
Vasey, M.D. and Josh Feldstein, 'The Silicone Breast Implant Controversy: What Women Need
to Know', The Crossing Press, 1993 ). The panel voted against approving silicone implants
made by the four manufacturers, yet the panel recommended and permitted the devices to
stay on the market temporarily and with limited access.under the mask of general interest:
"a public health need". The need for more safety data is unanimously
stressed. More tests, were needed.
--
MASSIVE HUMAN EXPERIMENT
In 1991 state New York passed measures requiring
physicians to provide printed risk information to all women considering breast
augmentation or reconstruction During almost 30 years the implants were in fact sold with
/ under the fairytale of a lifelong guarantee. Since 1991 manufacturers mention in the
information leaflet of their products that siliconegel implants should be replaced after
10 years. The FDA's expert advisory panel had recommended that implants should remain
available awaiting more tests. Head of the Public Citizen Health Research Group Dr. Sidney
Wolf: "A massive human experiment has been going on with women. At the very
least, it is outrageous women continue to be experimented on". The American
Society of Plastic and Reconstructive Surgeons: "We're delighted with the
outcome. It's nice to know common sense does exist". Common sense: no data, thus
okay ? Donald Perkins, general manager of silicone business of the General Electric
Company, the no.2 producer: "There's still a lot of art and a lot of
unexplored chemistry".
--
DUTCH STATESECRETARY: BREAST AUGMENTATION BY SILICONE
In Dutch Tv-programme 'Tros Aktua' (November 1991, bco
TROS) literal en figurative silicone-breast prothesis got talked about: the
Americans meant that implants caused cancer. The Netherlands did not (yet) share this
conclusion. In an interview in the Tv-programme Dutch plastic surgeon dr. Dijkstra said
that an increased risk on cancer was out of the question but R. Beckers-de Bruijn (Dutch
member op Parliament Greenleft party) asked for more clarity from Dutch Statesecretary
Simons (PVDA-party) about the safety of breastprothesis.
# - Dutch State secretary Simons (PVDA): "In
the medical professional literature several publications --by the way not from Dutch
researchers-- have appeared about harmful side-effects of silicone implants. The main
side-effect is hardening of the prothesis due to connective tissue forming around the
prothesis. Furthermore sometimes leakage of silicone takes place. This leakage leads to
defence-reaction around the leaked silicone. Also auto-immuun diseases, pain and
wound-infection are described. There is by the way no proven case of cancer due to
silicone prothesis known" (Attachement Dutch Second Chamber of Parliament,
1991-1992, nr. 173, Announcement of PVDA statesecretary H.J. Simons, Dutch Healthcare
ministry WVC, 22 November 1991 )
--
MARIANNE HOPKINS "AFTER BREAST IMPLANT, HORROR BEGAN"
In Dutch Dutch Tv-programme 'Around Ten' (Rondom Tien, bco NCRV, December 1991 ) spoken
about was the criteria for the plastic surgeon: profit in the intervention and the
operation certainly must not be at the cost of the health. And 'After breast implant,
Horror began' stated a headline of an article of the San Francisco Chronicle about the
case Hopkins-vs-Dow Corning, San Francisco. On 13 December 1991
the largest award yet (of four implant cases), $7.34 million, is given to 48-year-old
Marianne Hopkins whose mixed connective-tissue disease and painful arthritic-like
condition is linked to her ruptured silicone breast implants, according to the jury, based
on outside testimony of for example physician and silicone researcher Frank Vasey. After
the diagnosis of potential cancer, Hopkins had both breasts removed in 1976. Silicone-gel
implants were put in the next year. A treating physicians testified that Hopkins had
already displayed symptoms of connective-tissue disease 2 years before implantation, but
her official diagnosis of mixed connective-tissue disease did not come until after
implantation. None of Hopkins's treating physicians testified that they believed Hopkin's
illness was to be related to the implants. Dow Corning was accused of having known for
years the danger of implants and suppressed the information. The lawyer for the case, Dan
Bolton, wins the suit with the help of internal memos and studies from the Stern lawsuit,
which had been under protective orders, in addition to new studies he recently obtained
from Dow. The FDA had never seen the documents before. Eventually the internal Dow
documents are leaked to the media: Seth Rosenfeld, a reporter for the San Francisco
Chronicle, who passes them on to Dr. Norman Anderson, the chair of the November 1991 FDA
panel, and Dr. Anderson in 1991/1992 gave the documents to FDA Commissioner Kessler. Among
the evidence / documents was the Dow 'crossed fingers' memo of Chuck Leach. With this case
the rush for implants ended. Dow Corning's lawyer Frank Woodhouse said to appeal. Dow
Corning argued in the appeal that the expert testimony heard at the 1991 trial was not
based on accepted scientific principles and that the award "triggered the
explosion of breast-implant litigation". In January 1995 rather the Supreme Court
left the $7.34 million award intact. In March 1995, after 7 years of litigation, Mariann
Hopkins finally has some comfort: a check for $4.9 million from Dow Corning. http://altlaw.org/v1/cases/441365
--
CRIMINAL INVESTIGATION INTO DOW CORNING ?
On 21 December 1991 Dr. Norman Anderson, a plastic
surgeon (Johns Hopkins University Hospital), specialist on the dangers of gel-filled
implants, and member (former chairman) of FDA's expert advisory panel which gave it's
advice to the FDA in November 1991, said that Dow Corning had kept safety data from the
FDA and the public. Anderson: "It is certainly a breach of the public
trust". Robert Grupp, a spokesman for Dow Corning Wright, confirmed: a number of
memos were not made public because being sealed evidence in lawsuits. FDA investigators
visit Dow Corning offices for a search. Although the Dow Corning internal documents,
memo's were not yet been officially made public, a reporter made copies of the memos from
displays in open court. The memo's describe for example, besides inadequate testing,
insertion of implants into women before being tested in animals and even if they were
tested in animals, not in animal breast tissue. Dr. Norman Anderson found that none of the
studies in animals put silicone or implants in or under breast tissue, as is done with
women. But Dow Corning's chief of the health care business, Robert T. Rylee, believed and
said the implants had been adequately tested and shown to be safe. Silicone or other
materials in implant having an adverse effect on human immune system ? "We cannot
totally exclude that as a possiblity", Robert T. Rylee said. Dr. Norman Anderson:
"I think it is time to stop trusting and to take implants off the market".
Representative Ted Weiss asked the FDA to refer this 'withholding data' case to the
Justice Department for a criminal investigation. In May 1995 the Justice Department
dropped the investigation for lack of evidence.
--
DOW' IMPLANT INFORMATION LINE: MISLEADING
137 individual lawsuits are filed against Dow Corning in December 1991. On 31 December 1991, it was aanounced that the Dow Corning Hot
Line would be shut down. FDA staff members, monitoring the Implant Information Center, had
uncovered "false and misleading statements". Overstating safety, and
minimizing known or suspected side effects of breast implants. Dow Corning reacted with
denial and attacks. The FDA didn't understand, Dow Corning found.
--
BREAST IMPLANTS MORATORIUM
In January 1992 FDA Commissioner, David Kessler,
called together the FDA-advisory committee again to decide whether the 'public health
need' for implants was more important than the risks indicated by new information about
implants. Consultant to the FDA advisory committee was pathologist Dr. Nir Kossovsky.
On 6 January 1992 Dr. Kessler called for a voluntary
moratorium (limited prohibition) --a first step toward taking off the market for good-- on
the distribution, selling or implantation of all siliconegel breast implants --while
Britain's chief medical officer issued a statement saying silicone breast implants were
safe-- until the FDA and the advisory panel have an opportunity to consider newly
available information. Kessler: "Physicians should cease using them and
manufacturers should stop shipping them". The manufacturers agree. Dow Corning
temporary stops with the selling of implants. FDA and implant manufacturers agree: more
research on the effect silicone implants have on human health. In the meantime the FDA
called on doctors to stop using silicone gel breast implants. Saline's remained available.
Dow Corning said the company would release it's internal memos to the FDA. Having shown no
compassion and no reality worries about thousands of women's survival in the past years,
Dow Corning began to fear for its survival. Corning's stock plunged from $86.25 (December
1991 ) to $60.625 (January 1992 ) on the New York Stock Exchange. Dow's PR Firm
Burson-Marsteller advised strategy: "We must aggressively fight a world in which
'silicone-free' becomes a labeling boast", because, warned Burson-Marsteller,
Dow's "credibility is still low. Of course, company and its employees will play a
key role in disseminating message. But ....core of message must be scientific, third-party
support. Research studies already announced will be helpful when done....We must begin by
identifying supportive science, scientists, across the spectrum of uses for silicone;
training and supporting them to get our message out; ....using them proactively to brief
the trade, general and business media;....using them reactively as a 'truth squad' to
refute antagonists".
--
DOW CORNING "IMPLANTS ARE SAFE"
On 13 January 1992 Dow Corning released an
"independent report" reviewing it's safety tests and the company's handling of
the implants for which Griffin Bell ---Attorney General under President Jimmy Carter who
earlier was hired by the Exxon Corporation (Valdez oil spill)--- was hired. Conclusion ?
As noted in an article 'Breast implant firm combats charges of insufficient testing', from
Associated Press journalist Deborah / Debbie Mesce, who is mentioned on Dow Corning's PR
targeted media list: "'The studies establish that Dow Corning Wright's
breast implant products are safe and effective,' said Dr. Albert Kolbye Jr., a former FDA
official who led the analysis".
--
GATE-KEEPER: MEDIA
President of the American Society for Plastic and Reconstructive Surgery (ASPRS) Dr.
Norman Cole criticized the manner public got information about implants: "For
ten days, patients have been confused by bits and pieces of information that have leaked
to the media. That's outrageous. The fact that I have to tell my patients that I can't
tell you what your condition is because I haven't read the newspaper today..."
(Fed. News Service, News Conf. with Norman Cole, M.D., 15 January
1992 ).
--
IMPLANTS: TIME BOMBS
On 30 January 1992 the Boston Globe (Renee Graham)
published two stories of women with silicone-gel implants. One of them, Teresa Whitehurst,
experienced her breasts as time bombs: hardening, rupturing, leaking, shrinking and
becoming infected. Each day was a new horror: "It worried me to death. I
felt like I was walking around with enemies inside myself".
--
DOW'S INTERNAL DOCUMENTS
On 10 February 1992 Dow Corning announced
reorganization: executive changes. Dow Corning's CEO, Lawrence A. Reed and chairman, John
S. Ludington, were 'replaced' by crisis manager Keith McKennon. Chairman Frank Popoff (Dow
Chemical) stated in April 1992 that CEO Lawrence Reed was "not emotionally
equipped" to deal with the crisis. Keith McKennon was a shareholder in Dow
Corning who had broad experience with crisis management for Dow Chemical (dioxin
pollution, Agent Orange) and who be concentrating on the breast implant issues. Keith
McKennon was also skilled in dealing with the media, with as a result more than 100
interviews in his first month on the job, including an hour on the Larry King show. After
Dow Corning's own survival became disastrously endangered a Dow Corning official said: "Keith
McKennon had already made it clear that he puts women with breast implants at the top of
the list of people who have to be satisfied with how this comes out", "The
McKennon appointment reflects the seriousness of the breast implant controversy"
(The New York Times, Barnaby J. Feder). Dow Corning on 10 February 1992 released internal
memos, letters and documents revealing a (internal) history of (non public) worries over
silicone breast implants showing it has awarely known for two decades about potential
health problems from leaking and ruptures of implants. The conscience of Dow Corning. But
Robert LeVier, technical director of Dow Corning stated: "There isn't
anything new here". Dutch surgeon dr. R.J. Zeeman (Academic Hospital Leiden)
found in Dutch newspaper 'Trouw' (11 -02-1992, 'That
breastprotheses could leak, the manufacturer knew already for 20 years') that in the
United Stated an unjustly smear campaign was conducted against breast prothesis.
--
CLASS-ACTION: HUMAN GUINEA PIGS
In February 1992: A first class action lawsuit (with
joint plaintiffs) is filed in Cincinnati by Stan Chesley. The hope is to compensate women
at a faster rate than filing individual lawsuits. Individual lawsuits were more difficult
because for example Virginia law requires that product liability injury claims must be
filed within 2 years (in Maryland 3 years) of the date of an injury. Even if the person is
unaware of the injury. Later also Massachusetts women, with health problems linked to
silicone-filled breast implants, filed class action suit against Dow Corning, which,
besides Minneapolis, is the third class-action suit in the nation. 54-year old Chicago
actress Mara Martin, having had a reconstructive breast implant after undergoing a
mastectomy because of cancer, wanted to join a Chicago lawsuit. 10 years since her
implants she sometimes had to struggle out of a chair "like an 80-year-old
woman". She felt like being used as "a human guinea pig". New
Jersey law firms are accused of taking advantage of the breast implant controversy to draw
in clients with advertisements as: "Your dream can become a nightmare".
The race to represent breast implant victims, wrote Saundra Torry in The Washington Post.
--
SILENCING CRITICS
Around 20 February 1992 FDA's expert advisory panel would have a meeting to consider
whether silicone gel breast implants are safe and to recommend whether the FDA should make
the temporary ban, from the meeting in November 1991, on silicone-filled breast implants
permanent. On or off the market ? In the week 10-16 februari 1992,
a week before this FDA meeting, Dr. David Kessler, commissioner of the FDA, asked Dr.
Norman Anderson, member of FDA's expert advisory panel and a specialist on the dangers of
gel-filled implants who wanted to take the implants off the market (Time magazine), to
step down voluntarily as a voting member (one of the 11 ) of the Advisory panel. Anderson
refused and Kessler then placed Anderson after his refusal in nonvoting 'consultant'
status because Baltimore doctor Anderson would have been "biased",
according to Kessler. One of the major U.S. breast implant manufacturers even pleaded to
stop the Advisory Panel from meeting and that decisions regarding the implants should be
turned over to Secretary of Health and Human Services Louis W. Sullivan. But U.S. District
Judge John R. Hargrove on 15 February 1992 dismissed
the request for a temporary restraining order against the FDA.
--
DUTCH PARLIAMENT: BREASTAUGMENTATION BY SILICONE
(Dutch Second Chamber of Parliament, 1991-1992, Attachement nr. 393, 17
February 1992 )
# - Dutch State secretary Simons (PVDA-party): "The
from the reports of the FDA appearing side-effects of breast prothesis have already been
described several times in the medical profession-literature and consequently also known
by the profession-group"
# - Question R. Beckers-de Bruijn (member of
Parliament Greenleft-party): "Will you take care of Dutch women being
pointed to the risks associated with silicone implants ?".
# - Answer Statesecretary Simons (PVDA): "The
Medical Headinspection of Public Healthcare and the Headinspector of the Public Healthcare
have by means of circular letter just to be sure recommended the concerning medical
profession to point out to women who come into consideration for an implantation with
silicone breastprothesis the risks associated with those implants"
# - Question R. Beckers-de Bruijn (Greenleft): "Will
you take care of a systematical control, check-up of women, who have undergone sucj an
operation ?'
# - Answer Statesecretary Simons (PVDA): "After
the silicone breast prothesis has been implanted, a medical examination takes place untill
the wound has completely healed, and the with prothesis associated complaints, such as
pain, have disappeared. In case afterwards re-newed complaints should occur, I take the
line that patients will visit the doctor, after which examniation and treatment can
follow".
--
FDA: ADVISORY PANEL (2 )
From 18 February 1992 for three days FDA's General and
Plastic Surgery Devices advisory panel reconvenes to determine on basis of the new
information whether silicone breast implants --already in the bodies of millions of
women-- were safe. Hearings with several testimonies: "One of the things that
concerns me most is that these implants may rupture, leak or bleed more frequently than we
had originally believed". New studies had suggested that silicone gel breast
implants ruptured more than 10 times as often as manufacturers and plastic surgeons had
previously reported. Researchers (Washington University, St. Louis and University of
Pittsburgh) found that about 5 to 6 percent had implants rupture and leak silicone in the
body. 7 researchers told about patients who had both implants and auto-immune diseases or
scleroderma. But a link, besides a strong suspicion, between silicone and auto-immune
disease had not been established. Also Dr. Bernard Patten, a neurologist at Baylor,
testified, and experts testified that in many cases their patients dramatically improved
once the implants were removed. On the second day of the advisory panel hearing Dow
Corning pledged to fund 30 new laboratory and clinical safety studies. Also a National
Implant Registry would be created to monitor and track the health of women using implants.
The manufacturers of silicone gel breast implants believed and stated with help of color
slides and external experts that any connection between implants and health problems was a
coincidence. The panel on 20 February 1992 recommends
in it's (second) advice that the further use of implants be limited for reconstruction
only and that women receiving the implants participate in scientific protocols and that
epidemiologic studies be conducted to assess the risk of autoimmune disease. The panel
concludes that no causal link has been established between autoimmune disease and silicone
breast implants. But more study was needed. The Panel rejected an outright ban on
implants. "Panel Backs Marketing of Implants" (The Washington Post) and
the safety issue was not settled at all, critics found. "The most clear-cut
message of the implant advisory panel meeting: The devices are really experimental"
(The Boston Globe, Judy Foreman). The panel's recommendations were in the decisive hands
of the FDA. Ban or no ban ? Health insurers began to worry about the costs for possible
thousands of removal of implants even if a women currently had no symptoms.
--
FDA: BREAST IMPLANT INFORMATION LINE
In line with the advice of FDA's advisory panel, from 20 February
to July 1992 the FDA's 'Breast Implant Information Line' (free 800-number) was
operational for customer with questions regarding breast implants. The Information Implant
Center and informational materials emphasized that a patient's "physician is the
most important source of information about breast implants" and recommended that
women "should thoroughly discuss with [their] doctor[s] any questions or concerns
[they] might have about silicone breast implants, breast surgery or the risks associated
with both". According to a FDA report 41.000 callers called: more than 90%
were women of whom 70% already had implants. More than 50% reported several physical
complaints among others symptoms of autoimmune disorders, ruptured implants and
infections. The FDA also received thousands of letters from women with breast implants.
From 1 January 1992 to 1 July 1992 the FDA received 7.191 unfavourable mandatory Medical
Device Reporting reports from manufacturers and 1.136 voluntary Product and Reporting
Program reports from users of silicone breastimplants. A significant increase compared to
1988 through 1992.
--
DOW CORNING SHUT DOWN
Dow Corning announced on 19 March 1992 to stop with
the manfucturing of silicone breastimplants. Dow Corning applies for suspencion of
payments. A tactical creative stunt since the turnover of silicone implants were only 1%
of the total year-turnover. According to Dow Corning it was a pure economical decision:
"Gel implant is not profitable". The production departments of several
other companies divert to a.o. Europe. Also Bristol-Myers and Bioplasty (who purchased
silicone gel from Dow Corning) leave the silicone breast implant business. Bristol Myers
made its decision to stop making the products because of its inability to comply with
FDA's requests (pre-market approval: safe and effective). On 1 April 1992 Dow Chemical
(Dow Plastics) ceased selling its medical-grade resin and film products for use in cardiac
prosthetic devices and all other long-term implants. Mentor Corporation and McGhan Medical
Corporation will still manufacture breast implants.
# - 'H/S Product Summary' from Mentor (who purchased
silicone gel from Dow Corning) listed unknown risks to women with implants: "unusual
hair loss; memory problems; headaches; unusual loss of energy; greater chance of getting
colds, viruses and flu; muscle weakness or burning; nausea, vomiting, and Irritable bowel
syndrome, some women with breast implants have reported health problems in their
breast-fed children". Before the '90 just one study had been done on the effects
of silicone on the 'second generation'.
# - McGhan consent signed (10-22-1976 ) by McGhan
Quality Assurance Manager, Product Investigator, Production Manager: "Products
deviates from specifications due to visible flaws. Request approval to release products
for shipment to Mexico".
--
REMOVAL ASSISTANCE PROGRAM
The new Dow Corning CEO, Keith McKennon, admitted that Dow Corning had made errors. The
first time the company had publicly confessed to this. McKennon announced in March 1992 a $10 million dollar fund for breast implant
safety research and the new Removal Assistance Program (RAP) --under the same supervision
and shared toll-free phone number of the FDA's Implant Information Center-- available to "women
who have a medical need to have their Dow Corning implants removed but who cannot afford
the necessary surgical procedure" (19 March 1992, Dow Corning Press Release, CAC
Mem. Ex. 3 ). Dow Corning stated that the RAP program would be terminated in May 1995. The
offer was limited to woman whose removal surgery was performed on or after 6 January 1992
and to a maximum amount of $1.200,-. http://www.tortcomm.org/downloads/CAC_Memo_in_Support_of_DJ%20r.pdf
# - A woman from the Netherlands, member of Dutch
supportgroup SVS, wrote: "Finally is was that time, my silicone implant was
removed. But my new insurer does not have a contract with the clinic, so the costs were
for my own account. I have made an objection to this decision. After 4 years of fighting
with the insurer my husband and I were fed up to live with a timebomb in my body and had
decided to then just pay the FL. 9,450,- Dutch guilders ourselves, also because we want
children and I am almost 30" (SVS's magazine, 8th yr., September 2001, Nr. 3 ).
# - On 14 April 2006 a woman from America, member of a
supportgroup who wanted het implants removed, wrote: "My problem is
financially. As much as I want to do something about it, I do not have the money to do so.
I've gotten quotes from a few plastic surgeons and the cost is roughly about $6000. I do
not think the $6000 covers anesthesia or even hospital stay".
# - Another American member of a supportgroup wrote on
8 januari 2008: "The plastic surgeon informed me that it would cost around
$9,000 to have them removed and I knew that I could not afford that. I am a graduate
student who has never seen that kind of money in my life".
--
END OF MORATORIUM: LIMITED BAN
On 16 April 1992 the FDA ended the 3-month moratorium
on the use of silicone breast implants. FDA Commissioner Dr. David Kessler, in line with
the recommendation of the FDA Advisory Panel six weeks earlier, banned in America the free
use of silicone gel implants (for cosmetic reasons) awaiting further extensive safety
studies. Kessler noted a 70% rupture-percentage as one of the problems with implants. The
use of silicone gel implants is allowed but under limited conditions. Limited use of
silicone gel implants was only allowed for women who wanted implants after breast cancer
surgery (reconstructive), or after "traumatic injury" with a "urgent
physical and psychological need for breast reconstruction" ("Barbie
complexes"), or for replacement of existing gel-filled implants which caused
problems. All women who now wanted implants had to take part in clinical (controled and
registred) studies. Dr. Kessler at his decision had made a distinqtion between the dis-
and advantages for women. Many young women choose implant for cosmetic reasons
(augmentation) with risk for healthy breasts. Member of FDA's public affairs staff Marian
Segal: "Younger women will be exposed to silicone for a longer time".
Women are mostly older at the choice for reconstructive reasons for replacing sick or
deformed breasts as part of a (cancer / psychological) treatment. According to the
American Society of Plastic and Reconstructive Surgeons, since 1960, 80% of the women had
breast implants for breast enlargement and 20% for reconstruction after breastcancer. The
expectation was that but just only 1/5 of the estimated 150,000 women in the US who in
1990 got implants, could get implants and that one would go and seek others than
silicone-gel implants. E.g. the saline-filled breast implants which remained available
without restrictions for breast augmentation and reconstruction. However, as silicone
gel-filled implants, saline's have a silicone rubber envelop and the possibility to
release silicone parts from the envelop had never been evaluated. And the safety was also
never proven. Thus saline's were mentioned as a next review matter on the FDA-agenda.
Director of the FDA's center for devices and radiological health Jim Benson: "We're
going to call for the safety data". Dr. Sidney Wolfe (Public Citizen Health
Research Group): "Women simply will not use these implants when told what
the risks are, and those who do, it will be because the plastic surgeons will try to tell
women there are no problems". It becomes more and more known that powerful;
companies had made profits on products which formed a risk for the lives of thousands and
thousands of women: bringing harm upon. http://www.fda.gov/bbs/topics/CONSUMER/CON00146.html
--
DUTCH PARLIAMENT: MORATORIUM
Mr. Dr. J. de Koning (Dutch Headinspection Medical Public Healthcare): "In April 1992 in America there has been a moratorium
siliconeprothesis. That moratorium has been lifted. Under controled clinical circumstances
silicone prothesis may again be applied, on cosmetic basis and at patients with cancer. In
the Netherlands we have followed-up on the moratorium with a warning. In the Netherlands
we have the same kind of research set up as the FDA in America demands from the silicone
manufacturers" (Dutch Second Chamber of Parliament, 23 400 XVI, nr. 80 29, 1
Februari 1994 )
--
LEAKING PROTHESIS: MANUFACTURER KNEW
Lawyer Nancy Hersh, the 'godmother of courtcases around silicone breast implants', who is
convinced that there are many irresponsible people in the medical and pharmaceutical world
walking around, had in 1984 won a courtcase on behalf of a sick patient who had gotten
about one and a half million dollar compensation. The FDA ban on silicone implants came
after became known why Hersch had won the case: defaming information about breast
implants among which incriminating test-reports from Dow Corning itsself from the period
when Dow Corning brought implants onto the market. Dow had already known for a decade that
its implants could leak and that the released silicone gel could cause medical problems
(Dutch newspaper 'Trouw', 10-12-1994, Agnes Koerts, 'The fright of the American
Industry'). Top-officials of Dow Coming warned a decade ago for the problem of rupturing
implants. From own internal research of Dow Corning from the '60s and '70s appears that
the possibility exists that silicone stimulate the immuun system. In a memo from the
company from 1977 is posed: "At present can be established that the problem in
excessive degree keeps coming back". Even when implants remained intact, there
was a matter of "leakage" of silicone through the envelop to the body. Already
in 1961 the Board of Dow Corning was informed by the own Center for Aid to Medical
Research about this problem. The condition for the compensation in the Hersh-case from
1984 was that the incriminating information would remain under the Judge.
# THE PROOF: BREASTIMPLANTS INTOXICATING HUMAN BEINGS
Dow Corning's secret documents: Trial Exhibit-list
http://implants.clic.net/tony/Smoke/1.html
http://www.implants.clic.net/tony/Secret/index.html
http://www.siliconesurvivors.net/evidence.html
http://groups.google.com/group/alt.support.breast-implant/
browse_thread/thread/6daae0f0f21187ef/e28ead532e2b6693?
hl=en&lnk=st&q=#e28eaF32e2b6693
--
FURIOUS SURGEONS "HYSTERIA BY THE MEDIA"
After the FDA (limited) ban on silicone breast implants, US plastic surgeons did not agree
with FDA's decision. They pointed to the fact that silicone is being used in a broad scope
in medicine and prothesis devices, just because it was assumed as greatly inert in the
human body. Parts of pacemakers, needles and catheters are covered with silicone. Further
is silicone found in the inside of syringes, by which e.g. diabetes patients regularly get
great amounts of silicone into their blood. The FDA ban was a stimulation for plastic
surgeons in countries where the product still was legal. Dr. McGuire, a surgeon from Santa
Monica: "We hear that the orders for silicone breasts in Europe are
increasing. In fact, especially Great Britain studies this problem and found that there
was no reason to prohibit silicone breast implants. The customers will probably go
there". Some US plastic surgeons were in tears after the ban. Their was divided
into half. Santa Monica plastic surgeon Dr. Dennis Thompson: "We see about
50% less implants than in previous years". Other US plastic surgeons were furious:
unasked meddling in their practices, sowing unfounded fear, ridiculous panic, FDA's unjust
moralism and hysteria caused by the media: 'alarming and disturbing media signals' ?
President of the Los Angeles County Society of Plastic Surgeons: "It is too
soon to tell whether business is off for good, or whether business will pick up again. I
don't know what the future holds".
--
OPRAH WINFREY SHOW
But cosmetic surgery got more popularity (again) after an episode of the Oprah Winfrey
Show --the number one US talk show, seen by an estimated 49 million US viewers a week and
broadcasted internationally in 121 countries-- on 20 April 1992:
"Plastic Surgeons create their Perfect Wives". In later episodes Oprah
Winfrey invitd several guests related to the breastimplant issue, among who:
# - in 1994, Stephanie A. Burns, CEO Dow Corning,
liaison between FDA / Dow Corning,
# - on 27 September 1995, Sharon Green, Director
National Breast Cancer Organization Y-ME, arguing that without the implant option, women
would be scared to go for mammograms.
# - in 1996, James L. Baker, member of the
board-certified plastic surgeons, clinical research investigator for Liquid Silicone
Injections for the FDA and Dow Corning (1978 - 1981 ), who 3x testified for the FDA (1976,
1992, 2000 ) and who from 1994 - 1996 worked for the National Institute of Health
concerning safety of breastimplants.
Further appeared on the Oprah Winfrey show several people out of plastic surgery world
(Dr. Strock, Frederic H Corbin, Dr. Pearlman D. Hicks Jr., Dr. Steven P. Bloch, Robert S.
Hamas, Dr. William Carter), an actrice (Kari Wuhrer) who had her implants removed (2002 )
and on 8 Februari 2005 several people addicted to 'Extreme Makeovers'. Also crying girls
appeared on the show because the silicone breasts implants that had made them so happy a
few month earlier, had burst, leaked and got into their bloodstreams.
--
DUTCH SUPPORT GROUP WOMEN SILICONE IMPLANTS
Concerned Dutch women had united themselves into a workinggroup: Foundation
Supportgroup for Women Silicone Implants (Stichting Steunpunt voor Vrouwen Siliconen
implantaten , SVS). Marlou Boots, who after 18 operations was more dead than alife, had in
1991 her last silicone bag removed after which her health imrpoved. She started to dig
deeper into the silicone-literature and she placed a summons in a newspaper to seek
fellow-victims. Many reactions followed and in May 1992,
the month in which the first woman in the US got implants under the new FDA regulations /
law, and despite Marlou Boots herself being a recovering patient, Marlou Boots founded
SVS. Because American docters use the title M. D.(Medical Doctor, or as some find 'Medical
Divinity'), Marlou Boots (secretary) added an own created title to her name: V.E.
(Victim Expert). Marlou Boots: "I amused myself greatly with that, because
on the letters that I received back, it was written exactly that way on the envelop. It is
lamentable that titles appear to be interesting, closed doors open with it"
(Dutch newspaper 'Trouw', 20 June 1992, Gonny ten Haaft, 'the heavy as lead stories about
silicone prothesis') SVS: "The biological consequences of silicone parts on
the immuun system were well known at Dow Corning (but kept secret), who in reality tested
silicone as both a possible insecticide (cockroaches, '50s) and a mean to stimulate the
defence-system".
--
STATISTIC STUDY: IMPLANTS ARE NO CANCER RISK
On 10 June 1992 a Cook County judge threw out a
class-action lawsuit filed against manufacturers of implants. Reason ? A similar action
had been filed in January in U.S. District Court in Ohio. On 18
June 1992 Marcia Angell' New England Journal of Medicine publishes a study
among 11,676 Canadian women in Alberta with breast enlargment for cosmetic reasons,
compared to 14,000 women listed in province's cancer registry as having developed breast
cancer. Statistically, the first group' chance on breast cancer was 50% of what was
expected to be found in the general population over a 10-year period following surgery.
The study could not completely eliminate the possibility of risk. The researchers (Alberta
Cancer Board) cautioned that there was no reason to think implants might somehow reduce
the risk of this common cancer. (Berkel H et al., 'Breast augmentation: a risk factor for
breast cancer', N Engl J Med 1992 Jun 18 326 1649-1653 )
http://general-medicine.jwatch.org/cgi/content/full/1992/623/1
http://general-medicine.jwatch.org/cgi/external_ref?access_num=1588977&link_type=MED
--
OTHER SILICONE IMPLANTS: ALSO ADVERSE EFFECTS
On macroscopic level it seems that the body tolerates foreign 'unidentified' objects, but
on microscopic level: "The controversy over the health aspects of silicone
breast implants has alerted researchers to possible side effects of other polymers used in
medicine....(...)...X-ray microanalysis and electron microscopy have revealed this immune
response in the tissue surrounding breast implants (Plast Reconstr Surg. 1990;85: 38-41 ),
urinary sphincteric implants and penile prostheses (J Urol. 1991;146:319-322 ), TMJ
implants (Oral Surg Oral Med Oral Pathol. 1985;59:449-452 ), and implants of the hand and
wrist (J Hand Surg Am. 1986;11:624-638 ), to name a few. Of considerable concern to some
but not all researchers is the discovery of silicone granulomas in the lymph nodes near
these same implants (Semin Arthritis Rheum. 1987;17:112-118; J Urol. 1991;146:319-322;
Oral Surg Oral Med Oral Pathol. 1985;59:449-452; and J Hand Surg Am. 1988;13:411-412
)....." (Medical News & Perspectives ) Randall, Teri Citation: JAMA, The
Journal of the American Medical Association, July 1, 1992
v268 n1 p12(2 )).
http://www.info-implants.com/BC/0022.html
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=1608098
http://jama.ama-assn.org/cgi/content/citation/268/1/12
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=1608098
--
THE NETHERLANDS: LITTLE REASON TO BE CONCERNED
(Source: 16 July 1992, Dutch newspaper 'NRC
Handelsblad')
# - "...An important reason for the FDA to ban
silicone breastprothesis was the lack of even the most basal research for the
life-expectation of implants. The pull-strength of the material and the duration against
longterm burden have not been studies. Also the exact chemical composition ofthe silicone
which leak away to surroundings are unkown. Maybe free silicon is part of it due to
defective quality control during manufacturing. Silicon is a substance to which the
defence-system heavily reacts. Also there is a possibility that free silicon arises during
the breakdown of silicone into phagocytes (British Journal of Plastic Surgery, april 1992
)..."
# - "....Furthermore silicone is also being
used in dozens of other medical applications. Diabetes and kidneydialysis-patients receive
via syringes and dialysis-apparatus considerable amount of silicone into their body. Yet
there has never been reported a disease at these patients which could be linked to
silione. It is by the way remarkable that the FDA is completely leaving all these other
applications of silicone out of its consideration, as also joint-, heart-, bloodvessel-
and eyelensprothesis, pacemakers and stitchingmaterials. Also at the preparation of food
and cometics on large scale siliconematerial is being used..."
# - "...In the Netherlands by the Dutch
Medical Headinspection for the Publichealthcare an provisional advice has been issued on
24 Januari. It mentioned that silicone breast prothesis weren't banned in the Netherlands,
as long as the FDA hadn't enlightened its decision. Now that that has happened the Dutch
Ministry does not see any motive to change this advice. In the Netherlands thus silicone
breastprothesis remain available for everyone who wants them...".
--
ANTI-BODIES COMBAT SILICONE
Maybe having forgotten the studies in the 1970's ('Human immune system reaction to
silicone in breast implants by making antibodies attacking the silicone') from Dr. John
Paul Heggers who about it informed Dow Corning of it as of 1978 and the Plastic Surgery
Research Council in 1989 ('Silicone Hypersensitivity'), scientists for years believed
silicone was inert in the body: passive and not capable of stimulating antibodies,
and many believed that a combination of implant and immune disorder was coincidence. On 29 August 1992 medical journal The Lancet published a new
study 'revealing' the existence of antibodies against silicone. Antibodies are formed to
attack foreign substances. Breast implants and other devices could trigger severe illness.
The researchers (a.o. John Heggers) had studied the immune cells of two children who had
severe skin diseases and inflammation around an implant made with silicone. Director of
the study, Dr. Randall Goldblum, human biological chemistry and genetics department
University of Texas Medical Branch in Galveston: "This is the first
demonstration of any specific immune action to silicone in humans" (The New York
Times, 28 August 1992 ). Dr. Noel Rose (Johns Hopkins School of Hygiene and Public Health):
"The study was thought-provoking because it is contrary to what many scientists
thought".
--
IMPLANTS: NO WOMEN- BUT POLITICAL-ISSUE
President of the American College of Rheumatology Dr. John Sergen spoke on a conference of
plastic surgeons on 21 September 1992. Dr. Sergen
stated that a definite link between silicone breast implants and disease couldn't be
scientifically studied because the issue had become so political: "There is
such a vested interest in people having a silicone-related disease, that I think you're
doomed to failure before (a study) could begin".
--
DOW'S TRUE LIES
On 2 November 1992 Dow Corning revealed it had sold an
unknown number of silicone gel breast implants, manufactured in the 1980s, even though
their quality-control records had been "faked". But Dow' Chief Executive Officer
and chairman Keith R. McKennon was confident (in belief) that the implants posed no health
risk: "Because the devices were individually inspected" Sidney M.
Wolfe (Public Citizen) found Dow's statement not very reassuring (The Washington Post, 3
November 1992, Boyce Rensberger). In April 1980 the chief of biomaterial safety for Dow
Corning / senior Group Leader for the Health Care Group Research, William Boley was also
confident of implants having been proven safe in "extensive" testing,
while 3 years later William Boley suddenly believed the opposite: "no valid
long-term implant data to substantiate the safety". On 3
December 1992, Keith McKennon announced his retirement before the end of 1993:
"I will remain at Dow Corning as long as necessary to insure a smooth and orderly
transition". Dick Hazleton, president of Dow Corning Europe, would succeed
McKennon.
--
DOW CORNING SURVEY
In 1992, in the heat of the implant controversy, while
actrice Demi Moore (wife of actor Bruce Willis) had her first £3,000 pounds breast
implant operation before moving on to her thighs and bottom according to Jules Stenson of
The People (London, England), Dow Corning did another internal Organizational Survey. 77%
of Dow's employees still believed Dow Corning was a "highly ethical company".
Amazingly loyal employees to their guru Dow Corning ? 'Unbridled or uncritical belief in
the justness' in Dow Corning's assertions ?
--
ANTI-BODIES: DIAGNOSIS IMMUNE SYNDROME
The respected medical journal The Lancet on 28 November 1992
publishes a new study by scientists Eng M. Tan and colleagues (Scripps Research
Institute). They found antinuclear antibodies in the blood of women (17 out of 24 )
suffering from autoimmune disease after having had silicone gel breast implants. 7 of the
patients had scleroderma, a disease found in only 9 out of every 1.000.000 people in the
general population. The women with the highest levels of antibodies had the worst
symptoms. And women with ruptured or leaking silicone implants experienced symptoms more
than 5 years earlier than women with no ruptured or leaking implants. Physicians use
elevated levels of specific antinuclear antibodies to diagnose various autoimmune
disorders. The autoantibodies might be an early warning signal for a sort of silicone
autoimmune syndrome.
--
PAMELA JOHNSON: SAFETY FIRST, AHEAD OF PROFIT
On 24 December 1992 Johnson vs Bristol-Myers Squibb
(subsidiary Medical Engineering Corp.), Houston. The first civil lawsuit, product
liability case to go to trial against a silicone breast implant manufacturer in Texas and
the second multimillion-dollar settlement. 45-year-old Pamela Jean Johnson from Houston
wins $25 million, $5 million actual damages and $20 million punitive damages in a case
argued by Texas attorney John O'Quinn (Kerensky, McAninch & Riebschlager) who at that
time had about 800 implant cases waiting. A jury finds Pamela Johnson's ruptured silicone
implants (silicone in her system) were linked to her mixed connective tissue disease,
auto-immune responses, chronic fatigue, muscle pain, joint pain, headaches, and dizziness.
A critical role hereby played the testimony of Dr. Nir Kossovsky, a pathologist at
the UCLA Medical Center. Bristol-Myers Squibb lawyers argued that Pamela Johnson's leaking
implant may have been caused by Pamela Johnson's smoking up to two packs of cigarettes a
day for more than 20 years. Judge Wittig said a final ruling on the verdict would follow
on January 11, but in the meantime the stock of Bristol-Myers Squibb tumbled $3.875 on the
New York Stock Exchange. Pamela Jean Johnson: "It wasn't for me; it was for
all the other women". Lawyer John O'Quinn: "The message is you
have to put safety first, ahead of profit". This Houston-case was the 7th breast
implant trial (5 won by the plaintiffs) while in the meantime 3,558 individual lawsuits
had been filed against Dow Corning. Many women claiming to have developed autoimmune
disease. Dow Corning's 1992 net income had dropped 52%. But Dow chairman Keith R. McKennon
believed that the implant controversy would cause employees to think more carefully about
new products' possible effects. Immunologist Dr. John Naim of Rochester General Hospital:
"If one is going to implant something into the body one ought to do safety studies
first".
--
DOW CORNING "WITH GODS HELP....."
J. Kermit Campbell was Group vice president at Dow Corning Corporation from 1987 to 1992, responsible for all operations in the United
States. He started at Dow Corning in 1960. J. Kermit Campbell served as manager of new
products research; was technical director for the European area; vice president and
general manager of fluids, resins and process industries business; and vice president for
personnel, communications and governmental affairs. Lawrence A. Reed, Dow Corning's Chief
Executive Officer till February 1992 --when he was replaced by Keith McKennon-- had asked
J. Kermit Campbell to take primary responsibility for managing the implant issue. Campbell
holds 25 patents. After retirement (2004?) Campbell ---'interested in helping young
people' and active in his church being currently chairman of the consistory of Faith
Reformed in Traverse City--- joined the board of the religious Ministry Eagle Village
residential program for youth in Hersey: "With God's help and love, we
serve children and families".
--
CHIEF JUDGE SAM C. POINTER
The Judicial Panel on Multidistrict Litigation had in 1992
transferred all silicone gel breast implant product liability cases filed in federal
courts to the United States District Court for the Northern District of Alabama before
Federal District Judge Sam C. Pointer, Jr. who oversees implant litigation nationwide and
the negotiations between manufacturers and the implantwomen there. Judge Pointer appointed
a 17-person Plaintiffs' Steering Committee (PSC): a group of lawyers from around the
country who were to conduct fact-finding depositions in the litigation on behalf of the
silicone victims: among others attorney Stanley M. Chesley, Charles R. Houssiere, J.
Douglas Peters, cochair Ralph I. Knowles Jr.
--
SALINE-IMPLANTS: BUSINESS AS USUAL
On 5 January 1993 the FDA announced equal treatment of
silicone gel -, and saline-filled breast implants. The manufacturers of saline-filled
breast implants, the only breast implant which were still generally available, had to
prove safety to remain on the market. The FDA would review the data. A day later House
Goverment Operations subcommittee on human resources and intergovernmental relations,
which oversees the FDA, (again) accused the FDA, in a congressional staff report, of
failing to monitor the use of silicone gel breast implants since FDA's moratorium /
restrictions in 1992, of failing to act and of the industry of trying to cover up the
problems. Abuses of implants had continued. Representative Donald M. Payne (New Jersey),
chairman of the FDA subcommittee: "When attention was focused elsewhere, it
was business as usual at FDA". In countering the accusations, it was said that
the subcommittee report reflected the views of only one non- elected congressional staffer
who failed to consult members of the Committee or the FDA before releasing her report. So,
for the FDA, Silicone gel-filled breast implant contamination remained a serious issue, it
was said.
--
"INERT" IMPLANTS IRRITATE IMMUNE SYSTEM
On 20 March 1993 for the first time Dow Corning
reported that silicone may not be inert. New studies on laboratory rats showed that the
silicone gel used in breast implants was not inert, and a strong irritant of the immune
system. The results reflected the findings of Dow Corning scientists in 1974 when Dow
failed to report to the FDA. Dow did so about more than 15 years later when the
information was disclosed in papers filed in lawsuits. Hiding information to anticipate
damaging sales ? The chief medical officer for Dow Corning, Dr. Myron Harrison said he was
"not aware" of such a motive, acknowledged the 1974 study and is quoted as
saying: "The significance of this finding is that it raises a concern on
the part of people like me that silicone might play some role in autoimmune disease".
# - Earlier in the week researchers (Dr. Suzanne
Teuber, Dr. M. Eric Gershwin) from the University of California at Davis School of
Medicine by examining the blood found (published in the Journal of Autoimmunity) that
(35%) of women with breast implants had anticollagen antibodies against their own
collagen, a protein that variously gives body tissues stiffness or elasticity. Women's
immune systems were attacking their own bodies. Dr. Gershwin: "In order to
protect us, the immune system must be able to distinguish between our own bodies and
invading organisms". Dr. Suzanne Teuber: "The hypothesis is that
if implants trigger autoimmune disease, one of the first places you would see that would
be in an autoimmune response to the environment immediately around the implant".
And further the Dow Corning study was a copy of earlier results (March 1993 ) by
immunologist Dr. John Naim of Rochester General Hospital published in Immunological
Investigations. Silicone gel aroused the immune system to attack the body's own proteins.
Dr. Naim found that silicone gel in rats caused a reaction 100 times greater than salt
water (known to cause little reaction): "The results indicate that silicone-gel is
a potent immunological adjuvant".
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Retrieve&list_uids=8505070
http://cat.inist.fr/?aModele=afficheN&cpsidt=2066359
# - The FDA consequently demanded breast implant
manufacturers to update information in the informed consent documents for women receiving
these breast implants under clinical studies. Due to the 'possible' link: implants -
immune-related disorders. More research was needed. But tens of thousands of women with
implants were rushing to have their implants removed. Good business for the same plastic
surgeons who once made a living of enlarging breasts. And across the US, tens of thousands
of women, mostly those who already (still) had implants, were being asked to participate
in formal medical trials. Most immunologists had come to believe that there is no such
thing as a biologically inert substance. Silicone stimulated the immune system to produce
antibodies and inflammatory responses. In contradiction to advices given to women by
plastic surgeons, who for many years conscienceless had given millions of women implants
without them (or the so-called true skeptics) considering to ask for prove ---with which
alternative medicine is verbally tortured--- of the implant safety. Which 'proves' blind
belief ?
# - Dutch support group SVS / Marlou Boots: "Silicone
would be safe, because being inert. Chemical that is indeed correct, but biological
silicone dòes work. It has been scientificly proved that silicone biological are not
inert and thus give disturbances in the body. Furthermore there are, due to the chemical
manufacturingprocess, 39 chemicals and 8 heavy metals 'hidden' in implants. What exactly
the evil -the chemicals or the silicone- is not clear at this moment. But the substances
always come in combincation into your body. And how does your body react on that ?"
(Magazine SVS, 'The story of Marlou Boots and SVS: Implants always leak', 8e Yr, March
2001, Nr. 1 )
# - Dr. Saul Puzskin, Professor of Pathology at Mount
Sinai School of Medicine reported that "there [were]are at least 37 substances,
other than silicone, in implants including a.o. benzene, formaldehyde, polyvinyl chloride
and printing ink" (Sue Harless Wolf, 1995 ).
--
YOUNGER AND BETTER THROUGH COSMETIC SURGERY
In March 1993 an undercover FDA investigation led to
U.S. District Court for the Central District of California orders stopping two California
physicians (otolaryngologist Richard B. Aronsohn, M.D., dermatologist James E. Fulton Jr.,
M.D., Ph.D) from using liquid silicone on patients for cosmetic surgery (lip-,
cheek-enlargements, face lifts, wrinkles, ears, noses). Liquid silicone (medical device)
not being FDA approved for any cosmetic surgical procedure. And not having FDA pre-market
approval. Also the two physicians were ordered to stop promoting use of liquid silicone by
advertising. Aronsohn had written a book 'Your Looks: Younger and Better Through Cosmetic
Surgery' and claimed to have performed 33,000 liquid silicone injections in the last 22
years. Aronsohn told a female undercover FDA investigator, posing as a patient, of his
long experience and assured her that there were no side effects or complications from the
injections despite that 'other world' of publicity to the contrary. Aronsohn introduced
the FDA investigator / patient to another patient who had received the injections
('anecdotical evidence'). Aronsohn stated that he wanted to make people look younger,
prettier and handsomer and not to interfere with other body functions. The liquid silicone
used was Dow Coming Medical Fluid 360 from Michigan. The label read: "Notice:
Dow Coming does not intend that this product be used as a 'drag' as defined by the Food,
Drug, and Cosmetic Act. It is your responsibility to determine the status for your
intended usage". A patient consent form was found in another civil lawsuit filed
against Aronsohn in 1988: "I understand that the silicone solution and the
injected procedure are still experimental and consequently still under investigation both
in humans and in laboratory animals, and further, it has not been as yet approved by the
Food and Drug Administration". Aronsohn wundered: "What is meant
by unapproved ?". He would continue to use it: "To my knowledge,
the FDA has no legal jurisdiction over the practice of medicine". M.D.:
Medical Divinity ?
--
WHAT POLITICIANS NEED TO KNOW
In March 1993 at a meeting of the American College of
Rheumatology in Arlington physician Frank B. Vasey, M.D. (University of South Florida
School of Medicine) reported the experiences of 5 women with rheumatoid arthritis who had
their implants removed. After 16 months, 2 of the women enjoyed significant improvement in
health, requiring less treatment. In september 1993 silicone researcher Frank B. Vasey and
Josh Feldstein publish the book 'The Silicone Breast Implant Controversy: What Women need
to Know': about how breast implants can cause illness including testimonials from
sick women of which some were totally disabled for years before being properly diagnosed.
--
IMPLANT-CHILDREN ALSO SICK
Begin May 1993 doctors examined the children of
mothers with breast implants and found symptoms of unusual immune disorders. Silicone
might be contaminating breast milk or seeping into the womb.The evidence was too
preliminary, said Dr. Jeremiah Levine of Schneider Children's Hospital but further studies
would follow.
--
DOW CORNING CEO DICK HAZLETON: PROFIT FIRST
In June 1993 Dow Corning announced to sell the assets
of its large-joint orthopaedic business to an investor group. And in June 1993 Dick
Hazleton, who joined Dow Corning in 1965 and held numerous positions in engineering,
manufacturing and finance, becomes Chief Executive Officer (CEO) of Dow Corning
Corporation in Midland, Michigan. He takes over from Keith McKennon. He already was
president of Dow Corning since January 1993. Hazleton wanted to return Dow Corning to the
profitability of the late 1980s. Richard A. Hazleton served previously as president of Dow
Corning Europe including two assignments at Dow Corning's European headquarters in
Brussels. Hazleton became Chairman of the Board of Directors in 1994.
# - After his retirment from Dow Corning in 2001
("his business card now has 'Granddad' as his title"), Richard A. Hazleton was
director of the Chemical Bank & Trust Company, President and CEO of the Charles J.
Strosacker Foundation, Chairman of the Board of Dendritic Nanotechnologies Inc (DNT) in
2004, and in 2006 Director of Starpharma Holdings Ltd.: a world leader in the
development of dendrimer nanotechnology for pharmaceutical, life-science and other
applications. End of 2002 Richard Hazleton was honored with the Master of Business
Administration Outstanding Alumni Award from the Central Michigan University where he
earned an MBA in 1972 and was awarded an honorary doctorate in commercial sciences in
1993. Hazleton and his wife, Mary Lou, got very involved in community activities. Richard
Hazleton, as Dow Corning former Group vice president J. Kermit Campbell, is a member of
the board of directors of the religious Ministry Eagle Village: "With God's
help and love, we serve children and families".
--
IMPLANT'S IMPOTENCE
In July 1993 a 58-year-old man, so-called Ed, made the
news (Orlando Sentinel). Ed wanted a cure for the impotence that had wrecked his sex life.
Two times penile implants were put in. The doctors assuring him (a beliefconviction) that
would restore his ability. But Ed said: "The infection actually ate through
the side of my penis, and you could look through there and see the apparatus". Ed
is still impotent and one of the growing number of men having disastrous experience with
implants. In March 1994 an increase in lawsuits against makers of penile prostheses was
noted, 'suddenly' raising concerns about............. safety. Plaintiffs' attorneys
claimed that the FDA never fully investigated penile prostheses. Where had one heard that
earlier ? Does (the) history repeat itsself ? Plastic surgeon (Annapolis, Maryland) Marcia
Ormsbsy said on a February 1997 conference at the National Press Club in Washington, D.C.
called 'Women's Health, Law, and the Junking of Science': "Where else is
silicone found ? Penile implants. There is no device more fraught with complications than
penile implants ! And yet we don't hear about that. They break all the time. Why ? Because
they're subjected to force. Yet these men have never been brought up on CBS Tv-programme
Face the Nation with Connie Chung".
--
PROPOSED SETTLEMENT
The lawyers representing the manufacturers of silicone gel breast implants and women
claiming toe be harmed by the implants announced on 21 September
1993 the proposed establishing of a $4.75 billion fund --the largest payout in
a class action suit in history-- for a 'global' settlement of thousands of lawsuits funded
over 30 years by implant manufacturers, physicians, insurance companies and others
involved in the implant surgeries. Women with breast implants could draw from the fund
until about the year 2020. Silicone implant victim, 35-year-old nursing assistant Jackie
Toledo who's implants left deposits of polyurethane and silicone in her lymph nodes
and made her sick: "I don't think there's a dollar amount you can put on
it. You can't do that because they took away my health". On 1 October 1993 polls
indicated that Americans saw the women-lawyers as greedy, unethical and callous.
Social-unrest ? Based on ? Media-signals (of a few individuals 'influenced' by....) ?
Trial attorney Robert Bonsignore, in August 1993 elected chairman of the new lawyers'
section of the Association of Trial Lawyers of America (ATLA): "I think
lawyers are sick and tired of being scapegoats".
--
REPETITION: CANCER STUDY CLEARS IMPLANTS
A day after the announcement of the settlement-proposal, on 22
September 1993, 'suddenly' an study popped up in the newspaper Chicago
Sun-Times: "a long-term study has found that implants do not increase the
risk of breast cancer". The Breast Implant Cancer Study had begun in 1974 under
3,112 Los Angeles women. Report of the study was given by Dr. Dennis Deapen (University of
Southern California) at the American Society of Plastic and Reconstructive Surgeons
(ASPRS) annual 1993 meeting. "A statistical deficit in breast cancers".
However, the same (by 3 implant manufacturers funded) study by Dr. Deapen, Pike,
Casagrande, and Brody, conducted during the summer of 1988, had already been cited by Dow
Corning and other implant supporters at the 1988 FDA Advisory Committee meeting held to
determine at that time if breast implants increased the chance on cancer. Already then, an
internal FDA review found numerous errors and methodological limitations in this Deapen
study. Patients had been studied for about 6,2 years, too short to detect breast cancer
seen that cancer in humans appear in a range of 20-30 years, it was said.
--
DUTCH PARLIAMENT: BREASTAUGMENTATION BY SILICONE
In 1993 the European Parliament comes with a 'directive medical devices': among
others. "Member States have to take measures to take care of devices only coming
into trade if they are safe and do not harm health". In October
1993 Dutch Tv-presentator Jaap Jongbloed presentated the Dutch tv-programme
'deadline' (bco TROS) about the adverse consequences of a silicone breast enlargement
operation. A woman had become occupational disabled by physical complaints. Dutch plastic
surgeon Dr. F. Groeneveld meant that the complaints were psychological en that the
objections against silicone protheses were unfounded: a beliefconviction. But yet
member of Dutch Parliament Wilbert Willems (Greenleft-party) made a request to the Dutch
Statesecretary of Health Simons (PVDA-party) to institute a temporary ban on the use of
silicone prothesis.
# - Question W. Willems (Greenleft-party): "Howfar
to present time have docters followed up on the recommendations of the Dutch Medical
Headinspection of Public Healthcare and the Headinspector of the Public Healthcare for
Medicine to point women out onto the risks of an implantation with silicone
breastprothesis ? Do you consider the information upto present sufficient ?"
# - Answer Statesecretary Simons (PVDA): "The
complications with silicone prothesis are known with the professionalgroups. The Dutch
Association for Aesthecial Surgery and Plastic Surgery (Vereniging voor Esthetische
Chirurgie en Plastische Chirurgie) has upto now pursued on good information. I take the
line that the medical profession in general considers it as her task to inform patients in
a resonsible manner"
# - Question W. Willems: "Are you
prepared, awaiting results of further study, to ban the applications of silicone by breast
prothesis ? If not, why not ?"
# - Answer Statesecretary Simons: "At
the decision-making regarding the question whether bringing into trade and the application
of certain medical devices should be prohibited, must be weighed if the possibility of
unwanted side-effects form an unacceptable risk towards the medical goal that is being
served with the medical device. On this moment there is a lack of data to make a
responsible weighing possible. Although I do not want to deny that risks can be be
attached to that, I find the application of the silicone breast prothesis against the
background of the in above answers mentioned activities for now acceptable"
(Source: Dutch Second Chamber of Parliament, 2 December 1993, 1993-1994, Attachement
nr.169 ).
--
DUTCH WORK-VISIT TO THE U.S.
(Source: Dutch Second Chamber Parliament, 23 400 XVI, nr. 73, 27 January 1994 )
In 1993, in reference to the Dutch report 'Choosing
and sharing' of the commission-Dunning, prof. A.J. Dunning and prof. Els Borst-Eilers
(then yet vice-chairman of the Dutch Healthcouncil, and a year later Dutch minister of
Health), and a delegation of the Dutch Vast Commission for Healthcare visited te U.S. to
get ideas about the Dutch new system for healthcare. One was informed by employees of the
FDA a.o.:
# - "The devices, to which in use the greatest
risks are attached (e.g. implants, artificial heart-valve, pacemakers) fall into the
catagory III, by which documents of safety and effectiveness must be handed over before
they are accepted for use".
# - "The FDA even demands at her acceptance of
medical devices, that dubbelblind tests are being performed, at some devices (e.g.
pacemakers, implants), an impossible demand. When one thinks that many medical devices are
produced in small companies with high investments, than it is clear that this FDA-demand
kills this industry".
The workingvisit to the U.S. offered the delegation a number of starting-points for
further activities of orientating nature in the Dutch healthcare, Dutch politics found
sure and certain.
--
IMPLANTS CAUSED EXCESSIVE INTERNAL BLEEDING
In an article of 2 November 1993 the Washington Post
paid attention to Heather Farr. She had her silicone breast implant removed 3
months earlier because of encapsulation which caused excessive internal bleeding. In the
Hoag Memorial Hospital the silicone implant was replaced by a saline implant. Since then
physicians were unable to control the internal bleeding, according to hospital spokeswoman
Stacey Broussard, while physician Neil Barth said that due to the new surgery "complete
control of the bleeding from the chest wall site" had been gained. And Dutch
Tv-programme 'Here and now' (Hier en Nu, bco NRCV, November 1993 ) made a report about the
disputed use of silicone implants at breastenlargement: research had been done by
the Dutch Governmental Institute for Public Healthcare and Environment (Rijksinstituut
voor Volksgezondheid en Milieuhygiëne, RIVM http://www.rivm.nl
) and the Dutch Consumerunion (Consumentenbond) into the dangers.
--
DOW CHEMICAL NOT LIABLE
Based on the argumentation that Dow Corning was not a subsidiary of Dow Chemical but an
independent (non by the mothercompany 'influenced') company, U.S. Federal District Judge
Sam Pointer dismissed in December 1993 more than 3000
suits against the co-owners Dow Chemical and Corning. They were thus not liable for any
injuries from silicone breast implants. Dow Chemical claimed it never manufactured or
tested silicone breast implants. Pointer decided that Dow Chemical had to be dismissed
from the case because it had no direct knowledge of the implants made by Dow Corning. At
the end of 1993 12,359 individual lawsuits have been filed against Dow Corning.
--
US DOCTORS DISPUTE IMPLANT BAN
Begin January 1994 the Council of Scientific Advisers
of US doctors' organization the American Medical Association (AMA) stated (Journal of the
American Medical Association) that no convincing evidence showed implants cause health
problems. Openly disagreeing with the FDA('s 1992 moratorium). After being informed on
risks, women should be allowed to make their own choice, they found.
--
3 WOMEN -Vs- 3M
In March 1994 Darla Lawson, Judy McMurry and Susan
Doss -Vs- 3M (Minnesota Mining and Manufacturing) Corporation. The three women are awarded
a total of $27.9 million in damages. The third multimillion-dollar settlement. 3M
Corporation (Inamed: parent company and co-defendant) and two smaller companies were
charged with making leaking silicone breast implants that caused severe illnesses. The
three women suffered from either atypical lupus, neurological impairment, and a
"silicone induced" autoimmune problem. Expert testimony was given by pathologist
Dr. Nir Kossovsky (UCLA Medical Center). But Marsha Arko, a 3M spokeswoman believed
different: "We believe the products were safe". The lawyer arguing
the case was John O'Quinn who in his practice alone settled averaged 20 to 30 cases a
month. O'Quinn had asked the jury: "To send a message in language they
understand". McGhan Medical Corporation acquired 3M's implant business in 1984.
--
MULTIBILLION SETTLEMENT
In March 1994 the largest US class action suit in US
history is finalized, settled by manufacturers. The $4.25 billion Global Breast Implant
Litigation Settlement Agreement. Dow Corning Corporation was the largest contributor ($2
billion). The other contributors to the settlement include Baxter Healthcare ($556
million), Bristol-Myers Squibb/MEC ($1.15 billion). Two weeks later 3M (Minnesota Mining
and Manufacturing), Union Carbide Corp., and several smaller implant manufacturers and
materials suppliers join the agreement. In total around 60 companies. Women would be
eligible for between $105.000,- to $2.000.000,- in claims of diseases against the implants
implanted before 1 June1993, dependent on the type and severeness of the illness (Disease
Compensation Program: deadline 16 september 1994 ). No requirements are needed to prove
implants are the cause of their ailments. Also children of woman with implants could be
eligible. As a consequence of the December 1993 decision of U.S. Federal District Judge
Sam Pointer that Dow Chemical was not liable, Dow Chemical was not a participant in this
$4.25 billion "global" settlement offer to settle / buy off all lawsuits. If a
manufacturer believed too many women choose to bypass the settlement and take their
individual cases to court (opt out by Exclusion Form, deadline 17 June 1994 ), the company
was allowed to pull out of the agreement / settlement. If defendants stayed in, a hearing
(for 3 days) was to held on 18 August 1994 to determine the fairness of the settlement.
Women had to 1 December 1994 to join the Settlement. Later than that deadline might mean
less money. The payout to each woman would depend on the total number of claims filed. The
payout could decrease dramatically as the number of plaintiffs increased. Kathleen Anneken
of the Command Trust Network mentioned that since no registry was held, not knowing how
many women would need to be compensated, it could not be established if $4,2 billion would
be fair or unfair. Further were 50% of US-made implants covered by the case exported. The
case was closely watched because of implications for other bodily implanted medical
devices. Federal District Judge Sam C. Pointer Jr. gave preliminary approval to the
settlement on April-foolsday 1994.
# Adding insult to injury: The breast implant settlement falls short
(The Progressive, 1 July 1994, Thomas M. Burton)
http://www.encyclopedia.com/doc/1G1-15533724.html
--
1970'S TESTS INDICATED IMMUNE SYSTEM HARM
Dow Corning scientists (expert on viruses Dr. Robert S. Lake ?) performed an experiment in
1975. Laboratory mice were injected with various doses of a purified form of silicone gel
(D4 ) used for breast implants. It appeared that D4 could do more kinds of damage to the
immune system than was acknowledged in 1975, or in 1992 at the time of the implant
controversy. Dow Corning spokeswoman Barbara Carmichael denied. A copy of this internal
Dow study --saying silicone gel contained trace amounts of a substance that seemed to
impair the 'cellular immune system'-- was released by the FDA on 7
April 1994. And / Why not in 1992 during the FDA-hearings ?
--
DAMAGING PRACTICES
In April 1994 Dr. Norman Anderson (John Hopkins
University) --in 1992 demoted by FDA's chief Kessler as a voting member of FDA's crucial
Advisory Panel-- wrote a letter to Senator Herbert Kohl of Wisconsin warning about
practices of sealing in the courts damaging evidence against breast implant manufacturers.
Evidence which proved the dangers of silicone in the body. 'Secrecy -above- openness' ?
--
STEVIE NICKS "I'M LIVING PROOF IMPLANTS AREN'T SAFE"
Popband Fleetwood Mac's Stevie Nicks received silicone breast implant in 1976: "everyone
was told they were safe". "But I'm living proof that they aren't
safe"., Stevie Nicks says. Her growing lethargy had been diagnosed as the effects
of Epstein-Barr virus: causing constant fatigue. While doctors advising removal
would be painful and unnecessary, Stevie Nicks had the implants removed in 1994: "It turned out they were totally broken".
--
DOW'S OBSTINATE BELIEF: SAFE IMPLANTS
After Dow Corning having agreed to the $4.3 billion settlement and thus to the claims of
the women, Dow Corning in May 1994 maintained
obstinate in disputing the same claims, using absolutistic scientific evidence. Dr.
Richard Mast (Dow Corning's director toxicology and bioscience research): "We've
had 30 years of good results with implants. No definite connection between our products
and disease has been proved". After Dow Corning's decision in 1975 to stop
research into the immunological activity of silicone, then believing it was not necessary,
Dow Corning was now financing at least 2 laboratories which were researching the
immunological effects of silicone.
--
IMPLANT EXPLOSION
Freon (chloromethane, dangerous for environment) is found in implants. Dr. Bernard
Patten (Baylor) reported Freon in silicone implants. Patten's experiment proved that
flying in an airplane was hazardous to any implant patient's health because freon gas
(under pressure) expands when taken on a higher altitude with the result of leakage. The
(former) President of the American Society of Plastic and Reconstructive Surgery (ASPRS)
called Bernard M. Patten a 'junk scientist' http://www.humanticsfoundation.com/bernard_patten.htm
On 11 june 1994 the Britisch Medical Journal mentioned
that the breast implant of a woman diver exploded during ascent from 30 m. She suffered
major injuries to her chest wall. http://bmj.bmjjournals.com/cgi/content/full/308/6943/1574/b
--
STUDY MAYO CLINIC
On 16 June 1994 the Mayo Clinic (Rochester, Minnesota)
epidemiologic population-based study of women in Olmsted County is published in Marcia
Angell M.D.' New England Journal of Medicine (NEJM) which is stuffed with advertisements
by medical suppliers including Dow Corning. The researchers had reviewed the medical
histories of more than 2,200 women who had been treated at the Mayo Clinic between 1964
and 1991. The population included 749 women who had received at least one breast implant
during that time and 1,498 women (control group) who had not received implants. The
researchers (Sherine E. Gabriel et al.) found no difference in the development of
connective-tissue disease between women with or without silicon-gel breast implants. No
increased risk of connective-tissue disease and other disorders that were studied in women
with silicone implants. More extensive studies were found to be needed. The Mayo-clinic
(extrapolating) study contradicted the claims of 1000's of sick implant women made in
lawsuits and/or in front of the FDA as a testimony: anecdotal evidence. Many
epidemiologists, FDA officials and other believers welcomed the Mayo Clinic study as one
of the first pieces of scientific evidence about (no) implant risks (Sherine E. Gabriel et
al., Risk of Connective-Tissue Diseases and Other Disorders After Breast Implantation, 330
New Eng. J. Med. 1697 (1994 ) ).
--
MAYO-EDITORIAL DR.MARCIA ANGELL
The publication of the Mayo Clinic Study was accompanied by an editorial of Dr. Marcia
Angell, the executive editor of The New England Journal of Medicine: "The
accumulated weight of anecdotes was taken by judges and juries as tantamount to proof of
causation. Multimillion dollar settlements followed, along with poignant stories in the
media and appearances by plaintiffs on talk shows. All this added to the weight of the
anecdotes, which in a circular way became accepted by the courts and the public as nearly
incontrovertible evidence". The editorial claimed that the FDA had been
paternalistic and unnecessarily alarmist in banning these implants. Angell noted nobody
asking questions about the use of automobiles while they kill over 40,000 Americans a year:
"In the case of breast implants the benefit has to do with the personal judgments
about the quality of life, which are subjective and unique to each woman, the FDA has
acted as though there were none, FDA Commissioner Kessler may be holding breast implants
to an impossibly high standard". The editorial / Marcia Angell also criticizes
conclusions drawn on courtroom opinion and not on data: FDA's pseudo-science.
Everybody asks questions about the use of alternative medicine, while they kill a few
people a year ?
--
CRITICISM ON MAYO CLINIC STUDY
M.D.: Medical Divinity ? Medical Hippocratical smokescreen ? The Mayo Clinic study had not
examined patients and included (as 'healthy') patients, patients they had not seen since
implantation. On 1 September 1994 consumer advocates and lawyers (National Plaintiffs'
Steering Committee) questioned (the conclusions, the timing of) the Mayo Clinic study. The
study was criticised for its size and for looking at only classic symptoms of a few
well-defined diseases which occur in only 2 to 4 people per 100,000. Women might develop
other immune-related symptoms that don't conform to 'classic' disease descriptions.
Looking at 'the earth is flat', instead of round ? The studies group in the Mayo-study had
their implants for a mean of 7 years. The National Institute of Health finds that it takes
7 to 15 years before silicone-related diseases show up. Based on examples of chemically
mediated disorders, such as scleroderma in association with silica exposure, latency
periods of more than 30 years before disease develops may be possible. The lawyers'
statement: "In many instances, the signs and symptoms in women with
silicone-induced diseases present atypically so that the women do not meet the classic
diagnostic disease criteria".
# - S. Lori Brown, Ph.D.(FDA research scientist
officer, Center for Devices and Radiological Health): "Because of the
limitations in the size and type of the studies, however, the true risk of these diseases
is not known", "Although the criteria others may be using to assess those
studies show that some concerns are eliminated unfortunately, they don't rule out a small,
but significant, increased risk", "If you have a disease that has an incidence
of 1 in 100,000 in the general population, for example, and you do a study of 750 women
with implants, like the Mayo Clinic Study, then you wouldn't really expect to see even a
single case of that disease".
# - The Mayo researchers had concluded: "We
had limited power to detect an increased risk of rare connective tissue diseases.... Our
results cannot be considered definitive proof of the absence of an association between
breast implants and connective tissue disease". Dr. Sidney Wolfe (Public Citizen)
('Implant Study Too Small for Final Word', N.Y. Times, 28 June 1994 ): "The
researchers might better have concluded that because of the limited size of the study, the
negative findings should not be taken as an assurance that breast implants are not causing
connective tissue diseases".
# - An editorial from medical journal the Lancet took
an opposite stance. The Mayo Clinic was: "insufficiently powerful"
to detect an increased risk of connective tissue disease. Experts predict that 20% of
women with silicone breast implants will develop mild, moderate or severe symptoms of
toxicity, and more than 4000 women in Australia alone have registered silicone-related
illnesses with consumer organisations, according to senior research fellow at the
Australian University of Melbourne's Department of Surgery Dr Lynette Dumble (Green Left
Weekly, 5 December 1995 ). http://www.greenleft.org.au/back/1995/214/214p3.htm
# - Further documents showed (Legal Intelligencer, 30
October 1995 ) that the Mayo Clinic study had been funded by major implant manufacturers
including Dow Corning and Bristol-Myers Squibb. Also the Plastic Surgery Educational
Foundation (PSEF) of the American Society of Plastic and Reconstructive Surgeons (ASPRS)
had been a funding-source. The manufacturers contributed money to the Foundation. The
Foundation had paid the researchers. A same construction which had been used in 1993 in a
University of Maryland School of Medicine study ('Breast Implants/Scleroderma') by M. C.
Hochberg. Results ? "These preliminary data fail to demonstrate an association
between augmentation mammoplasty (with silicone breast implants) and the development of
SSc (scleroderma)". Dow Corning also had earlier directly funded a Emory
University study (Silicone Breast Implants/Connective Tissue Disease') by John A. Goldman
in 1992. Conclusion ? "Among patients seeking a rheumatologicalconsultation, those
with a history of breast implants were no more likely to have diagnostic considerations of
a connective tissue disease, whether the analysis was matched or unmatched". And
in 1994 a University of Michigan School of Public Health study ('Scleroderma and its
Causes') by David Schottenfeld. Conclusion ? The researchers found "no
statistically significant association between silicone breast implants and
scleroderma" and "no association between any contact with silicone and
scleroderma". The Mayo clinic study: does (the) history repeat itsself ?
# - The timing of the Mayo Clinic study: "A
clear attempt to scare women with breast implants into opting in to the $4.2 billion
global implant settlement" because the study was published a day before the
deadline of 17 June for women to opt in or out the massive class-action settlement. Dr.
Jerome Kassirer, editor-in-chief of the New England Journal of Medicine, played stupid:
"It was a complete surprise to us that the opt-out deadline was the day after the
study was published".
# - Against Mayo Clinic Study researcher
rheumatologist Sherine E. Gabriel legal "staggering" demands were filed by a
lawyer representing thousands of implant women, Gabriel complained in the New York Times.
The lawyer wanted over 800 manuscripts from researchers, hundreds of data bases and the
entire medical records of all Olmsted County women. The demands had "severely
compromised" Gabriel's ability to do research. Colleagues of her backed off from
doing own implant research, said Gabriel: "Some determined that the price
in terms of their own research careers is too high to pay".
--
SILICONE TIME LINE
--
IMPLANT-CHILDREN: SCLERODERMA
In 1994 studies bring to light that children of
implanted women have scleroderma-like symptoms such as difficulty in swollowing
(esophageal dysmobilities), serious breathing difficulties and other systemic health
complaints. Symptoms of an autoimmune attack. These children are often smaller and have
considerable more healthproblems than their before implantation born brothers and sisters.
More extended studies are needed.
# - Levine, J.J. et. al., Sclerodermalike Esophageal Disease in Children Breastfed by
Mothers with Silicone Breast Implants, JAMA, January 19, 1994, vol.271, pp. 213-216.
http://cat.inist.fr/?aModele=afficheN&cpsidt=3932064
http://www.fda.gov/bbs/topics/ANSWERS/ANS00550.html
http://www.artofbreastfeeding.com/cgi-bin/store/AoB2.cgi?ORDER_ID=206871584725&CPAGE=implant.html
http://www.thefreelibrary.com/Implants+linked+to+disorders+in+children.-a014965927
# - Teuber, S.S. et. al., Autoantibodies and Clinical
Rheumatic Complains in Two Children of Women with Silicone Gel Breast Implants, Int. Arch.
Allergy Immunol, vol 103. 1994, pp. 105-108.
# - Smalley, D.L. et. al., Immunologie Stimulation of
Lymphocytes in Silicone Gel Breast Implant Patients and Their Children, Ass. ofMedLab
Immunologists, Boston, July 14, 1994.
--
EUROPE: IMPLANT-HOLIDAY
Due to the ban of silicone implants in the US (as also in Canada, Japan, Italy, and
Norway), American women go to other countries (United Kingdom, Mexico and Germany) to get
implants. "Boobs n' Bard." was a popular holiday-package: getting
implantation in an English hospital combined with sight-seeing, a trip to the birthplace
of Shakespeare. The European Committee on Quality Assurance and Medical Devices in Plastic
Surgery stated in June 1994 that it "does not
support any restriction on the use of silicone-gel filled implants".
--
TRILUCENT: COLLAGEN ENTERS BREAST IMPLANT MARKET
US company Collagen Corp around 1 July 1994 made an
additional equity investment, increasing it's position from 32% to 37%, in Swiss company
LipoMatrix Inc.: a manufacturer of a triglyceride-filled breast implant (Trilucent
Inflatable Mammary Implant), developed in America in 1987. Up to then, as part of a
clinical evaluation programme, more than 50 patients had been treated by European plastic
surgeons with the Trilucent.
# - In 1991 US company Collagen was involved in a
controversy over its wrinkle-removing product: injectable bovine collagen. Begin 1999 Dr.
Hilary Pickles (a senior official working for the British government's special committee
monitoring the impact of 'mad cow' (BSE) disease) claimed, as new evidence from the
overall national BSE inquiry, that anti-aging wrinkle creams containing cattle parts could
had triggered the human form of the disease. Dr. Pickles was particularly concerned of
infection if the creams were used on broken skin. In 2001 the fears about collagen (a
protein found in animal connective tissue) derived from cattle and used for cosmetic and
reconstructive surgery reappear because of fears about mad cow disease. http://www.mad-cow.org/UKCJD/CJD_news55.html
In July 2004 the FDA recommended --in a risk assessment dealing with the potential for BSE
in cosmetics-- firms to not use certain cattle-derived substances in their products due to
the risk on the human version of mad cow disease if they applied cosmetics tainted with
bovine spongiform encephalopathy (BSE) to open cuts. More studies were needed ?
--
SPIRITUAL-MEDICAL-MANTRA "MORE STUDIES NEEDED"
Marcia Angell (editor of the New England Journal of Medicine): "We in the
scientific establishment often say `More research needs to be done'. Sometimes we mean it.
Sometimes we mean to cover our flank". More studies. This is the mantra of the
medical community in the face of controversial issues. More data needed to reach a
definitive conclusion. Scientific studies set the standard for public policy, medical
treatment and personal decisions (The Washington Post, 12 July 1994, Abigail Trafford).
--
NORPLANT
Norplant, a 5-year pregnancy-protectative silicone-coated birthcontrole pill, became
widely available in the US in the 1960s. FDA approval came in 1990. The well-promoted pill
is surgical implanted in the upper arm. Wyeth-Ayerst Laboratories claimed the pill as safe
and effective. A short-term believe-conviction, at which the long term risks, aware
willingly and knowingly, are taken into the bargain ? Or, due to a too blind short term
believe-conviction, playing the ostrich for long term reality ? Wyeth-Ayerst Laboratories
distributed the pill to about 1 million US women. Class-action lawsuits were filed in the
US since Summer 1994, as it became known that Norplant
had side-effects: affecting the antisystem, blindness, weight gain, depression, severely
irregular or prolonged menstrual cycles, headaches, and dizziness. While more and more
women were receiving Norplant, the defendant (in situation A.) made people believe that
the wide range of injuries of Norplant-women were 'minor' injuries. Would the defendant
also have found this if (situation B.) one of his or her children would get these 'minor'
injuries, e.g. go blind ? Like women with silicone breast implants, Norplant users
reported immunological problems possibly linked to the silicone.
# - End 1980s member of the Association of Trial
Lawyers of America (ATLA)'s Norplant Litigation Group / Steering Committee, attorney Sybil
Shainwald, testified before the FDA, as a member of a consortium of health groups
worldwide (Health Action International), opposing FDA approval of Norplant because
Norplant-problems, like those became known in the US in 1994, were reported in countries
outside of the US: "It was the quickest approval of anything I'd ever
seen". In 1995 Prof. Elizabeth Connell (Emory University, head of two FDA
silicone breast implant panels) said: "We have great concerns that any
medical device with silicone in it will not survive", "I think we're in a worse
mess in American medicine than we've ever been in. Instead of leading the world, we're now
a third-rate country in terms of our ability to develop new drugs and devices".
In 1996 there were more than 50.000 Norplant-lawsuits. Norplant, after more than two
decades in development, was taken of the UK market of Norplant in 1999.
# - But scientists (still) generally believed silicone
is an inert substance as silicone is routinely used in an array of medical devices
(artificial organs, -joints, penile prostheses, contact lenses). About 7.5 million medical
devices are implanted in Americans each year and most people (unkowing) use silicone daily
in one or another form via several other consumer products and some medicine. If silicone
were not inert, if the belief-conviction (based on no / lack of research) proved to be
wrong (based on (future) research), one could imagine the massive health -, liability- ,
financial- and political consequences ? In line with the Sylvia Millecam-case, Imagine the
national and international newspaper headlines and reactions: 'Those responsible
(for the out-dated beliefconviction) have to be slowly roasted' ? 'Did those responsible
have the peoples in its power' ? 'Lawyers want prosecution those responsible (and those
who obstinate preached the out-dated beliefconviction to the peoples)' ? 'Those
responsible (and their political guidancers) risks criminal prosecution after death
thousands' ? 'Culpable homicide' ? 'Those responsible to prison' ? 'Restore 'witches
scale' for those responsible' ? 'Those responsible guilty of death thousands' ?
'Healthinspection reports those responsible' ? 'Healthinspection: those responsible are
perilous' ? 'Those resonsible (and their media-voice-tubes who promoted the outdated
beliefconviction to millions of peoples) mislead thousands to hopeless cancer death' ?
--
- SILICONE TIME LINE
--
SILICONE GEL STIMULATES TUMOURS
A new study published on 20 July 1994 in the Journal
of the National Cancer Institute (NCI) confirm that the same silicone gel used in implants
causes a rare cancer in mice. But "extrapolating from a mouse model to a human
model was dangerous", said study NCI coauthor Michael Potter, which could raise
the question at certain people: dangerous in any case, any situation or
discriminatingly just dangerous in this specific case with in the back of the mind
medication-studies on testanimals ? Sydney E. Salmon (University of Arizona College of
Medicine) about this mouse-study: "But it certainly isn't something we
should ignore, finding a few cases doesn't mean there's a causal relationship".
'Further studies were required'. (Potter M, Morrison S, Wiener F, et al, Journal of the
National Cancer Institute, 1994, vol. 86, n14, pp.1058-1065 ). http://jncicancerspectrum.oxfordjournals.org/jnci/
SILICONE IMPLANTS INCREASE CANCER RISK
(Campbell A, Brautbar N, Vojdani A., Toxicol Ind Health. 1994 May-Jun;10(3 ):149-54 )
"Our findings show a marked significant increase in previously suppressed natural
killer (NK) cell activity in 50% of the patients. In the other 50%, no change or
suppressed NK activity was observed. These findings are compatible with recent studies in
experimental animals, which show that administration of silicone reduces natural killer
cell activity, and that this is reversible upon removal of the silicone. Since NK cells
are important in the control of tumour cell growth, we propose here that patients with
reduced NK cell activity are at a higher risk of developing cancer, a concept recently
described in experimental animals (Potter et al., 1994; Salhon et al., 1994 )". http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=7855864&dopt=Abstract
--
SILICONE CONSPIRACY
Pamela Stott-Kendall publishes in July 1994 the book
'Torn illusions: One woman's tragic experience with the Silicone conspiracy'. Pamela
Stott-Kendal had taken implants in 1980 to please her husband. She had the implants
removed in 1985 but still suffered related illnesses and great pain in total for 13 years
during which she lost her husband, her home, her job, and most of the childhood of her two
children. A story of lack of interest, cover-ups, denials by individuals, chemical
companies and governmental agencies. http://www.amazon.ca/Torn-Illusions-Experience-Silicone-Conspiracy/dp/0882820974
--
US TRILUCENT EXPERIMENT
The Associated Press and the The Boston Globe reported on 2
August 1994 that 50 US women would receive an experimental breast implant
filled with natural fat from soybean oil. In the search ("useless / desperate road
along alternatives") for a safer, more natural way to enlarge women's breasts: the
Trilucent implant filled with unsaturated triglyceride from soybean. This new experiment
was the first USA (pilot) study of a new implant, since the controversy began in 1991,
approved by the FDA around 1 October 1994. Officials of the manufacturer, LipoMatrix,
'claimed' the new implants would be safer than silicone-gel and saline implants: a
short-term belief-conviction. And also the Trilucent implant was the first implant that a
mammogram could penetrate. A doctor stated that "animal studies had showed that if
the Trilucent implant would leak, the body would metabolize (circulation of matter) and
throw out the fat just as if the woman had eaten it". Some memories could
remember in this Trilucent-specific-case the words (20 July 1994 ) of National Cancer
Institute co-author Michael Potter: "Extrapolating from a mouse model to a
human model is dangerous" ?
--
UNDERFUNDED SETTLEMENT
The $4.2 billion settlement appeared to be grossly underfunded. The court reduced the
amount of the settlement by 25% for use for attorneys fees and costs of litigation. Less
than 35,000 woman would qualify as claimants while about 400,000 women registered. . The
settlement made inadequate provision for an unknown number of foreign women. The
manufacturer at first wanted to almost exclusively give women in the own country a
damagescompensation with a small percentage for non US-women. This to great indignation of
Dutch Silicone Supportgroup SVS / Marlou Boots (Dutch newsjournal 'NOS Journaal', 18-08-1994 ). Dutch women, supported by the Dutch
Consumersunion, signed up for appeal with at stake a higher percentage compensation.
# NBC Evening News
18 August 1994 - The proposed nationwide settlement of breast implant lawsuits examined;
the deal offered by implant makers outlined http://openweb.tvnews.vanderbilt.edu/1994-8/1994-08-18-NBC-6.html
--
JUDGE POINTER POSTPONES RULING
Due to the unsufficient foreign situation U.S. Federal District Judge Sam C. Pointer Jr.
after a 3 day hearing said on 22 August 1994 needing
more considering time. Refusing to approve the $4.25 billion settlement proposed by the
lawyers in March 1994. Unexpected high numbers of women had chosen to opt-out, not joining
the settlement and pursuing own individual lawsuits. Pointer would decide about final
approval by 1 September 1994.
--
LEAKING IMPLANTS: LOWER CANCER RISK
26 August 1994 - Researchers at Massachusetts General
Hospital http://ww.mgh.harvard.edu suggested that
leaking silicone breast implants might provide some protection against breast cancer. http://focus.hms.harvard.edu/1994/August26_1994/BreastCancer.html
--
BREAST IMPLANTS: A SJOGRENS-LIKE SYNDROME
(Freundlich B; Altman C; et al, J Graduate Hospital, Philadelphia, PA 19146. Semin
Arthritis Rheum, 1994 Aug, 24:1 Suppl 1, 44-53 ) "Exposure
of breast tissue to silicone has been associated with autoimmune diseases in the medical
literature since the 1960's......(... )....These findings may indicate the presence of a
unique syndrome associated with silicone implants that is characterized by musculoskeletal
pain and autoimmune features". http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=
PubMed&list_uids=7801139&dopt=Abstract
--
JUDGE POINTER: APPROVAL SETTLEMENT
On 1 September 1994 U.S. Federal District Judge Sam C.
Pointer Jr. approved the US$4 billion settlement on breast implants: "reasonable,
fair, and adequate". And in the best interests of the women, found Pointer. News
reports stated that 90,500 women had applied for the compensation. Another 15.000 women
(40% non-USA) had rejected the settlement. At least $200 billion would be needed to cover
all the claims. These woman wanted to pursue individual claims. (Note: The 700 woman in
the Mayo Clinic study thus being 0,66 % of the in total 105.500 woman with claims).
--
PAGE-3 MODEL' IMPLANTS FUNDED BY NHS
End September 1994 in the UK (The Independent, Liz
Hunt) a public outrage. Fashion model Fiona McAndrew had plans for herself. She wanted to
move into glamour modelling. To be a 'page 3 girl'. Only handicap she thought was her 32A
bust. No problem for the Britisch National Health Service (NHS), said referring General
Practitioner Dr. David Moor with a one-man surgery in Fenham to McAndrew, campaigning for
her, while at the same time hundreds of people waiting for (e.g. hip) pain-relieving
operations. NHS paid £2,500 pounds for McAndrew' breast implant operation: a 32C bra.
# - EUTHANASIA: In 1997 controversial Dr. David
Moor --who at one point was considering a campaigning future which could even include
politics-- was arrested and charged with murdering by lethal injection ('mercy killing of
a cancer patient') of one of his patients: retired ambulanceman 85-year-old George
Liddell. Model Fiona McAndrew had became a close friend of Dr Moor and formed the 'Friends
of Dr Moor support group' after his arrest. Dr. Moor fuelled up the nationwide euthanasia
debate and was in a trial in May 1999 cleared of any blame. Two weeks later ---with in the
back of the mind the thousands and thousands of women with breastimplants who for many
years were / are involved in lawsuits--- due to the stress of the trial Dr. Moor,
father-of-two, became ill, internal bleeding, and after recovery his wife wanted at first
to divorce. This also due to Dr. Moor' drinking and depression, which had lead to a
drink-driving incident in September 1999. On 14 October 2000 due to a suspected heart
attack 53-year-old Dr. David Moor died. A year later a book 'Allowing Dignity in Death'
was published about the moral dilemma Dr. Moor had faced, the controversial euthanasia
trial and its traumatic effect. His widow, Sylvia, said she hoped the book would finally
put his side of the story across, even if it was from beyond the grave.
--
MEDICAL EDITOR PAID BY DOW CORNING
The Associated Press reported on 13 December 1994 that
national known rheumatologist Dr. Peter H. Schur (Harvard Medical School), editor of
leading medical journal Arthritis and Rheumatism of the American College of Rheumatology,
received $300-an-hour consulting fees from lawyers working for breast implant makers when
he in February 1994 had written and published an article defending the implants and
rejecting studies which found links implants and health problems. His consulting services
(1994: $30,000 ) included critiques of medical reports, reviews of patient records and
trial testimony. Also Harvard Medical School doctor Matthew Liang had ties to implant
makers, working as a consultant to the attorneys defending implant manufacturers from
lawsuits. Dr. Schur and Liang were the principal rheumatologists on the Women's Health
Cohort Study, a followup of 450,000 female nurses and other health professionals at the
Brigham & Women's Hospital in Boston: which is a major teaching hospital of Harvard
Medical School and partner in its research. Around 20 December 1994 Dr. Schur and Liang
resigned and stepped out of the nation's biggest study of breast implant safety, lead by
Dr. Charles Hennekens. After an 11-month investigation in November 1995 the Brigham and
Women's Hospital put strict limits on the right of its doctors to testify in court as
expert witnesses or as paid advisers to attorneys. Conflict of interest.
--
SURGEONS SUE DOW CORNING
In 1994 lawsuits are filed against Dow Coming by US
plastic surgeons who claim the company damaged their medical reputations by
misrepresenting the quality of implants. And women who had ruptured silicone breast
implants, would be denied Health Insurance Coverage. In the meantime Dutch plastic
surgeons believed that there was no reason for worries regarding the harmfullness of
implants. Promised was that during 1994 a registry-project would start off in consultating
with the Medical headinspection of the Dutch Ministry of Healthcare.
--
DUTCH POLDER-MODEL
http://en.wikipedia.org/wiki/Polder_Model
In the Netherlands there is still discussion about the damage of implants. The Dutch Vast
Commission for Healthcare (chairman: Jeltje van Nieuwenhoven / PVDA-party) said (Policy
Silicone Breastprothesis, Dutch Second Chamber, 1994-1995, 23 900 XVI, nr.17, 11 November 1994 ) that a preliminary report of Dutch
Governmental Institute for Public Healthcare and Environment (RIVM) was expected end of
1994: "Up to now the results of studies from abroad do not point into the
direction of a link between the presence of silicone breast implants and tissue-disorders
and other disorders..".
--
BREASTENLARGEMENT STILL POPULAR
In December 1994 19,092 individual lawsuits had been
filed against Dow Corning. Despite the FDA's 1992 ban on silicone breast implants --by
which cosmetic breast implantations dropped 32%-- breast augmentation was still in the US
the 3rd most common cosmetic operation in the US in 1994. In England (with no ban) the
number of women requesting breast enlargement operations decreased from 12,000 in 1991 to
6,000 in 1994.
--
SALINE IMPLANTS' FUTURE
On 23 December 1994 the FDA, although seriously
considered also pulling saline-filled implants off the market, announced that
saline-filled (with silicone envelop) breast implants would remain on US market pending
Pre-Market Approval applications (PMAs). The Women's Implant Information Network (WIIN)
applauded this decision. The FDA told the saline manufacturers what type of safety and
effectiveness data were needed. The PMA's had to be submitted in 1998. 97% of women who
got implants in 1994 choose for saline implants.
--
TALC: SILICONE GEL - PROSTHETIC DEVICES
Talcum powder is in a silicone prothesis. A study in 1994
concluded: "The high incidence of talc deposition in the skin and tissues
surrounding silicone implants suggests that talc either is introduced at the time of
implant surgery (possibly in association with the silicone elastomer bag, tissue sizers,
or surgical gloves ) or is released into the tissues as a silicone gel contaminant during
gel bleed. Talc, a known sclerosing agent, may contribute to periprosthetic
fibrosclerosis" (Kasper CS, Chandler PJ Jr., Baylor Univ, Dallas, Ambulatory
Plastic Surgery Ctr, Dallas, Arch Dermatol 130:48-53, 1994 )
--
SILICONE IMMUNE DYSFUNCTION SYNDROME
Stephen B. Edelson, M.D., personal correspondence, lectures and publications,
Environmental and Preventive Health Center of Atlanta, received 1994:
# - "Slow contamination of the body by this
chemical and the secondary effects on the body lead to what I am calling the 'Silicone
Immune Dysfunction Syndrome'".
# - "The back-ground burden of oxidants and
toxins from our surrounding environment, and the food we eat and drink, adds hugely to the
already overpowering burden from silicone leakage".
# - "Immune Disorder Symptoms, sometimes
occurring within months of implant, but often occurring 15 to 20 years after surgical
implant, include the following: Peripheral Neuropathy (weakness, tingling, numbness,
etc.), Central neurotoxic Neuropathy (cognitive difficulties, memory problems,
hyperactivity, attention deficits), Cervical and axillary enlarged or painful lymph nodes,
fatigue, malaise, weight gain/weight loss, joint and tendon pain, hair loss, dry eyes
& mouth, flu-like symptoms, burning skin, constipation, dizziness, enlarged lymph
nodes, depression, thyroid problems, hair loss, night sweats, fibromyalgia (multiple
tender areas), Myositis (painful inflamed muscles), abdominal pain, emotional instability,
chemical sensitivity, food sensitivity, and Pulmonary Hypersensitivity (shortness of
breath)".
# - UNLESS THE IMPLANTS ARE REMOVED FROM THE BODY,
SUCH PATIENTS WILL HAVE A CONTINUING DOWNHILL COURSE. "All of these symptoms are
caused by the dysregulation of the immune system and by damage occurring from the free
radicals produced by our own system in response to the chemical silicone". As
interviewed by Stephen B. Edelson, M.D.: "An overall body detoxification
process developed by Lee Cowden, M.D. of Dallas, TX of Texas has brought about complete
recovery from at least one lady who suffered from a combination of breast cancer and
silicone tetramer leakage",
(Source: The Art of Getting Well: Silicone Arthritis and Related Diseases by The Roger
Wyburn-Mason and Jack M. Blount Foundation for the Eradication of Rheumatoid Disease AKA
The Arthritis Trust of America, 1994.
http://www.freewebs.com/implants/siliconearthritis.htm
http://www.arthritistrust.org/Articles/Silicon%20Arthritis%20and%20Related%20Diseases.pdf
) http://www.info-implants.com/BC/0017.html
--
SBI LABORATORIES TESTS: IMMUNE SYSTEM
Professor of Surgery at the University of Chicago dr. Robert Parsons, dr. Heggers and
their research assistant pathologist Nir Kossovsky suggested in 1982 to Gene Jakubczak at
Dow Corning that their work may enable them to develop a method of screening patients for
'hypersensitivity to silicone' before they are implanted. But requests for further
research to better understand this immune response were denied by Dow Corning. Not
interested. Nir Kossovsky M.D. reported in January 1995
in an abstract (1 ): "Research has shown that silicone, an adjuvant, is a
tacky substance that adsorbs the body's own molecules, a process that denatures the
molecules (2 ) and may cause them to look foreign to the body's own immune system (3 ).
The adsorbed molecular layer then controls the biological response (4 ),(5 ),(6 ). The
body may then engage in cytokine-mediated immune and autoimmune activity (7 ), which, in
turn, may cause a wide range of symptoms (8 ),(9 )", "Standard rheumatologic and
immunologic tests for well established immune diseases may not detect the hypothesized
nontraditional immune reactions caused by silicone exposure (7 ), (10 ),(11 )".
(1 ) - Nir Kossovsky, M.D., 'A Capsule Summary of the Biological Response Triggered by
Silicone Implants', SBI Laboratories, received January 1995
(2 ) - Cheng SS et al. J Colloid Interfac Sci, 1994; 1662:135-143
(3 ) - Kossovsky N and Freiman CJ. Arch Path Lab Med, 1994; 118:686-693
(4 ) - Kossovsky N et al. J Biomed Mater Res, 1987; 21:1125-1133
(5 ) - Tang L and Eaton JW. J Exp Med, 1993: 178:2147-2156
(6 ) - Bonfield TL and Anderson JM. J Biomed Mater Res, 1993; 27:1195-1199
(7 ) - Kossovsky N and Stassi J. Sem Arthritis Rheum, 1994; 24 (Suppl 1 ):18-21.
(8 ) - Bridges AJ et al. Ann Intern Med, 1993; 118:929-936.
(9 ) - Wilhelm K. Autoimmunity, 1993; 14:341-342.
(10 ) - Kossovsky N and Papasian N. J Appl Biomat, 1992; 3:239-242.
(11 ) - Kossovsky N et al. J Appl Biomat, 1993; 4:281-288.
--
SILICONE IS NOT INERT
In January 1995 a study concluded: "Silicone
is not an inert substance and can rarely result in devastating local tissue destruction
where migration has occurred. The possibility of significant silicone gel migration should
be considered during evaluation of patients with ruptured implants". (Teuber,
Ito, Anderson, Gershwin, Division of Rheumatology, Allergy, and Clinical Immunology,
University of Calif.-Davis, Arch Dermatol., Jan.1995, Vol.131, Pg.54-56 ).
--
IMPLANTS: EFFECTIVE RUPTURE RATE OF 100%
Dr. O. Gordon Robinson presented a paper entitled 'Rate of rupture of silicone prostheses:
excerpt from a study of over 3000 personal cases and 25 years experience' at the Symposium
on Reoperative Aesthetic Surgery of the Face and Breast in Naples. Florida. Robinson
discussed results obtained after 115 patients were followed after the fall of 1990 after
receiving breast implants. Of the 115 patients, 57% had rupture of one or both implants.
An additional 20% had moderate to severe bleed (silicone) on one or both sides. The
patients had the implants from 6 months to 25 years. Dr. Robinson concluded that all gel
and bi-lumen implants: "should be replaced at about the 8 post-operative year
because it can be fairly well predicted that at this stage the prostheses in most cases
would still be intact and much easier to replace. If a period of time longer than 12 to 14
years is allowed to elapse, then the prostheses have a good chance of being ruptured and
the exchange would be much more difficult".
# - In another study / paper 'Disruption rate of
silicone gel prostheses - a report of 200 cases' (whom had their silicone gel implants
removed) dr. O. Gordon Robinson found that 52% had one or both implants ruptured, 21.5%
had severe bleed (silicone), and 73.5% had 'distortion' (rupture plus severe bleed).
Robinson projected future rupture rates and concluded that in 20 years only 3,4% of the
patients will have both prostheses still intact. "Based on this study, patients
can be advised with a certain degree of accuracy as to the probable condition of their
prostheses". An abstract by Dr. Robinson and Dr. Edwin Bradley of the study was
published in the January 1995 issue of the American
Medical Association Journal. In an updated version, of the prior 200-patients study /
paper, entitled 'Breast implant removal or exchange' Dr. O. Golden Robinson saw an
additional 100 patients. Of the 300 patients, 154 had a ruptured prosthesis, and 214 had a
'disrupted' prostheses, i.e. loss of integrity of the silicone shell or severe silicone
bleed where silicone "strings out at least 12 inches from intact capsule".
Based on the research, a 70% rupture rate among women having their implants removed, an
effective rupture rate after 20 years of 100%, is reported by the study of G. Robinson et
al. (Annals of Plastic Surgery 34:1-7, 1995 )
--
DOW CHEMICAL LIABLE.....NOT LIABLE
A day before a 41-year-old Santa Clara woman received the first experimental breast
implant filled with soybean-oil fat (Trilucent), on 15 February
1995 a trial found Dow Corning guilty of misrepresentation and deceptive
practices that was the cause of the injuries of retired nurse Gladys Laas after
leaking implants. Gladys Laas was awarded $4.2 million. Her husband Robert received $1
million for loss of affection and companionship. Dow Corning, owned by Dow Chemical and
Corning Inc., only had to pay 80% of the damage compensation, because also Dow Chemical
had been found liable, for the first time, clearing the way for other lawsuits against Dow
Chemical. Dow Chemical Company was found guilty of aiding and abetting. Dow Chemical had
to pay the other 20%. On 28 March 1995 this was overturned and Dow Corning had to pay the
full amount.
--
FRANCE LIFTS IMPLANT BAN
On 28 February 1995 French health officials ended a
3-year moratorium on silicone breast implants but will require careful monitoring of women
who receive them. http://www.sfgate.com/cgi-bin/article.cgi?f=/c/a/1995/03/01/MNR3WO20.DTL&hw=breast+implants&sn=037&sc=377
# - DUTCH HEALTHMINISTER ELS BORST: "In
France there is since 1995 a limitation on import and sale of breast implants, continuesly
for a period of a year (the last limitation dated 26 May 1999 ). Excluded from this rule
are implants filled with fysiological salt ('saline'). Other implants with other filling
are allowed if the terms set by the French government are met and if the implants are
included on a seperate list" (Report written consultation about breast implants,
Questions Dutch CDA-, SP-parties, 10 May 2000, Dutch Second Chamber of Parliament, 26800
XVI)
# - THE EUROPEAN PARLIAMENT: "All
European member states, except France, have no limitations on the use of silicone gel
breast implants (SBI). In France a limitation has been posed since 1992 and in 1995 all
breast implants, except the salt-water filled, are prohibited. Surgeons must ask for
permission for a specific medical application, in case of reconstruction, to use
SBI's" (Contactmagazine Dutch Support Group SVS, 7th yr,Dec 2000, Nr. 4 ).
--
MEET THE PARENT: DOW CHEMICAL LIABLE
US Federal District Judge Sam Pointer judged on 25 April 1995
that Dow Corning's mothercompany, Dow Chemical, could indeed be held liable in implants
lawsuits. This in contradiction to Judge Sam Pointer' earlier verdicht (December 1993 ) in
which was presummed that Dow Chemical did not have direct knowledge of Dow Corning's
implants. John Scriven, Dow Chemical's general counsel: "Silicone breast
implants are not Dow Chemical products. Dow Chemical is not and never has been in the
silicone implant business. Furthermore, we never tested implants or offered opinions about
their safety". Why a change of Judge Pointer's view ? Because new evidence had
come to light. Lawyers had brought to licht that Dow Chemical had done safety-tests on
liquid silicone. In contract with Dow Corning from 1943 to begin 1970. Dow Corning put up
a own toxicological (Medical Products Division) in 1964, the time when Dow Chemical also
obtained a considerable controling interest in Gruppo Lepetit: an Italian
pharmaceutical company which had an exclusive distribution agreement with Dow Corning to,
as another Dow Chemical daughtercompany, among others bring Dow Corning's breast implants
onto the market outside the United States: Europe, South-America and from 1970 Australia.
There were Dow Corning was taking care of the United States. Further there was a
"Proposed Agreement For Cooperative Research Program between Dow Corning and Lepetit
Pharmaceutical Company" to research the use of silicone compounds in biological
systems. The proposal notes that Dow Corning had acquired information that certain
silicones are biologically active (not inert). End furthermore Dow Chemical and Corning
had made a joint (secret) agreement to develop a productline of pesticide and insecticide
application, based on the silicone gel which was used in Dow Corning's implants. Found in
conclusion was that Dow Chemical had a duty to use due care in providing reasonably
accurate and complete information even if it did not specifically know in which part of
the body the products would be implanted. In performing tests and advising on how other
tests should be performed, Dow Chemical often served in the role of consultant.
DOW'S GRUPPO LEPETIT:
# - "Rifamycins were first isolated in 1957
from a fermentation culture of Streptomyces mediterranei at the laboratory of Gruppo
Lepetit SpA in Milan by a scientist named Piero Sensi, working with the Israeli scientist
Pinhas Margalith. Lepetit introduced Rifampicin, an orally active rifamycin, around 1966.
Rifabutin, a derivative of rifamycin S, was invented around 1975 and came on to the US
market in 1993" http://en.wikipedia.org/wiki/Rifamycin
# Company news: Dow Chemical Stock Drops
(New York Times, 19-11-1994 )
http://query.nytimes.com/gst/fullpage.html?res=9804EFDD1131F93AA25752C1A962958260
# - On 3 May 1995 the Dow Chemical Company (DCC)
issued a letter entitled 'Employment matters, certain Italian personell': "..DCC
has no objection to and will cause Dow Italia S.p.A. ("Dow Italia") to agree
that the following five Dow Italia employees shall be transferred to Gruppo Lepetit S.p.A.
("Gruppo Lepetit") The individuals shall resign and shall be hired the same day
by Gruppo Lepetit. Marion Merrell Dow Inc. has no objection to and will cause Gruppo
Lepetit to hire the five people on the day each of them resigns from Dow Italia...".
# - GIOVANNA VOLLARO: "first worked in
Gruppo Lepetit, a pharmaceutical division of The Dow Chemical Company, as the Executive
Secretary to the General Secretary of Italy and then, as Assistant to the Worldwide
General Counsel"
# - PAMELA R. DEMAIN: Executive Director,
Corporate Licensing, Merck & Co., Inc. (from 'How did the Vioxx debacle happen?',
'Merck to pay $4.85 billion over Vioxx suits'): "Pamela's pharmaceutical
career began in the natural products laboratory of Gruppo Lepetit, an Italian
pharmaceutical company, which was then a subsidiary of the Dow Chemical Company. She
joined Merck in 1981".
# - R. WILLIAM CALDWELL: Director (1994 ) of
Williams Controls Inc.: "From 1963 until 1967 Mr. Caldwell served in a
variety of positions with Dow Corning Corporation. From 1967 to 1968 he served as the
assistant general manager, Pharmaceutical, Agricultural and Consumer Product Department,
Dow Chemical, in Midland, Texas. From 1968 to 1974 he served as director of Dow Chemical,
SpA, Milan, Italy, president and director A.P.E.S.A., Luxembourg, president and director
of Worldwide Operations, Gruppo Lepetit, SA, Italy. From 1974 until his retirement in 1975
he served as executive vice president of Dow Lepetit, Ltd., Milan, Italy and Midland,
Texas. Mr. Caldwell received a bachelor of science degree in chemical engineering from
Michigan State University..."
# - DR. UBALDO LIVOLSKI: "From 1983 to
1989 was treasurer of Dow Chemical Italy's fully controlled subsidiary Gruppo Lepetit Spa,
the biotechnology research organization that was renamed Biosearch following its
management buy out. During the period 1964 to 1991, Dr. Livolsi was employed by Dow
Chemical Company (Italy/Europe), a chemical and agricultural products company, as its
financial director. Dr. Livolsi holds a degree in economics from the Catholic University
of Milan".
--
- SILICONE TIME LINE
--
MULTIPLE AUTOANTIBODIES: BREASTIMPLANTS
"...We report the analysis of 20 autoantibodies in 116 women with implants and 134
controls...(...)...Many patients harbored several autoantibodies; 20 had four
autoantibodies; 8 had 6 autoantibodies. The association of autoantibodies and implants
suggests an adjuvant action of silicon/silicone by products" (Journal of
Autoimmunity, Volume 8, Issue 2, April 1995, Pages
267-277, Bar-Meir E, Teuber S. S., Lin H. C, Alosacie I., Goddard G., Terybery J, Barka
N., Shen B., Peter J. B, Blank M., Gershwin M. E.and Shoenfeld Y)
--
SAVING THE SETTLEMENT
In the beginning of May 1995 talks in Washington
began. A federal judge, due to a rush of new claims, had concluded that the $4.2 billion
for the settlement would not be enough. U.S. Federal District Judge Sam Pointer ordered
women's lawyers and implant manufacturers to renegotiate in an attempt to save the
settlement / agreement. Due to the ruling of Judge Pointer on April 25 (Dow Chemical being
negligent / liable) plaintiffs' lawyers could force Dow Chemical into the new settlement
talks.
--
DOW CORNING: CHAPTER 11 BANKRUPTCY
In Europe consumer groups and lawyers were lobbying to establish a European Product Safety
Agency heading towards the American model. The European Commission was planning to take
Great Britain to court in an attempt to end a key corporate tactic. The development risk
defence, which allowed companies to avoid liability for risks that could not reasonably
have been foreseen (on the short profitable term). And US personal-injury lawyers had
victory when McDonald's was brought into court for selling a woman a cup of coffee that
had burned her. The jury verdict awarded her $640,000. However, US Congress made plans to
reform product liability laws. Especially to place caps on the compensation amounts
manufacturers had to pay due to defective products causing damage. The reforms were
approved on 12 May 1995 by the Senate. This was too late for Dow Corning, the largest
contributor to the global settlement. Bankruptcy was a threat for Dow Corning due to the
lawsuits. After months of rumours, on 15 May 1995 Dow
Corning (for protection) voluntarily filed a Chapter 11 bankruptcy petition for
reorganization to anticipate a further avalanche of damage claims. This was a path which
had been well-traveled by other big companies when confronted with long term reality /
consequences of the own deeds and words out of a short term beliefconviction:
bringing harm upon and the need of damage funding of billions of dollars (E.g. Manville
Corp.: asbestos and A.H. Robins Inc.:birth control device). Or a -traveled path if a
company e.g. isn't able (doesn't want) to fullfill it's pension-obligations as in the case
of the LTV Corporation. The Dow Corning bankruptcy essentially halted all litigation
immediately as the bankruptcy court stayed liability cases against Dow Corning resulting
in forced cancellation of hundreds of trials and the $4.2 billion settlement is
threatened. Dow Corning stated being disappointed having to take this step. Dow Corning
chairman and chief executive officer Richard A. Hazleton pointed out that Chapter 11
filing was the only reasonable choice because:
- (1 ) Attorneys with lawsuits outside of the global settlement had not reduced their
exorbitant demands, threatening Dow's long-term business, and, therefore, Dow's ability to
fund the global settlement,
- (2 ) Hoping to preserve participation in the global settlement. Dow had agreed to
contribute $2 billion.
- (3 ) Dow's insurance companies hadn't taken their responsibility, committed to pay their
share of more than $1.5 billion. As of 31 March 1995 Dow had only received less than $100
million.
Further Hazleton said: "Research has not shown a link between breast
implants and the diseases alleged in lawsuits. Research from prestigious institutions like
Harvard University, Mayo Clinic, Johns Hopkins, the University of Michigan and others has
consistently found that women with implants are no more likely to contract disease than
women without implants. In fact, recently, both the French and British governments have
reviewed the available research and concluded that women with implants face no greater
risk of developing autoimmune disease than the general population". The Chapter
11 process would provide closure by resolving all breast implant financial claims. Thus
being a combination of preserving business operations and fairness to the women, Hazleton
believed. In 1993 Dow Corning (Robert Sayler, Robert Marsac) had started suing about 100
insurance companies for more money and saying they broke their promise to defend Dow
Corning in breast implant lawsuits. An attorney for the insurers replied (2 November 1995
) that Dow Corning was guilty of a 35-year cover-up. About 400,000 women were to draw
money from the settlement fund, accepting the restrictions. Like cashier in a seafood
restaurant 68-year-old Mae Savage after having received silicone-gel-filled breast
implant in 1978 after breast cancer surgery and in 1995 having to deal with a left arm
swollen twice the size of her right arm. At least 11,000 other women did not accept the
settlement and would pursue separate legal claims. Diane Fjelstad's name was among
the hundreds of women who filed lawsuit against Dow Corning and was waiting the Judge's
verdict. Some of the women accused Dow Corning --the smallest of the four companies
(Bristol-Myers Squibb, 3M, Baxter)-- of stretching out the process to avoid bad publicity.
Forcing women, who need the money urgently (breast implants removal), to settle
(bankruptcy court) for smaller amounts. Chapter 11 cases greatly reduce payoffs to
individual plaintiffs and can delay them for years. Some asbestos claims had to wait 10
years for payment. Houston Lawyer Rick Laminack: "I look at this bankruptcy
as just a continuation of Dow's manipulation of the legal system to avoid responsibility
for implant claims". Laminack had more than 2,500 pending lawsuits outside the
global settlement.
--
MASS TORT LITIGATION (MTL)
(Source: Issue Paper: Biomaterials Availability: Potential Effects on Medical Innovation
and Health Care, Bruce Don, director Science and Technology Policy Institute, IP-194,
January 2000, RAND)
The ATLA American Trial Lawyers Association (Charles R. Houssiere: Houssiere, Durant,
Houssiere & Gold, L.L.P., Plaintiff's Steering Committee (PSC)) formed the 'Silastic
Gel Breast Implant Litigation Group' in 1983 which became known as the 'Breast Implant
Litigation Group' (BILG). ALTA authored a briefing paper supported by industry documents,
testimony, and publications. In short:
"# - INADEQUETE TESTING - Manufacturers have
not tested the breast implants adequately for safety in accordance with the standards set
by the scientific community and required by the FDA for use in humans.
# - SILICONE GEL / LIQUID - Migration, bleeding to all
parts of the body, atypical immune disease / human adjuvant disease.
# - INSTABILITY OF BREASTIMPLANTS - Shells rupture:
migration. Despite complaints from surgeons and experiments of Dow Corning and Dow
Chemical showing biological activity of liquid silicones in pharmaceutical and insecticide
applications, the implant manufacturers held their position that silicone was biologically
inert and safe for implantation in humans.
# - LOCAL COMPLICATIONS - Among others chronic
inflammations.
# - SYSTEMIC DISEASE - Doctors report cases of
atypical disease, which sometimes may not surface until 6 to 10 years after implantation,
resulting from a chronic immune response to the silicone in the implant and its
degradation products, including silica. Causal evidence for the link disease/silicone is
presented in the animal studies, epidemiological studies showing elevated antibodies in
women with breast implants, and a few publications in the scientific literature.
# - MANUFACTURER'S ACTION - Dow Corning has attempted
to use "grass roots" organizations to disprove allegations of cover-up,
destruction of documents detailing the need for a study of the safety of implants, and
charges that the company reluctantly funded external scientific studies only after
consulting with legal counsel to determine the impact on breast implant litigation.
# - SOCIETAL COSTS - Notwithstanding Dow Corning's
filing for protection under Chapter 11 bankruptcy, the company's financial
performance has remained strong and no job losses have occurred. In contrast, the implant
patients are imposing tremendous costs on society. An estimated 85% of the nation's health
insurance carriers have attempted to seek reimbursement amounting to hundreds of million
of dollars" (Source: Issue Paper: Biomaterials Availability: Potential Effects on
Medical Innovation and Health Care, Bruce Don, director Science and Technology Policy
Institute, IP-194, January 2000, RAND)
--
DOW CORNING: THE VICTIM
Dow Corning choose for a defensive PR strategy to portray itself as the victim of greedy
plaintiffs' attorneys. A million dollar law firm -Vs- a million dollar P.R. firm. Dow's
PR-firm Burson-Marsteller used ghost writers to co-author articles for journals, paid
well-known professors to present evidence at meetings, and was able to get
"positive" evidence front-page attention while negative results were buried
inside the papers. 'Influencing' the media-signals ? The play in the backyard of the
peoples of the puppets and the Divine master-guru Dow Corning in a sect-like atmosphere ?
Linda Chavez announced sombrely on CNN (15 May 1995 ): "A company has, I think,
been driven out of business". While (in another reality) Dow Corning's CEO
reassured investors (Chemical Week, 19 July 1995 ): "Dow Corning recently
completed the best quarter in the company's history and the demand for our silicone
technology remains strong worldwide.....The Chapter 11 process is specifically designed to
allow a company to conduct its normal business operations while it resolves its financial
disputes". The Wall Street Journal published an article by Dow Corning's CEO
entitled 'The Tort Monster That Ate Dow Corning': the criticism on implant research
from plaintiff lawyers was a manoevre to gain money from implant victims. ABC's Nightline
complained about the loss of jobs resulting from the bankruptcy. An editorial of an
article ('The Triumph of Greed', 9 July 1995 ) in the Detroit News, Dow Corning's local
paper, quoted a Dow Corning worker's son: "Dad, are you gonna lose your job
?".
--
DOW'S ADVERTISEMENT: GATE-KEEPER
Dow Corning published a full-page advertisment "Here's What Some People Don't Want
You to Know About Breast Implants" in 19 major newspapers offering free
information package, which one could order at the toll-free-number, of selectively quoted
study results of 'prestigious medical institutions' (Harvard Medical School, Mayo Clinic,
University of Michigan, Emory University) proving, according to Dow Corning, no link
between breast implants and disease. While Dow Corning's General Counsel testified in the
bankruptcy case that Dow Corning funded implant research specifically: "To
provide the epidemiological data necessary to defend against allegations of breast implant
plaintiffs". These studies were intended to be a centerpiece of Dow Corning's
generic defense, according to the Counsel. Further Dow's advertisement mentioned: "Plaintiffs
attorneys have spawned a whole new industry from suing implant manufacturers".
The development of "lifesaving devices" ("heart pacemakers")
were being "slowed down" by the lawsuits. In Dow Corning's advertisement
package there was a writing (Manhattan Institute Research Memorandum) of David E.
Bernstein about a Supreme Court verdict (113 S. Ct. 2786, 1993, Daubert -Vs- Merrell Dow
Pharmaceuticals, morning-sickness drug Bendectin / birth defects) which called upon judges
to serve as 'gatekeepers', forbidding plaintiffs from presenting certain scientific
evidence. In breast implant cases: "Some judges have been loath to exercise
their gatekeeper role", Bernstein concluded. Dow Corning's claims in the
advertisement were for free being reprinted by eating it up individuals of the press. "A
Case Of Justice Or a Total Travesty ?", wrote Gina Kolata of the New York Times
(13 june 1995 ). And the LA Times claimed: "Judges and juries have often
overlooked rational evidence". Cathy Young wrote: "Lawsuits Feed
Implant Hysteria" (Detroit News, 27 June 1995 ). A New York Times story by Gina
Kolata (18 september 1995 ) "Implant lawsuits create a medical rush to Cash
In", described the class-action implant women as greedy opportunists goaded on by
slick attorneys, but looking over the fact that the manufacturers in the settlement had
set a short deadline with consequently the 'rush' of women joing the settlement. Like some
journalists feel a urgency to eagerly in the rush to be the first and/or have to cope with
a deadline in the sensation of a news story / hype ? To be quicker than the competitors in
the puppet-show for the viewer-, salesfigures ? Influence media ? Mis-trials were called
when Dow's advertisements were published due to fear of prejudiced juries and reporters
quoted directly from the 'influencing' advertisement. Blind belief ?
THE OTHER SIDE OF THE STORY: THE TRUTH BEHIND BREASTIMPLANTS
What The Breast Implant Makers Don't Want You To Know
Mary Alice McLarty, Attorney at Law, Case Facts
http://www.maryalice.com/cases/implants.html
--
PROPER DIAGNOSIS: IMPLANTS CAUSE DISEASE
At least 200,000 breast-implanted women expected to show link between silicone and
disease, stated PR Newswire on 15 May 1995. In a major
research study, conducted by SBI Laboratories, a silicone-induced immune profile was
observed with a new test: the 'Detecsil Silicone Sensitivity Test'. Silicone breast
implants caused a non-classical, atypical autoimmune disease, which was not being detected
with standard rheumatologic tests. The Mayo Clinic study cited standard tests. "Because
silicone syndrome is a new disease, it requires a new test to make its proper
diagnosis", said Pathologist, silicone researcher and developer of the new test
Dr. Nir Kossovsky based on 14 years of research on silicone surface reactions. In stead of
statistical data, this was the strongest human data that linked silicones to disease. The
Detecsil blood test, and Kossovsky's testimony, helped win lawsuits against implant
manufacturers. But advertising the Detecsil-test, as of March 1994, had presented
Kossovsky and his family with a problem: was the Detecsil-test for research use
only or a diagnostic tool ? In May 1995 SBI Laboratories applied for FDA approval of
Detecsil as a medical device.
http://www.info-implants.com/Walt/170.html
http://www.info-implants.com/Kay/28.html
http://www.breastimplantsupport.org/view_topic.php?id=998&forum_id=5
--
DOW CHEMICAL NOT LIABLE.....LIABLE
Dow Chemical filed a motion on 19 May 1995 asking
Federal Judge Sam C. Pointer Jr. to reconsider his earlier ruling (April 25: Dow Chemical
being negligent / liable) and dismiss Dow Chemical from the federal litigation. Also Dow
Corning had asked US Bankruptcy Judge Arthur Spector, who is overseeing Dow Corning's
bankruptcy reorganization, to halt all breast implant suits against parent corporations
Dow Chemical and Corning Corp. A seldom-used maneuver under bankruptcy laws. A federal
judge refused. Dow Chemical remained defendant in 4 Houston implant suits in June. In June 1995 about 440,000 women have registered in the Global
Breast Implant Settlement Fund. About 70,000 can be immediately compensated.
--
HARVARD NURSES HEALTH STUDY
http://www.hms.harvard.edu
On 22 June 1995 the Harvard Nurses Epidemiologic
Study, a data analysis, is published in Marcia Angell' New England Journal of Medicine.
Researchers (a.o. Dr. Jorge Sanchez-Guerrero, Brigham and Women's Hospital and Harvard
Medical School) had assembled the Nurses' Health Study Cohort in June 1976 and had
reviewed the medical histories, data of 87,501 registered female, married nurses including
1,183 women with different kinds of breast implants (876 silicone gel, 170 saline, 67
double lumen, 14 polyurethane, 56 unknown type). The study did not include women with
ruptured implants. The researchers reported that 516 of the nurses (of which 3 with
implants, of which 1 with silicone-gel) had developed "definite"
connective tissue diseases. The study, by collaborating investigators and consultants of
the Harvard Medical School, Harvard School of Public Health, Brigham and Women's Hospital,
Dana Farber Cancer Institute, Boston Children's Hospital, and Beth Israel Deaconess
Medical Center, "did not find an association between silicone breast implants and
connective tissue disease, defined according to a variety of standardized criteria, or
signs and symptoms of these diseases". Woman with implants had no higher rate, no
increased risk of connective-tissue disease or symptoms. No evidence of silicone-related
illness. The results were reported to the FDA. Before this Nurses' Health Study (III) the
used data had been used earlier for other research purposes. The Nurses' Health Study (I)
was established in 1976 by Dr. Frank Speizer and the Nurses' Health Study (II) in 1989 by
Dr. Walter Willett.
http://www.channing.harvard.edu/nhs/
http://www.siliconesurvivors.net/harvard.html
--
CRITICISM HARVARD NURSES STUDY
# - Like the Mayo Clinic study the Harvard study did
not examine anyone and the research was based on questionaires. Since
questionnaire-questions that lead to a 'conclusion' or to a 'medical study' is not a
FDA-requirement, the FDA had not seen a copy of the study questions or the criteria (e.g.
chronology of what was asked when) before receiving the results. The FDA only saw the
finished, published product / report. Before the questions were send to participants, Dow
Corning was given an opportunity to 'review' at least some of Harvard's study
questionnaires. And according to Dow Corning's General Counsel, "Each external
scientific study that Dow Corning funded was only after consulting with legal counsel to
determine its impact on the breast implant litigation". During the study Mayo had
changed their study 'specifications'.
# - The questionnaire sent out --interviews about
abortions, implants etc.-- to the nurses had only 2 silicone questions, hand-written at
the end of the questionnaire which Harvard routinuely sent out to the nurses on their
list. Leading to doubt if anyone at Harvard or Brigham Women's Hospital (of Dow Corning's
$300-an-hour paid consultant, expert-witness Dr. Peter H. Schur) actually had sat down and
hand-wrote those 2 questions on all the questionnaires ?
# - Ben Lilliston of the Cancer Prevention Coalition
in Chicago: "Most researchers who have studied women with implants say that
it usually takes 10 years or more for symptoms to develop. In the Mayo Clinic study, women
had the implants in for a mean of 7.8 years. In the Harvard study the mean was 9.9
years". Shanna Swan (epidemiologist, University of California at Berkeley):
"It's easy to get a negative study; you just look too soon".
# - Implant recipient and activist Janice Ferriell:
"Why don't they look at us, and figure out what's going on ?". Another
implant litigant Mary Feller from San Rafael: "I have breast
implants. I know. The medical studies remind me of the old joke about the drunk looking
for his money under the lamppost because that's 'where the light is'. The same thing is
happening with implants. The disease is out there in the dark, but the medical community
insists on looking under the lamppost, probably because the light is provided by Dow".
# - Besides millions that went to Harvard's
co-sponsoring institution --according to plaintiff's attorney Stephen Sheller, Dow Corning
provided corporate grants to the hospital totalling at least $7 million during the period
that the study was underway-- Dow Corning (2 checks: $1.2 million) paid for the Harvard
Nurses Study. 50% of the Harvard study's authors were paid by implant manufacturers for
other research or had agreed to act as experts in litigation on Dow Corning's behalf. The
FDA did not know this.
# - Dow Corning's $300-an-hour paid consultant,
expert-witness Dr. Peter H. Schur supervised one of the major authors of the study.
Schur's colleague Dr. Matthew Liang (consultant for the manufacturers' law firms) also
worked on the Harvard-Brigham study. Liang later admitted having given information about
the Harvard study to Dow Corning while the study was in progress. He refused to give
clarify whether Dow actually had a hand in shaping the study's methodology.
# - Dow Corning funded another second and larger
Harvard study. After their roles of conflicting interests were disclosed, Liang and Schur
resigned from the second Harvard implant study to avoid "the appearance of
conflict of interest". The study found a 45%-59% increased risk of increased risk
of rheumatoid arthritis: a traditional classical connective tissue disease. The study was
abandoned in an early stage. The results, noted 'strictly confidential', came out only in
court (Mediawatch group FAIR, By Laura Flanders, January/February, 1996 ).
--
JAMES A. TRAFICANT
In letters (may 1996, 11 june 1996 ) from Representative James A. Traficant, Jr. (OH) to
colleagues among others was written: "I can assure you: The Mayo clinic
study and the Harvard Nurses study are seriously flawed:
- (1 ) Its authors excluded all women who developed diseases after May of 1990, thereby
excluding many women who developed symptoms years after receiving implants
- (2 ) Women were included who had implants in place for as little as one month. (Many
other studies report that symptoms of autoimmune disease do not manifest themselves until
8 to 15 years after implantation)
- (3 ) It did not look for the atypical diseases reported by thousands of women across the
country who have received breast implants.
- (4 ) The study group was so small that it would not have found an association between
cigarette smoking and cancer.
- (5 ) Three of the authors were either personally receiving monies from breast implant
manufacturers or had agreed to act as a paid consultant for a breast implant manufacturer
while they were conducting the study - yet they failed to disclose this at the time.
- (6 ) While Dow Corning had no direct involvement in the study, Dow Corning contributed
$7 million to Brigham & women's Hospital, the institution conducting the study, while
the study was in progress.
Out of respect for the thousands of women, who have suffered debilitating conditions from
silicone poisoning and have repeatedly been told it's "all in your head," I
respectfully request that you obtain all the facts on this issue"
--
- SILICONE TIME LINE
--
DUTCH SURGEON DOUBTS DANGER SILICONE IMPLANTS
While in Canada, Bristol-Myers Squibb agreed with payment of about $20.5 million for
settlement of class-action suits in Ontario and Quebec of women with silicone breast
implants, Dutch plactic surgeon J.D. Efting Dijkstra expressed his doubts about the danger
of silicone implants in June 1995 in the Dutch
Tv-programme 'Anno Joosten' (VARA) of Dutch presentator Astrid Joosten in which further
attention for the ban in the US, the problems of women with (leaking) silicone-implants
with their health and the payment of Dow Corning of damage-compensation to women.
--
FDA: POLYURETHANE IMPLANTS NO CANCER RISK
On 29 June 1995 the FDA released a clinical study of
women with polyurethane foam-covered breast implants. No significant, any excess risk of
cancer, said Dr. Elizabeth D. Jacobson, FDA's Deputy Director for Science at the Center
for Devices and Radiological Health, any cancer risk was negligible. Bristol-Myers Squibb
was pleased.
--
Y-ME BREAST CANCER ORGANIZATION "IF YOU NEED HELP"
FDA Commissioner David Kessler told the Govermental Oversight and Reform Subcommittee on
Human Resources and National Economic Growth that breast implants do not appear to affect
the incidence of some diseases. In August 1995, Y-ME
National Breast Cancer Organization's Executive Director Sharon Green testified before a
congressional panel: "We believe that women must be part of their health
care choices and this included accepting the risks associated with those
choices....Silicone gel implants provided the easiest, most inexpensive method of breast
reconstruction with some of the best cosmetic results, yet they are no longer a viable
option for women with breast cancer. What silicone product will be the next to go ?",
"In some instances, it is easier for a cancer patient to obtain insurance than one
who has implants", "The implant debate is out of control--and, as a result, we
all lose". Y-ME' Executive Director Sharon Green was called: "The
country's most vocal advocate for 'choice' as it concerns silicone implants" and
Y-ME was listed as the group to contact 'If You Need Help' in Ms. Magazine (March/April
1996 ). CBS-reporter Mary Ann Childers is a honorary board member of Y-ME and Y-ME is
funded by Dow Corning, Bristol Myers Squibb and Plastic Surgeons Associated.
--
TRILUCENT IMPLANT ON THE EUROPEAN MARKET
Seen the problems (healthcomplaints, damageclaims) with silicone-implants there had to
come alternatives. The urge existed to (too) quick give permission to (without solid
scientific long term studies) approve alternative implants and to let be brought into the
market. Hydrogel-implants (plastic material that expands in water) appeared on the market
in 1994. And, although dr. Rahim Karjoo, director of the American Medical Diagnostic
Laboratories (AMDL) immediately had already pointed to the dangers (leaking, promote
growth tumours, death) and healthlawyers and careful scientists warned about serious
possible dangers of the praised new product, in 1995
Collagen Corporation (LipoMatrix Inc.) brought the soya-oil filled Trilucent implants
--promoted as 'natural' alternative for silicone-- onto the European market. Also on the
Netherlands Trilucent came onto the market. Dutch support group SVS / Marlou Boots:
"The American protocol for soya-implants, disrespectful called 'Tofu titties',
demanded that this new round of female 'lab rats' had to be passed the fertility age, but
somewhere along the road above the ocean this demand disappeared".
THE NETHERLANDS: AB MEDICAL PRS
Owner (at that time) of the Collagen soya implants in the Netherlands was AB Medical PRS
in Dutch city Breda http://www.abmedicalprs.nl In
the information brochure of the National Co-operationalliance of the Integral
Cancercenters in the Netherlands (Landelijk samenwerkingsverband van de Integrale
Kankercentra in Nederland, iKCnet http://www.ikcnet.nl
) with information for oncology patients, is being mentioned, referred to (to order),
besides a numbers of brochures of the Dutch Royal Wilhelmina Fund (Koninklijke Wilhelmina
Fonds, KWF) Cancersociety, to brochures 'If you consider breastreconstruction' and 'What
are silicone' of AB Medical PRS: "the most leading company in the
Netherlands in the area of plastic and reconstructive surgery". AB Medical
supplies to all Dutch hospitals and private-clinics: "Also we do not always
see the trees within the forest anymore", said Maud Kas of AB Medical PRS in a
brochure of 2006, "We constantly look out for new and promising products, but also
that we exclusively intoduce these if the effectiveness and safety of them for us has been
proven". Further is mentioned in the brochure (Natural Body, Nr.1, http://www.btxa.dk ) about AB Medical PRS: "AB
Medical PRS delivers a series of silicone filled breast prothesis of McGhan. McGhan
silicone prothesis are so safe that a life-factory-quarantee is given on them".
--
TRILUCENT: SEE-THROUGH-BREASTS
In Great Britain (about £3.000,- pounds for breast enlargement) in September
1995 a new type of developed breast implant was reported in the media. The
Trilucent, made of triglyceride, a natural vegetable oil, available throughout the
European Union, but were still undergoing clinical trials in the US and Canada. A
'see-through-breast' as, unlike silicone and saline, the Trilucent allowed breast
screening X-rays to pass through for dectection of any abnormalities (signs of breast
cancer), since an implant could conceal 22-85% of breast tissue, said Terry Knapp, Chief
Executive of Swiss implant developer Lipomatrix, who was aware that there were over 100
peer-reviewed articles that showed silicone implants are not safe in the female breast The
Trilucent promised a greater safety for women. The implant (shell) also contained a grain
of rice sized micro-chip, holding patient information and a unique code.
# - Microchips Implants Cause Cancer In Lab Animals
(Katherine Albrecht, SpyChips.com, 09-08-2007 )
"Damning research findings could spell the end of VeriChip. The Associated Press
will issue a breaking story this weekend revealing that microchip implants have induced
cancer in laboratory animals and dogs, says privacy expert and long-time VeriChip opponent
Dr. Katherine Albrecht. As the AP will report, a series of research articles spanning more
than a decade found that mice and rats injected with glass-encapsulated RFID transponders
developed malignant, fast-growing, lethal cancers in up to 1% to 10% of cases. The tumors
originated in the tissue surrounding the microchips and often grew to completely surround
the devices, the researchers said...(...)...Since gaining FDA approval, VeriChip has
aggressively targeted diabetic and dementia patients, and recently announced that it had
chipped 90 Alzheimer's patients and their caregivers in Florida. Employees in the Mexican
Attorney General's Office, workers in a U.S. security firm, and club-goers in Europe have
also been implanted. Albrecht expressed concern for those who have received a chip
implant, urging them to get the devices removed as soon as possible. 'These new
revelations change everything,' she said. 'Why would anyone take the risk of having a
cancer chip in their arm?'.
http://www.SpyChips.com
http://www.rense.com/general78/cancer.htm
--
GROW-YOUR-OWN BREASTIMPLANT
In the 'search-journey along alternatives' to among others keep the plastic surgery money
machine pumping, scientists started to explore and experiment with a procedure which used
a woman's own cells to create tissue inside the breasts: a 'grow-your-own'
alternative. "We've been trying to outsmart the body's immune system",
said James Martin, research director at Carolinas Medical Center, half September 1995.
--
BRITISH DEPARTMENT OF HEALTH
After FDA advisory panel in 1992 recommended limited access to silicone implants and
concluded that not enough scientific evidence linked implants to disease for a complete
ban, Britain's Department of Health refused to place such a (limited) ban on implants
because "there was no scientific knowledge that warranted a moratorium".
In 1995 the British Department of Health reviewed
studies (270 papers published after 1971 alone) on the link between silicone gel from
implants to autoimmune disease or connective-tissue disease. Conclusion ? The animal
studies: "Provide no immunological reason for concern over the use of
silicone gels in implants", "None of these studies demonstrated that the
coexistence of connective-tissue disease with silicone breast implants is any more
prevalent than would be expected by chance".
--
IMMUNE-SYSTEM: SILICONE
In a report of Dow Corning from 1995, that had been
kept secret until the company was forced to make it public during a trial, was posed:
"De great amount of available animal-data also does remind of the possibility that
the presence of silicone plays a role at immunological disorders". By researchers
of the Harvard Medical School and of the Massachusetts General Hospital traces of silicone
had been found in vital organs such as the liver (Pfleiderer en Garrido e.a., Magnetic
Resonance Medicine, 1995 ).
--
BOOK: INFORMED CONSENT
A Story of "Personal Tragedy and Corporate Betrayal...Inside the Silicone Breast
Implant Crisis", by author John A. Byrne, a senior writer for Business Week, who once
said that the expansion of the breast implant market came in 1982 when the American
Society for Plastic and Reconstructive Surgery (ASPRS) decided that small breasts were to
be considered as deformities. The book, a behind-the-scenes view of corporate
irresponsibility, arrogance and risk management strategy, follows the breast implant
crisis (1960's through Dow Corning's bankruptcy in 1994 ) largely from the perspective of
(sort of co-producer of the book) ex-Dow Corning executive John E. Swanson: the
creator of Dow Corning's much-admired ethics program who had resigned after 26 Dow-years.
John A. Byrne: "What happens when you make a moral choice that separates
you from the company's official position and from your colleagues in a close-knit
organization" ? Also in the book the personal account of Colleen Swanson, wife
and victim of breast-implants from her husband's company. John Swanson had kept the secret
of his sick wife until just before resignation. The book is a review of court records and
documents filed with government agencies with more than 100 interviews with among others
former Dow Corning Co. employees. The reaction of the President of Dow Chemical to the
first jury award against Dow Corning: 'Why the hell are we in this business
anyway ?".'Informed Consent': a famous book and subject of three Harvard Business
School case studies. http://msnbci.businessweek.com/1995/40/b34441.htm
--
SETTLEMENT: BARGAINING ABOUT HEALTH
In September 1995 the $4.25 class-action implant
settlement / agreement, overwhelmed by claims, collapsed and negotiations began on a new
settlement. On 2 October 1995 Bristol-Myers Squibb,
Baxter and 3M, without Dow Corning, presented (Birmingham, Alabama) a preliminary
restructuring plan proposing individual (new) settlements, announced by U.S. Federal
District Judge Sam C. Pointer. The (absolutistic) stick behind the door: "Over
the past several years, the international scientific research community has demonstrated
that there is no association between silicone and disease". Nearly 20 scientific
studies. The new proposal covered fewer women and paying them less money, than in the
first settlement-deal. About $3 billion for 8,000 women: about 50% of the women in
the case. There was no unanimous support among the team of plaintiffs' lawyers for the
proposal. Federal District Judge Sam C. Pointer decided to let women individually decide
whether to accept it.
--
BREAST IMPLANTS: NO HEALTH RISKS
In the annual meeting (24 October 1995 ) of the
American College of Rheumatology (San Francisco) researchers issued a statement, based on
two new studies: "there is now compelling evidence that silicone implants
expose patients to no demonstrable additional risk for connective tissue or rheumatic
disease". The Council on Scientific Affairs of the American Medical Association
echoed: "To date, there is no conclusive or compelling evidence that
relates silicone breast implants to human auto immune disease") The first study
(rheumatologist Dr. Liam Martin, University of Calgary) showed there was no significant
difference (blood samples) in the frequency of autoantibodies between women with implants
(1,600 ) and woman (760 ) having had cosmetic surgery but no silicone implants. In the
second study (Dr. Fred Wolfe, the University of Kansas) 1,200 women with rheumatoid
arthritis or the fibromyalgia syndrom were surveyed to determine if they had implants, and
were then compared to 1,100 woman, randomly selected or having osteoarthritis. No
increased risk was found on developing either rheumatoid arthritis or fibromyalgia after
implantation of silicone breastimplants. Criticism came from Dr. Sidney Wolfe (Public
Citizen) saying the studies were not broad enough and too soon had been spoken: "The
studies were grossly over-interpreted". The directors of the rheumatology group
(Dr. Sam Ruddy) said the lawsuits claiming a link between silicone implants and connective
tissue disorders or rheumatic were only based on "anecdotal evidence"
which should not be used in courts or by the FDA. In the October 1995 Breast cancer
awareness month actress-playwright Brandyn Barbara Artis (of the play 'Sister Girl'
based on a journal Barbara Artis kept before, during and after her mastectomy and the
diagnosis of breast cancer) stated about woman speaking out: "I think that
it's scary for women to hear a bunch of stats spouted at them because we're not
statistics, I lost a breast, not a brain".
--
CHARLOTTE MAHLUM -Vs- DOW CHEMICAL
On 28 and 30 October 1995
Mahlum-vs-Dow Chemical, Washoe District Court in Reno, Nevada. State Court Judge Connie
Steinheimer. This is the first case where Dow Chemical, the parent company of Dow Corning,
is the sole defendant. Dow Chemical supplied some of the chemicals used in implants.
Charlotte Mahlum had originally sued Dow Corning and Dow Chemical. But after Dow Corning
filed for Chapter 11 bankruptcy protection in 1995, which froze thousands of pending
breast implant claims against Dow Corning, the court allowed the case to continue against
Dow Chemical. Charlotte Mahlum sued alleging that her implants caused a.o. skin disorders,
muscle pain. She got her Dow Corning implants in 1985. Ten years later the 46-year-old
wore diapers and was diagnosed with incontinence, hand tremors, atrophy in one foot and
brain lesions. Working was impossible and her husband was forced to clean up after her.
Charlotte Mahlum was awarded $3.9 million in compensatory damages (28 October) and $10
million in punitive damages (30 October). Her husband was also awarded $200,000. Dow
Chemical spokesman John Musser said the company would appeal: "We're
disappointed that the jury was influenced by emotion, misinformation and the big lie
strategy used by the plaintiff's lawyers", "Dow Chemical never made these
devices, never researched and never sold them and never offered any opinion on their
safety", "We will continue to defend ourselves vigorously and we will
prevail". But Dow Chemical did know how evil silicone (in the device) was due to
testing (Lepetit) in the '60 and early '70. The liquid silicone Dow Chemical tested, as
known to Dow Chemical, forms 85% of a finished silicone gel breast implant: "They
knew that silicone migrated to the brain in test animals and that it caused fetal
deformities in rabbits". What did Dow Chemical do ? They didn't tell. Plaintiff
attorney Rick Ellis told the jury that Dow had destroyed studies showing adverse effects
of silicone gel: "The heart of the case was that they fraudulently
concealed evidence that implants cause harm". The jury found that Dow Chemical
committed fraud and exhibited a conscious disregard for the health and safety of the
breast implanted women. Dow Chemical General Counsel John Scriven said Mahlum's attorneys
had "exploitated [jurors] emotions". During the trial Dow came with
medical studies as its defense. Under crossexamination they appeared having devastating
errors. Rheumatologist Dr. Peter H. Schur recommended "aerobic conditioning"
for Charlotte Mahlum. He testified, like in 5 other cases, that breast implants were not
making Charlotte Mahlum sick. He admitted having received three-quarters of a million
dollars from implant manufacturers during 2,5 years. Reporters ignored the testimony which
had convinced the jurors after hearing weeks of evidence. Media began to condemn the jury,
the plaintiff's lawyers, the law and even the judge. Lead of a column of Fortune editor
Joseph Nocera: "The first thing we do...let's kill all the plaintiff's
lawyers" (New York Times, 1 November 1995, 'What Did Dow Chemical Do?'). Mahlum's
lawyers had "persuaded the jury to punish Dow Chemical" (San Diego
Union-Tribune, 2 November 1995 ). Anyone but Dow. While "No Journal reporter had
attended the trial", wrote Laura Flanders of Mediawatch group FAIR ('Beware: P.R
Implants in news coverage') in 1996, "By failing to examine the court records, and
the evidence they reveal, journalists have become captives of corporate P.R.".
The Mahlum-verdict was a landmark decision. For the first time Dow Chemical was found
solely liable for injuries caused by breast implants manufactured by Dow Corning. Setting
precedent. More than 13,000 similar implant suits were pending against Dow Chemical. Dow
Corning's advertisment-package (May 1995 ) included a writing of David E. Bernstein about
a Supreme Court ruling at which Bernstein called on judges to serve as gatekeepers:
"Some judges have been loath to exercise their gatekeeper role". About
the Charlotte Mahlum trial, the Wall Street Journal (8 November 1995 ) concluded: "The
judge refused to act as a gatekeeper against pseudo-scientific testimony". On 17
November 1995 Dow Chemical requested judge Connie Steinheimer (Washoe District Court) to
throw out the Mahlum $14 million jury award (reversal of the verdict), to order a new
trial or for the elimination of the punitive damages. On 9 February 1996 all the request
were rejected. Dow Chemical said it would appeal.
http://www.cnn.com/US/9510/implant_verdict/index.html
http://www.cnn.com/US/9510/implant_verdict/rabiteau.aiff
http://www.cnn.com/US/9510/implant_verdict/rabiteau.wav
http://www.telegraph.co.uk/htmlContent.jhtml?html=/archive/1995/11/01/nbrest01.html
http://gyxe.com/breast-implant/50-579-dr-eric-gershwin-testified-at-
charlotte-mahlum-s-trial-in-early-days-of-breast-implant-litigation-read.shtml
--
DOW CORNING: THE INJURED STILL WAIT
Sybil Niden Goldrich (Command Trust Network and as a breast implant recipient serving as a
member of the tort claimants' committee which represents women with silicone breast
implant claims and other product liability claimants, for the Dow Corning bankruptcy)
about the Charlotte Mahlum case: "I can assure you that defense law firms
have billed far in excess of $190 million in costs to implant manufacturers. Dow Corning
would rather pay their lawyers than provide funds to undo the trouble they caused to women
all over the world. And what of taxpayers who will pay higher taxes to bail out big
corporations whose lawyers delay in settling this wrongdoing ? The verdict in Nevada
against Dow Chemical is nonetheless the beginning of more money for the defense and not a
dime for the injured or those who care enough to represent them without any assurance of
payment" (8 November 1995, The New York Times).
--
THE CASE AGAINST DOW CORNING / DOW CHEMICAL
(1995, By Attorney Richard Alexander: specialist in
personal injury litigation with 30 years in-depth experience )
"...Dow Chemical had responsibility for researching the bioreactivity of silica
and silicone compounds used in Dow Corning breast implants from 1943 until 1992 and for
controlling the quality of the products manufactured, distributed and sold by Dow Corning,
including silicone breast implants. As a result of both independent and joint research
projects with Dow Corning, Dow Chemical knew as early as the 1950's that the silicone and
silica in Dow Corning's breast implants were bioreactive, immunogenic, toxic and
inflammatory in the human body. Based on this evidence, plaintiffs claim Dow Chemical is
liable on the theories of direct products liability, negligent performance of an
undertaking, negligent misrepresentation and joint venture liability..." http://consumerlawpage.com/article/dow.shtml
--
WHAT DOW CORNING DIDN'T / WON'T TELL YOU:
# They have paid millions to cover up the hazards of silicone.
# They knew from the 50's that silicone is dangerous.
# They knew silicone gel attracted and killed cockroaches.
# They knew it crossed the placenta and caused hormonal changes.
# They knew it shrank the testicles of mice (Kabi Pharmaceuticals in Sweden).
# They knew it was biologically active in the body and was NOT inert.
# They bought science by paying for rigged studies.
# They paid for the Mayo and Harvard studies.
# Harvard and Mayo studies were done by their paid consultants and experts.
# The contributed $7 million to the hospital where studies were done.
# They controlled science by buying editors or medical journals.
# Peter Schur, Editor of Arthritis and Rheumatism, made $300 an hour on Dow's payroll.
# Dow conspired with plastic surgeons to try to cover up the risks.
# Plastic surgeons and Dow inflated the number of women with implant to 2 million.
# 2 million, inflated numbers, deliberately made the risks look smaller.
# Implants contain silica, benzene, formaldehyde, vinyl chloride, aluminum, platinum.
# Silicone migrates to all organs of the body and the brain.
# Silicone breaks down to crystalline silica in the body.
# The mixture of chemicals are toxic and even create a chemotherapy drug in the implants.
# Implants become contaminated with body fluids.
# Some implants contain fungus not normally seen in humans.
# Dow Corning falsified documents.
http://www.freewebs.com/implants/humanadjuvantdisease.htm
--
GREEDY DOW CORNING SUING INSURERS
On 1 November 1995, Dow Corning -Vs- It's insurers.
Dow Corning started a lawsuit to establish how much its insurers had to pay in settling
and defending against breast-implant lawsuits. 'Greedy' Dow Corning wanted more money from
it's insurers, that they would contribute more to the settlement. Dow Corning eventually
filed cases against 73 insurers. The insurers maintained that Dow Corning failed to
disclose important facts about its implants and that some of its litigation costs have
been unreasonable (high ?). Dow Corning obstinate held on to it's (absolutistic) ray of
straw and belief, insisting implants are safe: "no major scientific studies
have found that.......". Dow Corning attorneys rested their case on 14 December
1995. The jury trial (testimony) resumed on 2 January 1996 (Wayne County Circuit Court).
--
DOW' THREAT: BIOMATERIAL
Medical devices that incorporated biomaterials had been at the center of extensive
litigation. In 1992 (FDA ban on silicone implants) DuPont, Dow Chemical and Dow Corning, 3
major suppliers of biomaterials for medical applications, threatened that they would cease
supplying their products to manufacturers of implantable medical devices. Due to legal
factors, costs of litigation. Dow Corning supplied more than 90% of the medical market of
medical silicone. In May 1995 after Dow Corning's Chapter 11 Bankruptcy, Dow Corning
(Hazleton) announced it would cease supplying silicone to medical equipment companies
(industrial, construction, cosmetic and printing applications). Once bankruptcy would be
overcome, Dow Corning could not be sued for products it had stopped making. After the
Charlotte Mahlum-case, due to liability worries, on 12 November
1995 a raw material supplier stopped sales of a key material for an orthopedic
implant maker. Biomet Inc. wasn't alone. A survey by the Health Industry Manufacturers
Association had showed that 75% of the companies had trouble getting some materials.
--
NEW SETTLEMENT: GOOD DEAL FOR THE COMPANIES
On 12 November 1995 the company's Board of Directors
approved a new settlement of 5 companies: Bristol-Myers Squibb, Baxter Healthcare
Corporation, 3M Company, McGhan Medical Corporation and Union Carbide Corporation, for
about $3.5 billion if all eligible women participate. Dow Chemical, found liable, refused
to settle and Dow Corning was not included due to bankruptcy proceedings. Federal District
Judge Sam C. Pointer, Jr still had to approve the new settlement. John L. McGoldrick
(senior vice president and general counsel of Bristol-Myers Squibb): "Perhaps
most important for claimants, the revised settlement empowers women to put this behind
them and move on with their lives". Women's compensation under the old deal was
based on women's level of disability and type of illness. Under the new deal only on level
of disability. The payments to women in the new offered settlement were 12,5% of the
original settlement / agreement amounts. Under the same claim submitted in the earlier
settlement / agreement, option 1. in the new proposed settlement, offered women a payment
of $10,000 to $50,000, increasing to $25,000 to $100,000 if proof was given of ruptured.
Option 2. offered a higher compensation ($75,000 to $250,000 ), but for this choice more
stringent terms (medical documentation) were set to show disability. Also the 5 companies
were allowed to challenge or reject claims. The revised settlement did not apply to
non-U.S. residents. ATLA's Breast Implant Litigation Group, about 500 'greedy' plaintiff'
attorneys handling the implant cases, in November 1996 proposed to the court (Judge Sam
Pointer Jr.) to decrease attorney fees paid under the new offered settlement. Ralph
Knowles: "We didn't feel it would be right" to charge the usual
fee when the women would get less. Although more force was put on women (who needed money
urgently) to accept the new offer, it seemd unlikely women would accept the new, lower
settlement. Bristol-Myers Squibb's John McGoldrickm with the bargaining-chip being less
money, found that the new settlement: "provides much more certainty, and
claimants are provided compensation without having to prove causation".
--
SILICONE SICKNESS IS VERY REAL
# - "We report an unusual case of aggressive
chest wall fibromatosis originating within the right breast of a woman with silicone
implants" (Vicki L. Schiller MD; Rolf D. Arndt MD; and R. James Brenner MD,
Chest, Nov 1995; 108: 1466 - 1468 )
# - "The data presented confirms that silicone
implant patients respond immunologically to the silicon dioxide contained in mammary
prostheses" (David L. Smalley, Douglas R. Shanklin, Mary F. Hall, Michael V.
Stevens, and Aram Hanissian, Baptist Memorial Hospital, Memphis, FASEB Journal, Vol 9,
424-427 )
BREAST IMPLANT: MASSIVE CHEST TUMOUR
In a women with silicone breastimplants a 13 cm long uncommon tumour was found, centered
within the breast and protruded into the lung, thorax and ribs: "tumours
centered primarily within the breast tissue may arise from the fibrous capsule that
develops around silicone implants". This was reported in the November 1995
publication of the American College of Chest Physicians, but was issued by Plaintiffs
Counsel for the Silicone Breast Implant Class Action Suit on 18 January 1996 (PR
Newswire).
SILICONE IS TOXIC
"Abstract - While most organometallics enter the environment through their
industrial release, silicones are organometallic compounds purposefully introduced in high
volume directly into healthy humans. A chemically centered study of the behavior of
silicones in the biological environment reveals numerous degradative reactions and surface
interactions that can produce bioreactive substances. Data from a variety of disciplines
suggest that the preponderance of evidence supports the argument that silicone is a toxic
organometallic" ('Non-covalent Surface Interactions between Silicone and
Biological Macromolecules Yield Bioreactive Substances', Nir Kossovsky, Biomaterials
Bioreactivity Characterization Laboratory, Department of Pathology and Laboratory
Medicine, University of California-Los Angeles, Vol. 11, Issue 5 , Pg. 353 - 368, 20 December 1995 ) http://www3.interscience.wiley.com/cgi-bin/abstract/9026/ABSTRACT?CRETRY=1&SRETRY=0
--
JURY IN FAVOR OF IMPLANT MAKERS
On 7 December 1995 Gamblin-Vs.- Minnesota Mining &
Manufacturing Co (3M), San Antonio, Texas. A breast implant mistrial, granted to
plaintiffs by State District Judge Charles Gonzalez of Bexar County Court. The 12-person
jury failed --in Texas a majority vote of 10 is required-- to reach a verdict: 9 to 3 in
favor of 3M: "The outcome of the trial means that the plaintiff was unable
to prove that silicone causes disease". Also on 7 December 1995, 4 women: Debra
Schilleci, Sheryl Berry, Theresa Hammes, and Gayle Hendricks -Vs- Baxter Healthcare /
Heyer-Schulte, Houston, Texas. The jury unanimously found that there were no defect in the
manufacture or sale of the breast implants; the manufacturer did not engage in any false,
deceptive or misleading statements regarding breast implants; and the jury found that the
plaintiffs suffered no injuries caused by silicone breast implants made by the company
Heyer-Schulte which Baxter acquired in 1985.
--
IMPLANTS INAMED RECEIVES EUROPEAN APPROVAL
On 23 December 1995 Inamed Corp. announced that its
European subsidiary, McGhan Ltd. (Ireland), had been qualified to CE mark (stamp of
approval) 2 of its silicone gel-filled breast implant products --the most popular and
highest volume gel-filled breast implants sold at that time by Inamed outside the United
States-- to be sold within the European Economic Area (EEA). Inamed Chairman Donald K.
McGhan: "The early approval validates their safety and efficacy".
Marcia Angell "Where's the science" ? http://earth.fjc.gov/BREIMLIT/ORDERS/inamed.wp5
--
BREAST IMPLANTS ? A BAD IDEA
# - ANTINUCLEAR ANTIBODIES - "Recent evidence
suggests that immunologic abnormalities are not uncommon in individuals with silicone
breast implants...(...)...These findings suggest that ANA positivity is relatively common
in individuals with silicone breast implants, and may support the existence of autoimmune
mechanisms in the pathogenesis of the clinical manifestations seen in this
population" (Marta Lucia Cuelarr, J Rheumatol 1995;
22:236-40 ).
http://www.freewebs.com/implants/serum.htm
http://implants.clic.net/tony/Pam/02.html
# - MOTOR NEURON DISEASE SYNDROME - "We
conclude that attention should be paid to those patients who develop an MNDS after
receiving foreign material. Patients with such a condition might benefit from removal of
the foreign body, e.g., silicone breast implants. The surrounding capsule tissue must be
removed together with the implants since it presents antigenic character, being full of
leaked silicone, inflammatory reactions, and damaged tissue" (International
Journal of Occupational Medicine and Toxicology, Vol. 4, No. 1, 1995, Britta Ostermeyer
Shoaib and Bernard M. Patten) http://members.aol.com/dowlied/page5/
# - A NOVEL NEUROLOGICAL DISEASE - "26 women
developed a systemic disease with central nervous system involvement after receiving
silicone breast implants or fluid injections into breasts.... We believe our patients
developed a new syndrome triggered by the foreign material in their body.."
(''Human adjuvant disease: presentation as a multiple sclerosis-like syndrome', Britta
Ostermeyer Shoaib, MD, and Bernard M. Patten, MD, Houston, Tex Southern Medical Journal,
February 1996, Vol. 89 No. 2, p179-188 )
http://www.freewebs.com/implants/hadasmslikesyndrome.htm
http://www.bio.net/hypermail/immunology/1996-December/009211.html
# - "HUMAN ADJUVANT DISEASE (HAD) is an
autoimmune condition associated with foreign materials in contact with the human
body...(...)...Hence, in conclusion: Foreign materials in contact with the human body can
be a bad idea. And Foreign materials installed within the human body are a bad idea. A bad
idea for those who made them. A bad idea for those who put them in. And a bad idea for
those who have them in." ('Disquisition on Human Adjuvant Disease', Bernard M.
Patten and Britta Ostermeyer Shoaib, Perspectives in Biology and Medicine, Vol. 38, No.2,
Winter 1995, Pages 274-290 ) http://www.freewebs.com/implants/humanadjuvantdisease.htm
--
BIG BROTHER BREAKABLE BY A FEW INDIVIDUALS
The Dow Corning Corporation was once one of US's 100 most profitable industrial companies.
Around 31 December 1995, against Dow Corning around
19,000 individual lawsuits had been filed along with 46 class action lawsuits. Only 15
individual lawsuits (involving some 19 plaintiffs) against Dow Corning have gone to trial:
leading to bankruptcy of once US' largest producer of breastimplants, silicon and world
leader in the area of silicone-based materials. Of these trials, Dow Corning have had 8
trial "wins" and 6 trial "losses," with one split decision. The
Company received $71.4 million in insurance recoveries in 1994 and $163.5 million in 1995.
http://implants.clic.net/tony/Corner/F/0271.html
--
BRISTOL MYERS SQUIBB WINS
Begin January 1996 Yaren Love -Vs- Bristol-Myers
Squibb, Jacksonville, Florida, Duval County Super. Court. Yaren Love claimed her
Bristol-Myers implants had caused severe pain, inflammation, and tissue damage.Yaren Love
went to court because she believed the settlement' compensation was too little. The jury
rejected her claims: not injured by her breast implants. Former implant-maker
Bristol-Myers Squibb (general counsel, John McGoldrick): "The verdict
serves as a reminder of the risks of litigation versus the certainty of participating in
the settlement". Also on 26 January 1996 a
six-person state court jury ruled in favor of Bristol-Myers Squibb and against a woman
blaming Bristol-Myers her health problems.
--
BREAST ENLARGEMENT POPULAR
Plastic surgeon in the 'Baywatch' state California Jane S. Weston (chair of the Women
Plastic Surgeons' Caucus Committee of the ASPRS): "Women's desire to
augment their breasts didn't go away during the implant scare". Popularity of
breast-augmentation surgery was increasing, wrote Marc Spiegler (American Demographics, January 1996 ). While the Eva Herzogovic's Wonderbra
(Natural Look Bust Appeal Pads, £ 14.99,- pounds) sold in the UK about 30,000 a week, the
Wonderbra didn't do the trick for all US women, according to the American Society of
Plastic and Reconstructive Surgeons (ASPRS). Other replacements --the Baywatch' Pamela
Anderson's breasts (big and round) were considered out of date-- were being found "Breast
boosts without the Surgery !", read a magazine advertisement for the 'Curves':
"Worn outside the body, they're waterproof and fit easily inside any bra or
swimsuit". The 'curves', look liked foam shoulder pads, were silicone made and were
sold for $160 to more than 150,000 women worldwid. And other replacements were promoted
including their advantages, as shown by well-respected leading plastic surgeon Basim
Matti. An exact shaped implant: filled with a clear gel that didn't leak even if cut in
half, to be shaped to the outline of a young woman's breast without losing their form,
thus was alleged. Basim Matti also showed an implant filled with soya bean oil: the
Trilucent which doesn't block mammogram rays and was microchipped so that if anything
would go wrong with the implant at any stage, it could quickly be notified to a centre in
Switzerland: "What is wrong with a woman wanting to look more beautiful ?
The only fault in that comes from the people who try to make her feel guilty",
said Basim Matti. Writer Marilyn Yalom argued in her book 'A History of Breasts' (Pandora):
the more society becomes obsessed with breasts as erotic targets, the further breasts
depart from their original nurturing function.
--
FEMINISTS IN FOOTBALL ?
In 1996 there was outrage by women's healthgroups,
after rumours that the bad boy of British football, Paul Gasgoigne, had insisted his wife,
Sheryl Gasgoigne, to have breast enlargements. This gave the campaigners an opportunity to
get the entire Glasgow Rangers team, where Paul Gasgoigne played at the time, to sign
footballs to raise money for the anti-silicone implants campaign. The Gasgoine's marriage
eventually ended in divorce.
--
DOW CORNING BEATS IT'S INSURERS: GREAT FOR WOMEN
Dow Corning -Vs- It's insurers. Dow Corning had filed cases against it's insurers, to get
more money-coverage in the settlement, disputing about $1 billion in coverage. The biggest
insurance company (American International Group Inc. (AIG) and its subsidiaries) settled
with Dow Corning on 5 February 1996. The terms were
not disclosed, but a settlement which "represented a significant portion of the
case", said Dow Corning attorney Robert Marsac. On 12 February 1996 Dow Corning
had reached settlements (out of court) with 13 of its insurers amounting to about $545
million in claims and up to $630 million in future claims. The Wayne County Circuit Court
Detroit State jury, presided by Judge Robert J. Colombo, on 14 February 1996 judged that
about 30 insurance companies, who had not yet settled earlier, were liable for about $400
million in product liability coverage including costs of defense and settlement of Dow
Corning. The jury decided that Dow Corning hadn't misrepresented nor concealed significant
facts about implant risks. Dow CEO Richard A. Hazleton: "Once again, we see
science - and now the legal system - reinforcing the fact that silicone breast implants do
not cause disease". The insurance proceeds were used in the Federal bankruptcy
court to pay costs associated with the breast implant claims or other claims against Dow
Corning, said Edward Rich, Dow Corning's treasurer. One insurance company attorney said
there wouldn't be an appeal. A spokeswoman for another insurance company (Northbrook-based
Allstate Insurance Co.), being disappointed, would consider a possible appeal.
--
'FINGERS CROSSED': TRILUCENT IMPLANTS
About 1 million women in North America had received breast implants since 1966. Since
silicone gel was eventually banned, begin February 1996
3 woman in Ontario became the first Canadians to receive the Trilucent: "a new
type of breast implants filled with soybean oil" with a rougher surface to
prevent scar tissue from growing and with unique features: not obscuring breast X-rays and
a microchip, reported Wallace Immen of the Toronto Globe and Mail ('3 Canadains get breast
implants filled with special soybean oil'). The exact same story was published in the
Milwaukee Journal Sentinel, 'Safety of soy oil Touted', rather on 27 May 1996. According
to head surgeon Lloyd Carlsen of the Scarborough General Hospital, one of three testing
facilities, purified soy oil had a long history of safety in the body. Although the
implant' outer shell was made of silicone rubber, it wouldn't enter tissue, because it was
the same material as in artificial joints and heart valves, Lloyd Carlsen believed.
Manufacturer Swiss Lipomatrix had, after testing in several European countries, received
approval for Trilucent's general use. The study of patients, to wait and see how their
bodies would react to the Trilucent had to be completed before Canadian approval. In the
US, Jan Thompson was one of the very few women in the country with breast implants filled
with soybean oil. The, 'more natural' and 'much safer', Trilucent were placed,
participating in a medical studie, in 1996. The housewife Jan Thompson with a loving
husband and two great kids was very happy: "They look great and feel great.
I'm very fortunate. They're the answer to all my prayers".
--
DOW'S PR-FIRM BURSON-MARSTELLER IN ACTION
In February 1996 PBS Tonight's 'Frontline' (David
Fanning) started an investigative news Tv series "'Breast Implants on Trial"
looking at the ongoing silicone breast implant battle between medical science and the
court system: sick women ("We are the evidence !"); winning lawyers,
support groups, a few doctors -Vs- scientific evidence. The presented case in the Tv
series was build around Dr. Marcia Angell, editor of the New England Journal of Medicine.
Frontline: "the most prestigious medical journal in the world".
Marcia Angell told Frontline: "What was so startling to me was the
disconnect between the science.....and what was happening in the courts and what was
happening at the FDA and what was happening in public opinion. The disconnect was
amazing". The evidence of implant health problems from over 90,000 women given to
the FDA, Marcia Angell described as "coincidental": "Passion,
anecdotes, claims, testimonials will not settle this issue. It can only be settled by
science". Frontline described FDA Commissioner David Kessler as being "horrified"
by the effect of his 1992 decision to ban silicone breast implants, and Kessler now
suddenly believed science has proven the implants safe. Former president of the American
College of Rheumatology John Sergent: "Science is not what's ruling this
discussion. It's the plaintiff-lawyer frenzy". Frontline and Marcia Angell forgot
to mention the several scientific studies which found evidence of silicone-related
diseases and were published in medical journals including the Annals of Plastic Surgery,
The Journal of Aesthetic Plastic Surgery, The American Journal of Clinical Pathology, The
British Journal of Plastic Surgery, Plastic and Reconstructive Surgery, The Journal of the
American Medical Association, Arthritis & Rheumatism, and The Archives of Pathology
and Laboratory Medicine. Frontline and Marcia Angell never mentioned these studies in
their 'passion-anecdotes' aimed at the passion and emotion of thousands and thousands of
Tv-viewers.
--
HARVARD: IMPLANTS ON TRIAL - NO RISK ON DISEASE
A new Harvard study, the largest study so far was published on 28
February 1996 in the Journal of the American Medical Association (JAMA) The
study involved 396,000 female health professionals, many nurses, who filled in
questionnaires about diseases diagnosed between 1962 and 1991, of which 10,830 reported
having breast implants and 11,805 reported having a connective-tissue disease. The study
found a 'slight' association between silicone- filled breast implants and diseases, a 24%
increase in risk of autoimmune diseases, including rheumatoid arthritis. But, with in the
back of the mind Marcia Angell's plea in Frontline to let science rule the world, "don't
be fooled by 'the science'", the Harvard researchers said, the (maybe illusory)
found percentage was (now suddenly) deceiving. Also, in addition, the study found no
proportional link between the risk of disease and the length of time a woman had an
implant, Gina Kolata reported in the New York Times (28 February 1996, 'Study reports
small risk, if any, from breast implants'). Thereby flushing the "ticking time
bombs"-argument and the criticsm on the earlier Mayo Clinic and Harvard studies
--which included some subjects which had implants for as little as 30 days-- down the
toilet. "And even if the risk is real......", Gina Kolata continued, "the
authors (of the study) calculate that it would mean only 1 extra case of connective-tissue
disease a year for every 3,000 women with implants". The normal incidence of
these diseases was small: average 1.14 cases per 1,000 women. The Harvard investigators
determined, for a woman with implants, a relative risk of developing any kind of
connective tissue disease of 1.24. No attempt was made to verify the diagnoses of the by
questionary questioned women. The researchers planned a follow-up study to verify the
diagnoses. The increased risk was "barely significant", the Chicago
Sun-Times reported. While the Boston Globe reported that this study was the first study "to
find any evidence of possible health effects" with "a small but
significant increased risk". The study, which started 4 years earlier, reviewing
data from the ongoing Women's Health Cohort Study, was being used by both sides of the
implant controversy. The same facts resulting in different interpretations dependent on
individual belief-convictions ? Lead author epidemiologist Dr. Charles H. Hennekens of
Harvard Medical School, Brigham and Women's Hospital: "The study is far
more reassuring than alarming", "Our study's great contribution is to show that
the idea that women with implants had a large hazard of connective-tissue disease, is not
plausible". http://jama.ama-assn.org/cgi/content/abstract/275/8/616
--
3M WINS AGAIN IN TEXAS
End February 1996, Jeannene Daugherty, Mary Jenke and
Sue Whitley -Vs- 3M, Houston, Texas, Harris County Court, District Judge Don E. Wittig.
The jury in a 10 to 2 verdict found 3M not liable for allegations by the 3 women (filed in
1992 and 1993 ) that the implants caused them to have health problems: "We
are extremely pleased by the verdict, which confirms that silicone does not cause
disease". Cardozo Law School professor Lester Brickman: "The
weight of real science has begun to be recognized by juries as outweighing the junk
science that plaintiffs' lawyers have been relying on. Even in Harris County, Texas, the
epicenter of the junk science universe".
--
JUDGE THROWS OUT LAWYERS
On 21 March 1996 in Michigan Judge Arthur J. Spector,
overseeing Dow Corning Corp.'s bankruptcy reorganization, ordered that the attorneys
("tort claimants committee"), representing thousands of women in breast implant
claims, be replaced. Their negotiations, Spector found, were inherently rife with
conflicts of interest: "The eight attorney members are not 'creditors
holding unsecured claims' because none of them holds a claim". The women
themselves had to make up a new negotiating committee. Lawyers involved with Dow's
bankruptcy proceedings said Dow Corning was now offering only $188 million to settle the
claims.
--
COLLAGEN' FUTURE
After Collagen / LipoMatrix' soy-bean-oil implant Trilucent came on the market in Europe
in 1995, US firm Collagen (CEO Howard Palefsky, chief operating officer Gary Petersmeyer)
announced in March 1996 to have bigger plans. It's
future business strategy was aiming to be more active in the areas of plastic surgery and
dermatology with investment in 'appearance' medicine such as injectable collagen products
for soft tissue. Someone had to the job, taking care of enhancing appearances and the
slowing down of the (evil) aging process ? "In the US we experienced our strongest
year since fiscal 1991", "Our international business saw unit growth of 21%.
Internationally, growth was achieved in virtually every major market", stated
Collagen Gary Petersmeyer on 15 August 1996 (Business Wire), "The launch of the
Trilucent breast implant in the United Kingdom and other European countries has been very
exciting and exceeded our expectations".
--
IMPLANT MAKERS: UNBEATABLE
On 3 April 1996 Laura Samuelson & Wendy Werner
-Vs- Bristol-Myers Squibb / subsidiary Medical Engineering Corp., Dallas, Texas. Victory
for Bristol-Myers Squibb in an implant trial (implants causing a variety of ailments) by a
jury verdict of 12 to 0: "This verdict is a victory for sound science".
The 4 manufacturers involved in the revised settlement had now won 9 of their last 10
implant cases which had been taken to a verdict.
# - On 29 February 1996, Lori and Joseph Shaw -Vs-
Bristol-Meyers Squibb. Healthy and vital Lori Shaw had become sick (fatigue, aches and
pains) due to leaking implants which she got in 1990. The couple was awarded $1.5 million
in compensatory damages. The Multnomah County Circuit Court jury would decide on punitive
damages later. But on 22 April 1996 Circuit Judge Frank Bearden, granting a new trial,
threw out the $1.5 million award because plaintiff' attorney's would have prejudiced the
jury by improper questioning and remarks. Bristol-Myers was pleased.
# - In a silicone breast implant lawsuit (Mildred and
Kenneth Valentine) end April 1996 a Superior Court Judge, Richard P. Figone, reversed 2
mistrails (1995 and 27 March 1996 ) in favor of Baxter Healthcare Corp. following Baxter's
motion for a directed verdict. Also on 14 May 1996 a San Diego County Court jury judged in
favor of Baxter Healthcare in a silicone breast implant lawsuit. The 16th victory of
Baxter against women claiming injury from breast implants.
--
BOOK: OUR STOLEN FUTURE
Dow and other chemical companies were confronted with a book 'Our Stolen Future' in the
early spring of 1996. The book's main issue:
even very small amounts of some chemicals could interfere with hormones in humans and
wildlife, leading to reproductive impairment and diminished intelligence in offspring.
--
FDA'S KESSLER: 'SAFETY'-STUDIES SHOW ERRORS
A month after PBS TV-programme Frontline --in which Kessler showed believe of science
proving implants are safe-- among other researchers, FDA Commissioner David Kessler
authored an article (Silverman, Kessler e.a., Annals of Intemal Medicine), published in April 1996. The article reviewed studies showing implants
were safe. The article found methodological errors in all 13 of the epidemiological
studies which had been performed to that date on systemic health problems related to
implants: "Sample sizes inadequate to rule out rare outcomes, Study methods
inappropriate for detecting atypical syndromes, Poor choice of comparison group",
and "Inadequate duration of follow-up or information-gathering techniques that may
have biased the detection of implants or clinical outcomes". From the
literature-appendix of the study it appeared that at least 70% of the implants showed
ruptures within 10 years.
http://www.annals.org/cgi/content/abstract/124/8/744
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&
dopt=AbstractPlus&list_uids=8633836&query_hl=36&itool=pubmed_docsum
--
DUTCH 'PSEUDO-WOMEN SPEAK OUT
In a Dutch documentary 'Breasts: source of life, admiration and disappointment' (May 1996 ) of the Dutch radio-programme 'Gebeurtenissen'
(bco RVU) about breasts among others three women came to word. A woman who in 1973 due to
pressure of her husband at the time had breast enlargement. The silicone started to leak
in 1993. Another woman had had breast enlargement in 1972 due to pressure of a surgeon.
She underfound many problems with the silicone, underwent 15 operations and eventually
breastamputation. And another woman who had choosen for breastaugmentation in 1983. It
went wrong. She underwent a new operation but got troubles with a 'crawling
breastimplant'. She underwent another 4 operations, which she found okay because her
husband found her breasts so beautiful.
--
IMPLANTS RUPTURE
# - In a study, of 54 patients (seen from 1974 until
1995 ) who had silicone injections, problems ( a.o. foreign body reactions and movement of
material to near and distant parts of the body) were found which usually demonstrated
themselves many years after injection (Rapaport MJ, et al., Aesthetic Plast Surg, 1996 May; 20(3 ): 267-276 ).
# - Scientists of the University of Toronto and the
Wellesley Hospital concluded from a by Dow Corning funded study that after 6 years 40%,
and after 12 years 95% of the implants showed ruptures (Peters e.a., Canadian Journal of
Plastic Surgery, spring 1996 ).
# - Another study observed a significant correlation
between capsule fibrosis and elevated values in silicone gel-filled -, but not in
saline-filled implant recipients (Brunner CA; et al., Ann Plast Surg, 1996 May, 5-36, pg 512-18 ).
--
FEAR OF OTHER DEVICE MAKERS
On 26 June 1996, Laura Lohr -Vs.- Medtronic Inc. Laura
Lohr believed she nearly died in 1990 when her Medtronic pacemaker to her heart failed
to work. The U.S. Supreme Court, in a 5-4 decision, reduced the possibility of Medtronic,
the world's biggest producer of heart pacemakers, and other medical device makers, to
block lawsuits by patients claiming to suffer from defective products. Laura Lohr from
Florida was allowed to sue Medtronic for damages, under state law because manufacturers'
compliance with federal laws, did not necessarily protect a medical device from
product-liability lawsuits filed under state laws. The ruling could affect thousands of
lawsuits over allegedly defective medical devices including pending silicone
breast-implant cases.
--
IMPLANTS SAFE ? McGHAN "DEFINITELY YES"
In a McGhan 410 patient handout in The Netherlands, McGhan-Inamed (8/1996
) answered questions about implants. Question: "Can I be confident that silicone
is a safe and reliable material ?", Answer McGhan-Inamed: "Definitely
yes. Silicone is a very well studied and scientifically understood product. Silicones are
widely used in food and cosmetics, as well as in hundreds of critical medical
applications. The majority of medical implants, including all breast implants rely on some
form of silicone. If you have specific concerns, ask for information regarding scientific
studies involving thousands of women which document long-term safety", "What
case reports tell us. The first wave of reports of 'human adjuvant disease' in women who
had undergone cosmetic breast surgery came from Japan. The obscure and medically unsound
method of cosmetic breast surgery used in these cases involved injecting large volumes of
various substances of unknown purity, including silicone fluid, paraffin (liquid wax) and
petroleum jelly. The case reports, involving a total of about 60 women, suggested that
these injections served as adjuvants to worsen symptoms of pre-existing disease. It is not
surprising that the voluminous, direct injection of unkown purity that these women
received could worsen pre-existing conditions".
--
BOOK: (JUNK) SCIENCE ON TRIAL
The book "Science on Trial: The Clash of Medical Evidence and the Law in the Breast
Implant Case" of former New England Journal of Medicine (NEJM) executive editor
Marcia Angell M.D., also author of 'The Truth About Drug Companies', discusses,
investigates the conflicts between scientific -, and legal reasoning, the different
methods to obtain results, in the litigation over silicone breast implants. After Angell
read an article of FDA Commissioner David Kessler, submitted to the NEJM, explaning the
implant ban, Angell got interested in the implant issue. According to Marcia Angell there
is no scientific evidence to support women's claims or their awards, evidence which Angell
puts in the public spotlight in her book. Because courts allowed "junk
science" into evidence, a woman won millions of dollars from Dow Corning. Emotion
and money, not truth, are the ruling the legal system resulting in judgements not based on
reliable scientific evidence: "Instead, a growing number of Americans had
come to believe that breast implants could cause devastating effects on the rest of the
body", argues Marcia Angell (emotionally) in her book. In another reality it
appeared that even in 1998, despite the implant controversy and negative publicity, women
were still getting breast implants in record numbers, a 275% increase in the (saline)
operations since the ban of 1992: even called a trend in medical practices across
the country, according to the American Society of Plastic and Reconstructive Surgeons.
Further Marcia Angell writes in het book among others about the history of breast
augmentation, the design and evaluation of scientific studies (Harvard Women's Health
Cohort study , Mayo Clinic study) and about her concern for the future of science: "Reliance
on concrete evidence distinguishes science from all other human endeavors",
Angell writes, "there are many individual stories of connective tissue diseases
developing after the placement of breast implants, but these reports alone are not enough.
Anecdotes do not constitute evidence that the implants caused the disease".
However, in another reality it appeared that the research Marcia Angell cited to support
her contention, was actually a better candidate for the term "junk" (science),
than what she attacked. http://www.thenetnet.com/readme/angell.html
--
GATE-KEEPER: MARCIA ANGELL
# - In 1923: Frye -Vs- The United States. Frye
required that scientific expert testimony reflect the consensus of scientific opinion.
Even more stifling than the Frye standard, were the new standards established by Daubert
(-Vs- Merrell Dow Pharmaceuticals). The U.S. Supreme Court established new rules (for
District Courts) for determining the admissibility of scientific expert testimony. Marking
a new era: "Some judges have been loath to exercise their gatekeeper
role" (see earlier). In her book 'Science on Trial' NEJM-editor Marcia Angell
calls for reinstating the Frye standard. Angell beliefs that publication in peer-reviewed
journals are an essential test of reliability. Angell's book, writes Philip Buchan (Trial,
1 March 1997 ) is being used as a weapon by the 'liability limits'-lobby to treat all
plaintiffs' scientific evidence with suspicion. The 'liability limits'-lobby: placing caps
on the compensation amounts manufacturers have to pay due to defective products causing
damage.
# - In 1982 Marcia Angell's New England Journal of
Medicine (NEJM) published a French study from a federation of French
artificial-insemination centers. The study raised female fears of infertility:
woman over age 30 had a nearly 40% chance of being infertile. The editorial (by Marcia
Angell ?) thus moralized that women should "reevaluate their goals" and
have babies before starting careers. Lateron (in another reality) research by the US
National Center for Health Statistics showed that the true rate of infertility at 30 was
only 13,6%. The conclusions of the NEJM-French-study were eventually abandoned even by its
own authors.
# - In 1986 the NEJM published one (pro)study (A) and
rejected another (contra)study (B) which had opposite conclusion about the antibiotic
amoxicillin. Both studies were based on the same data. Scientists from study A were
sponsored ($1.6 million) by the drug manufacturer. The critic B had refused corporate
funding. NEJM proclaimed the pro-amoxicillin study (A) the "authorized" version.
The critical study (B) was published in the Journal of the American Medical Association 5
years later, showing, based on large-scale testing of children, that those who took
amoxicillin actually experienced lower recovery rates than people who took no medicine at
all. (Source: "Science under pressure: Dow funded studies say 'No Problem'",
John C. Stauber, Sheldon Rampton)
# - In 1996, the NEJM published an editorial claiming
the benefits of diet drugs outweighed the risks. NEJM did not inform readers that the
authors were paid consultants for companies that made or marketed one of those drugs. The
drug, Redux, was banned by the FDA in 1997.
# - Mirror, mirror on the wall ? Michael Castleman:
"Junk science, the term has been bandied about a lot lately, especially in defense
of silicone gel breast implants. But if you look beyond the headlines and sound bites,
it's quite clear that implant apologists - notably Marcia Angell, executive editor of the
prestigious New England Journal of Medicine- are guilty of the very sin they accuse
implant critics of: junk science". http://www.motherjones.com/news/outfront/1998/01/wellbeing.html
# - According to Marcia Angell "the scientific
method is always the superior, if not in fact the only approach". Had Marcia
Angell over her scientific years (time) come to the / her belief of wanting to make some
kind of a guru / a God, of science, of scientific evidence to which the mass of peoples
all should pray to while obeying the Scientific Ten Commandments as mentioned in highly
respected scientific 'peer-reviewed journals' written by a few individuals with (also)
personal 'emotion' and/or interest (sponsering) ? The will of Marcia Angell to from out of
a superior "guru-position" present scientific "diagnosises" as "unpeachable
judgements" ? A book: anecdotal evidence of an author' personal emotion ?
# - Former Medical Journal Editor Outlines
Conflicts of Interest
http://www.medicalconsumers.org/pages/FormerMedicalJournalEditorSpeaksOutAboutConflictsOfInterest.html
# - Fingerprints: scientific proof or just a matter
of opinion ?
Forensic evidence faces crisis after head of Scottish Fingerprint Service argues that
ID from prints is 'judgement' rather than fact.
http://www.shirleymckie.com/documents/SundayHerald20.11.05.pdf
# - Doctor: Merck tried to influence article in
highly respected medical journal
http://www.beasleyallen.com/news/2005/dec/04/article/486/
# - Fake Research Puts Medical Journals Under
Microscope
http://www.forbes.com/lifestyle/health/feeds/hscout/2006/01/26/hscout5
30580.html
# - Scientists study scientific secrecy
http://www.physorg.com/news10257.html
# - Doctor Who Faked Cancer Study Admits More Fraud
http://www.yourlawyer.com/articles/read/11194
# - Cancer researchers fall victim to fraudulent
study
http://www.utmb.edu/imh/announcements.asp?id=108
# - The Prostitution of Science: When you
hear the words "scientific authority," check to be sure your wallet is still
there and hold onto it tightly. Prostitution of science is using its good name for base
purposes: falsifying data, and misinterpreting statistics to support a new theory, with
the objective of gaining personal fame and fortune. Recent publicity about such debased
conduct should have two consequences: (1 ) people ought to become more skeptical about new
scientific pronouncements, and, as they do, (2 ) they ought to become more aware that the
supposedly sharp dichotomy between scientific certainty and metaphysical inquiry is simply
an illusion" http://www.michnews.com/artman/publish/article_11072.shtml
# - Global Trend: More Science, More Fraud
http://www.freerepublic.com/focus/f-news/1543824/posts
# - Whistleblower wins drugs study inquiry
http://observer.guardian.co.uk/uk_news/story/0,6903,1664688,00.html
# - Clinical trials: Private tests a risky business
http://seattletimes.nwsource.com/html/businesstechnology/2002608440_dr
ugtesting07.html
# - Drug Industry Human Testing Masks Death
http://www.bloomberg.com/apps/news?pid=specialreport&sid=aspHJ_sFen1s&
refer=news
# - Corporate Corruption of Science
http://www.ijoeh.com/pfds/IJOEH_1104_Egilman.pdf
# - 70% Drug Panels Rigged with Pharma-Money /
financial links
http://www.mentalhealth.org.uk/profilenews.cfm?pagecode=
PMSTLN&areacode=mh_strategies_treatments_news&id=8709
# - A cheat's guide to clinical trials
15 tricks pharma companies use to get the right results
http://pharmawatch.blogspot.com/2005/10/cheats-guide-to-clinical-trial
s-15.html
# - Drug Firm accused of manipulating drug data
http://www.corpwatch.org/article.php?id=12692
# - The truth about medical journals
Drug companies exert heavy influence over published scientific articles
http://www.newstarget.com/012119.html
# - Most scientific papers are probably wrong
http://www.newscientist.com/article.ns?id=dn7915
# - Why Most Published Research Findings Are False
http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371/journal.pmed.0020124
# - Drug companies suppressing data on clinical
trials for decades
http://www.newstarget.com/003185.html
# - Study says medical journals allowed conflicts
http://www.cspinet.org/new/200407123.html
# - Massive medical fraud exposed: sham clinical
trials
http://www.newstarget.com/001298.html
# - Negative results DrugTrials routinely
suppressed
Researchers rarely publish negative research results in mainstream medical journals,
and even purposely suppress results that fail to prove links between diseases and drugs or
genes http://www.newstarget.com/021227.html
# - Rent-a-Researcher
Did a British university sell out to Procter & Gamble ?
http://www.slate.com/id/2133061/
--
- SILICONE TiME LINE
--
DOCTOR JAILED
Oklahoma family practitioner J. Dan Metcalf, M.D. was charged by a U.S. District Court in
July 1995, and sentenced in March 1996 to 6 months in a federal prison. Metcalf had
Hippocratical violated U.S. restrictions, by illegally importing unapproved silicone
gel-filled breast implants through doctors from Brazil and the Bahama Islands into the US,
using them for breast on women, and selling to other U.S. doctors.
--
NATIONAL SCIENCE PANEL
In April 1996 two Federal judges (New York, Oregon)
had appointed an (own) impartial, expert panel to review the scientific issues involved in
breast implant lawsuits in their districts. This rare move 'influenced' judges throughout
the country. Ralph Knowles (Plaintiffs' Steering Committee) reacted that plaintiffs, to
avoid potential conflicts, rather would have a nationwide panel. Implant manufacturers
didn't think that (at first: some procedures) would be a good idea. But in May 1996 U.S. District Judge Sam Pointer of Birmingham
announced the creation of a National Science Panel (NSP). The panel "would be
available to advise judges and juries around the country on the scientific evidence
surrounding the implants, which has been sharply divided" (3
June 1996, Wall Street Journal). While the panel's decision would likely to be
very influential, use of the panel would mean extra costs for the court-parties and other
(besides scientific) evidence also being important in a jury decision, the 'neutral
scientific experts' had to review, critique, and evaluate existing scientific literature,
research, and publications in the implant controversy, in four fields: epidemiology,
immunology, rheumatology, and toxicology. The videotaped testimony of the experts could
provide 'neutral commentary' for courts to insure the studies were examined in an
'unbiased' way. In August 1996 Pointer ordered (Court
Orders Search for Neutral Experts in Breast Implant Litigation, TRIAL, Aug. 1996, at 15.),
under Federal Rule of Evidence 706 which allows judges to appoint experts to testify, an
advisory search-panel, chaired by expert on scientific evidence Brooklyn Law School
professor Margaret Berger, to start looking for NSP members.
--
IMPLANTS: WHY SHOULD MY CHILD SUFFER ?
The British Health Department in 1995 had set up a medical advisory panel. They reviewed
implant research and found no risks. But in September 1996 a new 2-year research showed
that women with breast implants, besides also causing harm to their own health, may also
harm their babies and their children: underweight, suffering from lethargy, aching
limbs and joints, hairloss, skin thickening and stomach problems. The warning of Dr David
Smalley (University of Tennessee), stated in the Sunday Mirror (1
September 1996 ): "There is no doubt that there are links
between silicon breast implants and the symptoms the children show. It could happen
through breast-feeding, but it is also likely that the silicon does cross to the
placenta".
# - Sylvia Ball, mother of two children, from
Liverpool had breast implants in 1981. She immediately suffered side-effects:
fatique, dizziness, painful joints. After the implants she had two more children. They (8
and 11 years-old) also had complaints: tired, headaches, pale-skin, leg pain. The
two children of before the implants were perfectly healthy.
# - Terese Allen also complained that, after
she had implants in 1985, her baby stopped growing in the womb two weeks before the baby
was born Dr David Smalley' colleague, Professor Douglas R Shanklin: "I advise
women against implants and would like to see them banned completely", "100% of
breast implants leak, either during a rupture or by a slow leak over a period of time.
Even with the new saline implants, the silicon casing breaks down into the body".
http://www.freewebs.com/implants/chronology.htm
# Events in the History of Silicone Immunopathology
(Science & Medicine, Vol.3, Nr.5, Pg 22, Oct. 1996, Douglas R. Shanklin, David L.
Smalley)
http://iubio.bio.indiana.edu/news/bionet/immunology/9612.newsm
http://www.sciandmed.com/sm/journalviewer.aspx?issue=1060&article=732
# Widespread silicone sickness is very real in woman with past and continuing exposure
to silicone breastimplants
Douglas Shanklin, MD, professor of pathology and of obstetrics and gynecology at the
University of Tennessee in Memphis
http://implants.clic.net/tony/Corner/A/0017.html
http://www.fasebj.org/cgi/content/abstract/9/5/424
http://gyxe.com/breast-implant/92-049-widespread-and-rising-silicone-associated-disease-s-read.shtml
http://forums.newbody.com/TopicMessages.aspx?Forum=Breast_Enlargement&Topic=39606&Page=1
--
UNDIFFERENTIATED CONNECTIVE TISSUE DISEASE
Former president of the American College of Rheumatology, John Sergent, in February 1996:
"Science is not what's ruling this discussion. It's the plaintiff-lawyer
frenzy". At the American College of Rheumatology conference, fall 1996, a study at the University of Michigan was
presented. Reported was that women with silicone implants, including breast implants, were
3 times more likely to contract Undifferentiated Connective Tissue Disease (UCTD): a
medical term for the types of non-classical immune system symptoms.
--
DOW CORNING WINS: OUTLAWING PEOPLE
In September 1996, Kempf -Vs- Dow Corning. In the
breast implant trial, Judge John Marshall of the District Court, Dallas County, Texas,
ordered exclusion, under Daubert-standards as adopted by the Texas Supreme Court, of the
testimony of plaintiff's expert witnesses. Judge Marshall does the same in Bailey -Vs- Dow
Corning also in September 1996.
--
FDA'S 'ANECDOTICAL' EVIDENCE
The FDA has on file over 6000 pages of physician reports on the health endangerment of
breast implants to women since end 1960's. In February 1996 FDA's Dr. Larry Kessler said
that about 40,000 women a year had been telling the FDA of diseases that they attribute to
their implants. Between 1 January 1985 and 17 September 1996
the FDA had received 103,343 adverse reaction reports associated with silicone breast
implants and 23,454 reports involving the saline implants.
--
DOW CHEMICAL WINS: NOT RESPONSIBLE On 26 September 1996
(Daily News, September 27, 1996 ) a California Court of Appeals (Justice Patricia Benke)
upholds in a 3-0 decision, an earlier San Diego judge's decision in 1994 which dismissed
Dow Corning' parent companies, Dow Chemical and Corning Inc., from 1,600 breast-implant
lawsuits. The California Court of Appeals found them not responsible for the alleged
defects in the implants. Dow Chemical's general counsel, John Scriven, was pleased. http://www.thefreelibrary.com/parent+companies+held+not+liable+in+implant+suit-a083968827
--
MEDICAL DEVICES: IMMUNE SYSTEM
(FDA, Annual Report, 1 October 1995 - 30 september 1996
) "Immunological Effects of Silicone - Preliminary results have shown that
silicone gel can induce an autoimmune response indicated by the presence of antibodies in
the serum of some of the test animals. Tissues have been collected and are being analyzed
to determine if the autoimmune response may cause tissue damage...(...)...tumour formation
can occur, and may be dependent upon genetic predisposition, although its relation to the
presence of silicone is unclear". http://www.fda.gov/cdrh/ost/reports/fy95/interactions.html
--
SAME GAME, SAME STRATEGIES, A MERE COINCIDENCE ?
(Law Firm article, By Michael R. Hugo of Alexander LLP, 1 October
1996 )
Vaccine and Breast implant manufacturers - Lawyer Michael R. Hugo of Alexander LLP, member
of the Settlement Advisory Committee, long considered as one of the leaders in the
silicone gel breast implant litigation, has been part in litigation of many pharmaceutical
cases in the US. Litigation around vaccines, Rezulin, Baycol. And Vioxx, where his work
contributed to the declassification of thousands of documents which manufacturer pharma
Merck had tried to keep from the public eye.
http://library.findlaw.com/1996/Oct/1/126110.html
http://www.tortcomm.org/plandocs.shtml
# - BAXTER WINS AND LOSES: Baxter Healthcare
Corporation had been named in litigation over HIV-contaminated blood products and Baxter
was named in silicone breast implant litigation as a result of acquiring implant
manufacturer Heyer-Schulte Corporation. Heyer-Schulte had been an early manufacturer of
medical shunts. Heyer-Schulte spent 3 years of study on potential consequences, prior to
introducing those shunts. Heyer-Schulte did no such research on breast implants. Lawyer
Michael R. Hugo of Alexander LLP (1 October 1996 ): "In recognition of the
potential harm caused by liquid silicone, the manufacturers admitted that ruptured
implants should be removed. The migrated silicone has been found, in large amounts, in
lymph nodes, knees, arms, and even, in a recent case, in spinal fluid. One woman found
silicone gel in her elbow, gel that had migrated from her ruptured Heyer-Schulte implant.
In fact, her plastic surgeon has testified that he removed a half Dixie cup full of
silicone from her arm. Repeat surgeries to remove continuing evidence of silicone have led
to further disfigurement not to mention serious financial demands on women".
# - On 18 September 1996 a Dallas County court
returned a verdict in favor of Baxter Healthcare. So far Baxter had won 20 breast implant
lawsuits, had 2 mistrials and lost 2 cases of which 1 awaiting appeal, and in the other
Baxter was granted a new trial.
# - In October 1996 Judges Weinstein and Baer (US
District Courts for the Southern and Eastern Districts of New York) found plaintiffs'
expert witnesses' evidence insufficient for a trial.
# - While Paul L. Schnur, M.D. (et al Plast Reconstr
Surg., Oct 1996; 98(5 ):798-803 ) found elevated levels of silicon in both breast and
periprosthetic capsular tissue in patients, independent of implant brand or length of
exposure, (ofcourse) "not implying any claim of a causal relationship between
silicone and any reported illnesses", on 17 October 1996
Florence Vassallo -Vs- Baxter Healthcare / Heyer-Schulte. A Middlesex County jury awards
$1.1 million in damages to Florence Vassallo who in 1977 had received Heyer-Schulte
silicone gel implants which were replaced with saline implants in 1993. Baxter's liability
stemed from a merger about a decade earlier with American Hospital Supply Corporation,
which had owned the no longer existing Heyer-Schulte Corporation. Baxter lawyer Bruce
Parker: "It's unfortunate that the jury didn't have the benefit of hearing
the details of numerous scientific studies conducted by institutions like the Mayo Clinic
and Harvard School of Medicine". Baxter now had lost 3 trials. On 3 December 1996
the lawsuit, Vassallo -Vs- Baxter, would continue with a hearing (Middlesex Superior
Court, Judge Margot Botsford).
--
BREASTIMPLANTS: "LIVING THE HORROR EVERY DAY"
Mary Lee Taylor, head of a US national group of breast implant survivors, about the
Harvard and the Mayo Clinic studies: "I know what implants do to the body,
I live the horror every day". In the UK about 100,000 women had breast implants.
60,000 (a la Paula Yates) for cosmetic reasons, 40,000 for reconstruction after breast
cancer. http://cat.inist.fr/?aModele=afficheN&cpsidt=2209663
While silicone gel implants were banned in the US, in the UK every woman having implants
was registered by the Department of Health. British women were being encouraged to join
the US action against the manufacturers. Begin November 1996 around 15,000 women were in
the proces of trying to sue a manufacturer. Thousands had their old implants removed. Many
plastic surgeons played safe using other substances. (The Independent, 5 November 1996,
Rita Carter). For example the Trilucent because: leakage was tolerated by the body,
and allowing X-rays to pass through, mammography being more effective. Mammography is the
primary method used for the early detection of breast cancer.
http://www.pulsus.com/Plastics/05_02/pete_ed.htm
http://www.implants.clic.net/tony/Ant/E/22.htm
--
BRITISH MEDICAL MIRACLE: HUMAN ENGINEERING
Judy Fitch had medical nightmares at age 13 after a mastectomy. She then had two silicone
implants but two weeks later her body rejected one implant. But later Judy Fitch was the
picture of health and happiness: by a "tramflap"-operation, a new right
breast had been created from her own stomach muscle (The People, England, 3 November 1996, Linda Udall).
--
MEDICAL SPECIALISTS MINIMIZE REALITY
Dutch current affairs Tv-programma 'NOVA' reported on 11-11-1996
about cosmetic surgery being an opening in the market for all kinds of private-clinics
which minimize the risks of cosmetic interventions.
--
IMPLANTS: ALSO BRITISH WOMEN HAVE RIGHTS
In 1995 a court in Alabama had ruled that only US women should be allowed to claim
compensation for injuries due to implants. This decision was appealed by lawyers / woman
outside the US. But on 15 November 1996 lawyers
(Bristol-Myers Squibb, Baxter, 3M) agreed that also thousands of British women should be
entitled to sue and compensation: to "settle the claims of all foreign
claimants". Only women who had already registered claims in the earlier global
settlement would be be entitled to a $25 million fund which was to be set aside. And only
hundreds of woman would qualify for this compensation because they had to be able to prove
the source of the implant and the injury it caused, said lawyer Paul Balen. Not an easy
job, seen the lack of a register. No claims (deadline: 14 February 1996 ) were allowed
against Dow Corning.
--
TOBACCO HEALTHCARE: SAME GAME, SAME STRATEGIES ?
On 25 November 1996 FDA Commissioner David A. Kessler
announced he would step down from his position and return to private life (becoming dean
of Yale University's medical school) as soon as a successor was found. Shares of every
major tobacco company rose on this prospect. Kessler was namely seen as US' toughest
cigarette regulator, leading the most significant government fight ever against the
tobacco industry.
# - The London Guardian (17 October 2005 ) reported
that the world's 2nd largest cigarette company, British American Tobacco, for the four
previous years had secretly been operating a factory, in a joint venture with a company
owned by the state with Tories' Ken Clarke on the payroll, in North Korea. The country,
some people say, caring not such about human rights.
# - Dutch documentary Tv-programme 'Zembla' (bco VARA,
10 June 2007 ) made known that the Dutch Cancer Society Queen Willhelmina Funds
(Nederlandse Kankerbestrijding Koningin Wilhelmina Fonds, KWF) --which also, supporting
the Dutch Quackbuster organisations, participated in the image-forming around the
controversial silicone breast implant case of Dutch actrice Sylvia Millecam-- invested a
part of it's wealth in the four largest tobacco-manufacturers of the world noted on the
Stock Exchange.
--
DOW CORNING: PLAN OF REORGANIZATION
Dow Corning announced on 2 December 1996 having filed
a $3 billion Plan of Reorganization (POR) including a new settlement offer and a
Disclosure Statement with the U.S. Bankruptcy Court (Judge Arthur J. Spector) in Michigan.
Documents showing a plan how to settle all the claims, based on 3 important concepts, said
Dow Corning CEO Richard A. Hazleton. (1 ) - Provinding choices, flexible for women. (2 ) -
The value of the claims based on scientific evidence available (support National Science
Panel). (3 ) - Fair treatment for everyone with legitimate claims and at the same time
preserving viability of the company, for customers, employees and others who rely on Dow
Corning. Women claiming the implants caused disease would receive up to $2 billion.
Hazleton believed the POR and Disclosure Statement would be approved within 12 to 18
months by the U.S. Bankruptcy Court. Then the plan would go into effect.
--
DOW CORNING'S MOONWALK: STICT(ER) TERMS
Dow Corning's old settlement ($6,666 per woman) had collapsed because the court was
flooded with thousands of claiming women. The new proposed Dow Corning $3 billion plan
included $1 billion for commercial claim compensation. The remaining $2 billion, for
product liability claim, would be released under stricter terms. Dow Corning would only
pay $600 million for women favouring settlement over litigation, who would choose early
settlement. 300,000 women with Dow Corning implants = $2,000 per woman. The new plan paid
women far less. Since the $2 billion Dow Corning pledged to settle claims two years ago,
Dow Corning in their new plan offered less than 50% of the original offer. The effect of
Marcia Angell's science: a (sponsered) tool to influence peoples and outcomes of
human affairs in a certain desired manner / direction ? The new DC offer included an
additional up to $1.4 billion which Dow Corning, under the mask of "Pain real, causes
unkown", would pay more if a panel of scientists would agree, if a court would rule
in a new separate science / causation trial in which a jury would decide whether
scientific evidence supports implants are hazerdous and causing diseases. If not so, no
compensation. Dow Corning spokesman Michael Jackson commented: "The
evidence disproving a link between implants and disease has been overwhelming".
The Dow Corning POR offered women 5 settlement choices / options from the Settlement Trust
Fund: Expedited Payment- (physical injury), Explant- (implants removal), Scheduled
Review- (range of criteria), Individual Evaluation- (higher level of proof), Mediation
(rejecting prior options: agree to non-binding mediation as an alternative to a jury
trial). Rejecting all these 5 options would mean claims to be handled by three steps:
enhanced review, mediation and litigation/arbitration (Litigation Trust). After the U.S.
Bankruptcy Court would approve the Disclosure Statement, the POR had to be voted on by all
claimants including patients. For the POR to be accepted, claimants holding at least 2/3
of the dollar amount claimed and more than 1/2 number of the allowed claims within the
class, had to vote in favor. But representatives of the women opposed. There was
criticism. Implant victim Lynda Roth (President coalition Silicone Survivors):
"It's a joke, every time they try to make a deal, it becomes less and less
favorable to the people they have victimized, which is not surprising for a company with
very little morality and very few ethics when it comes to dealing with the problems
they've created". And Sybil Niden Goldrich (woman' representative on the Dow
Corning tort claimants committee / Command Trust Network): "This settlement
offer would not even cover the full cost of needed surgery to remove leaking implants over
the length of their disease". Thus on 10 January 1997, joining Dow Corning's
creditors, an alternative plan was filed by the women to the bankruptcy court. The women
proposed that Dow Corning at least pay $2.95 billion to settle their claims. In the
meantime, the separate settlement offer by the other manufacturers (Bristol-Myers Squibb,
Baxter, 3M) had been accepted by about 91,000 women. http://bankrupt.com/TCR_Public/961202.MBX
--
MARLOU BOOTS "IT IS MAINLY ABOUT RECOGNITION"
Dow Corning made also known that foreign women who had suffered damage by products of Dow
could file a claim. Dutch Support Group SVS, which in the mean time got acknowledgement
from Lucas Reijnders (professor ecology and staff employee of the Dutch foundation Nature
and Environment), from a few docters among who two immuunologists of the Free University
in Amsterdam, and from the Dutch Consumer Union: "For Marlou Boots it is at
first not about the money. 'It is mainly about recognition. And further I hope there will
come a medicine with which the silicone which have come into the body can be broken down
and carried off'" (Dutch newspaper 'Trouw', 4 December
1996, Monic Slingerland, 'Manufacturer breastimplants now offers 2,5 billion
dollar to women with complaints'). The Dutch Consumer Union (N. van Zanten) was going to
bring together these complaints and Marlou Boots, besides Dutch plastic surgeon G. Efting
Dijkstra, appeared in Dutch current affairs Tv-programme 'Netwerk' (17 February 1997; bco
NCRV): "The use of silicone prothesis for breast enlargement remains
disputed".
--
VICTORY FOR IMPLANT MAKERS: EXCLUDING PEOPLE
Dow Corning could immediately emerge from bankruptcy if the courts would decide to junk
the breast implant cases. When in April 1996 two Federal Judges had appointed an (own)
expert panel to study the scientific implant matters, it was said that that rare move
would 'influence' judges (disadvantageous?) nationwide. On 19
December 1996 implant makers (Hall -Vs- Baxter Healthcare, Bristol-Myers) won a
major victory. With in the back of the mind the upcoming US debate on Biomaterials of the
Product Liability Bill (liability for suppliers of subcomponents or raw materials,
silicone being the most important, of medical implant devices), and in the (influential)
spirit of Marcia Angell' book 'Science on Trial' (Frye standard), U.S. Federal District
Judge Robert E. Jones in Oregon, Portland threw out a testimony from a case which was
saying implants causes immune system diseases. The comments from plaintiff's expert Shanna
Swan were ruled out by Judge Jones: "Dr. Swan's well-traveled opinions are
no more than educated guesses dressed up in evening clothes". An anecdote. Judge
Jones ruled that in his court expert witnesses in lawsuits cannot testify or introduce
evidence, saying implants cause disease, because it is scientifically invalid and not
meeting the threshold of scientific proof to be presented to juries. Judge Jones also
prohibited testimony supporting claims of emotional distress from fear of becoming ill in
the future: "At best an untested hypothesis", said Jones.
Therefore not to be presented to a jury. Ruling out 'junk science'. Selectively in certain
situations, the ruling out certain kinds of people, the people behind the outer
compartment / box of junk science ? Lawyer Frederick Ellis (representing Oregon
plaintiffs) said Judge Jones: "misunderstood the law", "The judge
totally blurred the distinction between the experts' methodology and the experts'
conclusions", "The distinction between methodology and conclusions is difficult
for some judges to comprehend". The Judge Jones ruling conflicted with other
federal court decisions (Hopkins-Vs- Dow Corning Corp, 9th Cir.1994 ) which did allowe
causation evidence. But the Portland judge Jones dismissed 70 cases / claims. Previous to
the case-ruling, in handling these 70 cases, Judge Jones had listened to Baxter Healthcare
and Bristol-Myers Judge Jones had asked plaintiffs' lawyers to give him a list of expert
witnesses that they would call in the case. The manufacturers then had asked Judge Jones
in July 1996 to exclude the scientific testimony from the plaintiffs' witnesses because it
was, to their belief, not based on science. Judge Jones asked advice, on plaintiffs'
evidence, from a by Judge Jones self appointed panel of independent scientists who studied
the scientific papers and documents. The by Judge Jones appointed independent advisers on
science: ''four totally unbiased and uncommitted experts in the necessary
fields", were immunologist Dr. Merwyn R. Greenlick, rheumatologist Dr. Robert F.
Wilkens, immunologist and toxicologist Dr. Mary Stenzel-Poore and polymer chemist Dr.
Robert McClard. After a (science)hearing the Jones-scientists/advisors gave their
assessments of the plaintiff's scientific evidence. But Judge Jones appeared to have an
already made up mind and will of his own: "Judge Jones overruled their
advice when they reached a decision contrary to his preformed judgment. He decided that no
expert could testify about connective tissue disease because he found the evidence
unreliable. It marked a dangerous turn toward judges substituting their judgment for that
of the jury" ("Junking 'Junk science'", Philip Buchan, Trial, 1 March
1997 ). Judge Jones concluded, thus non-evidence based and based on his own belief
influenced by...., that the plaintiff' evidence was of unsufficient quality to be
presented in court. Federal District Judge Robert E. Jones in opinion: ''The
Supreme Court charged District Courts with the duty to act as 'gatekeepers' to insure that
any and all scientific testimony or evidence admitted is not only relevant but
reliable". The verdict of Judge Jones was a shock for the litigation community
because the ruling, if upheld on appeal as Jones's order wasn't final, could potentially
affect tens of thousands of women awaiting trial across the US 'influencing' other courts
and judges on how to handle scientific evidence. The women pointed out ("Beware of
'junk' lables", Tribune News, 14 February 1997 ) that it wasn't so long ago that
'experts' dismissed the claims, as "junk", of those who believed asbestos was
dangerous while there also still being tobaccao PR-chiefs maintaining the view, preaching
the belief of no link between smoking, heart disease and cancer.
SAME GAME, ANOTHER (OUTER) JACKET
The 'diagnosis' presented from out of a 'legal atmosphere' by Federal District Judge
Robert E. Jones would influence the behaviour of many. John McGoldrick, general counsel
for Bristol-Myers, said: "'I think it will have a major impact".
Peter Schuck a law professor, Yale University School of Law: "'It will
certainly make more judges willing to take this step". The situation surrounding
the Judge Jones verdict reminded Michael Green, a law professor at the University of Iowa,
of the situation surrounding the morning-sickness drug Bendectin. ((1993, Daubert -Vs-
Merrell Dow Pharmaceuticals. Federal courts had to conduct a 2-step analysis under Federal
Rule of Evidence 702 to determine the admissibility of scientific expert testimony)).
Michael Green: "After a few years a few courts began dismissing Bendectin
cases, saying there was no scientific evidence that the drug hurt fetuses. Other courts
took notice. And soon it became a landslide, a snowball". Does (the) history
repeat itsself ? http://www.questia.com/googleScholar.qst;jsessionid=
HlkJ0Rkw8pPqyL3BYdpQ8F2yvp8lBMGvlq9ztn2r0bdPSkptbLTp!1665258631?docId=5001641839
--
NATIONAL SCIENTIFIC PANEL
While Federal District Judge Robert E. Jones was consulting his own appointed
scientists/advisors, U.S. Federal District Judge Sam Pointer of Alabama appointed his own
panel of scientific experts, not connected to implant litigation, to advise him on the
value of scientific evidence. The NSP eventually ended up with four members / scientists:
immunologist Betty A. Diamond of the Einstein College of Medicine in New York;
epidemiologist Barbara S. Hulka of the University of North Carolina; rheumatologist Peter
Tugwell of the University of Ottawa in Ontario, Canada; and toxicologist Nancy I.
Kerkvliet of Oregon State University.
--
EARLIER BELIEF WRONG: 80% IMPLANTS RUPTURED
A 1996 study by a Harvard Medical School team led by Dr. Leoncio Garrido found
concentrations of silicone in the livers of women whose implants had ruptured. Another
study: 80% of second generation silicone implants now ruptured. "Of the
second generation implants removed between 1991 and 1995, 77% had failed. The failure
properties were similar for the three main manufacturers: Dow Corning, Heyer-Schulte and
Surgitek. The failure rate for second generation implants is much higher than was
previously believed. This is particularly significant in view of the current difficulty in
diagnosing implant failure" (Walter Peters et al, Wellesley Hospital and the
University of Toronto, The Canadian Journal of Plastic Surgery,1996;4(1
):55-58 )
http://www.info-implants.com/Kay/12.html
http://p102.ezboard.com/fimplantinformationnetworkfrm1.showMessage?topicID=976.topic
--
SCIENCE RULES ? KELLEY -Vs- BAXTER / HEYER-SCHULTE
In January 1997, Judge Edward Prado of the U.S.
District Court for the Western District of Texas ruled in favor of Baxter Healthcare.
Plaintiff claimed silicone breast implants caused systematic disease. Citing Daubert,
Judge Prado excluded the plaintiffs' disease causation experts from testifying. Had Judge
Prado been hit by a snowball of Federal District Judge Robert E. Jones ?
--
SILICONE: THE ONE BELIEF -Vs- ANOTHER
In January 1997 the American Academy of Neurology
reviews existing silicone implant studies and reports that "existing research
shows no link between silicone breast implants and neurological disorders".
SCIENTIFIC EVIDENCE PROVES THAT:
(1996, The Light Party )
"Silicone breast implants can produce autoimmune illnesses....
1. Silicone is a biologically active and toxic substance.....
2. Implants will likely rupture and leak within ten years of placement....
3. Silicone migrates from the rupture site throughout the body....
4. Silicone produces abnormalities in immune system functioning....
5. Silicone produces a classifiable new disease marked by autoimmune symptoms....
6. Silicone-associated symptoms go away when implants are removed.....
Once the implants are removed, you still need to detoxify the body of silicone
residue....". http://www.lightparty.com/Health/SiliconePoison.html
--
SURGEONS ON TRIAL
In the Dutch Tv-discussion programme 'Vesuvius' (13-02-1997;
bco IKON) presentator Cees Grimbergen asked questions about among others the risks of and
complaints about silicone implants: "Why was looking perfect so important
?". In 1982 the American Society of Plastic and Reconstructive Surgeons (ASPRS)
had claimed small breasts were "deformities". The scientific evidence of their
claims ? Marcia Angell in her book 'Science on Trial' argued that emotion and money, not
truth, are the ruling the legal system resulting in judgements not based on reliable
scientific evidence. On a February 1997 conference at
the National Press Club in Washington, D.C. called 'Women's Health, Law, and the Junking
of Science', where Marcia Angell was the keynote speaker, Plastic surgeon (Annapolis,
Maryland) Marcia Ormsbsy showed a (before-implants)picture of one of her patients with
very small breasts: "She looked like a boy scout. She was typical of
patients I see in her difficulty in dealing with her body image. These are women who are
very embarrassed to dress in the gym". The next slide Marcia Ormsbsy showed was
the after-implants-picture: "Here is her result. You can see she's been
wearing her bathing suit and going to the beach. What do I have to offer this woman now a
days ? Now my only option is saline implants --for this very, very thin woman -- which
ripple and hang like a bag of fluid. If we care about patients, such as her, we have to
learn to empathize and reflect to them what their problems are, because that's the only
way we can get to the flesh of the problem". In a study Frank Vasey M.B.
concluded: "that the majority of women exchanging saline for gel-implants
did not manifest a significant improvement in their clinical status and 50% actually
demonstrated a deterioration" ('Clinical status in symptomatic women exchanging
saline for gel breast implants', F. Vasey, N., J. Valeriano, University of South FL).
Emotion and money, not truth, are ruling the (surgical) medical system resulting in Divine
judgements not based on reliable scientific evidence ?
--
IMPLANTS LINKED TO IMMUNE DISORDERS
Plastic surgeon (Annapolis, Maryland) Marcia Ormsbsy also said on the February 1997
conference at the National Press Club: "Women have been unnecessarily
terrified by media reports about problems with breast implants. It seems there's no
increase in autoimmune disease. That's fact. That's science". Is that so ? On 14 February 1997 researchers at Tulane University said they
had developed a test (Anti-Polymer Antibody Assay, APA Assay) linking silicone breast
implants (SBI) to a new kind of immune system disease. The researchers, in an article in
respected British medical journal the Lancet, reported about a double-blinded study (153
women) which found 68% of SBI recipients, who were severely ill, were reactive on the APA
Assay. Women with breast implants could become allergic to the silicone in breast
implants. The APA Assay test provided objective proof. Dr. Robert Garry of Tulane
University said: "It's still being defined, but there is a disease out
there among some women with silicone breast implants". (Lancet, 1997, vol. 349,
no9050, pp. 449-454, Scott A Tenenbaum, Janet C Rice). That's also (another) fact, that's
also (another) science ?
http://cat.inist.fr/?aModele=afficheN&cpsidt=2567748
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=
PubMed&list_uids=9040573&dopt=Abstract
--
AWARENESS OF ANOTHER REALITY
Margo Cameron, founder of the Silicone Support Group UK, dedicated years of her life
raising awareness to the dangers of various silicone implants.
http://www.humanticsfoundation.com/margo-cameron.htm
HORROR OF BOOB OP VICTIMS: SUN EXPOSES BREASTIMPLANT SCANDAL
Mainly by the grace of her silicone breast implants ex-Baywatchstar Pamela Anderson had
become a Hollywood-phenomenon.
Star witnesses celebrity women: Pamela Anderson, Cher,
Sharron Davies, Paula Yates, Demi Moore, Brigitte Nielson, Anna Nicole Smith, Danni
Minoque, Ivana Trump, Joan Rivers, Dolly Parton, Nikki Diamond, Britt Ekland, Daryl
Hannah, Tori Spelling, Heather Locklear, Sophia Loren, Victoria Principal, Kate O'Mara
and Melinda Messenger.
(The Sun, UK, 19 february 1997 )
At last, it has finally happened, the foreign newspapers are beginning to pick up on
the horrid stories of silicone breast implant women. Margo Cameron of Glasgow,
Scotland has been a leader in the crusade for public awareness about silicone and its
dangers ever since she became ill after having silicone lip injections. Margo has boldly
spoken out even in the face of ridicule by doctors and amidst death threats.....
http://p102.ezboard.com/Horror-of-the-Boob-Op-Victims/fimplantinformationnetworkfrm1.showMessage?topicID=889.topic
--
DEGRADING WOMEN TO RABBITS
Shirley Goodner: Editor / Publisher of the Offical Journal United Silicone Survivors of
the World (USSW, February / March 1997 ): "Doctors
looked for ways to surpress the SYMPTOMS, rather than find a cure for the problem. Did it
never occur to anyone of them to call for a halt to implantation while they looked for
CAUSES to the problems ? The most oustanding piece of information about all these studies
is actually a total lack of information. Never - not in one study - was the woman
considerd as a human being, or for that matter even mentioned. In every case they talk as
if we were so many rabbits or mice and to be treated as such !"
--
1ST CLASS ACTION: DOW CHEMICAL TRIAL
Dow Chemical attempted to avoid a trial. But on 4 March 1997
Dow's request (for a summary judgment) was denied by State District Court Judge Yada
Magee. The claims of hundreds of women --including fraud, conspiracy, negligence,
responsibility for the product, and aiding and abetting manufacturer Dow Corning--
deserved a fair hearing in court. The first largest class action lawsuit ever against
silicone breast implant makers in the US going to trial in New Orleans, started on 27
March 1997. During this Spitzfaden trial, plaintiffs John O'Quinn said: "This
case is about values putting safety ahead of profit". Dow Chemical attorney Lorna
Propes replied: "The company never hid anything".
--
MAYO CLINIC: IMPLANTS INCREASE COSTS HEALTHCARE
Mayo Clinic researchers (Dr. Sherine E. Gabriel) --not looking at diseases linked to
implants-- published another study in the New England Journal of Medicine on 6 March 1997 involving involved 749 women in Minnesota who
had breast implants at the Mayo Clinic between 1964 and 1991. Up to 34% had complications
requiring more surgery within 5 years. There was a difference in complication-rate between
women with implants after mastectomy (1 in 3 ) and for breast enlargement (1 in 8 ).
Complications included among others infection and chronic pain. Breast cancer patients ''have
a serious underlying condition", Dr. Gabriel said, "In these women tissue
damage from the cancer surgery can contribute to trouble with the implants, and follow-up
chemotherapy and radiation can also affect the surrounding tissue". The FDA found
this Mayo Clinic study the first reliable estimate of how many women experience medical
problems serious enough to undergo additional surgery.
http://www.cnn.com/HEALTH/9703/05/briefs.pm/implants/index.html
http://www.sciencenews.org/pages/pdfs/data/1997/151-13/15113-14.pdf
# - "A Mayo Clinic study shows that 1 on 4
women needs more operations as a consequence of medical complications with their
breastimplants. These multiple interventions are not uncommen. These co-called localised
problems vary from bodily mutilations to chronic pains, rotting breasttissue and migration
of the implant from out of the chest-area. Salt water of ruptured implants also spreads
through the body, sometimes after they in the body have been infected with fungus (kind of
botulism)". ('Painful truths', Dutch supportgroup SVS's magazine 'De Stille
Kracht', 7th yr. september 2000, Nr 3, source: Command Trust Network West Los Angeles) http://www.thefreelibrary.com/Implants+almost+exonerated.-a015533190
# - Sybil Niden Goldrich (Command Trust Network):
"The choice facing women is either get those implants out or risk having them
break open inside your body. Had I known of all these terrible side effects, I certainly
would never have chosen to have implants put in. And almost every woman I speak to feels
exactly the same way". http://www.pslgroup.com/dg/1F866.htm
--
DOW CHEMICAL NOT LIABLE
On 20 March 1997 Wayne County Circuit Judge Robert J.
Colombo, Jr. in Michigan ruled that the Dow Chemical Company is not liable for the medical
problems of hundreds of women in the state. Michigan became the 3rd major jurisdiction,
joined California and New York, dismissing all silicone breast implant lawsuits (about 800
cases) in Michigan against Dow Chemical. Dow Chemical's general counsel John Scriven
applauded (the decision). Thus far, some state appellate courts have upheld Dow Chemical's
liability (a.o. New Orleans) and others have not.
--
DOW CORNING: SEEKING RAY OF STRAW
While legislation ---sponsored by Senator Joseph Lieberman and republican Senator John
McCain (US president candidate for the November 2008 elections) and pushed by medical
supply groups--- being introduced in both US House and Senate, at the urge of big
biomaterials companies (Dow Chemical, DuPont) to create liability protection for the
makers of biomaterials besides under certain circumstances of willful harm, on 7 April 1997 Dow Corning in it's Chapter 11 case filed a
motion with Judge Arthur J. Spector of the U.S. Bankruptcy Court objecting to
disease-based claims and requesting, as Dow Chemical earlier had done in the class action
Spitzfaden trial, a summary judgment about whether scientific evidence justifies claims
saying implants cause disease. Dow Corning was seeking separation of claims about local
complications and rupture from the more controversial claims implants cause disease. The
additional motions --requesting lumping expertise together-- that were filed by Dow,
concerned procedures involving the Bankruptcy Court, the District Court, and potentially,
the Judge Pointer appointed National Scientific Panel.
--
IMPLANTS: HEALTHRISK CHILDREN
In Dutch current affairs Tv-programme 'Netwerk' (15-04-1997;
bco AVRO) an interview with scientific researcher Douglas R. Shanklin: "from
recent study it appears that silicone breast implants stimulate the immune system to the
production of anti-substances. The more anti-substances, the more complaints",
"Children of these women have similar complaints".
# - Dr. Shanklin about silicone breastimplants and
children (28-06-1999 ): "A great number of women has come to the
realization that having children after having had silicone breast implants contains a
healthrisk for these children. It is in the mean time 5 years ago that in de medical
literature the first report about these disorders were published (Levine, et al., Swallow-
and Gullet complaints at children after breastfeeding with implants Med.Assoc.
271:213-216, 1994 ) More recent data point out that it is more likely that chemical
breakdown-products through the placenta-barrier is the main way of oversensitivity, at
which the not completely developed system of the foetus is affected (Smalley e.a.,
Immunobiol. 196: 567-574, 1996/97 ) Out of this the conclusion can be drawn that there is
at hand a chance of secundairy, re-newed stimulation of the immune system by breastmilk in
which organosilicon-substances are present".
--
CANADA: DOW CHEMICAL WINS
In Canada a different approach. British Columbia Supreme Court Justice Kenneth Mackenzie
in Vancouver ruled on 17 April 1997 that Dow Chemical
is to be excluded from a breast implant class-action lawsuit. Dow Chemical was not an
appropriate defendant. A significant victory for Dow Chemical.
--
TAXMAN PAYING FOR SILICONE
While earlier was known that the UK National Health Service paid for a woman's implants,
The People on 20 April 1997 reported that celebrities
get silicone from the UK taxman by claiming face -, breast -, and body 'lifts' against tax
for an estimated of £66 million pounds a year.
--
IMPLANTS NOT SAFE
(source: Magazine Dutch Support group SVS, 6the yr, Dec.1999, nr.4 )
A by the US National Institute of Health appointed panel of independent scientific
researchers comes to the conclusion that the sofar available epidemilogical study-results
are not sufficient to call the use of implants as safe. One asks for extra research,
especially into the a-typical influence of health-undermining symptoms as these have been
seen at women (Summary of the workinggroup a-typical rheumatic diseases and silicone
breast implant, april 1997 ).
--
IMPLANT CASES MERGED
10,000 women had opted out of the 1994 settlement: not joining the settlement On 8 May 1997 the US 6th Circuit Court of Appeals upholded its
April 1996 decision to unite about 10,000 pending state (70%) and federal lawsuits
(implants causing disease) nationwide against Dow Corning and give the cases to a court of
a federal judge (US District Judge Denise Page Hood) in Michigan. After Dow Corning had
filed for it's bankruptcy these lawsuits had been frozen when the cases were abstained
from handling by US District Court of the Eastern District of Michigan in Detroit. The
Appeals Court did not order the federal judge to handle litigation against other
manufacturers and suppliers of implants including 3M.
# - On 23 May 1997
an Albuquerque, N.M. jury ruled that 3M should not be held liable for allegations breast
implants caused health problems in a case involving Nancy Duke in the 2nd Judicial
District Court trial presided over by Judge Robert Thompson. The ruling in favor of 3M in
5 of 6 issues also found that 3M did not commit any misrepresentation.
# - Another trial concerning about 400 cases was one
step closer to the courtroom doors, when Oklahoma County Judge John M. Amick approved an
order outlining the process of selecting the plaintiffs and defendants. If proceeded to
the court system, it would be (beginning 1998 ) the state's first product liability case
concerning breast implants.
--
DUTCH DENIAL
In Dutch radio-programme 'Spijkers met Koppen' (24-05-1997
and 21-06-1997, bco VARA) of presentator Jack Spijkerman, a conversation with Marlou Boots
of the Dutch Support Group SVS about the harmful influence at later age of silicone breast
implants on the defence-system of the body. Also a conversation with a woman with
breastenlargement who denies the side-effects of silicone.
--
IMPLANTS: GOOD FOR ALCOHOL-USE AND SEX ?
End May 1997 researchers (Cook, Daling and Weiss) in
an article in the Journal of the American Medical Association (JAMA), about research on
3,750 women, stated that other researchers should include demographic, lifestyle,
reproductive and medical characteristics ("potential confounding variables")
in their studies to assess the safety of breast implants. The characteristics may
contribute to the risk of developing an illness. According to Linda Cook, Daling and
Weiss, women with breast enlargements were; nearly 3 times more likely to have 7 or more
alcoholic drinks per week, about 4.5 times more likely to have used hair dyes, nearly 9
times as likely to have had at least 14 sexual partners, and more than 1.5 times more
likely (although taking more birth control pills) to have been pregnant before age 20 and
more likely to have abortions. Such a stereotypical report would be more expected in a
Cosmopolitan magazine or some supermarket tabloid, the Milwaukee Journal Sentinel wrote.
Why publish such an article ? Why do such a study ? Linda S. Cook of the Fred Hutchinson
Cancer Research Center in a telephone interview said: "(leaking) implants
could be getting the blame for health problems caused by other risk factors". For
example, hair dye could increase the risk of connective tissue diseases. John Musser,
spokesman for Dow Chemical praised the Linda Cook-study: "It's important
research because it does pitch up the importance of other lifestyle factors in determining
one's health risks". http://jama.ama-assn.org/cgi/content/abstract/277/20/1612
--
CRITICISM ON THE LINDA COOK-STUDY:
# - Sybil Goldrich (Command Trust Network): "We
believe it would be an insult, not only to these women but to the authors of the JAMA
study as well, if self-serving parties were to use the JAMA study as a means for character
assassination".
# - The Linda Cook-study on 3,750 women had gathered
data from previous studies of women in Washington state, New Jersey and Atlanta and used
this data. Pamela G. Dowd: "The Linda Cook 'study' was based on 21
responses to certain questions (about abortions, implants etc.) on random phone calls.
This 'call center' study was called 'science' and came out at an important time for the
breast implant manufacturers. The call center was working from a list of names, derived
from a patient data base provided by doctors. It was impossible to know if the person on
the other end was who they said they were or if they had the medical problems they
claimed".
http://yukonmom47.tripod.com/id18.html
http://www.medkb.com/Uwe/Forum.aspx/breast-cancer/2113/
No-long-term-cancer-risk-seen-from-breast-implants
# - Co-author of the study was Janet Daling: an expert
witness for among others Dow Corning. Another co-author Dr. Noel S. Weiss was a consultant
to law firms representing implant manufacturers.
# - Linda Cook said: "You have to look
at these factors anew in every study that you do". In any study ? Had e.g. the
Mayo Clinic and the Harvard studies looked at these lifestyle-factors ?
# - Linda Cook's study did not mention if women with
silicone (from implants), and/or with other chemicals (from e.g. hair dye), in their body
(and which might bleed / migrate to the brain) which consequential could contribute to
certain lifestyle-characteristics, were more likely to commit suicide ? After a couple of
alcohol drinks on a dark night while having looked back in time: on terrible sex with a
few partners but still gotten pregnant despite birthcontol pills, and on a few abortions ?
# - At least the women with breast enlargements (of
the 3,570 study group women, 80 had breast enlargement) were much less likely to be heavy
in weight, were slimmer, Linda Cook mentioned in her study. A great comfort ? As smoking
cigarettes seems to have effect on the weight of people, maybe wanted to be slimmer (in
line with advertisements), the Cook-study might just give a motive / reason to seek breast
enlargement ?
--
- SILICONE TIME LINE
--
UK: INQUIRY SAFETY IMPLANTS
(Media-)Influences on behaviour and choices ? (Political) Choices based on correct and
complete ? Although UK's Health Department had twice said implants are safe, UK New Labour
health minister Lady Jay on 30 May 1997 ordered Sir
Kenneth Calman, the Chief Medical Officer, to start an inquiry into the safety of silicone
breast implants. Why ? Due to implant-criticism on an investigative Tv-show a day earlier.
BBC1's 'Watchdog Healthcheck' had conducted a survey and found that 73% of the women, some
appearing in the Tv-programme along with Dr. Douglas Shanklin, claimed not being given
proper advice (informed consent) on the risks before having surgery and having
side-effects in breasts, cheeks, chins and lips from silicone implants, and after rupture
silicone moving around the body. One woman from Glasgow, Scotland, Margo Cameron
had been told that the only way for removal of silicone in her lips was by amputation. As
some people find (belief) that chemotherapy is a (their) only way to battle breastcancer,
by which the patient consequently could make a choice based on the by the doctor awoken
fear (or false hope), because if the doctor sais it, it must be 'correct and complete' ?
Margo Cameron had been a leader in the crusade for public awareness about the dangers of
silicone. She spoke out, even when Hippocratical being ridiculed by doctors and amidst
death threats (because some did not belief what she believed). Margo Cameron traveled to
appear on radio and Tv programs in Scotland and England. "Scotland Sun exposes
breast implant scandal: horror of the boob op victims" (see above), The
Sun reported in February 1997. Lynn Malone, after viewing the medical records, was
convinced that her sister, Ann Clifford, died from silicone poisoning. Dr. Douglas
Shanklin agreed to study the case: "If she died from ruptured implants and
the medical records are complete, I should be able to tell straight away. I have been
studying silicone diseases for 12 years and it's almost guaranteed that women get silicone
poisoning from breast implants. Britain is 10 years behind America and I think it's
because most breast implants operations are carried out privately in the UK"
('The Story of Ann Clifford', The Herald, 31 May 1997 ). Lynn Malone was astonished that
no autopsy had been performed on her sister and she did not rule out the possibility of
having her sister's body exhumed if necessary, to do the autopsy, that should have taken
place at the time of her death.
AUTOPSY: DISTRIBUTION OF SILICONE
A study comparing women with and without silicone breast implants concluded: "that
organosilicon polymers routinely migrate from the site of breast implantation to regional
tissues near the implant site". ('Distribution of organosilicone polymers in
augmentaion mammaplastics at autopsy', Barnard J, Todd E., et al., Plastic and
Reconstructive Surgery, Vol 100, No.1, July 1997 ) http://cat.inist.fr/?aModele=afficheN&cpsidt=2738708
--
THE COMMON TRUST NETWORK
The actrices, two-times Oscar nominee Mary McDonnell ('Dances With Wolves',
'Passion Fish') and Gail O'Grady (NYPD Blue), created the national organization the
Common Trust Network to warn against unsafe implants. On 25 June
1997 a docudrama 'Two Voices' was broadcasted on cable's Lifetime channel:
silicone breast implants cause serious health problems.
--
IMPLANTS: OVERSTIMULATION IMMUNESYSTEM
Researchers of the Wayne State University, who guided an exeriment of siliconen effects on
the immunesystem of mice, said that they had found proof of overstimulation of the
immunesystem (Schaefer, et al, Arthritis and Rheumatism, June
1997 ). This information was in line with earlier evidence, originated from an
internal study of dow Corning. Of the four dogs at which in an experiment in 1970 silicone
was injected, one died and the other 3 developed a chronic inflammation which pointed to a
disruption in the immunesystem.
--
NATIONAL SCIENTIFIC PANEL NOT CONVINCED
End July 1997 the neutral expert panel National
Science Panel, NSP) of four doctors, among who Nancy I. Kervliet of Oregon State
University, had not been convinced by scientists testimonies seeking to prove a link
between implants and immune-system disease. The scientists testifying before NSP were:
Lu-Jean Feng (Case Western Reserve University http://www.drfeng.com/drfeng.asp
), John S. Sergent (Vanderbilt University), Anarnol Starr ( University of California at
Irvine) and Sander Greenland (University of California). The trial took place in
Birmingham, Alabama in the courtroom of U.S. District Judge Sam C. Pointer Jr. who
directed the panelists to give video-taped depositions.
--
1ST CLASS ACTION: MIGHTY DOW HAS FALLEN AGAIN
In August 1997 the New York Times reported that implant manufacturers have been winning
80% of cases against them. Dow repeatedly tried to prevent a jury from hearing the
evidence by filing more than 30 appeals. On 18 August 1997
in the nation's first class action silicone breast implant trial a Louisiana state court
jury in New Orleans found that the behaviour of Dow Chemical justified Dow Chemical being
brought to trial for the claims of the women. John Scriven, Dow Chemical general counsel:
"All this decision really means is that the jurors believe Dow Chemical's conduct
warranted moving to Phase II of the litigation. Nothing in this finding speaks to whether
Dow Chemical or silicone breast implants caused the illnesses claimed by the women. This
case should never have been allowed to come before a jury as a class action. Further, the
jury was unduly influenced by the improper courtroom tactics of plaintiffs counsel, such
as mischaracterization of the evidence and improper emotional arguments". Command
Trust Network: "In the largest silicone breast implant trial ever, the jury
has found Dow Chemical guilty of fraud and conspiracy for inadequately testing and
researching silicone breast implants, intentionally misleading women and doctors about
their dangers, and conspiring with subsidiary Dow Corning to market an unsafe
product". John O'Quinn, lead counsel for the women: "Three out of
three times juries have evaluated all the evidence and found the giant chemical company
guilty".Phase I of the five-month trial established the parent company's
culpability. Phase II will determine actual health damages caused to the 8 women
representing the class of more than 1,800 Louisiana women among who Faye Armond: "You
can't enjoy your grandchildren, because you're always so sore from the surgeries they've
done for you". Plaintiff Marilyn Spitzfaden: "My life has been
devastated by a product that was promised to last a lifetime. I praise the good Lord that
this company will not be allowed to get away with what it did to me and thousands of other
women". Implant-victim Peggy Musmeci of Metairie, Louisiana: "I'm
not crazy anymore. I have closure now. They've been proven wrong. That's the important
thing. The doctors we went to, they think we are nuts. This proves we're not nuts".
http://bankrupt.com/TCR_Public/970818.MBX
http://www.cnn.com/US/9708/20/breast.implants/index.html
--
DOW CORNING: NEW REORGANIZATION OFFERS
On 25 August 1997, bidding to get out of bankruptcy,
Dow Corning announced an new offer to settle the implant-claims: up to $2.4 billion as
part of a $3.7 billion reorganisation plan. Creditors and the claiming women had to
approve the deal. Or propose an own settlement or continue with their litigation. Houston
Lawyer Ed Blizzard: "The amounts of compensation appear to be
inadequate". On 17 February 1998 Dow Corning offered to pay $3.0 billion to women
who allege injuries due to defects in silicone breast implants. From the total fund, 50%
would go to women who settle, and the other half woud be for court-cases. $1.4 billion
would pay the remaining creditors.
--
IMPLANTS PROTECT AGAINST CANCER
While at least 20,000 Norwegian women having had silicone breast implants, the Western
Journal of Medicine released a study on 17 September 1997
reporting no evidence linking silicone breast implants with connective tissue diseases and
breastcancer. This Federal review of scores of medical studies by the National Cancer
Institute pointed out that the risk of breast cancer might be reduced among women with
implants. "More studies were needed". (Louise A. Brinton, S. Lori Brown, Journal
of the National Cancer Institute, Vol. 89, No. 18, September 17, 1997 ) http://jncicancerspectrum.oxfordjournals.org/cgi/reprint/jnci;89/18/1341.pdf
Also a Danish study found no evidence linking breast implants with increased cancer risk
(Søren Friis, Joseph K. McLaughlin, Et al., International Journal of Cancer, Volume 71,
Issue 6 , Pages 956 - 958, 1997 ). http://www3.interscience.wiley.com/cgi-bin/abstract/41905/ABSTRACT
LEAKING SILICONE "OMNI-PRESENT"
(Source: Dutch Supportgroup SVS's magazine, 6th yr, september 1999, Nr. 3 ).
# - "In a study (Brinton en Brown, Journal of
the National Cancer Institute, september 1997 ) of the
National Cancer Institute and FDA scientists (S. Lori Brown) posed is that leakage from
silicone is "omni-pressent", that "yet has to be determined how far the
unpleasant consequences of this stretches" and that there "has not been found a
solution yet" with reference to a-typical disease Further is being posed that the
epidemiological studies so far show shortcomings, by which it is not possible to rule out
the chance on systemic diseases on basis of this study".
# - "In a investigative report of Dr. Brown is
described how siliconegel had moved from the breast of a woman to her hand, where it had
caused pain, swelling, unfeelingness and lasting scar-forming (Brown e.a., Lancet, november 1997 )".
--
DOCTORS WARN: LEAKING BREAST IMPLANTS
While manufacturers of breast implants put rates of rupture at 0.2 - 1.1%, a study, a
summary of research studies, in medical journal The Lancet said that 5% of women can
expect to have both implants intact after 20 years and 51% after 12 years. Recommended was
that implants be removed after 8 years, the UK Telegraph reported on 21
November 1997. 95% of implants will break within 20 years.
--
PLATINUM LEAKING FROM INTACT IMPLANTS
"We have conducted a series of studies addressing the chemical composition of
silicone gels from breast implants......The rates at which both low molecular
(LM)-silicones and platinum have been observed to leak from intact implants could lead to
significant accumulation within lipid-rich tissues and should be investigated more fully
in vivo" (Lykissa ED; Kala SV; et al Baylor College of Medicine, Houston, Texas
77030, USA. Anal Chem, 69:4912-6, 1997 Dec 1 )
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=9406537&dopt=Abstract
http://cat.inist.fr/?aModele=afficheN&cpsidt=2171499
Dr. Michael Raymond Harbut (Wayne State University, Detroit) found that a type of platinum
used in implants could leach out, causing allergic reactions similar to those seen in
people who are exposed to platinum in the workplace.
--
PHASE II: CONFUSED JUDGE "NO CLASS ACTION"
Louisiana Civil District Court Judge Yada Magee on 4 March 1997 had ruled in the nation's
first class-action lawsuit over silicone breast implants against Dow Chemical that the
plaintiffs' claims deserved a fair hearing in court by which the class-action status was
upheld. But on 16 July 1997 the same Judge Magee suddenly ordered a mistrial in favor of
the Dow Chemical case by which the class-action status was withdrawn, because plaintiffs
lawyer had "irreversibly prejudiced the jury against Dow Chemical by repeated and
intentional misconduct in the courtroom". The lawyer for the women had socalled
used "improper eye contact" with jurors, and "inappropriate body
language" and other courtroom foolishness. Marcia Angell: Where's the science ?
But a day later (after a goodnight's rest) the same Judge Magee again reversed this
decision in favor of plaintiffs: upholding the class-action status. But on 2 December 1997 Judge Magee again changed mind and ruled
that only the 8 original plaintiffs could try to win damages from Dow Chemical. The 1,800
women in the class-action, along side with the 8, had cases too dissimilar to group into
one lawsuit, according to Magee. The 1,800 women, once part of the class, would not be
included in the damage phase (II) of the trial. Judge Magee: "There are
simply too many individual issues due to the fact that members of the class were implanted
with various types of breast implants, at different times in varying degrees and the
implants have caused different diseases", so that different legal standards had
to be used for each plaintiff. Mission impossible ? Plantiffs' lawyer Dawn Barrios
characterized the decision of Magee as a "procedural ruling". Dow
Chemical stated the 1,800 women could pursue their claims by accepting the new Dow
Corning's bankruptcy reorganization plan. Attorneys on both sides agreed that subsequent
breast implant lawsuits concerning thousands of women would lose their class-action
status. As a consequence of the state of mind on one single moment of one single
individual: Judge Magee, resulting in a 'diagnosis' from out of 'legal-atmosphere'
presented from a 'guru-position' as an 'unpeachable judgement' ? On 30 January 1998 the
Louisiana Court of Appeals for the 4th Circuit refused to consider Magee' decision by
Magee to remove the 1,800 women from the trial: the 8 women, who originally sued
Dow Chemical, would only represent themselves. But the decision would be appealed to the
state Supreme Court.
--
FDA APPROVE SILICONE INJECTIONS
Currently over 500 medical products contain measurable amounts of silicone. The FDA has
never approved the marketing of liquid silicone injections for any cosmetic purpose. But
long used without official sanction and then banned by the FDA, the FDA approved the use
of liquid silicone for medical use in 1997 to hold
detached retinas in place. The approval meant it could be used in other medical procedures
as well, for example in removing facial lines and scars.
--
FDA: PROLONGING BAN
In 1997 the FDA again looked at the implant-ban (since
1992 ) on the general sale and decided to maintain the ban for another 10 years because
there was still no adequate data available about the safety.
# Chronology: American Food and Drugs Administration (FDA) Activities related to Breast
Implants
1976 - 1998 http://implants.clic.net/tony/Myrl/Janvier/29.html
--
DOW CORNING SUED BY 18-MONTH-OLD BABY
In the UK lawyers were considering to file a case against Dow Corning on behalf of an
18-month-old baby who was suffering various diseases including allergies and digestive
problems suspected to be caused by mother' defective silicone breast implant; reported
Business Insurance (Carolyn Aldred) on 2 February 1998.
--
PETITION: EUROPEAN PARLIAMENT
With Schotland as coördinator, the different European Silicone Support Groups (England,
Scotland, Swiss, Germany, Belgium and the Netherlands) offered on 25
March 1998 a petition to the European Parliament, via Scotisch representative
Bill Miller: "I've been campaining for women with silicone poisoning for
years and we really need to raise awareness like this, I am aiming to petition Parliament
about this, I want a Europe wide ban on silicone implants and injections". http://europa.eu.int/comm/enterprise/medical_devices/meddev/2_5-7____07-1998.pdf
--
SILICONEN: ADVERSE EFFECTS
# - At a series of tests with lab-mice a team of
Baylor University found silicone in all researched organs. The researchers of Baylor wrote
in their report that they were worried about the "adverse biological effects"
(Leiberman e.a., American Journal of Pathology, March 1998
). http://ajp.amjpathol.org
# - Dutch Tv-presentator Sonja Barend let Robert
Schoemacher, Dutch doctor and director clinic for plastic surgery, come to word in Dutch
Tv-programme 'Barend en Witteman' (1 April 1998; bco
VARA) about the ethical and aesthetical sides of plastic surgery.
# - In April 1998
two large Scandinavian studies fail to show that silicone implants are linked to
neurological disease.
--
BIOMATERIALS: THE SHOW MUST GO ON
In the debate on the Biomaterials Subtitle of the Product Liability Bill, the Boston
Herald on 11 June 1997 had reported about 40-year-old Randy Markey. One of the first
people to have a silicone-coated brain shunt. But, as suppliers of silicone for shunts
running scared of liability lawsuits, the father of a 2-year-old also feared not being
able to get replacements: "I'm definitely afraid. My family depends on me.
Without the shunt, I'm dead". Concerned about potential biomaterial shortages,
threatening the health of patients who would benefit from biomaterial implants (e.g. heart
valves, shunts and orthopedic prostheses) and about threatening possibilities of research
that require biomaterials to create future new medical devices, U.S. Congress in July 1998 enacted the Biomaterials Access Assurance Act to
ensure biomaterials access for device manufacturers and those who develop implantable
devices, and to give biomaterials suppliers some shelter from liability lawsuits. (Issue
Paper: Biomaterials Availability: Potential Effects on Medical Innovation and Health Care,
Bruce Don, director Science and Technology Policy Institute, IP-194, January 2000, RAND)
--
THE IMPLANT BATTLE ENDS ?
On 8 July 1998 Dow Corning Corporation agreed to pay
$3.2 billion to settle the claims of the tens of thousands of women, to compensate 170,000
women worldwide who registered claims against them. Plantiffs still had to approve. Dow
Corning also filed motions, asking for dismissal of all the implant claims, before US
Bankruptcy Court (Judge Arthur J. Spector) in Michigan and also before Judge Pointer in
Alabama. Dow Corning lawyer Schoettinger: "This takes it a step further and
says the science is so clear that a causation trial isn't necessary". Before
deciding, these judges were waiting for the report by Judge Pointer's panel.
--
DOW CORNING KNEW: IMPLANTS CANCERRISK
After Dow's new settlement annoucement, Mark Christy of the Sunday Mirror reported that
Silicone Support UK accused Dow Corning of knowing for more than 30 years that implants
were a cancer hazard based on a copy of a Dow Corning 1965 report, marked "proprietary
trade secret" and obtained by the US Coalition of Silicone Survivors in the US
through the Freedom of Information Act. The report revealed Dow Corning was aware of one
woman who had developed cancerous cells as a result of silicone implants. Margo Cameron
(Silicone Support UK): "The report appears to prove beyond doubt that Dow
Corning knew all the time that their silicone implants were dangerous". Also Dow
found silicone danger in a 1975 study, Dow in 1975 warned its representatives that
newly-developed silicone implants were subject to leaking: "the study, had
it been made public in 1975, could have prevented the marketing of silicone implants by
being the first indication that an agent in silicone gel could harm cells of the immune
system" (Sandra Blakeslee, N.Y. Times, 7 April 1994 ).
--
UK INDEPENDENT REVIEW GROUP: IMPLANT INFECTIONS
In the UK, where 8,000 women seek cosmetic operations every year and 70% of breast implant
operations happen in private clinics, on 15 July 1998
the report of the by New Labour health minister Lady Jay ordered Independent Review Group
(IRG) on Silicone Gel Breast Implants was published, rejecting claims silicone breast
implants causing long-term sickness, no convincing evidence of a link with an abnormal
immune system response or with connective tissue disease. Thus no ban of implants in
Britain. Two earlier UK Government inquiries in 1992 and 1994 had reached the same
conclusion. But IRG called for stricter controls over the use since information given to
women undergoing breast implantation was often inadequate, (offensive, discounts)
advertisements had to carry "health warnings" (just like with smoking). The
report further recommended a "cooling-off period" for women to change their
mind. Because women were too quickly in thought and consequently in the acting influenced
by.....? And further the IRG-report recommened a voluntary national register, a specific
informed consent form to report any adverse side-effects to the Medical Devices Agency.
The IRG found that "more research was needed" into the possibility implants
causing infection, from the surgery, or being a later infection that "seeds" in
the area of the implant, said Roger Sturrock, professor of rheumatology at Glasgow Royal
Infirmary and chairman of the committee: "Low-grade chronic infection may
be associated with low-grade implants in some women, which leads to ill health, and we
need to keep this under review. We recognise that some women are unwell. The question is
why". F. Petit, D. Maladry et al, reported a case of breast implant infection, 40
years after augmentation (Ann Chir Plast Esthet., 1998 Oct; 43(5 ):559-62 ).
http://www.silicone-review.gov.uk/index.htm
http://www.silicone-review.gov.uk/silicone_implants.pdf
--
PETITION EUROPEAN PARLIAMENT
The petition offered to the European Parliament with the support of Glasgow MEP Bill
Miller (25 March 1998 ) was (at first) turned down by the European Commission after the UK
Independent Review Group (IRG)- review found no evidence to link silicone implants with
illness. Margot Cameron (Silicone Support Group UK) called for the resignation of New
Labour Lady Jay, calling IRG's review "a total farce". While the implant
makers, all denying liability, say science has not found a link between the implants and
disease supported by statements from several medical associations and the governments of
Britain, Germany and Australia, (where there is no implant-ban), Elaine Coomber,
the founder of Survivors of Silicone, Breast Implant Support Group, who had serious side
effects (pain, swelling in arms and joints, partial blindness, dizziness, fatigue) just 3
years after she received her implants in 1976 and eventually ended up with lumps of
silicone being removed from her neck and arm, and multiple sclerosis said: "They
should look at the evidence of other countries that have banned it and be honest with
us". Remembering the old joke about the drunk looking for his money under the
lamppost because that's 'where the light is' ?
--
GO QUACKBUSTERS ! COWBOY CLINICS
From the UK Independent Review Group (IRG)-report it also appeared that many commercial
clinics employed doctors without specialist qualifications in plastic surgery. Quackery in
regular "cowboy" clinics ? In the US, Florida in 1998
became known (by investigative journalist Fred Schulte and writer Jenni Bergal in
'Cosmetic surgery: The Hidden Dangers') that 34 people died, of which 13 since 1997, older
people with healthproblems, who had undergone several cosmetic operations in
private-clinics. The research made a final place for the Pulitzer Prize and it won a
'Gerald Loeb Award' and the 'Clark Mollenhoff Award' for excellent 'Investigative
Reporting'.
--
SEARCHING FOR 'ALTERNATIVES': HUMAN ENGINEERING
While in the quest for the movie-star perfect face and the perfect body, in the pursuit of
perfection along the endless road of plastic surgeons, CNN reported in the City of Angels
about plastic surgeons saying medical advances over the past five or 10 years have made it
possible to replace almost any part of the body. Media-influence ? In July 1998 at the yearly conference of the British Medical
Association a motion was taken on by the large majority to condemn media's obsession with
superthin models (e.g. Kate Moss). It promoted disorders in eating-habbits and anorexia.
--
CONFERENCE: INSTITUTE OF MEDICINE
(Source: Dutch Supportgroup SVS, Report of the Conference of the Institute of Medicine
about the safety of silicone breast implants, July 1998
)
Women ("silicone survivors") presented their stories, about the changes
breastimplants brought into their lives, at the Institute of Medicine (IOM) in Washington,
D.C. on 24 July 1998 on the last day of the 3-day
scientific meeting as part of an independent study about safety of implants, which would
at least last another year. For example Merry Grant of Metairie: "You
want to know why I came here ? I'll tell you why I came here. 'I hurt all the time. I burn
all the time. We need research and I'm asking you to help us, because I am dying one day
at a time". Also Dow Corning scientists testified. In contrast with the published
(media)news about the safety of silicone breastimplants:
# - Dr. Lu-Jean Feng (Case Western Reserve University
clinical researcher) admitted during a presentation before the Institute of Medicine that
in a study 60-70% of the cases within 10 years there is a matter of rupture, confirmed at
explantation. Dr. Feng uses ultra-sound diagnostic tests to discover holes in the envelop
of implants.
# - During the same meeting University of California
research radiologist Dr. Michael S. Middleton (UC San Diego) reported that by means of
MRI-scans (magnetic resonance imaging) it was determined that at 50% of the implants,
within 10 years after implantation, there was a matter of rupture. In the largest
study-group research for rupture-research (1,300 women). Dr. Michael Middleton, with help
of MRI, found a nearly 100% rupture rate for older implants with polyurethane envelops and
an average-out rupture rate of 35% for all implants. Dr. Middleton testified in
breastimplant lawsuits on order of the court under subpoena. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=9622095&dopt=Abstract
# - The prominent National Cancer Institute
epidemiologist Dr Louise Brinton posed in fornt of the scientific panel that studies, of
which in general was assumed that they cleared breast implants of any blame, were
statistically too limited in size to be able to exclude the possibilities of diseases
occuring.
# - Dr Lightfoote, assistent-director attached to the
Center for Devices and Radiologie Health of the FDA, reported that from her researchwork
appeared that silicone act as a katalysis at immuunreactions with animals.
--
LAWSUIT AGAINST THE FDA & PLASTIC SURGEONS
On 25 July 1998 nurse and president of 'Toxic
Discovery Network', Kathy Keithley Johnston, announced her group had filed a
class-action lawsuit in Federal court in the District of Columbia against the FDA and the
American Society for Aesthetic Plastic Surgery. Because surgeons --"breaking all
moral and ethical codes"-- Hippocratical failed to inform patients and the FDA of
the dangers of implants. The FDA still permited implants to be used on an experimental
basis. Implants had to be banned entirely, found Toxic Discovery Network. (Absolutistic)
Reaction of the President American Society of Plastic and Reconstructive Surgeons Dr. C.
Lin Puckett: "There is an impressive body of evidence 'that would tell us
that these implants are safe systemically".
--
LINK SILICONE - UNUSUAL SYMTPOMS
Two by the industry funded researchteams had found evidence that there was a link between
the presence of silicone breastimplants and the prevention of unusual symtpoms. A team of
the University of Michigan reported that at women with silicone implants the chance on the
prevention of "not to be differentiated" connective tissue symptoms was 3x as
high as at women without implants. A team of the University of Galgary came to the finding
that there was a matter of a high average of "periphere" neuropatic (=the sum of
brain- and spinal marrow nerves), cognitive disfunction and myalgy at women with breast
implants (Schottenfield e.a., Summary presented at the meeting of the American College of
Rheumatology, October 1996, and Edworthy e.a., Journal of Rheumatology, 1998 ). Also a
team of UCLA came to the same last finding (Greenland en Finkle, Annals of Epidemiology, July 1998 ).
--
TUE LIES: HUMANITY
Futures analyst Prof. Ziauddin Sardar: "...The most famous line in George
Orwell's 1984 reads: 'Who controls the past controls the future; who controls the present
controls the past'. This formula is slightly out of date. Today, who controls the fake
controls reality and thus controls the past, the present and the future. In our postmodern
world, fakes and simulations have grown so large that they entirely cover the things they
imitate. The culture of imitation, of fake bodies, fake reality, fake commodities, fake
history, is all about control. Unlike the real which is unpredictable, unmanageable and
therefore uncontrollable, the fake is totally predictable and manageable, thus so much
easier to control. And, it seeks to control all those things that we value most in
ourselves - our Self, our identity, our bodies, our imagination, all that makes us human.
The only size that matters is the size of our humanity. We ought to remember this, the
next time we ogle at a fake breast" ('True Lies', The Herald, 31 October 1998 ).
--
SURGERY FOR TEENS ? "NO PROBLEM"
In the UK Caroline Sigley (The Birmingham Post) reported that a 12-year-old girl would be
the youngest to receive breast implants, and in November 1998
the 11-year old girl Jamie-Lee Mason for BBC's programme 'Here and Now' undercover
visited a private-clinic in London for a nose-operation. A consultant, although no surgeon
or medical qualified appeared afterwards, did a free research ('making a diagnosis') and
discsussed the possible treatments. Surgery was not a problem at all. In January 2001 a
surgeon stated that he would not conduct a breast enlargement which was promised by a
mother to her daughter as a gift for her 'sweet sixteen' 16th birthday. http://news.bbc.co.uk/1/hi/health/1101015.stm
--
AGREEMENT ON DOW SETTLEMENT
On 9 November 1998 Dow Corning and the women with SBI
claims (respresented by the Tort Claimants Committee) jointly --with a helping central
role of federal mediator Francis McGovern-- filed with the U.S. Bankruptcy Court the
details of the $3.2 billion settlement, part of a $4.5 billion plan, Dow Corning had
offered begin July 1998. The ageement allowed that Dow Corning would get out of bankruptcy
procedures and that the plaintiffs should receive their money within a year. According to
the plan / agreement, woman had 3 choices / types of payments. Those who want to cash-out
immediately and not file a disease claim will be paid $2,000. This figure can also be
combined with $5,000 for implant removal surgery and $20,000 for a ruptured implant. Those
who have already filed a disease claim will receive between $10,000 and $25,000 plus any
compensation claimed for removal or ruptures. Before filing for Chapter 11 Dow Corning had
a short-lived Implant Removal Program. Now this offer was the first time Dow Corning
agreed paying for implant removal since filing for bankruptcy. Sybil Niden Goldrich
(Command Trust Network, Tort Claimants Committee): "That's what most people
have been waiting for", "We need to get our implants taken out", "We
know that over 70 percent of these implants rupture". In a speech to the Midland
Noon Rotary Club Dow CEO Richard Hazleton said his research indicated ruptures occur in
about 5% of people with implants. Woman not accepting the agreement could still sue Dow
Corning. The settlement was dependent on the approval of 2/3 vote of the 170,000 women who
filed claims and U.S. Bankruptcy Judge Arthur Spector had to confirm this
settlement-offer. Disagreement between the parties remained about whether there could be
or should be a causation trial.
--
REPORT NATIONAL SCIENCE PANEL
http://www.fjc.gov/BREIMLIT/SCIENCE/summary.htm
On 1 December 1998 a by the implant manufacturers
welcomed report appeared from Judge Pointer's National Science Panel (NSP) of 4 scientists
about a study of the scientific literature: "the main conclusion that can
be drawn from existing studies is that women with silicone breast implants do not display
a silicone-induced systemic abnormality in the types or functions of cells of the immune
system". An unanimous (not legally binding) conclusion: no definite links between
implants and diseases, claims implants causing disease were not supported by the available
scientific evidence in four major areas: toxicology, immunology, epidemiology &
rheumatology, thus the report.
# - Sybil Niden Goldrich (Command Trust Network)
faulted the NSpanel for not looking at the medical records of women who have filed suit
over their implants: "Nowhere in the report does the Pointer panel say that
silicone is safe in the body. The essential question still has not been resolved: Why have
so many thousands of women been struck with joint pains and neurological disorders and
other health problems after receiving breast implants ?"
# - Michael W. Liberman, M.D., Ph.D., Department of
Pathology, Baylor College of Medicine, Houston: "I would like to call
attention to several important studies from Baylor College of Medicine that I believe have
received insufficient attention from the panel Judge Pointer and one that is scheduled to
be published in April that the panel has not yet seen...(...)...Let me conclude by noting
that I believe there is significant evidence that components of breast implants are highly
toxic and may cause serious health effects" (Press Conference, called by
Congressman Gene Greene, remarks 12/1/98 ).
# Congressional record articles, 1997 - 1998
http://thomas.loc.gov/cgi-bin/query/r?r105:@phrase(breast+implant
)
--
CHARLOTTE MAHLUM -Vs- DOW CHEMICAL
In December 1998, Mahlum-vs-Dow Chemical, Reno. After
two years, the panel of four independent experts appointed by Judge Sam C. Pointer
concluded that scientific evidence so far failed to show that silicone breast implants
cause disease. The Nevada State Supreme Court overturns the earlier awarded (31 October
1995 ) $10 million for punitive damages. But the Supreme Court upholds a compensatory
damage award of $4 million against Dow Chemical to Charlotte Mahlum for her
multiple-sclerosis-like symptoms: "Dow Chemical had a duty to ensure the
safety of Dow Corning's implants". Dow Chemical was earlier found liable for
helping Dow Corning conceal evidence about the harmful effects of silicone. http://caselaw.lp.findlaw.com/scripts/getcase.pl?court=nv&vol=114nvadvopno155&invol=2
# Nevada's Supreme Court upholds Junk Science
(Lemon Tort, Nevada Journal, Vol.7, Nr.4, April 1999, by D. Dowd Muska)
http://nj.npri.org/nj99/04/feature.htm
--
LAWYER BRENDA MEISTER -Vs- MEC
In December 1998 Lawyer Brenda Meister was awarded $10
million in compensatory damages by a Washington Federal jury. In 1977 Meister had received
implants, from manufacturer Medical Engineering Corp (MEC), which started to leak and
caused scleroderma. Testimony was given by Meister's treating rheumatologist, who never
had testified in a breast implant case before. In 1991 the implants were removed. MEC was
acquired by Bristol-Myers Squibb in 1982. During the Meister's trial the report of Judge
Pointer's National Science Panel was released, but Meister's lawyer, Robert Weltchek said
the jury's verdict was "compelling".
--
THE BREAST IMPLANT FIASCO
David E. Bernstein http://papers.ssrn.com/sol3/cf_dev/AbsByAuth.cfm?per_id=51817
, who's 'gate-keeper' writing was part of Dow Corning's May 1995 newspaper advertisement
package, wrote in 1999 the article 'The Breast Implant
Fiasco' (George Mason University - School of Law, California Law Review, Vol. 87, No. 2,
pp. 457-510, March 1999 ), a review essay of Marcia Angell's Science on Trial, in which
Bernstein claims that Public Citizen, which released internal Dow Corning documents
showing a link between silicone and cancer in animals, actually played a critical role in
heating up the fire of the breast implant controversy.
--
DANGERS OF CERTAIN DOCTORS UNDERSTATED ?
Dr. Elizabeth Connell wrote (7 February 1999 ) in the
Washington Times (Forum): "Dangers of silicone are overstated,
overhyped". Reaction of Ilena Rosenthal ('Women with implants are not
faking symptoms for cash', 25 February 1999, The Washington Times), Director Humantics
Foundation for Women: "Dr. Elizabeth Connell' disinformation failed to
mention her long term association with former TASSC (The Advancement of Sound Science
Coalition) which used to be located in the offices of the Dow's PR company APCO and whose
purpose was to disseminate industry press releases and viewpoints such as hers. This
campaign defaming all doctors and scientists who dare to report their findings on the
damage to women's bodies and immune systems by calling them 'junk scientists' is well
planned and financed by the silcone giants. To imply that hundreds of thousands of
implanted women are faking serious autoimmune symptoms and removing their ruptured
implants at the whim of plaintiff attorneys is preposterous. Dr. Connell's myopic review
of the science of implants gives false assurances to millions of women with leaking and
ruptured implants. It is now known that up to 95% of implants will break within 20 years
(Lancet, 11/22/97 ) often requiring multiple invasive, disfiguring surgeries. As of
9/10/98, 127,500 women reported serious adverse reactions from silicone gel implants".
http://www.BreastImplantAwareness.org
--
BREAST IMPLANTS KILL MICE
Begin February 1999 scientists found that the silicone
used in breast implants could kill mice. Also silicone could leak from an intact implant
increasing fears that the devices put women's long-term health at risk. http://news.bbc.co.uk/1/hi/health/277602.stm
In a study by Michael W. Lieberman, Ernest D. Lykissa was found that silicone can migrate
out of breast implants and be widely distributed in many organs: "These
mice developed inflammatory lesions of the lung and liver....". http://www.ehponline.org/docs/1999/107p161-165lieberman/abstract.html
--
HERE COME THE DOWS AND THEIR ERRANDBOYS
Dow Corning started a PR campaign: making the public believe that there is zero, no
evidence whatsoever that their previous cash cow, silicone, causes harm. It resulted,
through their intricate and expansive network (Dow's errandboys), in several articles
about "Poor Dow" and "Generous Dow" in the media: the
gate-keeper between untruth and truth. On 15 March 1999
Dow Corning's bankruptcy division began mailing a couple hundred thousand implant
recipients a settlement offer for their vote because 2/3 of the votes were needed for
approval of Dow's settlement-offer.
--
TEEN BREASTENLARGEMENT POPULAR: BRITNEY SPEARS
In March 1999 the English BBC reported about a
research: surgery was increasing in popularity, 1 on 3 UK-women considered an
operation. Thighs like supermodel Naomi Campbell or breasts as glamour model Melinda
Messenger (Horror of Boob op Victim). A day later Dutch current affairs Tv-programme 'Twee
Vandaag' (bco TROS) reported about the increasing number of American teenagers dat has
treatment: "Popular are a.o. breast enlargement. Will one have regrets ?
Exaggerated obsession towards perfection ?". In 2000 it is reported that
superstar teen idol Britney Spears, at age 17, would have had breast augmentation surgery
in 1999 ('Britney is 18 but she's already had Breast
Implants and there are plenty of other young Americans queuing to go under the knife', The
Scotsman, 28 January2000, Chrissy Illey). Britney Spears denied the reports ('Britney's
Wild Ride', People, 14 Febr. 2000 ).
--
TRILUCENT-IMPLANT: POTENTIAL RISK
PRECEDED:
# - Until 1 July 1994 50 European patients had taken
part in a Trilucent 'clinical evaluation programme'.
# - Begin August 1994 it was annnounced that 50 US
women would get an experimental Trilucent implants in the first US-pilot study: an
41-year old was the first 'lucky' US woman on 14 February 1995.
# - In 1995 the Collagen Corporation (LipoMatrix Inc.)
wuth soya oil filled Trilucent implants, promoted promoted as á 'natural' alternative for
silicone, came onto the European market. Also in the Netherlands.
# - In England the Trilucent was introduced by the
media in September 1995.
# - In February 1996 the first 3 Canadian women
received a Trilucent.
# - In May 1996 Dr. Pierre Comte was named Corporate
Officer of the Collagen Corp (employment contract http://www.socratek.com/Agreement-Details.asp?num=425958
) and Chief Executive Officer of Collagen Corp.'s 100% owned (1997 ) subsidiary,
LipoMatrix Inc.: the new venture which Pierre Comte started in 1995 and the maker of the
Trilucent(TM) soybean oil-filled breast implant. Today Dr. Pierre Comte is founder and
chairman Switzerland's Sigma Professional: consulting and coaching services based
on Value Creation, a strategic tool to develop sustainable growth plans. http://www.startupcafe.ch/cv/CV_Pierre_Comte.htm
# - "Finally, The Ideal Breast Implant",
was the title of an Trilucent-article in Cosmopolitan (Sally Ogle Davis) on 1 April 1997.
# - Researchers reported on a meeting (May/June 1997 )
of the American Society of Aesthetic Plastic Surgery that a breast implant made from
soyabean oil, which masked x-rays, then was going into it's final researching studies.
# - For the receival of regulating approval, the
Collagen Corp. made known on 8 April 1998 http://www.businesswire.com/cnn/cgen.htm
that it will get rid of it's daughter LipoMatrix, producer of the Trilucent, to be able to
concentrate more on it's core business. Gary Petersmeyer, president and CEO of Collagen
Corporation: "We are pleased with the safety and efficacy of the Trilucent
breast implant in clinical studies and in the marketplace. Alliant Partners of Palo Alto,
California, has been engaged to assist us with this divestiture, which includes the
Trilucent implant technology, marketing rights and know-how", "We take our
responsibility to our physician customers and their patients throughout the European
marketplace and in the U.S. clinical setting very seriously, and we will continue to
provide the same dedication and support to this product as we move into this new
phase".
# - Lipomatrix in November 1998 was bought by Sierra
Medical Technologies.
# - In 1999 Dr. S. Montrey (Department of Plastic
Surgery, University Hospital in Belgium) published a report 'Biocompatibility and
Oxidative Stability of Radiolucent Breast Implants'. The report showed that when soya
implants leak, peroxyde are being formed and form in the body poison.
--
TRILUCENT-IMPLANT: POISON-WARNING
While the UK health minister Lay Jay's Independent Review Group of experts in July 1998
yet had concluded that there was nog convincing evidence of a link between implants and
disease, the English government (Department of Health) in March
1999 took a type of breast implant (Trilucent) of the market, out of sale. A
type which a few individuals (and consequently a.o. 5,000 UK women) until than had lived
(were brought) in the delusion and believed (were made believe) that they were 'safe'.
Some women had in the past had 'unsafe' silicone implants removed and just replaced them
with the 'safe' Trilucents. Elaine Coomber (Survivors of Silicone): "I
had silicone implants taken out after 21 years and I was told that these were a good
alternative". She had felt certain at, and had put faith into the advice of, her
plastic surgeon. False hope. The Trilucents were, according to Dutch Supportgroup SVS
noiseless taken off the market (recall) after women had gotten health complants to prevent
unnecessary panic ('social unrest'). More than 74 cases of "adverse effects"
(leakage, rupture, inflammation, swelling) were reported at the UK's Medical Devices
Agency. Anecdotical evidence ? Plastic surgeon Ruth Waters said that there is no such
thing as a safe implant. Not in reality, only in the mind / fantasy of a few individuals
driven (´negatively influenced´) by $$$ signs ? Amanda Cameron (Collagen vice president)
and Allen Andrews (president Lipomatrix): "While we are confident of the
safety of the product, we have fully co-operated with the Medical Devices Agency".
The UK Health Department said it hadn´t known, denied blame: "We had
nothing to do with the authorisation of this product". Could have or should have
to do with, known in all (legal) responsibility, reasonability and fairness ? David Sharpe
(professor of plastic surgery at Bradford Royal Infirmary): "The problem is
the way the oil breaks down. In some cases it has produced an emulsified product like
yogurt at the site. It has not dispersed". Producing 'biologically active
substances'. Jeremy Metters (the deputy chief medical officer) said: "Not
enough is known about the long-term safety". The government decided that
"more research was needed". A 24-hour hotline was put up and advised was to not
use the Trilucent implants: "It is prudent to stop more women being exposed
to any potential risk". A private clinic in Birmingham started to write the women
whom had the breast implants in their center.
--
- SILICONE TIME LINE
--
POINTER´S NATIONAL SCIENTIFIC PANEL WAS TAINTED
While actress Pamela Anderson Lee announced (Entertainment Tonight) having her implants
removed to return to a more natural state for personal, not health, reasons, a motion was
filed on 13 April 1999 in a federal court by the
Silicone Gel Breast Implants Products Liability Litigation to terminate the Judge Pointer
court-appointed National Scientific Panel (NSP), which evaluates the safety of silicone
breast implants, and to invalidate its findings. Why ? Conflict of interest by one of the
four scientists of the NSP. Dr. Peter Tugwell, a rheumatologist at the University of
Ottawa, failed to disclose a series of financial and professional relationships with
pharmaceutical firm Bristol-Myers Squibb which was a defendant in implant litigation. The
National Science Panel thus wasn't neutral, while around installation of the NSP the mass
public was made belief that the NSP would exists of 'neutral scientific experts' who would
be "available to advise judges and juries around the country on the scientific
evidence surrounding the implants, which has been sharply divided" (3 June 1996,
Wall Street Journal). Dr. Peter Tugwell, as a paid consultant, earned $1,500 a day from
the pharmaceutical firm. At the same time serving on the 'neutral' NSP and agreeing to
conduct a clinical trial for drug maker Bristol-Myers Squibb on rheumatoid arthritis
therapy. While the thousands of implant-victims are accused of having diseases linked to
implants 'between the ears', one can assume that a 'well-educated' doctor acts awarely.
Dr. Peter Tugwell: causial mixed-up priorities 'between the ears' consequently
resulting in deeds and choices ? Dr. Peter Tugwell also advised another doctor who
conducted an industry-funded silicone breast implant study that was favorable to the
manufacturers' position. Taken into account the words of NEJM editor Marcia Angell in her
1996 book 'Science on Trial' about "the scientific method always being the
superior, if not in fact the only approach", Sybil Goldrich (Command Trust
Network) said: "It's time to eliminate the influence of industry money on
the scientific process. The trustworthiness of the scientific community is at stake. So is
the health of thousands of women. I don't know where the women are going to go to get
answers now".
--
IMPLANTS REMAIN OFF MARKET
In Spring 1999 silicone-gel-filled implants remain off
the market in the U.S. pending manufacturer safety studies. They are available only to
women who have had or will have breast surgery for a medical condition or have other
complications from existing implants, and only if they agree to be part of a scientific
protocol, or study. But end 1999 the FDA would reconsider its ruling against silicone
breast implants: silicone implants might soon be back on the market (Houston Chronicle, 5
December 1999, Eric Rosenberg).
--
DOW'S JOINT PLAN OF REORGANIZATION
Thousands of women had settled in Dow's new offered settlement, or withdrawn their
lawsuits, based on, after the 'objective' report of the National Scientific Panel
(December 1998), estimated Robert Gordon, an attorney with the Plaintiff Steering
Committee which represented women with silicone breast implant and other product liability
claims. On 1 June 1999 Dow Corning and the Tort
Claimants Committee announced the Joint Plan of Reorganization had been accepted by women
with claims related to silicone breast implants. More than 300,000 votes were made on the
plan for all categories of claims. The majority (94%) of those voted in favor of the plan.
--
SBI STUDY: INSTITUTE OF MEDICINE (IOM)
On 21 june 1999 the Institute of Medicine (IOM) --a
private federal advisory panel, part of US's most prestigious scientific organization.the
National Academy of Sciences and from which former Dutch minister of Health (1994-2002 )
Els Borst in the present still is a member of-- published (Mass Tort Litigation Reporter,
June 1999 ) an analysis, evaluation study of evidence linking silicone breastimplants with
health. Also this IOM-study, like the one from NSP, did not find evidence of an
association between breastimplants and increased risk on cancer or connective-tissue
disease. Implants being still a big risk but not a cause of killer diseases, thus the
IOM-report. "No 'unique disease syndrome'. No increase in breast cancer. No
increase in connective tissue diseases, cancer or neurological diseases. No evidence of
elevated silicone in breast milk", CNN reported. Congress had asked the National
Academy of Sciences / IOM to set up the committee to do the study. The committee chaired
by Stuart Bondurant did not conduct any original research; they examined past research and
other materials, and conducted public hearings to hear all sides of the issue. The
IOM-report of 400 pages, prepared by an independent committee of 13 scientists, concluded
that although silicone breast implants may be responsible for localized problems such as
hardening or scarring of breast tissue, implants do not cause any major diseases such as
lupus or rheumatoid arthritis. Further IOM concluded that, in its review of over 50 years
of toxicology studies and industry reports, the studies of individual substances found in
breast implants, demonstrated no significant substance toxicity. The report said implants
could cause localized problems in the area of the implant: hardening of breast
tissue, leakage, rupture and infections.
# Institute of Medicine: Safety of Silicone Breast implants
1999 - "...Human adjuvant disease is not a defined disease, and the term should be
abandoned...", "..The committee concludes that a review of the toxicology
studies of silicones and other substances known to be in breast implants does not provide
a basis for health concerns..." http://books.nap.edu/html/silicone_safety/
--
CRITICISM ON IOM-STUDY
# - Media: Diana Zuckerman (National Women's
Health Network): "This report says in a new and very strong way that there
are many serious problems with breast implants that aren't the ones that have been in the
media".
# - 'How Scientific is Scientific ?', dr. Diana
Zuckerman thought (SVS's magazine 'De stille kracht', 8th jr., December 2001, Nr. 4 )
after reading the IOM-report: "5 of the 20 studies were not published in
medical magazines. They were presentations on scientific gatherings or non-published
doctoral thesises. Just 6 of these studies looked at the A-typical
connectivetissuediseases or fibromyalgy-like symptoms which so many patients report. The
biggest of these studies found a remarkable higher risk for women with implants compared
to the controle-group. Just one of the studies was based on a medical study. Factual all
these studies were about women which often very recently had implants, just a few months
or years. One of the most 'praised' studies, the Harvard Nurse Study, had even included
women who just had implants a month. And another study contained just 250 women who had
implants since 30 months average. This overview of earlier studies of IOM underlines the
insight that most women do not become ill from the wellknown autoimmune sicknesses after a
short period. Thus: No answer on the main question !" http://www.center4research.org/iom1.html
# - Edward A. Luce, MD, FACS (President,
American Society of Plastic Surgeons): "In May 2000, the IOM concluded,
'Evidence clearly shows that silicone breast implants do not cause breast cancer'. It also
reported: 'There is no evidence that silicone breast implants contribute to an increase in
autoimmune diseases'..
# - Diana Zuckerman, Ph.D: "Two
National Cancer Institute studies found that women with silicone or saline implants were
at increased risk of dying from brain cancer, lung cancer, or other respiratory disease.
These women had a 21% increased risk of cancer, compared to women in the general
population. These NCI studies were published after the IOM report so they were not
included". http://www.center4research.org/bi040802.html
# - Dutch Supportgroup SVS: "The IOM
report shows that implants do not live a lifelong, but did not draw a conclusion out of
the high rupture-percentage. MRI-scans showed that silicone floated around outside the
breast at 21% of the women who had ruptured implants, even if those women had not sought
treatment for the problem".
--
- SILICONE TIME LINE
--
BOOK: SILICONE NIGHTMARE
In 1977 the very first lawsuit had been filed against Dow Corning for faulty implants. Dow
Corning was thus aware problems with implants could occur. Book 'Silicone Nightmare' (14 July 1999 ): The Dow Corning corporation was
considered one of the most ethical and progressive corporations in the world with a code
of conduct that was cited as a model in case studies by business schools. In the 1977
version of this code, the company agreed that, "Dow Corning accepts as our
responsibility a recognition, evaluation and sensitivity to social needs. We will meet
this responsibility by utilizing our technological and management skills to develop
products and services that will further the development of society......". http://bart.tcc.virginia.edu/book2/chapter4sec7.htm
--
THE GOLDEN COSMETIC INDUSTRY
In April 1999 a 25-year old fitness instructor died as consequence of liposuction in a
clinic in California: blood poisoning. 'All as Reborn', headed Dutch newspaper 'De
Telegraaf'on 24 July 1999: "The cosmetic
industry is a golden industry. Not for nothing the most plastic surgeons drive in big
expensive cars and live in huge houses. An average treatment costs 10,000 Dutch gildens,
yearly a small 1000 operations are conducted. A simpel sum in arithmetic learns that it is
about a turnover of 10 million Dutch gildens and that is just a part of the market. One
could imagine that many customers do not see the forest through the trees anymore. The
Netherlands in the meantime counts about 15 private-clinics". The Netherlands was
before this industry an uncultivated territory because the Netherlands for years was
closed for any kind of private healthcare.
--
DOW CHEMICAL EXPANDING
Begin August 1999, for $11.6 billion Dow Chemical
takes over Union Carbide: the chemicals group known for its role in the world's worst
industrial accident in Bhopal, India (6,500 people dead and 50,000 injured). The merger
created the world's second-largest chemical group behind DuPont.
DOW CORNING LIES AGAIN: MASS KILLING
The Dow-Union Carbide Facilities worldwide - "...From the Hawks Tunnel silicosis
disaster of 1930 to the Vinyl Chloride cover-up that began in 1954 and lasted fifty years,
taking in along the way Hiroshima, napalm, dioxin and Bhopal, Local communities, beware,
if you live near or work in a Dow-Carbide chemical plant, you are in great danger of being
poisoned, just as the people of Bhopal were. If you are a Dow investor, you were shaken by
the asbestos liabilities inherited by Dow from Union Carbide. They are nothing compared to
what is to come. You should know the following: when Dow took over Union Carbide, it
declared that there were no outstanding criminal charges against the company: as a court
in Bhopal affirmed last month, that is a lie.....1930: Hawks Tunnel silicosis disaster,
2000 dead, mostly black workers who died of silicosis. Some buried in mass graves to try
to hide the deaths. It was Union Carbide's first experience of mass killing....".
http://www.bhopal.net/oldsite/dow-watch/index.html
--
STUDY EUROPEAN PARLIAMENT: STOA
In September 1999 the European Parliament announced to
Dutch Supportgroup SVS that in reference to the petition (of 25 March 1998 ) there yet an
offcial investigation had started by STOA (Scientific and Technological Options
Assessment: scientific researchbureau of the European Parliament) into the silicone
problems. The results would point out whether or not a total ban on breast implants would
be possible and whether the subject would become an issue on the European political
agenda.
--
ADVICE DUTCH HEALTHCOUNCIL: ELS BORST
End October 1999 a press release 'Breast enlargement
asks for solid information' was published by the Dutch Healthcouncil (Gezondheidsraad), in
reference to an advice ''Healthrisks of silicone-breastimplants", by the Dutch
Healthcouncil (Gezondheidsraad) of the Commission Silicone-implants to the familymember of
Prof. Piet Borst, convinced believing member of Dutch quackbusterorganisation 'Vereniging
tegen de Kwakzalverij', Dutch Minister of Health Els Borst-Eilers (D'66-party), who on 30
June 1997 had asked the Dutch Healthcouncil for advice on the silicone-problems. Els Borst
from 1986 to 1991 had been vice-chairman of that same Healthcouncil, among others
responsible for reports on effective medical dealings. From 1994 - 2002 Els Borst was
minister of Healthcare. Els Borst was appointed to Fellow of the Royal College of
Physicians in Edinburgh (1997 ) and was chairman Corecommission Ethical Medical Study,
member of the Advicecouncil for Science and Technology, member of several editor-boards of
medical scientific magazines, and is still yet member of the Institute of Medicine (IOM)
in Washington.
# - In the Healthcouncil advice was mentioned that it
was not out of the question that silicone breast implants occasionally lead to
healthproblems. The Healthcouncil Commission pressed among others on a serious approach of
women with implant-complaints, directed to recover and lighten the complaints. Further the
Commission Silicone-implants of the Dutch Healthcouncil had concluded: "on
ground of publications about epidemilogical study that the existence of a link between
breast implants and auto-immune disease, is implausible. The commission has not found
clues for an increased chance on cancer at women with breast implants and also for a
belated detection of breastcancer" and "Great value is attached to
registration of an implant".
# - Since 1995 plastic surgeons in the Netherlands are
being asked after the placing of a silicone implant to send in a standardform. Dutch prof.
Chantal van der Horst (plastic surgery, Amsterdam AMC) and Steven Klein (student medicine):
"There is an advance going on in living barbie-dolls.We aren't allowed to become
old anymore in a natural manner". In practice it appears rather that the number
of reports do not agree with the number of sold implants. In 1999 1354 implants were
registered, against 11,966 sold silicone breast implants to private-clinics and hospitals
(Dutch medical magazine 'Medisch Contact', yr 58, nr1, 01-03-2003 ).
# - Further the Commission Silicone-implants of the
Dutch Healthcouncil had concluded: "The commission means that adequate
information to potential bearers of silicone implants is essential. The -personal-
decision regarding whether or not taking an implant can only be taken after sound
information. At this information there should not only be spoken about the definitely
settled possible side-effects and risks, but also -under notice of the lack of scientific
evidence- about the non-proven but indeed experienced by some and to silicone implants
ascibed side-effects".
# - In Dutch newspaper 'De Telegraaf' the Dutch
Supportgroup Women with Silicone Implants SVS criticized the paper study of the Dutch
Healthcouncil. Marlou Boots in the Telegraaf: "No patient has been heard or
examined", "Uncareless, misleading and irresponsible", "It would have
been more in place if the Healthcouncil had brought out the advice to the minister to
limit the unlimited use of silicone breast implants". The Healthcouncil had based
itsself on the 'Literature study into complicaties which can occur after implantation of a
breastprothesis' of the Scientific-shop Medicine in Utrecht from December 1992. More up to
date data wasn't known, the Healthcouncil believed. Marlou Boots in a letter brief (29
Sept.2002 ) to the then new Dutch minister of Healthcare dhr. E. Bomhoff: "The
literature-selection by the involved doctors, in reference to the advice of the
Healthcouncil (Oct. 1999 ) is a poignant example. The by independent researchers and Dutch
Supportgroup SVS handed over literature / readings / study-results and field-data have
been systematicly ignored". http://www.gr.nl/pdf.php?ID=866
--
DUTCH MINISTER BORST SUPPORTS PRIVATE-CLINICS: BUNGLING
In November 1999 continuesly more Dutch political
parties wanted that minister Borst of Healthcare took measures against private-clinics due
to uncarefull medical care, use of non-qualified doctors, businesspeople without medical
background who saw cosmetic surgery as big business and excesses around cosmetic surgery.
Dutch member of Parliament Agnes Kant (socialistic SP-party) asked questions in the Dutch
Second Chamber of Parliament to D'66 party minister of health Els Borst: "This
bungling shows again that marketing / commerce does not belong in healthcare. Commercial
interests then count more heavy than medical interests". http://www.sp.nl/nieuwsberichten/525/991120-kant_wil_einde_beunhazerij_priveacute_klinieken.html
The Dutch Health Inspection (IGZ) did not have a view on many clinics because they did not
fall under regular care, as also with some alternative medicine (e.g. medium Jomanda). The
turn-around came in the year 2000, the year when Herre Kingma took office as Inspector
General at the Dutch Health Inspection, when Health-minister Els Borst decided to grand
more than 40 private-clinics enterance to the regular circuit by means of handing out
special licenses. Aim ? To shorten the waiting-lists in healthcare, one was made belief.
--
COURT CONFIRMS DOW'S REORGANISATION PLAN
The bankruptcy court confirmed the $4.5 billion bankruptcy plan of reorganization in December 1999. Of that amount, Dow Corning set aside $3.2
billion to settle the women implant claims. Dow is facing 20,000 lawsuits, some with
multiple plaintiffs and about 410,000 potential claims that had been filed in the global
settlement. It became clear that the settlement would only be able to pay a small
percentage of the women who registered for the settlement. Many opted out, 94% favored the
bankruptcy plan, and 7.000 women chose to continue their individual actions against Dow
Corning. In December 1999 a woman was allowed, by a
federal court ruling in Detroit, to sue Dow Corning's corporate parents, Dow Chemical Co.
and Corning Inc.. Each owned 50% of Dow Corning. The woman voted against the $3.2 billion
settlement plan.
--
MEN AND THEIR TOYS
In January 2000 the Britsh BBC reported a drastic
increase in the number of people going under the knife. Research from the US showed a six
time increase in breast enlargements: men demanded larger breasts for their female
partners.
--
INFORMATION-CENTER BREASTIMPLANTS
A panel of 14 independent scientists and legal experts said (Examiner, Washington Bureau)
that the US Federal government should put up an information office about medical implants
to inform patients better about the life-expectancy of a device and the possible
complications. Once upon a time.....? In the Netherlands in 1981 by the Dutch Ministrial
Commission Muntendam / Commission Alternative Medicine (CAG) an advice was given a.o. to
found an information- and documentationcenter for alternative medicine. The advice
appeared to be a waste of breath.
--
DUTCH MINISTERY-STANDPOINT BREAST IMPLANTS
http://www.nieuwsbank.nl/inp/2000/01/0131E056.htm?fmt=INPPRINT
ON 31 January 2000 Dutch Health minister Els Borst
send a letter (26800 XVI, Kamerstuk 1999-2000, Nr. 69 ) to the chairman of the Dutch
Second Chamber of Parliament in reference to the advice of the Dutch Healthcouncil
(October 1999 ). 80% had breast implants for breast enlargement, 20% for e.g.
breastcancer. The (ministry) point of view of minister Borst about breast implants:
"The advice of the Healthcouncil offers valuable recommendations", "I
underline the importance of a serious approach of bearers of silicone-breast implants with
healthcomplaints". An approach which had to get shape by means of better
information to women considering implants: "To come to this decision women need
adequate information". For support of the adequate information an
information-brochure would be published.
# - Reaction Dutch Supportgroup SVS (02-02-2000 ) to
the standpoint of the minister: "This point of view is rather brief, many
words but little real content. A plaster on the wound, which should have been stitched, is
the first impression of Supportgroup SVS. How long must this go on like this ? The
minister again ignores the personal suffering, the many ruined lives, of the women and
their family".
# - A reaction of a victim (W.) in an open letter to
the minister in the Dutch Supportgroup SVS magazine (June 2000, Nr.2 ): "Well,
mrs. the minister of Healthcare, see here theresult of ruptured implants, you say ? For
the implantation I was a healthy active woman, afterwards sick, helpless and dependent.
Also several operations have been needed to remove the silicone lumps. My life and that of
my partner has been ruined, do you realise that ?".
# - Another reaction in the Dutch SVS-magazine (March
2001, Nr. 1 ): "Twelve years ago, after amputation, I received a Dow
Corning implant. The pain and misery, the leaking, has undermined my entire life
completely. Many inflammations and problems. In total I have been operated about 28 times.
To then go in a 'sunny' way through life is sometimes an inhuman task. I rather be
dead".
--
DUTCH RIVM-STUDY: BREAST IMPLANTS
Dutch Minister Borst of Healthcare had on 31 January 2000
(ministry standpoint breast implants, in reference to the advice Healthcuncil) further
notified the Dutch Second chamber of Parliament that she had requested the Dutch
Governmental Institute for Public Healthcare and Environment (RIVM www.rivm.nl
) to conduct a followup-study into th relation between silicone breast implants and the
immune-system: "The study has started in November 1999", said
Borst and results would be expected in autumn of 2000.
# - Dutch Supportgroup SVS (1 November 1999 ): "The
RIVM study on direction of the minister of healthcare must yet be started. About 600 women
from the SVS-file will be approached via an extensive questionary, out of which a small
group will be selected for further study. The old, use silicone implants were not studied
or analysed on composition as chemical additations and heavy metals. Nobody in the
Netherlands has ever studied the working-effect in the human body of this
combination".
# - Dutch Member of the Euro-parliament for the
CDA-party Ria Oomen-Ruijten (Brussel, 19 November 1999 ): "Furthermore in
the study by the Dutch Healthcouncil there would not have been heard any single woman.
This is the case in a study that the RIVM, again on direction of the minister, soon will
carry out".
# - RIVM (13 January 2000 ): "The plan
is as of half March 2000 to begin with summoning of the women with a silicone breast
implant for taking off blood and the clinical research".
# - Send in reaction of a reader (R.A.) of the
contactmagazine of Dutch Supportgroup SVS and participant in the RIVM-study: "What
an awfull, cold, uninterested show there in Dutch city Utrecht at that Dutch ministry
study ! It looked like if they had gotten the direction to make it as unpleasant as
possible ! Unclear, wrong direction where you exactly had to be, long distances to walk,
everything very hastely and in short. After 17 tubes of blood there couldn't even come a
cup of coffee, while I was very weak and dizzy... When I finally was done, they told me
that they yet actually had to see my breasts (the remainders that is). 'Well no, never
mind, I already know it', she said then" (SVS's magazine 7the yr, June 2000 ,
Nr.2 ).
--
REPETITION "META-ANALYSES: NO DANGER IMPLANTS"
On 16 March 2000 in Marcia Angell' New England Journal
of Medicine (NEJM, Vol 342, Nr 11 ) an article about a study (University of North Carolina
at Chapel Hill) finding no evidence that the implants impair women's health: "For
each of the conditions analyzed, the findings provided no evidence of an association
between breast implants and specific or combined connective-tissue diseases". The
researchers ((Dr. Esther C. Janowsky, Drs. Lawrence L. Kupper (biostatistics),
epidemiologist and member of Judge Pointer's National Science Panel Barbara S. Hulka))
combined and analyzed information (computer searches, citations world's medical
literature) from previous studies (meta-analysis: 9 cohort -, 9 case-control -, and
2 cross-sectional studies), exclusing patients who had direct injections of any material
into their breasts: "Useful when previous studies have lacked enough
subjects to produce a clear result", "The goal of our research was to look at
the question of possible harm from silicone breast implants using several different
approaches while at the same time including as many studies as possible. Our conclusion is
consistent with earlier work indicating no relationship", Janowsky said. This
UNC-CH study was originally part of the report (1 December 1998 ) by Judge Pointer's
National Science Panel. U.S. Federal Judge Sam Pointer retired from court on 31 March
2000.
http://www.medscape.com/viewarticle/419145_print
http://www.pa-awis.org/Women's_issues/health_and_safety.htm
--
PLASTENIUM PROOF: DEFORMED CITIZINS
In March 2000, three months into the millenium
1999/2000, Italian pornstar Lolo Ferrari, who had had her breasts enlarged to gigantic
proportions with silicone implants, died at age 30. And in the Newsletter of the Dutch
Association for Plactic Surgery (NVPC, jrg. 3, nr.4, 2000, 'Plastenium proof') could be
read: "Yes, great and new times have arrived and it is a necessity that we
as plastic-surgeon community stick the heads cool together. We must not only take care
that we remain the best paid and highest qualified doctors in the Netherlands, but also
that we do not let ourselves be confused by hospital-directors, jealous colleagues or the
long waitinglist of deformed citizins" (source: Dutch Supportgroup SVS).
--
US SUES IMPLANT MANUFACTURERS
The US federal government is suing former silicone breast implant manufacturers:
Baxter International, Baxter Healthcare, Bristol-Myers Squibb, 3M, Union Carbide Chemicals
and Plastics, and Union Carbide. Goal ? Recovering costs made treating implant-related
injuries under federal health care plans: e.g. Medicare (Chemical Week, 12 April 2000 ). Why not sue plastic surgeons who are aware
of the risks and deedly implant the causes of the costs (breast implants) at 'deformed
citizins' ? Is a manufacturer sued for producing bullets ? Or is a person charged who uses
those manufactured bullets in a shooting and harms someone else's health ?
--
DUTCH REPORT WRITTEN CONSULTATION: BREAST IMPLANTS
Due to the letter of Dutch minister Borst of 31 January 2000 (ministry standpoint breast
implants, in reference to the advice of the Dutch Healthcuncil) the Dutch political
parties CDA and the socialistic SP posed questions in the Dutch Second Chamber of
Parliament to which Health minister Els Borst on 9 May 2000
answered by letter: "The Dutch Association for Plastic Surgery (NVPC) are
busy with developing a guideline for silicone-breast implants","There is no
clear overview of the number of women with complants in the Netherlands",
"Hundred percent safety of a product can never be quaranteed", "Women with
a prothesis do not have more complaints, are not more often sick as comparable groups of
women without prothesis (Janowsky 2000 )", "There has been no study initiated by
the government into the composition of at women removed implants because it is not
plausible that there is a relation between the composition and the complaints which some
bearers of silicone breast implants experience". The Dutch Socialistic party (SP)
asked among others the following question to minister Borst: -"Do you find,
seen the reported serious health complaints of so many women, that here can be spoken of
'incidental' ? Are these women sufficient enough taken serious ?", - "That
attention must according to the Dutch Healthcouncil be directed not only to enlightment of
the complaints but also to the recovering of their causes. Do you follow up on this advice
?", - "Is the fact that many women in the Netherlands have serious health
complaints for you a reason to consider a ban on the unlimited use of silicone breast
implants ?". http://www.nieuwsbank.nl/inp/2000/05/0510B042.htm
--
TRILUCENT: DUTCH HEALTHCARE INSPECTION
Begin 2000 Marlou Boots of Dutch Supportgroup
SVS --with the availability of a study on one Trilucent (soya-oil) prothesis after it was
explanted-- had telephoned with the Dutch Inspection for the Healthcare, because women,
according to SVS, were not informed about the recall by the manufacturer of Trilucent
breast prothesis in March 1999. The Inspector for the Medical Technology of the Dutch
Healthinspection (IGZ) made known in a letter to SVS (18 May 2000,
reference: FMT / MT-U 00 / 05670, Mrs. A. van Sliedregt) that the Dutch Association for
Plastic Surgery (NVPC) in March 1999 hadn't seen a reason for explantation of already
implanted Trilucent breastimplants, and that the NVPC had adviced doctors to check up on
women with Trilucents and to inform them. The Dutch Healthinspection IGZ did not doubt the
carefull dealingmanner of the doctors and did not see reason to change the conducted
policy.
# - A woman in the Dutch Supportgroup SVS magazine 7th
yr, December 2000, Nr.4 ) stated: "In May 1996 I had the somethingth
breastoperation. It was said to me: 'There are new ones on the market with soya-oil, with
them nothing can go wrong. When they start to leak it wil just disappear again into the
body'. In May 2000 they were removed for medical reasons. I do not know anymore who yet to
trust, I become so dispirited by it ! Already 15 years I have no single day without pain.
My prothesis were never yearly checked up".
About the conducted study on the explanted Trilucent prothesis, in possesion of Marlou
Boots, the Dutch Inspector for Medical Technology of the IGZ consequently wrote in the
letter: "I see no reason to deviate from the point of view of the NVPC
based on study on one prothesis". The Inspector had heard from the English
governemnt that coming summer information was to be expected about a large study into the
Trilucent. When that would give inducement, further deliberation would follow. Thinking
about the "serious approach" words in the advice of the Dutch Healthcouncil
(October 1999 ) which accordingly were underlined by Dutch Health minister Els Borst in
the Dutch Second Chamber of Parliament, the Dutch IGZ Inspector ended the letter to Marlou
Boots / SVS with the statement: "It can be clear that I take you and the
information you send to me serious".
--
SALE OF SALINE IMPLANTS: FDA OKAY-ED
PRECEDED:
When the FDA in 1992 took silicone implants off the market, salines (saltwater filled
implants: in a envelop of silicone !) were the only implants which were commercial
available. Salines would be safer than silicone implants. They had been already sold for
many years, before 1976, without FDA approval. In 1993 studies (proof of safety) and
application for FDA-approval from the manufacturers were aksed, at least so was promised
and made one believe.
# - In 1995 fungal contamination was reported when a
box of saline was left open in the operating room prior to filling and placement of the
implant: microbial growth and reproduction in the internal environment of a saline
implant (V. Leroy Young; et al Plast Reconstr Surg, 1995 Nov, 6, 96,1430-4 )
# - In 1996 was reported that bacteria were able to
proliferate in saline in breast implants (Chen NT; Butler PE; Ann Plast Surg, 1996 Apr, 4
Issue:36 Pg 337-41 ).
# - In the first report from a continuing study of
more than 500 women who received saline implants from 1980 to 1989, scientists found 50%
of the implants went flat within 10 years, by which women might had to undergo perhaps
even more than three times additional surgery; the Rocky Mountain News reported on 9 July
1996.
# - In July 1997 a study showed "that several
types of bacteria (particularly gram-negative species ) and fungi can grow and reproduce
in a retricted saline environment for extented periods of times" (Plast Reconstr
Surg, 1997 Jul;100(1 ):182-196, Young VL, Hertl MC, et al Washington University School of
Medicine)
# - September 1997 / Oct. 2001 (Chris Woolston) - In a
study using rabbits, researchers at Washington University School of Medicine in St. Louis
demonstrated for the first time that a wide variety of potentially harmful microbes can
live and grow inside saline implants. They also discovered that microorganisms frequently
live in the tissue surrounding implants.
# Systemic disease in women following the insertion of saline breast implants
(By Britta Ostermeyer Shoaib, M.D. and Bernard M. Patten, M.D., F.A.C )
"We suggest saline breast implants might cause or provoke a systemic autoimmune
disease with findings of systemic vasculitis in some patients...". http://www.freewebs.com/implants/salinepatten.htm
# Safety Data are lacking on saline breastimplants
(30-12-1999, Los Angeles Times, By Diana Zuckerman, Ph.D.)
"....Unfortunately, nobody really knows if saline implants are safe. There are
almost no published studies evaluating the safety of saline breast implants, and the FDA
has never approved any saline breast implants, or any other kind of breast implants, as
safe...(...)...Experts on both sides of the implant safety debate concede that saline
implants will break, usually after five to 15 years, and that bacteria can grow in the
implants...(...)...More than six years after they promised to do so, the FDA finally
required the manufacturers of saline implants to submit safety studies in late
November...". http://www.center4research.org/implantsc.html
# FDA warns of dangers of breastimplants
(9 January 2000 ) ".....Dr. Diana Zuckerman: 'It is especially shocking that more
than one-third of the reports are for saline implants, most of which have been sold in the
last few years. The photographs help illustrate how disfiguring augmentation can be. A
cosmetic product should not cause disfigurement to so many women'......". http://www.center4research.org/newsfda.html
--
SALINE-IMPLANTS: IGNORING FIELDDATA / REALITY
Despite new scientific evidence that salines form a considerable risk, the FDA on 10 May 2000, after hearings begin March 2000 (FDA Advisory
Committee), gave their approval to two manufacturers of implants (McGhan Medical Corp. and
Mentor Corp. at Santa Barbara) to be allowed to maintain selling salines: "safety
approval". FDA commissioner Dr. Jane E. Henney: "Although there is
benefit to some women from having breast implants available, there is now a much clearer
understanding of the risks involved", "With the data that has been presented,
women and their physicians will be able to make informed decisions about whether the
benefits are worth the risks" http://www.sfgate.com/cgi-bin/article.cgi?f=/c/a/2000/05/11/MN23820.DTL&hw=breast+implants&sn=007&sc=663
# - Diana Zuckerman / Patricia Lieberman: "The
manufacturers have cheated about the safety of their implants and were in this supported
by plastic surgeons who had told the FDA about the beautifull results in their practices.
The FDA had ingnored the terrible stories of women ('field-data') completely. Women with
healthproblems. Women who were refused by the insurance company due to an increased risk
as a consequence of their implants and possible complications. Women who's symptoms did
not improve, untill after the implants were removed. Consumers should have the certainty
that the term 'FDA approved' means that a product is solidly tested and found safe.
Unfortunately, concerning breastimplants, the FDA lays the responsibility at the women
(reversal burden of proof). Women must zigzag between plastic surgeons and splendid
promotion-brochures of manufacturers to find the information they need. We can no longer
count on the FDA !" (Source: Dutch Supportgroup SVS).
# The FDA Advisory Committee on Saline Breast Implants
Statement of Diana Zuckerman: "...I was at the FDA Advisory Committee meeting when
saline implants were approved in 2000...(...)...Two members of Congress wrote to the FDA
last month and again yesterday to ask about a criminal investigation of Mentor and to ask
to see inspection reports for both Mentor and McGhan. I have a copy of their letters,
which specifically asked that this Advisory Committee be informed of the criminal
investigation, since it might have implications for the integrity of the research data.
The Congressmen also asked that you be provided information about studies published by the
National Cancer Institute last year. One showed an increased risk of cancer for women with
saline or silicone implants compared to other women. The other showed an increase risk of
deaths from brain cancer, lung cancer, and several other diseases among women with saline
or silicone breast implants, compared to other plastic surgery patients....". http://www.center4research.org/bi070902.html
# Saline-Filled Breast Implants: A continuing area of Concern
(P. Blais, FDA Advisary Committee On Saline Filled Breast Implants: Hearings of 1-3 March
2000 ) Saline Inflatables and their Problems:
- "....Fine particles with systemic inflammatory properties disperse in the
implanted area and eventually spread throughout the lymphatic chains initiating systemic
phenomena, as noted for the finger joint prosthesis (21 CFR 888.3230 ). This problem is
central to adverse reactions surrounding spallating joint implants such as the
Vitek/Proplast temporo mandibular joints (TMJ), objects of other FDA regulatory actions in
the early-nineties...."
- "...Problems of saline implants that undergo spallation of the surfaces in
abrasive environments must be acknowledged as capable of initiating phenomena similar to
that encountered with Swanson joint prostheses (21 CFR 888.3230 ) and Vitek/Proplast
temporo mandibular joints implants (TMJ). Accordingly, users of saline implants must be
forewarned of possible adverse reactions similar to Swanson and TMJ implants which were
the object of FDA regulatory actions and Talk Papers in the early-nineties....". http://implants.clic.net/tony/Blais/037.html
# The Role of FDA on breastimplants: Watchdog or Grandma ?
(Knight Ridder newswire, May, 2000, By Diana
Zuckerman, Ph.D.)
"....FDA was told that of the almost 2 million women who already have breast
implants, 1 in every 8 will get breast cancer, and 20,000 to 40,000 of these women will
have a potentially deadly delay in their diagnosis because of their implants. The FDA
decided that, despite those risks, women should have a right to choose implants if they
want them...." http://www.center4research.org/implantsj.html
# - A woman in the Dutch Supportgroup SVS magazine
September 2000, Nr. 3: "Silicone I did not take, but salt water. They have
been approved by the Amrican FDA, my specialist told me. But eeehhh, that may sound dumb,
but that water is yet not injected loose ! How is that actually ?".
# - Dutch Supportgroup SVS: (source: Command
Trust Network West Los Angeles, CA) "There is no doubt possible that breast
implants decrease in quality and break down in the body. Several scientific studies have
showed that the thin silicone envelop inwhich the silicone-gel is packaged in, get worse,
weaker over the years. After ten years half of the silicone gel implants start to break
down and to leak. (often already sooner). After 20 years almost all implants are defect.
Also when the implants seem intact, the silicone will sweat yet through the envelop en
disappear in the body. The rupture rate for salines, the salt- water filled implants, is
even yet higher".
# - A plastic surgeon in an article: "Even
after 30 years not a single researcher has been able to show a relation between disease
and silicone. In our hospital we therefore offer only silicone implants" (Source:
SVS).
--
- SILICONE TIME LINE
--
FDA "7 OF 10 IMPLANTS LEAK"
On 18 May 2000 at the 6th World Biomaterials Congress,
a FDA-sponsored study (telephone questionnaire), among women who had their first implant
prior to 1988, was presented. 1/3 of the women reported having had at least 1 surgery in
which their implant was removed or replaced. 56% of these women reported that at least one
of their implants was ruptured or leaking: "Almost 7 out of 10 silicone-gel
breast implants scanned by researchers had developed a leak. The US Food and Drug
Administration (FDA) study could reawaken the debate over the safety of breast
implants...." ('Huge rupture rate in Breastimplants', 19
May 2000, BBC, http://news.bbc.co.uk/2/hi/health/755103.stm
) Breast implant manufacturers had to then claimed rupture rate of implants being about
1%. The FDA stated: "In the past, breast implant rupture was thought to be
rare, but the FDA study indicates that rupture of silicone gel implants is much more
common than previously thought". Than previously believed, based on ? Reality or
$$$ ? Marcia Angell: Where's the science ? One could have or should known in all (legal)
responsibility, reasonability and fairness, since breast implants are on the(ir) market
since..... ?
# - 1995 Dr. O. Gordon Robinson had presented a paper
entitled 'Rate of rupture of silicone prostheses: excerpt from a study of over 3000
personal cases and 25 years experience' at the Symposium on Reoperative Aesthetic Surgery
of the Face and Breast in Naples. Florida. A 70% rupture rate, an effective rupture rate
after 20 years of 100%, was reported by the study of Dr. Gordon Robinson et al. (Annals of
Plastic Surgery, 34:1-7, 1995 ). An abstract by Dr. Robinson and Dr. Edwin Bradley of the
study was published in the January 1995 issue of the American Medical Association Journal.
# - 1998 In July 1998 the Institute of Medicine had a
hearing, previous of the publication of their / the famous, massively by individuals of
the media reported and by critics quoted, IOM-study (21 June 1999 ) which found no link
between implants and diseases. At that IOM-hearing Dr. Lu-Jean Feng (Case Western Reserve
University) presented a study which found a rupture-rate of 60-70% within 10 years. And
Dr. Michael S. Middleton (UC San Diego) presented to IOM a study in which MRI-scans were
used finding a rupture-rate of 50% within 10 years and an almost 100% rupture-rate for
implants with polyurethan envelops.
http://list.mc.duke.edu/cgi-bin/wa?A2=ind0105&L=occ-env-med-l&D=0&P=9669
http://www.FDA.gov/cdrh/breastimplants/extracapstudy.pdf
The researchers in the FDA-7-out-of-10-leak-study had looked at women who had participated
in a National Cancer Institute study. As stated by Diana Zuckerman at the FDA Advisory
Committee meeting (March 2000 ) on saline implants: one National Cancer Institute study
(out of two studies published in 1999 áfter the IOM-report thus not included in the
IOM-report) had found that women with silicone or saline implants, compared to women in
the general population, had a 21% increased risk of cancer. Ralph Knowles (Plaintiffs'
Steering Committee) regarding the FDA-7-out-of-10-leak-study: "This study
confirms the results of other recent studies into the rupture rate of breast
implants", "This is just the most recent study to show the reality".
--
DOW'S PR-FIRM BURSON-MARSTELLER IN ACTION
Associate Professor of Communication Angela Powers PhD in May 2000 analyzed the newspaper
coverage (New York Times, Chicago Tribune, Wall Street Journal) of the silicone breast
implant (SBI) controversy from 1992 through 1996 ('Newspaper Coverage of the Breast
Implant Controversy', Women & Health, 30(2 ),83-98, 22 May
2000, Northern Illinois University). Was a fair and balanced account presented
to the public of millions by a few 'gate-keeper' individuals hiding behind 'the' media ?
The SBI coverage appeared to have swifted from a focus on health risks in the beginning to
the financial situations of the implant manufacturers. Most-interviewed sources were
spokespersons for the implant manufacturers. The least were women with implants, about
whom actually the controversy in reality should serve to be about. The results of Angela
Powers analysis suggested that reporting patterns were 'influenced' by the PR efforts of
the implant manufacturer.
# - Conclusion ? The care-duty of 'gate-keeper'
journalists to provide millions of patients with correct and complete information reaches
to making a full exercising of the choice of freedom and the right of self-determination
of the patients in full scope possible ? Every journalist for itsself had for a certain
longer period made an important contribution to the post-understanding and maintaining
certain thoughts / beliefs at millions of patients about the silicone breast implant
controversy ? Individual reporters behind the media were 'influenced', by which they had
acted in a different manner, by which they had choosen for 'alternative' behaviour,
different than they would have done without the PR-efforts of Dow Corning ? The millions
public were / are being saddled up with individual personal choices in dealing-manner,
behaviour (based on belief) and psychological defensibility against external influences,
of a few journalists hidden behind 'the' media who yes or no due to that influence had /
have lost contact with (another) reality ?
--
EUROPEAN POLICY: U- TURN
A Europe- wide petition (25 March 1998 ) was turned down by the European Commission after
the UK IRG-review (July 1998 ) found no evidence to link silicone implants with illness.
But in September 1999 the European Parliament announced an investigation into the
silicone-controversy. And after the new FDA research had showed a 70% rupture rate among
silicone implants, Scottish Member of the European Parliament Bill Miller and
Silicone Support UK (Margo Cameron) in the week 15 - 21 May 2000
persuaded the European Commission's Petitions Committee to order a further study. They
also recommended implant patients receive independent advice before undergoing surgery,
and the establishment of a national register of implant patients. The European Commission
ordered study into safety of silicone implants. A landmark, which make the way free for
compensation claims from up to 80,000 UK women. ('Implant campaigner: U-turn too late to
save the women who died', The Sunday Herald, 28 May 2000, Susan Flockhart).
--
STOA: THE EUROPEAN PARLIAMENT
For a long time several supportgroups in Europe had flooded the STOA-committee
(independent researchpanel of the Euro-Parliament) and the political
peoples-representatives with stacks of letters and documents to make them see the
seriousness of the situation, to make them aware of the dangers of silicone implants. Marlou
Boots: "Dutch Supportgroup SVS finds that the Dutch government serious falls
short in her care-bearing task. A concerning care-abstinence. There is still no
recognition for this problem, thus also no medication. Due to the denial and the often
strange A-typical and contradicting healthcomplaints, many doctors refuse to take the
complaints of the sick women serious, by which the women irresponsibly long walk around
with leaking or ruptured prothesis. The more silicone in the body, the more medicine they
get prescribed, the sicker they get. Except that this puts extra burden on the
healthcostsbudget, it also strengthens psychological and medical suffering. The
international rights of man -The right on adequate medical care and the right on a human
existence- are by this care abstinence greatly violated", "Has one still yet not
learned from the medical history ?", "Must Silicone-gate become the number one
on the list of medical failing devices with a record of number of victims ?"
# - In May 2000 the STOA-report of the European
Parliament appeared: "Final Study: Health risks posed by silicone implants in
general with special attention to breast implants".
http://www.europarl.europa.eu/stoa/
publications/studies/19992002_en.pdf
An information source had told Dutch Supportgroup SVS that apparantly all registers were
pulled open to safequard the lucrative source of income by stressing the 'benefits' of
silicone. STOA showed in het report no link between silicone-implants and serious risks
for diseases such as cancer and tissuedisorders.
# - On 23 May 2000
there was a hearing in the European Parliament.
http://news.bbc.co.uk/1/hi/scotland/760735.stm
http://news.bbc.co.uk/1/hi/health/761749.stm
# - On the hearing the STOA-report was read by
professor José Martin-Moreno from Spain: "This working-document of the
STOA Panel is not an official publication of the STOA. This docuement represents not
neccessarily the opinion of the European Parliament". A representative of the
Dutch Supportgroup for women with (questions about and/or problems by) Silicone implants
(SVS) spoke on the hearing: "How many women have yet to get serious
disorders or even die, before the problem is taken serious and there finally will be
issued a ban on the use of silicone filled breastimplants". While one long before
was informed by SVS --date, place, with stacks of information-- nobody of the Dutch Member
of Euro-Parliament were present at the hearing. Not interested. While at the hearing
German and Italian Members of Euro-Parliament were remarkable fierce, being absolutely
opposed to the use of silicone implants, also seen the far stretching consequences for the
users and their families. Dutch Supportgroup SVS had send in photo's of ruptured / used
implants, which the SVS-representative showed. One was shocked to death. Nobody had ever
seen reality, had ever seen a ruptured sticky prothesis "in real".
The following could an will mostly happen (PIC's):
-PIC- http://www.svs.i8.com/Page_3/IMAG0009.GIF
-PIC- http://www.svs.i8.com/Page_3/IMAG0005.GIF
-PIC- http://www.svs.i8.com/Page_3/IMAG0008.GIF
-PIC- http://www.svs.i8.com/Page_3/IMAG0012.GIF
-PIC- http://www.svs.i8.com/Page_3/IMAG0011.GIF
-PIC- http://www.svs.i8.com/Page_3/IMAG0007.GIF
-PIC- http://www.svs.i8.com/Page_3/IMAG0006.GIF
Remainders of silicone breastimplants (PICs):
- Silicone Bomb ? -PIC- http://www.svs.i8.com/Page_3/IMAG0010.GIF
- Bon Appétit ! -PIC- http://www.svs.i8.com/Page_3/IMAG0015.JPG
- Horror collection "safe implants" -PIC- http://www.svs.i8.com/Page_3/IMAG0013.JPG
- Horror of leaking implants -PIC- http://www.svs.i8.com/Page_3/IMAG0014.JPG
--
TRILUCENT BREAST-TERROR: "A NIGHTMARE FROM BEGINNING TO
END"
On 6 June 2000 the British Government / health
authorities warned for leaking soya-oil from Trilucent breastprothesis and advised women
as a precaution to have them removed. According to the British controle-institute Medical
Devices Agency (MDA), which tests devices, the implants could cause cancer and harm to the
unborn child because the oil over time could become poisoning, among others based on the
report (1999) of Dr. S. Montrey (Reuters, July 2000, 'Assets: Beauty and the Implanted
Breast - Asset or disaster ?', By Richard Chang http://www.implantinfo.com/reuters.htm
). Government Deputy Chief Medical Officer Dr Pat Troop said: "We are
recommending that women with these implants should have them removed and, until then,
avoid pregnancy and breast feeding. This type of implant could be harmful. An increased
risk of cancer, or damage to an unborn baby, cannot be excluded". MDA medical
director Susanne Ludgate admitted: "It was wrong ever to have allowed these
implants to be used".
# - The owner of LipoMatrox Inc., the manufacturer of
Trilucent, was Collagen Aesthetics. Collagen Aesthetics, later known as AEI Inc.,
manufacturer of medical products and a subsidiary of the Inamed Corporation, pointed out
in its comment (6 June 2000 ) first that greater profit margins could be expected and
second that: "We deeply regret any distress suffered by patients and
families. As a responsible company, we have set up a program which is designed to provide
them with support and assistance".
# - Once on the European market a product can very
diffifult be taken off, unless excellent evidence proofs that...... Because Trilucent was
approved by a private German organisation (TUV Munich), which meant a safety-approval
hallmark (skeptical: a 'licence to kill' ?) for the whole of Europe (European CE quality
mark), Trilucent could come onto the British market without clinical trials and without
interference of British authorities.
# - The soya oild type implants were in the past
heavily promoted, as 'safe alternative', by a few individuals of the cosmetic surgey
clinics, to women who were concerned about the safety of implants as a consequence of the
silicone controversy. The Trilucent-advertisemnets at that time read: "Made
by women for women". The samen women now stood, besides possible lifetime
consequences, for a second expensive operation to have the iplants removed, as a
consequence of the ($$$ influenced) thoughts and believe-convictions of a few individuals
in the past.
# - The 39-year old mother-of-two children Gillian
Clark had received Trilucents (£6,000 pounds), on advice of consultant plastic
surgery Roger Smith in UK private-clinic Somerfield Hospital, in 1996. In October 1997 her
right breast had become 25% smaller than the left, Roger Smith ordered to have the
removed. Gillian Clark: "These implants have ruined my life and now there
is the very real fear of cancer".
# - Another woman of the 5,000 UK-women who had
received Trilucents was the 24-year old Lynsey Irvine from Edinburgh who had her
breast enlarged in Decemver 1997, a few months after her son was born, in reference of an
advertisement for private-surgery in a woman's magazine. Problems almost occured
immediately. Hardening and pain in breast and arm. Her breast splitted open to the side.
She could herself even touch the implant: "They put surgical tape across it
and said it would heal itself". False hope, (a 'misleading and criminal way of
dealing', thus a consistent Dutch oncological surgeon Emiel Rutgers ?) because it did not
heal. Further repair would cost £1,100 ponds.
# - Because soya is a natural product and it gets
entangled with breast tissue, the soya oil breast implants of the 29-year old accountant Jan
Temple had to be 'ripped out'.
# - The twin Lydia and Debbie Colbert
had been offered free soya oil implants worth £3,000 pounds by two Harley Street plastic
surgeons. In exchange for promotion for the Trilucent in magazine's, newspaper and on Tv.
# - On 9 June 2000
the Belgium minister of Health Magda Aelvoet made an appeal in Belgium newspaper 'De
Standaard' to track down women with the 'poisoness' Trilucent-implants (implanted between
1996 and 1999 ) with the advice to get in contact with the plastic surgeon or hospital.
The physicians were informed of all necessary information.
# - In Northern-Ireland there were about 100
Trilucent's used in the private sector. On 9 June 2000 the Women's Coalition MLA had to
ask the minister of Health Bairbre de Brun for a reaction on the Trilucent-panic.
# - The Netherlands reacted with an ('taking serious')
awaiting, passive, looking-on policy. Dutch newspaper 'De Telegraaf' reported on 8 June
2000 'Alarm about breastimplants with soya-oil': "The Dutch ministry of
Health had already been informed about the British investigation into the product and is
awaiting the advice of the Dutch profession-asscoiation of plastic surgeons, the
NVPC". The Dutch Inspector for Healthcare (IGZ) said that "there was no
imminent danger threathening public healthcare" while the British government
advised women "not to breastfeed or not to get pregnant, as long as they bear the
prothesis".
# - Co-CEO of Inamed Corporation Ilan Reich betted
that silicone implants would make a comeback and scientists (Martin Ingman of Swedish
manufacturer Q-Med ?) were developing (The Mirror, 22 June 2000; Katie Wood) a 'simple'
injection to pump up breasts by an extra couple of cup sizes in just minutes. A boob job
in your lunch hour ? The injection procedure would be, so was claimed / believed: "a
safe alternative". The show MUST go on !
http://news.bbc.co.uk/1/hi/scotland/780097.stm
http://news.bbc.co.uk/2/hi/uk_news/scotland/780097.stm
http://implants.clic.net/tony/Corner/M/903.htm
http://archive.nics.gov.uk/hss/000606d-hss.htm
http://www.allbusiness.com/company-activities-management/financial-performance/6451859-1.html
http://implants.clic.net/tony/Corner/M/887.htm
http://www.allbusiness.com/medicine-health/medical-science-medical-research/6452341-1.html
http://news.bbc.co.uk/2/hi/health/779346.stm
http://www.thisislondon.co.uk/news/article-945284-details/The+implant+scare+continues/article.do
http://www.dailymail.co.uk/pages/live/articles/health/healthmain.html?in_article_id=125943&in_page_id=1774
http://krant.telegraaf.nl/krant/archief/20000608/index.html
--
- SILICONE TIME LINE
--
THE NETHERLANDS: DOING NOTHING AND WATCHING ?
Was Marlou Boots / Dutch Silicone Supportgroup SVS, and thousands and thousands of fellow
humans with silicone breast implants, 'taken serious', as mirrored in a (temporarily)
outburst of thought in the past by the Dutch Healthcouncil's advice, Dutch Minister Borst
and Herre Kingma's Dutch Healthinspection IGZ ? On 11
and 30 July 2000 Marlou Boots of Dutch Supportgroup
SVS wrote letters to the Dutch Prime-Minister Dhr. W. Kok (PVDA-party): "Because
after many years of fierce battling with several government bodies, there appears to be
none or hardly any result or even but understanding been brought up for the problems
caused by silicone breast implants", "Your intervention can prevent many
unnecessary pain and suffering". Dutch Prime-Minister Dhr. W. Kok lead the Dutch
government at the time (11 July 1995 ) of the fall of the, by the United Nations declared
"safe", Muslim enclave Screbenica (Yugoslavia), where no intervention took place
(by Dutchbat, the Dutch soldiers ordered by.....) to prevent unnecessary pain and
suffering of the fellow-human. Reason ? An (absolutistic) higher / greater goal ? Two
important permanent members / countries of the United Nations Security Council (Uk and
USA) were already in the beginning of June 1995 informed and aware of the Serv plans to
conquer (witchhunt) the enclave Srebrenica, but didn't inform the Netherlands, thus former
Dutch minister of defence Joris Voorhoeve (VVD-party) in the Dutch bco IKON Tv-programme
'Spraakmakende Zaken' (9 July 2005 ) presented by former Greenleft-party leader Paul
Rosenmoller. On the memorial-ceremony on 11 July 2005 of the genocide in Srebrenica spoke
the British minister of foreign affairs Jack Straw: "We did nothing. I
bitterly regret this and I'm deeply ... I'm deeply sorry, I feel indignant about this and
I am truly sorry".
--
LAWSUITS AGAINST TRILUCENT
On 10 August 2000 Miami attorney Jeffrey Herman filed
a product liability lawsuit against US companies that developed, manufactured and/or sold
the Trilucent breast implants used in about 9,000 surgical procedures conducted in the UK
and Europe. The companies were: - Collagen Aesthetics Inc. / AEI, - Inamed Corp., -
Cohesion Technologies, - TUV Munich (CE stamp), - Washington University, St. Louis
(invented, patented and sold Trilucent), - LipoMatrix, Inc. and a British Virgin Islands
company with US offices that manufactured the implant. Jeffery Herman (lawfirm Herman
& Mermelstein): "It is heart-wrenching to think that many of the women
who received these implants and have been put at risk of developing cancer did so after
having successful mastectomies to remove breast cancer". Although Business Wire
reported that Trilucent implants were not approved by the FDA and therefore unavailable in
the US, the FDA did approve the first US (pilot) study of Trilucent around 1 October 1994,
in which 50 US women would receive the experimental Trilucent, as reported by the
Associated Press (2 August 1994 ). "According to the FDA approximately 200
American women received the implants as part of a clinical trial", wrote Adam
Pasick in 5 September 2000. About the pull-off the market of the Trilucent, Dr. Leroy
Young (Washington University) who worked on the study: "purely a
precautionary measure". Implant-victim Caroline Bromm: "The
medical profession has sided with the rich companies, and turned a blind eye to the women
and the illnesses they have". At least one company had offered package deals in
the past for American women to fly to London to receive the soya implants. "Boobs n'
Bard" ? But FDA officials said not being informed, having no knowledge or
jurisdiction over such cases. UK based manufacturer, AEI, and its Barcelona based
importer, Colagen Biomédica, were also sued by Spanish women.
--
BIOSIL LIMITED AND NAGOR SUED
Flat-chested Tanya had Trilucent implants on the UK National Health Service (NHS). The
Daily Record reported on 28 August 2000 that UK-based
companies Biosil Limited and parent company Nagor --both linked to implant scandals around
the world stretching back to the early 1980s-- were taken to court by 3 Scotswomen. Nagor
implants had ruptured inside them causing catastrophic health problems. Despite products
made by Biosil Limited being banned from sale in the US, implants made at the Biosil
factory were still widely available on the NHS.
--
THE EUROPEAN PARLIAMENT: OPTION 3
Despite that Member of Euro-Parliament Frau Margot Kessler underlined 'option 2' (ban on
silicone implants due to lack of data about the risks and due to petitions by
interest-groups), and despite that one yet was shocked about "the scary
resemblances in the stories of women from 6 different member-states", the
majority of the present parliamentmembers found the the comite-meeting of 28 August 2000 'option 3' desirable: no full ban, but
approval en conducting of strict specific measures for improvement of information,
(quality)controle, tracking down, guarding and study into alternatives.
http://www.europarl.europa.eu/meetdocs/committees/envi/20000911/417110_en.doc
http://www.europarl.eu.int/meetdocs/committees/envi/20000911/417110_en.doc
--
FDA WARNS: DANGERS BREAST IMPLANTS
On 15 September 2000 subsidiary of Inamed Corp, McGhan
Medical Corp --who recently had received FDA approval for its pre-market application on
the saline implants-- raised the price of its saline-filled breast implants by 12%.
According to FDA's new consumer booklet * --providing much clearer warnings-- more than
190,000 problems from breast implants had been officially reported to the FDA. 1/3 of the
reports were from saline implants. Dr. Diana Zuckerman: "The number of
reported adverse reactions is amazingly high, since most medical problems are not reported
to the FDA". http://www.center4research.org/newsfda.html
(* September 2000 - FDA breast implant consumer handbook 'Breast Implants - An Information
Update - 2000' http://www.fda.gov/cdrh/breastimplants
)
--
1 IN 7 IMPLANT PATIENTS HAVE COMPLICATIONS
Also the UK Department of Health wrote and published on 5 October
2000 a booklet for women considering having breast implants with objective
advice: "One in seven women experience problems after breast implant
operations". For the first time, so was said, women were being provided with
information about the risks (no "lifelong guarantee") covering the 4 types of
breast implants available in the UK: Silicone Gel, Saline, Hydrogel and Polyvinyl
pyrolidine solution (PVP). http://news.bbc.co.uk/1/hi/health/956247.stm
# - A Dutch woman in the magazine of Dutch
Supportgroup SVS, September 2000, Nr. 3: "My implants were ruptured during
removal, my doctor told me. That why he had thrown them immediately away. But than I do
not understand why the operation than took so long and he has been busy so long with
cleaning up, like my sister told me. I cannot ckeck it, but trusting it I do not ! Do they
really still think that we are retarded ?".
--
BODY-AWARENESS
Food-expert professor Leann Birch of the Pennsylvania State University warned in September
2000 that young children are not immune for the pressure on women to be thin. Even 5-year
olds were aware of their weight and thought about a diet. And in the UK the BBC reported
on 12 October 2000: "Women are obsessed by
their bodies". 'Negative influenced' by the few individuals of the
beauty-industry, making women start a desperate search-journey for 'alternatives' for
their bodies along the long road of (sometimes non-qualified) plastic surgeons,
private-clinics, who sometimes offer false hope based on $$$ ?
--
THE DEATH OF POPSTAR PAULA YATES: SILICONE IMPLANTS
Silicone implants had become fashionable with former tv-presenter Paula Yates among their
ranks. On 17 September 2000 40-year-old Paula Yates
(Horror of Boob op Victim) was found dead at her London home leaving behind four children.
After Paula Yates married Boomtown Rats singer-turned-businessman Sir Bob Geldof, she was
involved with INXS singer Michael Hutchence who died in Sydney in 1997. Cause of death ?
Paula Yates had larger-than-life silicone boobs and she was just earlier been treated for
depression at the Priory clinic in Roehampton. Mark Stephens, told BBC News 24: "Whatever
the circumstances, which are still unclear, our hearts have to go out to the
children".
--
CHEMICALLY ASSOCIATED NEUROLOGICAL DISORDERS
In 1996 government scientist Raymond Biagini, a research toxicologist at the National
Institute for Occupational Safety and Health and a leading platinum expert, proposed a
study to explore if silicone gel breast implants leaked toxic forms of platinum into
women's bodies, as some health professionals feared. The US government remained passive,
did nothing with the suggestion. Doing nothing and watching. In the spirit of Marcia
Angell, the proof of goverment's claim (anecdote), alleging being concerned with public
healthcare, came four years later. Because in the last months of 2000
the discussion switched to leaking platinum from breastimplants. The FDA 'suddenly' said
it needed more data to determine if platinum was a cause of the diseases of some of the
half-million women who had sued implant manufacturers. Dr. Michael R. Harbut, an
internationally-known expert in the diagnosis and treatment of environmental and workplace
diseases, came with a petition to the FDA with the request for action: a warning
statement: "In conclusion, specifically as to individual patients with
individual signs and symptoms, and generally, as to the mechanisms of toxicity and
hypersensitivity as outlined in this Submission, a compelling medical and scientific case
is made that platinum salts, as a residual contaminant in silicone gels and elastomers are
a probable factor, or co-factor, in a variety of the complaints and diseases presented by
women exposed to silicone gels and elastomers. These facts compel a conclusion that,
silicone gels and elastomers can cause systemic disease in humans" (16 Oct. 2000, Dr. Michael R. Harbut MD, MPH:, Chief of
Occupational and Environmental Medicine http://www.fda.gov/ohrms/dockets/dailys/00/oct00/102300/cp0001.pdf
)
# Asthma in patients with silicone breast implants
(Michael R Harbut, Brenda C Churchill - IJOH 1999; 3:73-82 )
http://list.mc.duke.edu/cgi-bin/wa?A2=ind9901&L=occ-env-med-l&D=0&P=14678
PETITIONS: PLATINUM
# - Marlene Keeling, President Chemically Associated
Neurological Disorders, submitted a petition, received by the FDA on 3 November 2000,
requesting that FDA revoke the implantation of silicone gel-filled breast implants for any
reason, and that remaining inventories of these devices in the United States be destroyed.
http://www.fda.gov/ohrms/dockets/dailys/03/Nov03/111903/03p-0530-cp00001-Exhibit-Tab-O-vol1.pdf
# - Public Citizen came with a petition for revocation
of breastimplants: "Citizen Petition for Revocation of Silicone Gel
Implants from market: The undersigned submits this petition to request the
Commissioner of Food and Drugs, revoke the implantation of silicone gel-filled breast
implants for any reason, in light of new research documenting the significant release of
platinum in a reactive valence from intact implants....."
http://implants.clic.net/tony/Keeling/index.html
http://implants.clic.net/tony/Keeling/01.html
--
POPSTAR TONI BRAXTON: EXPLOSION BREASTIMPLANT
While M. Deutinger et al. (Univ. Klinik für Chirurgie, Klinische Abteilung für
Wiederherstellende und Plastische Chirurgie, Wien, Geburtsh Frauenheilk 2000; 60: 440-445
) concluded that the risk of failing breast implants increases 10 to 15 years from
implantation, the sexy singer Toni Braxton in October 2000
missed the presentation of the Mobo Music Awards because one of her breast implants
spontaneous had exploded. In 2003 the Grammy-award winner Braxton stood in 'Aida' on
Broadway. During one of the evening-performances she didn't feel well during the break.
Mother of two Braxton fainted and had to stop the show. In the ER she told the doctors
that she felt tired, was quickly out of breath with a strange tightening feeling in the
breast. Diagnosis ? "heart disease, pericarditis, an inflammation of the heart
lining". Braxton, together with first lady Laura Bush, several celebrities and
fashion designers, decided consequently to support the 'Go Red for Women' campagne http://goredforwomen.org of the American Heart
Association. Tony Braxton: "We all have things we need to do for our
families and loved ones, and we keep ignoring our own discomforts, that's why I wanted to
spread the word: pay attention to what's going on with you. A moment to look at what's
going on in your health may seem like an inconvenience, but it just may save your
life". End August 2007 the rumour (National Enquirer) went round that Toni
Braxton had breastcancer in an early stage be treated with chemotherapy. Braxton wanted to
keep it secret and she herself denied the rumour: "After feeling something
abnormal uncomfortable in my left breast, I went in for a screening. I was very fortunate
that they did not find anything and I am in great health". In 2008 Toni Braxton
had the diagnosis 'high blood pressure' for which she received medication.
--
IMPLANTS: GREATEST CRIME AGAINST WOMEN
Professor Buddy Ratner of the University of Michigan: "The recent attention
given to breast implants and their relative safety is a sham perpetrated by the billion
dollar companies that manufacture these lethal bags and the plastic surgeons that put them
in. If the truth about these implants were to be known it would be revealed to be the
greatest crime against women in the 20th century. The reports are RIGHT ! They can't prove
a link to any known diseases because the disease that these women are getting is a NEW
disease with symptoms similar to many known diseases. But actually it's a reaction to
toxic chemicals that spread throughout the body. Silicone being only one of them".
http://acad.bioeng.washington.edu/590/BuddyLecture.pdf
--
TRILUCENT-COMPENSATION
End November 2000 it was reported that women who had
been forced to remove their soya-oil Trilucent implants would receive compensation, paid
by the suppliers, from £5,250 to about £15,000,- UK pounds depending on impact on their
health and/or a loss of income. The deal included more compensation in the future if a
women suffered from cancer or reproductive difficulties, mentioned in the government
warning. Women also was given the option of having the implants replaced free of charge
with other implants of a different material. Government Deputy Chief Medical Officer Dr
Pat Troop said that the UK Government was pressing European partner states to put implants
in a higher risk category to ensure implants were subject to tougher checks and clinical
trials.
--
BREAST IMPLANTS: AMERICA'S SILENT EPIDEMIC
(Ilena Rosenthal, Total Health for Longevity Magazine, November/December 2000, Vol. 22,
Nr. 6, pg 41-42, ) http://www.mercola.com/2001/jun/6/breast_implants.htm
--
`UNSAFE' HYDROGEL IMPLANT WITHDRAWN FROM SALE
Just a couple of years after coming onto the market, the UK Department of Health, after an
investigation by the Medical Devices Agency which found 'inadequacies' in the safety
assessments of the manufacturers, pulled hydrogel-filled implants off the UK-market in December 2000. The hydrogel implants proved to be
unreliable, the volume was subject to change (inside or outside), misformed implants,
safety / toxicity was not determined / ruled out, no long term studies.
# - 80% of hydrogel implants were inserted for
cosmetic reasons by private clinics. Products affected by the warning were: the France
made PIP hydrogel breast implant, supplied in Britain by Clover Leaf Products. 4,250 UK
women had received the implants, and the NovaGold implant, made in Germany and supplied in
Britain by Somatech Medical. About 250 women had received them since introduction in 1996.
# - Hydrogels used in other products (contact lenses,
medicines, food) were not affected by the warning, the Department of Health said. Dr Pat
Troop, the Government's deputy chief medical officer, said: "It must be
stressed that no definite health risk has been identified. At present there is no
information to indicate that there is any risk to women with these implants, or their
children. The recall is purely a precautionary measure, until the manufacturers have
addressed the Medical Devices Agency's concerns regarding their biological safety
assessments". The Department of Health: "There is no evidence to
suggest they should be removed from women who currently have them. The concern is only
with the way the safety of the hydrogel fillers has been assessed".
# - All filler materials are foreign to the body. In
the United States in 2004 about 11.9 million cosmetic surgical and nonsurgical procedures
were performed. Injection of fillers was the number 1 increasing cosmetic procedure in
2004/2005, with an increase of up to 659% of procedures compared to the year 2003. In 2006
the International Committee for Quality Assurance, Medical Technologies and Devices in
Plastic Surgery (IQUAM) in a position-statement (Indian Journal of Plastic Surgery, July
15, 2006, Regensburg, Germany) said: "Injections of permanent fillers in
relatively high volumes, especially hydrogels, have been reported to cause severe
irreversible damage and therefore have generated substantial concern", "IQUAM
recommends that permanent hydrogels should not be used due to the high incidence of severe
complications". http://www.iquam.org/archive/IQUAMConsDec_FINAL_July_2006.doc
Regarding hydrogel-filled implants, after the silicone-controversie and the
Trilucent-debacle, again followed ---Dutch Inspector general Herre Kingma's magic word
rather in certain ('positive' discriminating) cases--- "social unrest"
and lawsuits, since the motivation for Kingma for the Sylvia Millecam-investigation were
'media-reports' and consequently the 'social unrest'. The 'media-reports' about Sylvia
Millecam / Jomanda lasted about 1 month before Herre Kingma of the Dutch Healthinspection
of the ministry of Healthcare Hippocratical decided not to do nothing and not to stand by
watching but take action, to show muscles and deeds. Reports about silicone-breast
implants controversy have been showing up in the media since at least 1990 ? And Dutch
silicone support group SVS, which send many signals to Dutch politics, was founded in May
1992.
--
BREAST IMPLANT WEBSITES BIASED
Dr. Julian B. Gordon and colleagues at the Cooper Hospital University Medical Center made
study of 41 websites focused on breast augmentation. 57% of the websites were by Gordon
and colleagues not recommended because more than 50% did not discuss complications of the
procedures. The websites included photographs but 2/3 only posted good results. More than
80% of sites were "biased toward a particular surgical technique". "No
site met the criteria of accurate, complete information on the surgical procedure of
breast augmentation" (January 2001, journal
Plastic and Reconstructive Surgery).
--
HURRAH ! AND THE WINNER IS...
While J. F. Winther found no causal association between silicone breast implants and
neurological disease (Acta Neurologica Scandinavica, February 2001 ), on 6 February 2001 care worker 26-year-old Kerry Froggett won a
breast implant operation (£2,500,- UK pound) on the UK Joel Breakfast radio show (Key 103
radio station's JK). According to her mother, who had written to the radioshow, Kerry had
lost her figure after child-bearing and was depressed. Breastimplants would for certain
(therapeutical) help her.
--
INDONESIA: SILICONE INJECTION NIGHTMARE
Professor in surgery dr. Dicran Goulian Jr. had in 1960 started experiments with silicone
injections. While Dow Corning CEO Richard A. Hazleton retired on 1 March 2001 and was
succeeded by Gary E. Anderson, Don Fry in the Straits Times on 11
March 2001 reported: "They wanted perfect noses, fuller lips and
voluptuous breasts. They ended up with grotesque snouts, disfigured lips and breast
cancer. Thousands of women in Indonesia have become victims of a trendy beauty treatment
called the silicone injection, long outlawed in most developed countries. Mrs Tike
Suhariadi, 33, had her shots at a beauty parlour a year ago. 'I wanted my husband to stay
attracted to me,' she said. 'For less than 400,000 rupiah (AUS$ 80 ), I could have a new
nose and be able to wear a low-cut dress.' Two months later, her nose started to go red
and swollen and painful hives appeared on her breasts. Now every time she looks in the
mirror, she cries. She may have to surgically remove her breasts because of severe
infection. Thousands of women have been lured by door-to-door salespeople who showed them
photographs of beautiful celebrities". Quackery ? Go anti-quacks ?
CLEOPATRA'S NEEDLE: THE HISTORY AND LEGACY OF SILICONE INJECTIONS
(M. Sharon Webb, M.D., PH.D, Food and Drug Law, Prof. Peter Barton Hurr, January 1997 )
"Scientists and science fictionwiters alike have fantasized that an entire
parallel universe could be built on silicone rather than carbon base" Philip Hilts)
...(...)...Why do good people do bad things ? This philosophical question has preoccupied
religious and secular moralists for millenia. In this case, a close reading of the texts
of the times reveals a scientific and technical optimism that suggests that participants
in the silicone fluid project genuinely thought that they were doing good rather than
bad.......Only after scientists began to react upon the human consequences of technical
progress was this hubris challenged...(...)...The history of experimentation with silicone
injections shows the importance of regulation in curtailing irresponsible practices. The
medical use of silicone fluid demonstrates that the informal moral and social controls
that serve to protect patients do not always work.....". http://leda.law.harvard.edu/leda/data/197/mwebb.pdf
# - DICK GOULIAN:, had started in 1960
experiments with silicone injections. In July 1989
surgeon dr. Dicran Goulian Jr. ---Professor of Surgery, the former director of training
for plastic surgery, the longtime Director of the Division of Plastic Surgery at the New
York Hospital-Cornell Medical Center who in 1960 started experiments in laboratory with
silicone injections--- married Nancy Beth Knauer, a lawyer in private practice in New
York. Dow Corning's director Center for Aid to Medical Research Silas A. Braley said in
1993 about the experiments in that past: "...There were no tests for
implant materials...All we could do was put it in and look and see what happens. There
were no standards.There was no protocols..There was nothing". For the women there
was only 'May the force / God be with you' ? On 28 April 2008 the Division of Plastic
Surgery had a golf-outing honoring Dr. Dicran Goulian 80th birthday.
--
PETITION COMMITTEE EUROPEAN PARLIAMENT
On 21 March 2001 the Petition Committee of the
European Parliament, under chairmanship of Eurosommisioner dhr. Erkki Liikanen from
Finland, again came together for further deliberation about silicone implants. After the
openingwords of mr. Liikanen followed several fierce speaches, in front of the commission
members MEP's who made notes and asked questions, for good en also preventive European
guidelines of these doubtful medical devices. Everybody agreed that there were many and
serious problems by implants. The representative of the women-Supportgroups --Marlou
Boots (Holland), Christine Williamson (UK), Cosima Meyer (Swiss) en Ingeborg
Vurgun-Kent (Germany)-- were officially invited to defend their point of view ('option
2': ban) in Brussel in 5 minutes speakingtime (!! a great realistic honour ?), and to
inform the Committee about the situation in the several European memberstates. The
American lawyer Melissa R. Ferrari, working in Germany involved in US Dow-claim
procedure and representative of many sick women, hadn't received speakingtime despite
earlier made agreements. One could wunder why not since lawyers mainly work with
'evidence' ? Mr. Liikanen declared that the European Commission was preparing an
announcement about the information-provision regarding the possible consequences of
silicone implants for cosmetic purposes. Further was suggested to the Members of the
European Parliament:
- to include warnings in breast implant advertisements,
- a register for putting down every silicone implant operation in Europe,
- a register for qualified surgeons and
- to do more study into the risks of implants,
because the public had to be made fully aware of the dangers. To forecome 'media-signals'
and consequently 'social unrest' ? After the meeting of the Euro-Committee there were many
reporters and photographers present in the meeting-space from all countries. Except from
the Netherlands. They were (in freedom of choice) not interested and rather watched ?
http://news.bbc.co.uk/1/hi/health/1232441.stm
http://www.publications.parliament.uk/pa/cm200001/cmselect/cmhealth/308/1032202.htm
http://www.telegraph.co.uk/news/main.jhtml?xml=/news/2001/03/22/nimp22.xml
--
HARVARD: SUPPORT TO BREAST IMPLANTS
On 25 March 2001 researchers from Brigham and Women's
Hospital and Harvard Medical School published a (data)study, review of the medical records
of 288 women who had had or still had breast implants. There was little evidence that
silicone breast implants triggered production of an antibody, linked to cancer and other
diseases, thus the study. And no increased risk was found for an immune system abnormality
called monoclonal gammopathy of undetermined significance (MGUS). Only 5 had an excessive
production of an antibody protein in blood plasma cells and 9 cases of MGUS were reported
(Dr. Elizabeth W. Karlson, 26 March 2001, Archives of Internal Medicine).
http://www.healthyme.md/viewArticle?ID=58771
http://app1.chinadaily.com.cn/star/2001/0329/he15-3.html
--
LOOKING GOOD FOR NATION'S GLORY
In 1982/1983 the American Society for Plastic and Reconstructive Surgery (ASPRS) promoted
breastenlargement, suggesting that a bigger cup-size would also lead to greater
self-esteem at women, and small breasts were 'deformities', according to ASPRS. On 26 April 2001 it was revealed that a number of English
female soldiers had had breastenlargement in the Royal Haslar military hospital in
Portsmouth. Paid for by the Ministry of Defense. Other breastenlargement operations could
have been conducted at militairy departments of the National Health Service
(NHS)-hospitals, which already a.o. in 1994 took care of the breastimplants foor the
fashion model Fiona McAndrew betaalden to become a 'page 3 girl': "We have
got no central records of them", an Ministry of Defense spokesman said: "Medical
necessary" was the justification because the implants were only given to soldiers
with "repeating en chronic psychological troubles" what kept them from
being effective soldiers. Breasts influencing effectiveness of a soldier ? Marcia Angell:
Where's the science ? Vice-Statesecretary of Defense Iain Duncan Smith found the course of
things ("second front") rediculous: "waisting money to matters
which will have little effect on the fighting-capability, although they do raise the
moral". Repeating history ? Same (human) content, different outer (Divine) jacket
/ box ? In 1945 in Japan free silicone was injected in the breasts of bargirls and girls
of pleasure to the American soldiers, stationed there, 'satisfied' so that they could
remain 'effective' soldiers ?
THE MILITARY: FREE BREAST IMPLANTS
Forums.Military.com (21-01-2006 ): Is it true that you can receive free cosmetic
surgery through military doctors ? My wife would like to know how to receive the 'free'
breast implants from military / Army doctors ?: "Yes, it's true. You can
get some cosmetic surgery done by military doctors almost for free. I say almost, because
the people I personally know that have gotten things done (liposuction and tummy-tuck) had
to pay for the anaesthesia. First, your wife must go to her primary care doctor and
discuss it with him/her to get all the information available. If your area is anything
like here (Hawaii - Tripler Army Medical Center), then she will have to go on a waiting
list. When she gets to the top of the list, she gets it done. It's that simple".
# Modern Medicine and its Military Links:
Interview with Alan S. Levin, M.D., a brave medico and self-declared "quack".
Dr. Levin provides a rare insider's view and courageously speaks "on the
record". This interview is a unique document, clarifying some of the past few
decades' little-known and little-understood bouts of military and medical madness.
http://www.mold-survivor.com/modern_medicine_and_its_military.html
--
BREAST IMPLANT CANCER LINK
On 26 April 2001 National Cancer Institute (NCI)
researcher Dr. Louise Brinton revealed (in the New York Times) preliminary results of
study involving nearly 13,500 women who had breast implants before 1989. Their progress
and health in the following 12 years were compared to other female plastic surgery
patients and compared to the general population. Breast implant patients suffered
significantly higher rates of cancer. Women in the implant group were 3x as likely to die
of diseases of the respiratory tract, primarily lung cancer, and 2x as likely to die of
brain cancer. And scientists said saline replacements, not just the controversial silicone
ones, were also being linked to tumours. 'More research was needed' (Brinton LA, 'Cancer
Risk at Sites Other Than Breast Following Augmentation Mammoplasty', AA Epidemiol 2001;11
248-256 ). Although the study only showed a statistical link, Diana Zuckerman: "I
see this as a warning ... I think this is very alarming". David Hinchliffe, the
Labour MP for Wakefield and chairman of the health select committee --which a little
earlier recommended a surveillance system to monitor the possible side effects of breast
implants-- said women before having breast enlargement should "think very
carefully".
# - End June 2001 a new bill urged the FDA and the
National Institutes of Health to step up research into the possible negative health
effects of breast implants. "Legislators cited 3 new epidemiologic studies, one
finding an increased incidence of lung and other cancers in 13,000 women who had either
silicone or saline implants" (Healthcare Purchasing News).
--
UK INDEPENDENT REVIEW GROUP MEETING
The 80,000 patient information booklets of the UK Department of Health which were
originally printed had all been sent out. The document was being revised prior to
reprinting. On 14 May 2001 the UK Independent Review
Group had a meeting to update the recommendations. Professor Shanklin and Dr. Diana
Zuckerman had submitted to the UK Independent Review Group several reports and letters
were also received from members of the public. Also IRG members in the meeting provided
summaries of recent published literature. "While there continue to be concerns
about the use of expert witnesses and the validity of scientific evidence in the United
States of America, the position is very different in the UK, where measures are in place
to ensure that the courts have control over these", the UK Independent Review
Group concluded.
http://www.mhra.gov.uk/PrintPreview/DefaultSP/CON2032830
http://www.mhra.gov.uk/Safetyinformation/Generalsafetyinformationandadvice/
Product-specificinformationandadvice/Breastimplants/Siliconegelbreastimplants/
IndependentReviewGroup-siliconegelbreastimplants/Toxicityofsilicones/index.htm
--
DOWN UNDER: BREAST IMPLANT SETTLEMENT
End May 2001, while most of the affected women
worldwide were still fighting for compensation from Dow Corning, the Sydney Morning Herald
reported that more than 3,000 Australian women would each receive up to £22,000
compensation for suffered severe health disorders from ruptured silicone gel breast
implants. On 27 August 2002 a court heard that Bristol-Myers Squibb Co. had reached an out
of court settlement with a group of Australian women over faulty breast implants. And on
11 September 2002 the Sydney Morning Herald reported that thousands of Australian women
received individual payments of up to $120,000 after having sued the Dow Corning
Corporation over faulty silicone breast implants. About six New Zealand women had received
the Dow Corning silicone breast implants in Australia. One of them, Kathy Rogers,
suffering caused by Dow's silicone gel breast implant, attacked the size of the payout.
--
FDA APPROVAL: (NEW) SILCIONE IMPLANT TRIAL
End May 2001 the FDA approved a US clinical trial, a
multi-centre study, for the silicone-filled McGhan Style 410 breast implant which was
already in use in Europe. 220 patients would have augmentation and another 220 breast
reconstruction. Evaluation would continue for 10 years after surgery (Biomedical
Materials, 1 June 2001 ). This while the National
Institute of Health found that it takes 7 to 15 years before silicone-related diseases to
show up, and latency periods of more than 30 years before disease develops were possible.
--
EUROPEAN ANNOUCEMENT: NEW GUIDELINES
GREEN LEFT "STOP USE OF SILICONE IMPLANTS"
The European letters of request committee concerning siliconen breast implants decided to
draw up a design-resolution (Catherine Stihler, reporter http://www.cstihlermep.com , Ria Oomen-Ruijter
(Dutch CDA-party)), in which the STOA-report (May 2000 ) with 'option 3' (no complete ban)
was included. The design-resolution was eventually offered to the European Parliament on 13 June 2001 for approval among others: "All
patients must have free access to extensive and by independent experts drawn up
information".
# - Erik Meijer (GUE/NGL) (The Netherlands, Green
Left-party): "...In the circumstances, it is better to stop using the
silicone implants and to focus on developing alternatives. France has now banned the
implants, but other Member States are wavering and indecisive. I agree with those who
submitted the petitions that silicone breast implants should not be used until they have
been proved not to be harmful....". http://europa.eu.int/constitution/futurum/documents/speech/sp130601_2_en.pdf
# - The new European Guidelines were not brought out
via the official channels. Two months after the eventual official signing of the
resolution (15 november 2001 ) "Announcement of the committee concerning communautary
and national measures in reference to breastimplants", the Dutch Supportgroup SVS, Marlou
Boots, in 2002 informed the Dutch government, media, docters and about 100 hospitals
where plastic surgeons worked, about the new European Breastimplant Arrangement. Reason ?
Dutch media didn't react at all on the information send by Dutch Supportgroup SVS. The
Dutch media kept waiting on a 'unimpeachable judgement', the redemptive word: the
offical pressrelease. One hadn't been informed yet by the Dutch Ministry of Healthcare,
Minister Els Borst.
# - Gerlach Cerfontaine, president-director of Dutch
airport Schiphol http://nl.wikipedia.org/wiki/Gerlach_Cerfontaine
in his speech 'Governance in the Dutch western area Randstad' at the acceptance of this
function of Professor in the Faculty of Law University Utrecht: "At my
transition to the Academical Hospital Utrecht (AZU) I got a change during a very dynamical
phase of radical changes in organisation and the movement to the Uithof to put together a
winning team: 'I learned a good many from Els Borst about medical ethnical and
incorruptible dealings".
# - The new European Guidelines aimed at strengthened
application of the Guideline of 1993 concerning breastimplants, and aimed mainly at good
information, follow-up and supervision, controle and security of qaulity and study. The
European Committe emphasized the importance of suiting information to women who considere
silicone implants and advised the Memberstates to take measures. In the resolution a
national plastic implants register was obligated for all European countries. http://www.bmj.com/cgi/content/full/323/7323/1207/a
# - England had since 1993 a National Breastimplant
Register. On 31 January 2000 (Dutch cabinetstandpoint breastimplants, in reference to the
advice of the Dutch Healthcouncil) Dutch Minister of Healthcare Els Borst in the one
world, Dutch Parliament, had yet underlined the importance and the role of an
implant-register: "In the outline of post marketing surveillance (PMS),
traceability, recall and vigilance in the devices-provision in healthcare". But
registrating, in the other world, reality, was stopped in August 2002 because one didn't
get subsidy anymore from the Ministry of Healthcare. Contrary to the (new) guidelines /
resolution of the European Parliament. In February 2007 the Dutch Orthopaedic Association
for a national register for prothesis. Why ? Because it appeared that registration in the
Netherlands had difficulties to get started. One rather did nothing and watched ?
--
CANADIAN CRIMINAL INVESTIGATION: MENTOR
In the US, Government documents, obtained by ABC News, showed that since 1986, the FDA has
repeatedly accused manufacturer of implants Mentor of inadequate quality controls. A
criminal investigation of Mentor was closed in 2002. With in the back of the mind the
Canada breast implant cover-up concerning Health Canada / Bristol-Myers (Meme implants) in
1990 and the book 'A woman in my position; the politics of breast implant safety' by Linda
Wilson, the Canadian Broadcasting Corp. (David McKie; Sandra Bartlett) reported on 25 June 2001 that an investigation found that Mentor, one of
the two biggest companies in implant business, might have knowingly allowed faulty breast
implants onto the market, forcing women to go under needless surgeries. The implants made
Canadian women too sick to work so they had to apply for long-term disability. Women from
4 provinces (Ontario, Saskatchewan, Quebec and British Columbia) had filed class-action
suits against Health Canada.
--
DUTCH ACTRICE SYLVIA MILLECAM DIED
Sylvia Millecam died on 20 August 2001. On that same
day ---with in the back of the mind the words in the advice of the Dutch Healthcouncil
(October 1999 ) to the Dutch Ministry of Healthcare, which Minister Els Borst claimed to
subscribe to, streching to 'a serious approach of the silicone implants problems'---
became known that: "The Dutch Ministry of Healthcare has made 6,7 million
Dutch gildens available for study into the chronic fatique-syndrome, also called ME. The
decision of the Ministry is seen as a recognition of the disease. 'Up to now ME-patients
were not always taken serious', thus fund-director Jacqueline van Male" (Dutch
newspaper 'De Telegraaf', 20 August 2001 ). Marlou Boots: "If Sylvia
Millecam was called back on time when her kind of implants were taken of the market, she
might have been alife today" (SVS-Magazine 'De Stille Kracht', 10th year, March
2003, Nr. l ). Marlou Boots: "Sylvia Millecam died the silicone-death
!" (SVS: magazine 'Stille Kracht' September 2003, nr.3 ).
--
BRISTOL-MYERS: DUPONT'S TEFLON
Bristol-Myers Squibb in October 2001 took over the
medicinedivision DuPont Pharmaceuticals for $7.8 billion. Wikipedia: Bristol-Myers
Squibb was involved in an accounting scandal in 2002. Result ? A $150 million settlement
with the Justice Department. In a report submitted by Iraq president Saddam Hussein to the
United Nations shortly before the 2003 invasion of Iraq, it was revealed that DuPont had
participated in Iraq's nuclear weapons program. DuPont has not faced any sanctions because
of this. In July 2006 a criminal FBI investigation of Bristol-Myers Squibb was made
public.
# Whistle-blower: DuPont knows Food-Packaging Risk
(Jack Kaskey, Bloomberg News, 17 november 2005 )
"DuPont Co., the third-largest U.S. chemical producer, is tainting candy, butter,
popcorn and baked goods with a potentially cancer-causing chemical that seeps out of
grease-resistant packaging, a former company scientist said yesterday....". http://www.mindfully.org/Plastic/Teflon/Zonyl-DuPont-Risk17nov05.htm
# Multimillion dollar Penalty against DuPont sets a record: DuPont fined for hiding
Teflon Dangers
(Randall Chase, The Associated Press, 15-12-2005 )
"DuPont Co. has agreed to pay $10.25 million in fines and $6.25 million for
environmental projects to settle allegations by the Environmental Protection Agency that
the company hid information about a toxic chemical used to make the nonstick coating
Teflon....."
http://www.implants.clic.net/tony/Ant/V/20.htm
http://www.law.com/jsp/article.jsp?id=1134554714168
http://www.glrc.org/story.php3?story_id=2875
# Oral Surgery: E-PTFE Implants / Membranes
"ETFE is short for "Ethyleen-tetrafluorethyleen copolymeer", this is a
copolymer of ethen and tetrafluorethylan (the monomer of PTFE or TEFLON. ETFE was first
brought onto the market in 1972 by DuPont, onder the brand Tefzel..". http://nl.wikipedia.org/wiki/ETFE
# Biocompatibility of TEFLON-coated Protheses
The first implantation of bulk Teflon into the dog peritoneal cavity was reported in
1949 by Leveen and Barbario. Teflon has been used as a solid implant in cardiovascular
surgery (e.g., cardiac valves, vascular patches and catheters), orthopedics (e.g., hip
prostheses), facial surgery (e.g., maxillary and orbital implants), and neurosurgery
(e.g., dura mater implants, derivation valves).... http://www.nanomedicine.com/NMIIA/15.3.4.3.htm
# Dutch Plastic Surgeons 'Het Gooi': E-PTFE
"e-PTFE is short for expanded polytetrafluoroethyleen. It is a soft and porous
artificialmaterial that has been used already dor years in for example vascular surgery.
The material has recently been made suitable for use in plastic surgery. With e-PTFE deep
wrinkles in certain parts of the face can be filled up with lasting result. After a local
anaesthesia two small openings are made in the skin, after which the e-PTFE material will
be put in. The effect is visible immediately". http://www.plastischechirurgie-hetgooi.nl/Behandelingen/Gelaatsverjonging/e-PTFE/body_e-ptfe.html
# Comparison between Textured Silicone Implants and those bonded with Expanded
Polytrafluoroethylene (E-PTFE) in rats
(Acta Cir. Bras. vol.22 no.3 São Paulo May/June 2007 , Douglas Haddad Filho, et. al.)
PURPOSE: Comparison of the inflammatory reaction promoted by textured silicone implants
and that caused by the implant bonded with e-ptfe. CONCLUSIONS: The acute stage of the
inflammatory response was more severe and irregular in the silicone implant; both the
silicone implant and the silicone bonded with E-PTFE promoted chronic inflammatory
reaction and weak foreign body inflammatory response. These reactions were greater in the
silicone implant group. http://www.scielo.br/scielo.php?pid=S0102-86502007000300006&script=sci_arttext
--
- SILICONE TIME LINE
--
NO DATA: THUS OKAY ?
Chlorotrimethylsilane also known as Trimethylsilyl chloride. Specific terms for
Organosilicon compound: Silanes, Siloxanes, Trimethylsilyl Compounds
DUTCH HEALTH COUNCIL: CHLOROTRIMETHYLSILANE
(report Dutch Expert Committee: committee of the Health Council of The Netherlands, 15 November 2001 )
Chairman Dutch Health Council, prof.dr. J.A. Knottnerus: "In 1993 the
Statesecretary of Health, Welfare & Sport, on behalf of the Minister of Social Affairs
& Employment, requested to derive health-advice-values on behalf of the protection of
professionally exposed people to substances. The chairman of the Dutch Health Council (GR)
thereby founded on 1 January 1994 a GR-committee which followed up on the work of the, by
the Minister instituted, advicecommission Workinggroup of Experts (WGD):
"Chlorotrimethylsilane is used as an intermediate for silicone fluids, as a
silylating agent. Because of the high reactivity, chlorotrimethylsilane must be
manufactured, stored, and used in airtight, highly specialized installations",
"The committee's conclusions are based on scientific publications prior to March
1998", "No toxicological data in humans were found in the literature",
"There are no data from repeated dose toxicity studies", "There is no
information from repeated dose (including reproduction toxicity and carcinogenicity)
studies. Based on the genotoxicity data, the committee does not consider
chlorotrimethysilane to be genotoxic", "The Dutch Expert Committee on
Occupational Standards considers the toxicological data base too poor to justify the
recommendation of a health-based occupational exposure limit for
chlorotrimethylsilane"
# ACUTE TOXICITY - "The acute toxicity of chlorotrimethylsilane is high after
exposure by inhalation", "When exposed to nearly satured vapours, all exposed
female Sprague-Dawley rats died within twelve minutes", "Conclusion: Based on EC
criteria, chlorotrimethylsilane would be classified as toxic if swallowed and as harmful
in contact with skin".
# CARCINOGENICITY STUDIES - "Conclusion: The toxicity (including reproduction
toxicity and carcinogenicity) following repeated dosing of chlorotrimethylsilane cannot be
evaluated because of lack of data. Although chlorotrimethylsilane showed some carcinogenic
potential in the A/He mouse lung tumour model, the significance of this finding is
questionable........"
http://www.gr.nl/pdf.php?ID=273
http://www.ehponline.org/docs/2001/109p1095-1101luu/abstract.html
--
DUTCH FAMILY MAGAZINE -Vs- SVS
In the middle of the Sylvia Millecam controversy, the fnal-editor of Dutch family magazine
'Margriet' decided to publish an article in Margriet nr.45 in 2001
'100 Questions Plastic Surgery' with answers concerning silicone of Dutch plastic surgeon
dr. Gijs van Selms (Lucas/Andreas Hospital): "Silicone are safe, not
causing disease, never been proven, no risks for children, last for 15 - 20 years".
Even replacement of used-implants was mentioned. But they were cleaned first, the plastic
surgeon / Margriet made its readers believe. Reaction of Marlou Boots / Dutch Supportgroup
SVS (6 December 2001 ) to magazine Margriet: "Remarkable misleading,
perilous fairytales and absolutely forbidden !", "A remarkable hypocrit way to
go about with the oath of Hippokrates", "Margriet can just like that make future
silicone victims of readers, do you realize that ?". Marlou Boots asked for a
rectification. Answer magazine Margriet: "The subject breastimplants for
the moment does not fit in our planning".
# - Dutch book "Looking for Sofie" -
explorations of a mother after the death of her daughter: "In Dutch
magazine 'Margriet' (nr. 20, 2002 ) Margriet Hunfeld wrote about her findings during her
search-road to Sofie, which made her end up at psychics, a psychoscopist, at Jomanda. It
gave her just disappointments". http://www.vook.nl/gelezen_detail.cfm?seq=238BACFB-0330-4843-B1BF83E5F51FE14B
# - A Dutch scientist once let know that the network
of the Dutch quackbuster 'Association against the Quackery' (VtdK): "has
been put up many times better, than somebody dares to hope. There are squealers in the
most hospitals. People who hold a lecture for xxxxx are sometimes approached by the
professor to not do so. The Dutch newspaper Parool is completely in hands of the quack,
they can write what they want. The same for magazine Margriet".
--
IMMORAL SCIENCE ON TRIAL
Or immoral individuals (hidden behind the outer jacket / box of 'the' science) on trial ?
Marcia Angell in her book 'Science on Trial': "The scientific method is
always the superior, if not in fact the only approach". When research scientist
Andreas Toupadakis accepted a permanent, highly paid, classified position at Los Alamos
and Lawrence Livermore National Laboratories (LLNL), he had certain believes about his new
work. But actually working in the laboratory he realized that hose believes had been an
illusion. His conscience didn't allow him to work for the development or maintenance of
nuclear weapons. Andreas Toupadakis resigned at LLNL in January 2001: "I
believe that if a foundation or institution is corrupt you must wash your hands and
withdraw from it". On 31 December 2001
Andreas Toupadakis wanted to tell the world his story: "Immoral science and
my nuclear odyssey" - The (Other) "World behind the Security Fence:
An Appeal to all Scientists Worldwide". Since spring 1991, while the breast
implant issue being in the news almost daily, Andreas Toupadakis worked for Dow Corning:
"I lived in the place of proprietary information and secrecy for profit",
"I realized that everything there was done for profit and not for the wellbeing of
humans. The vision of the company was to put a deodorant in the hand of every African and
Asian citizen. I was shocked to recognize their plans while at the same time they talked
about integrity. By then, I was really disappointed about being a chemist". After
two years Andreas Toupadakis left Dow Corning: "I was providing my skills
to immoral science, helping the company make profits at the expense of the uneducated
public". http://linkage.rockefeller.edu/wli/reading/toupadakis1.html
Marcia Angell: Where's the science ?
--
REGULATIONS: INCOMPETENT SURGEONS
The BBC on 1 January 2002 reported tighter
Governmental regulations being drawn up for doctors practising cosmetic surgery privately
to prevent patients being left in agony by incompetent surgeons. The UK National Care
Standards Commission was to be introduced in April 2002. Margo Cameron of Glasgow,
Scotland (Silicone Support Group UK) had liquid silicone injected into her lips. A surgeon
failed to warn that silicone was not licensed to be injected in the lips because of
dangerous side effects. Margo Cameron: "The surgeon jokingly said that the
only side effect I could suffer was that as I got older I might have a wrinkly face but
would have permanently luscious lips, which of course suited me fine". http://news.bbc.co.uk/2/hi/health/1731910.stm
--
DUTCH RIVM-STUDY: FALSE HOPE
In 1997 a team of the Louisiana State University and the Tulane University had reported
the existence of a discovered link between implanted women with high numbers of
anti-polumer anti-substances (an indication for immunesystem problems), and of women with
serious a-typical autoimmune symptoms (Garry, et al, Lancet, February 1997 ). On 26 March 2002 the report 'Study to the presence of
antipolymer antibodies in a group of Dutch women with a silicone breast implant. Part II'
appeared of the Dutch Governmental Institute for Public Healthcare and Environment (RIVM www.rivm.nl ). The RIVM-study concerned the possible relation
between the presence of antipolumer anti-substances (APA) and healthcomplaints at women
with a silicone breast implant. Conclusion ? No relation between the APA-value and the
presence of healthcomplaints. Member of the RIVM Supervision Committee was prof.dr. J.A.
Knottnerus, the chairman of the Dutch Healthcouncil. Reaction Dutch Supportgroup SVS /
Marlou Boots (4-4-2002 ) to the Dutch Ministry of Health VWS on the RIVM-report: "That
this study would not have the (by us) aimed effect, namely finding an answer to the
question 'why are these women so sick', was already prior known. Again there has been
looked at rotten apples for rotting pears. Again the women have been made happy with a
dead bird, false hope has been awoken and again they have fallen between two stools. A
very very sad case !", "It is about time that there really be listened to the
peoples themselves, who out of the pratice can deliver the 'field-data', in stead of
staring blind at and obstinate holding on to statistics and (out-dated) protocolls which
are not realistic or aimed at practice. It is about humans, about human lifes !...In the
hope that you can see the seriousness of the problems I trust onto a serious approach from
your side".
--
MARLOU BOOTS: ASIDE
In March 2002 an article 'Terriers' (by Femke van
Zeijl) was published in the Dutch magazine 'Opzij' (Aside) about Marlou Boots and Dutch
Supportgroup SVS. Marlou Boots: "...The most heavy is yet that the women
you know via the Supportgroup die becaise they have turned into a wreck by their implants.
As not so long ago somebody who would come home from the hospital after her somethingth
operation, unfortunately came home in a coffin. Or three years ago when an even younger
woman committed suicide, because she would not go on with the pain and her deformed
body", "At everything I think: how long do I still yet have ? When I go under,
it is fighting, and not waiting helpless". Not passive, awaiting and watching ?
Human lives, humanity -above- Divine $$$ ?
--
DUTCH GOVERNMENT SUBSIDIZES BREASTIMPLANTS
The Netherlands Foreign Investment Agency ** (NFIA) http://www.nfia.com
, part of the Dutch ministry of Economic Affairs, "facilitates / assists a.o. US
companies' direct investments / in expanding their activities in the Netherlands. The NFIA
offers support completely without costs". A service directed to inform the
businesses about the 'progressive position' which the Netherlands holds as a
companylocation in Europe. Dutch Supportgroup Women Silicone Implants (SVS) / Marlou Boots:
"Yes, the rumour is correct ! Our 'kind careful' government has indeed subsidized
the capacity-expansion (from 80.000 to 120.000 implants a year) of the largest producer
with a marketshare of 70%. The department Foreign Investment Agency of the Dutch ministry
of Economic Affairs in The Hague has about taken that company 'by the hand', thus a
spokesman of that company. Our taxmoney ! Subsidy from our taxmoney mark you ! While the
maincompany in the US over 2001 had a turnover of 321 million dollar and the women in the
claim-procedure have been put off with a tip of $ 750,- by that same company. CAN it be
more crazy ? Again the MAMMON goes above the HUMAN ! Well, that actually did not happen
already also in the past, think about the polyurethan coated prothesis, the Trilucent soya
prothesis and another 3 or 4 other things which have almost disappeared silently of the
market. How many victims would they together already have made here in the Netherlands
?" (SVS''s contactmagazine, March 2003, Nr.l )
--
** NETHERLANDS FOREIGN INVESTMENT AGENCY (NFIA)
# - Roger Kleinenberg worked between 1985-2000 for the
Ministry of Economic Affairs at various departments, such as the Chemical Industry
department, Netherlands Foreign Investment Agency, Research and Development
department and the Home Office for Science & Technology Attachés. In 2001 he was
posted by the Ministry of Economic Affairs as the attaché for Science & Technology in
the USA and Canada at the Royal Netherlands Embassy in Washington DC: http://www.twanetwerk.nl/upl_documents/syllabus_octrooi.pdf
# - Roger Kleinenberg, Attache for Science and
Technology, Dutch embassey Washington TWA Office http://www.twanetwerk.nl
TWA-themeday 'Innovative technologies for a Bio-based economy'. Marloes Telgenhof has the
function / post of Embassy secretary for Researchmatters at the Permanent Representation
of the Netherlands at the European Union aswell as the post of Technical Scientific
Attaché for Europe. Permanent Representation Netherlands (EU-Brussel) Email:
Brussel@twanetwerk.nl http://www.twanetwerk.nl/default.ashx?FolderId=614
# - Although busy with the day-to-day business of
participating in a second EU Presidency, Mr. Roger Kleinenberg took some time out
to meet with bridges. Mr. Kleinenberg discussed the recently concluded Netherlands EU
Presidency (July 1 - December 31, 2004 ) and commented on the current Luxembourg EU
Presidency http://www.ostina.org/html/bridges/article.htm?article=1228
# - JOB-DESCRIPTION: "Senior Secretarial
Administrative Employee / TWA Office, Department/post: Embassy Washington, Financial
Management and Planning office Washington and office Silicon Valley, Application
can be directed to....".
http://www.netherlands-embassy.org/files/pdf/TWA_Office_manager.pdf
http://64.233.183.104/search?q=cache:UhblC_YkTMMJ:www.netherlands-
embassy.org/files/pdf/TWA_Office_manager.pdf+%22Secretarieel+Admini
stratief+Medewerker+/+TWA+Office%22&hl=nl&ct=clnk&cd=1&gl=nl&ie=UTF-
# - SILICON BIOTECHNOLOGY
(Anouschka Versleijen, Roger Kleinenberg and Hans van der Nat - 1-9-2003 )
"Abstract: ....Silicon Biotechnology, Genencor and Dow Corning....and the
knowledge of Dow Corning in the area of Si-chemistry.....". http://www.twanetwerk.nl/default.ashx?DocumentId=1532
# - TECHNOLOGY FOR PREVENTIVE HEALTHCARE IN THE US
Roger Kleinenberg and Bart Sattler 17-10-2006 - ....Biotechnology, Systems biology... in
Seattle, Systems Biology tries to unite biology in vivo with the date from biology in
silico...Pharmacogenomics, Farmacogenetica is the research terrritory that decribes the
genetics of the respons on medicine. The research is aimed at the treatment of patients
with custom-made medicine based on the unique genetic make-up... http://www.twanetwerk.nl/default.ashx?DocumentId=7174
# - "FIDDLING WITH FIGURES - Officials of
Dutch cities Delft, The Hague, Zoetermeer and Leiden who work for the Dutch regional
lobbybureau 'West-Holland Foreign Investment Agency' (WFIA) have for years fiddled with
figures about foreign companies...(...)...According to director Wapenaar other
acquisationbureau's like the Dutch national NFIA work in the exact same manner. A
spokesman for this Netherlands Foreign Investment Agency denies that 'We work with
prognosis, yes, but we always make that clear'.....". http://forum.nederlandtransparant.nl/forum/viewtopic.php?p=
1313&highlight=&sid=add57add8e4e493fc7ec1b1fc62e2127
# - Marlou Boots / SVS: FIDDLING - "And
than also the fiddling with the registration of breastimplants ! According to the latest
figures 10,612 sold implants are 'missing' ! The profitable dark circles thus seems even
bigger than suspected. And we women are again outlawed. At disasters with proven unsound
implants nobody can be tracked down, thus nobody can be called back" (SVS''s
magazine, 10the jr., March 2003, Nr 1l )
# - "LYING LOBBYISTS 15-04-2006 The Hague -
Foreign companies come with far less employees to this region than officially is
mentioned. The Dutch regional lobbybureau 'West-Holland Foreign Investment Agency' (WFIA)
for years fiddles with figures. That appears from a research of this newspaper...".
http://www.ad.nl/denhaag/article276555.ece
http://www.ad.nl/denhaag/stad/article300948.ece
# - Dutch political parties CU/SGP: "'WFIA
MANY TIMES IN THE NEWS' 15 april we asked written questions to M. & Alderman, the days
after the one after the other comment with astonishment appeard in the press. What the
seriousness is of this case will appear the next days and weeks. Below the multiple
reactions, also from 2002, 2003 and 2005!!!! Already 12 articles from the press...."
http://zoetermeer.christenunie.nl/k/6334/news/view/57414/44682/WFIA-vele-malen-in-de-pers-ChristenUnie-SGP-was-er-snel-bij.html
# - COLLECTIVE COMPANY-BLINDNESS, APOLOGY WFIA
(Dutch political party PVDA, 24-06-2006 )
http://www.zoetermeer.pvda.nl/renderer.do/menuId/188308/sf/187897/
returnPage/187897/itemId/267105/realItemId/267105/pageId/187897/instanceId/188319/
# - FOREIGN COUNTRIES INVEST ROBUST IN THE NETHERLANDS
21-02-2008 (Novum) - Foreign countries have invested robust in the Netherlands last
year. The number of investments has grown with 40% in comparisment to 2006. That appears
from the yearly figures from the Netherlands Foreign Investment Agency (NFIA) which
statesecretary of the ministry of Economic Affairs Frank Heemskerk (PvdA-party) thursday
made known during a conference about globalisation in Rotterdam. The NFIA realised last
year 155 new projects in which in total 578 million euro was in stake. These investments
were good for 3107 new jobs. The Netherlands is especially popular among investers in
Asia. Projects from this region made up about 60% of the total. India, Corea and China
* topped everything, followed by Singapore and Japan.... http://www.trouw.nl/laatstenieuws/laatstenieuws/article922656.ece/Buitenland_investeert_flink_in_Nederland
http://www.trouw.nl/laatstenieuws/ln_economie/article922581.ece/
Aantal_buitenlandse_investeringen_flink_gegroeid?backlink=true
* Human Rights Watch - China - Beijing Olympics 2008
http://www.hrw.org/campaigns/china/beijing08/toolkit.htm
Verhagen: Olympic Games and promoting human rights can go hand in hand
18 Jan 2008 - "The Olympic Games have brought the human rights situation in China
under closer scrutiny. This is a perfect opportunity for China to enhance its image by
improving human rights", said Dutch foreign minister Maxime Verhagen yesterday during
a panel discussion about China, the Olympic Games and human rights. Minister Verhagen
joined Jet Bussemaker (state secretary for sport, PVDA-party), Erica Terpstra (president
of the NOC-NSF) and Eduard Nazarski (director of Amnesty International Nederland) in an
open panel discussion on issues related to the 2008 Games. Several members of the audience
called for a boycott. Minister Verhagen believes that boycotting the Games would be
counterproductive: "Serious human rights violations still occur in China. It seems
that repression has increased in the past year, particularly with regard to the status of
human rights defenders and freedom of religion. I believe that critical engagement is more
effective than isolation. Supporting the Olympic Games and promoting human rights can go
hand in hand." The Minister also said that the Netherlands had made cautious progress
in its human rights dialogue with China.. http://www.minbuza.nl/en/news/newsflashes,2008/01/Verhagen--the-Olympic-Games-and-promoting-human-ri.html
--
- SILICONE TIME LINE
--
HOLLYWOOD ACTRESS'S INTIMATE DIARY: BREAST IMPLANTS
Former MTV-VJ, one of the Sexiest Women in the World and actress Kari Samantha Wührer
in 1989 had silicone breast enlargement at age 22. An A-cup to C-cup, due to pressure she
received from a prominent record producer who said to her: "I really like
it when you can see a woman's breasts from the back". On 2
March 2002, during the shooting of the film Spider's Web with costar actor
Stephen Baldwin, her right breast encapsulated: scar tissue underneath the implant
had turned rock hard, making and pushing her right breast twice as high as her left. She
felt looking deformed. Kari Wuhrer had enough. In a Glamour Magazine exclusive, Kari
Wuhrer shared her diary of rediscovering her real body and real self, about the
insecurities that led her to get implants early in her career and the sense of
self-acceptance she acquired. In April 2002 she had
the implants removed: "People I've seen on a daily basis for years have
been looking at me more closely. But I no longer feel the need to talk about my surgery or
to explain why I look different than I did last month. I'm just me: 35 years old with
beautiful, real breasts. Even though it was a hard road, it's been well worth it. I feel
strong and sexy and womanly, and now when I walk into a room, my breasts don't arrive
before I do. I arrive".
http://www.kariwuhrer.net/articles.html
http://www.kariwuhrer.net/glamourmag.html
http://www.cwu.edu/~relation/pr-oct4-05.html
--
THE NETHERLANDS: IMPLANT INFORMATION-BROCHURE
On 10 April 2002 Dutch Minister of healthcare (VWS)
Els Borst by letter to the Dutch Second Chamber of Parliament / chairman Vast Commission
VWS answered questions of Members of Parliament, which were faxed to the several
Parliament-parties and to the private-number of Minister Borst by Marlou Boots /
SVS a.o.: Have you taken knowledge of the since 15 November 2001 being in effect
Legal European Guidelines breastimplants from out of the European Commission ? When and
how will this news service officially be made public ? Minister Borst said she had "taken
knowledge of it". And the official news service was to be made public by means of
a by VWS "drawn up card-index / marker in which the by the European Commission
proposed measures were applauded and supported" and which in document-form was
already offered to the Dutch Second Chamber on 16 January 2002. Two month after the
official signing of the European Resolution. http://www.minbuza.nl/nl/actueel/ecvoorstellen,2002/01/
nieuw_commissievoorstelx_mededeling_borstimplantaten.html
--
DUTCH HEALTH MINISTRY: INFORMATION-BROCHURE
According to the Director Medicine and Medical Technology of the Dutch ministry of
Healthcare in a letter (20-09-2002, reference: GMT / MT 2318547, drs. J.M. Puiman) to
Marlou Boots / Dutch Supportgroup SVS, the former Healthminister Els Borst on 10 April
2002 had answered --to the question 'Which steps in the mean time have been taken in the
Netherlands ?'-- that Els Borst intended to have a information-brochure made about
silicone breast implants "in consultation" with the Dutch Association for
Plastic Surgery (Nederlandse Vereniging voor Plastische Chirurgie, NVPC) ánd Dutch
Silicone Supportgroup SVS. The Healthcare Director Medicine and Medical Technology in his
letter, on behalf of the (in the meantime new) Dutch minister of Healthcare dhr. E.
Bomhoff, repeated, so was written in his letter to Marlou Boots, the answer which the
earlier minister Els Borst already had pronounced in her letter (31 January 2000, cabinet
point of view SBI) to the Dutch Second Chamber in reference to the advice of the Dutch
Healthcouncil (October 1999 ). Rather minister Els Borst on 10 April 2002 by letter to the
Dutch Second Chamber hadn't answered about 'a information-brochure in co-operation with
SVS and NVPC' to the question 'which steps in the meantime have been taken in the
Netherlands', as the VWS Director Medicine and Medical Technology suggested in his letter,
but that was Els Borst' answer at a next question of the parliamentmembers 'Does the Dutch
Government bring out brochures rergarding with risks and benefits?'. On the index-card /
marker (16 January 2002 ), for the official reporting of the European guidelines, of
minister Borst was spoken about "There will be brought out an information
brochure". The VWS Director Medicine and Medical Technology spoke in his letter
to Marlou Boots about a brochure in cooperation with Dutch Association for Plastic Surgery
NVPC ánd Dutch Supportgroup SVS. There were the document 'Accepted Texts' of the European
Guidelines resolution ---also signed by the Netherlands and to which memberstates have to
comply--- clearly spoke about "all patients must have access to extensive and free
information drawn up by INdependent experts". The only sentence in which
minister Els Borst used the word 'independent' in her answers of 10 April 2002 to the
questions of the parliament-members was: "The promotion-material should
include coherent information which stimulate women to gain suited and independent advice
for example by consulting their doctor".
--
SVS "INDEPENDENT INFORMATION-BROCHURE"
Dutch Supportgroup SVS / Marlou Boots in a answer-reaction (29-09-2002 ) to Healthminister
Bomhoff: "Ofcourse we are perfectly informed about the EU-guidelines of 15
November. The Dutch ministry of health, mainly mrs. Puiman but also the minister himself,
were informed of this from the beginning. We have emphasized that e.g. a
information-brochure should be drawn up by INdependent authorities, just to prohibit
conflict of interest and to be able to offer objective information", "In
the Netherlands up to now not a single step has been undertaken ! For your information,
that plan of mrs. Els Borst concerned a very extensive Australian information-brochure,
including a page 'informed consent' for signing by doctor and patient. Foundation SVS has
spent many days in studying and complement this brochure for the Dutch women relevant
information. Result ? Not a single reaction back !". Not interested. While the
Director Medicine and Medical Technology, on behalf of Healthcare minister dhr. E.
Bomhoff, in his letter (20-09-2002 ) yet (again) had spoken about "taken people
serious", thus no single reply to SVS's effort and information. Could there be a
reason for that choosen SVS neglecting behaviour ? Dutch Healthminister Els Borst (report
written deliberation about breastimplants, questions CDA-, and SP-parties, 9 May 2000 ):
"I am in the opinion that the information to women who consider to have a silicone
breast prothese, primairily should be provided by the treating doctor despite his
working-territory. I take the line that a doctor out of his professional responsibility
acquits itsself in a carefull manner of this information-task".
--
- SILICONE TIME LINE
--
UK INDEPENDENT REVIEW GROUP
With 8,569 British women having had implants in 2001 alone, the cosmetic surgery boom
showed no sign of slowing. The UK Independent Review Group (IRG) on Silicone Gel Breast
Implants had another meeting, chaired by Professor R Sturrock, on 23
May 2002 in London. Issues of attention were a.o.:
- The revised version of the UK Department of Health's patient information booklet was
published in April 2002.
- The Care Standards Act was now in place.
- And IRG was reviewing the final draft of the Royal College of Surgeons; clinical
guidelines for surgeons carrying out breast implant surgery.
Among the summaries provided by IRG members in the meeting was a study 'Do silicone breast
implants cause rheumatic disorders ?' (Arthritis-Rheum, 2001 Nov, Vol.44 (11 ), P:2477-84
): "This special article in Arthritis and Rheumatism details the activities
of a National Science Panel (NSP) set up by an American court to investigate the
scientific evidence for a link between silicone breast implants and connective tissue
diseases. The paper describes how the panel reviewed the available literature and came to
the conclusion that no evidence could be found of an association between silicone breast
implants and connective tissue diseases". Authors of this article ? Among others,
Dr. Peter Tugwell: professional related (paid consultant) to Bristol-Myers Squibb,
and at the same time serving (as member) on the 'neutral' NSP and agreeing to conduct a
clinical trial on rheumatoid arthritis therapy for drug maker and participant in the
breast implant litigation Bristol-Myers Squibb, as was revealed 13 April 1999. http://www.mhra.gov.uk/Committees/Devices/IndependentReviewGrouponsiliconegelbreastimplants/CON2033075
--
WHO: "SILICONE BREASTIMPLANTS: STUDY PRIORITY"
World Health Organisation (WHO): "Science and Societial public dialogue in
Scientific research) From community action to policy impact: The case of silicone breast
implants. To consider silicone breast implants a research priority and make funds. To
facilitate consensus on a breast implant consent form including. information. To guarantee
marketing control over breast implants in order to avoid any....". http://www.euro.who.int/observatory/Publications/20020527_15
--
FDA: SALINE IMPLANTS
While in the UK end June 2002 actress Danniella Westbrook was in a lot of pain
rushed to hospital when one of her saline breast implants had ruptured, in the US in July 2002 there was another FDA Advisory Committee Meeting
on Saline Breast Implants. Cynthia Pearson, Executive Director National Women's
Health Network, gave testimony before this FDA-meeting: "...The National
Women's Health Network remains very concerned because there have been more than 150,000
adverse reaction reports to the FDA for women with breast implants, and there are still no
long-term safety studies. This meeting provides the first opportunity to re-visit the
FDA's approval of saline breast implants since they were approved in 2000. The
manufacturers' studies were strongly criticized by the FDA's Advisory Committee two years
ago because of the poor quality of their research"...."It should be noted that
in 2001, more than 62,000 breast implant removal procedures were performed in the
U.S." http://www.breastimplantinfo.org/what_know/bi070902cp.html
Every year an estimated 150,000 American women undergo breast implant surgery.
