WHAT Dow Chemical Knew and When They Knew It:
From: Court Documents, Internal Corporate Memos
1950:
Silicones later used in breast implants by Dow Corning were
bioreactive, immunogenic, toxic, and inflammatory in the human body.
1954:
Dr. Spencer of Dow Chemical reported that chemical compounds
of silicone gel are highly toxic.
1955:
Dr. Rowe of Dow Chemical reports that materials of implant
shells cause diffuse cellular infiltrates and fibrocystic changes
in the lungs and organs of animals.
1956:
Dow Chemical study of the biological effects of Octamethylcyclotetrasiloxane
(D4), the building block of silicone gel used in implants, found if administered
orally or by intramuscular injection, led to traces of siloxans throughout
the bodies of laboratory animals that caused
a slight initial weight loss and moderate liver pathology.
Dow Chemical study of D4 found that it had a biological
effect on the eye and that contact would cause painful irritation
of the conjunctival membranes. Nine Dow Chemical reports indicated
in test results that D4 caused irritation to the eyes and skin.
One report indicated that the silicone fluid caused hyperemia,
edema, and general skin rawness in all cases.
Dow Chemical funded a research project with the University
of Miami in which results found that a silicone compound (Z04141)
caused deposits of silicone in the livers of laboratory rats,
a fact not mentioned in the final report.
1957:
Dow Corning report sent to Dow Chemical reports that: Dow
Corning Fluid 200 was absorbed through the skin and found
in the adrenal and kidneys of laboratory rabbits.
1961:
Dow Chemical tested Dow Corning Fluid 200 when it was heat
treated. The fluid caused death in all but one laboratory rat
in the test. Irritation of the respiratory tract was given as
the cause of death.
The Dow Chemical Company, parent company of the leading manufacturer
of silicone breast implants, Dow Corning, researched the health
effects of exposure to commercial silicones as early as the 1940's.
(See below: a partial quote of Dow Chemical Co.'s own report in
the Journal of Industrial Hygiene and Toxicology by Drs. Spencer
and Rowe of Dow Chemical, published in 1948.
Dow Chemical and Dow Corning also conducted secret research in
the 1960s that revealed that certain silicone compounds possessed
sufficient biological activity to have potential uses as pharmaceuticals.
Specifically, the research showed that silicones could affect
the central nervous system. The companies pursued the development
of silicone-based drugs for central nervous system disorders.
Out of this research, the companies' scientists also learned that
silicone compounds could affect the immune system.
Heyer-Schulte, a subsidiary of American Hospital Supply Corp.,
Dow Corning, Bristol Meyers, 3-M, the Veterans Hospital (which
did testing for them), the FDA (who was warned many times but
allowed these manufacturers to set their own guidelines ignored
complaints and warnings from around the world about leaking implants
for 30 years.
1975:
A 1975 Dow Corning memo (and other implant manufacturers
internal memos) state that demonstration implants were bleeding
and instructed sales staff to wash the implants with soap and
water and towel dry them before letting doctors handle them. The
Plastic Surgeons Society was well aware of the bleeding and failure
rate and wrote warning letters to these companies.
1977:
A 1977 memo relates how a Dow Corning employee told plastic surgeons
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. In fact, Dow Corning
was not studying contracture, a complication that occurs when
the scar around the implant contracts.
1983:
In 1983, Dow Cornin'gs head of biomaterial safety wrote top company
management: However, I want to emphasize that to my knowledge,
we have no valid long-term implant data to substantiate the safety
of gels for long-term implant use. This statement was made
twenty-one (21) years AFTER Dow Corning first put silicone implants
on the market and assured women that implants were safe.
1987:
In a 1987 study, the Medtox Project Report, Dow Corning acknowledged
that the chronic reactions to silicones seen in test animals could
trigger autoimmune-type diseases in humans.
In a Bristol-Meyers Squibb document from 1985, a company employee
states: Polyurethanes have no real history of implantation
without deterioration and we know deterioration products of polyurethanes
are toxic and in come cases carcinogenic. Whether they are released
in such low levels as to be no threat to the human body -- time
will tell.
A 1976 3-M (Minnesota Mining and Manufacturing) document states
that: It appears virtually no documented safety and efficacy
data exists on (Don McGhan's) implant products. McGhan's
breast implant company, McGhan Medical Corp., was purchased by
3-M. The McGhan Corp., Don McGhan, spun off from Heyer-Schulte.
Heyer-Schulte Corp., spun off from Dow Corning. (See inspection
photos of Corning Glass Works and Dow Chemical owners (Amory Houghton
and CEO, William Armistead and Dow Chemical at Dow Corning Plant.)
1990's:
Dr. David Kessler, Commissioner of the Food and Drug Administration,
reiterated in testimony before Congress in August, 1995, that
the law requires manufacturers to prove affirmatively, with
valid scientific data evaluated by the FDA, that their devices
are safe and effective. The manufacturers have consistently
failed to comply. Now they are bullying Dr. Kessler as they have
all the previous FDA Commissioners.
Dr. David Kessler wrote in the Journal of the American Medical
Association in 1993 that: the adverse effects data on silicone
get implants submitted by the manufacturers were so poor that
the FDA could not determine where these devices were safe and
effective. He added that the manufacturers' documents suggested
that there were inadequate quality control procedures to prevent
safety problems and that problems had been evident for years.
Saline breast implants were never approved. There have been seven
saline breast implant deaths. Three employees of Heyer-Schulte
breast implant manufacturing company died of human adjuvant disease
and cancer in handling silicone. Manufacturers told women that
implants would last a lifetime and that ruptures occurred less
than 1 percent of the time. Studies published in the American
Journal of Radiology in 1992 and the Annals of Plastic Surgery
in 1995 reveal a rupture rate of 51 percent.
A third study, published in Plastic and Reconstructive Surgery
in 1993, ties rupture to the age of the implant. Of implants aged
one to nine years, 35.7 percent had ruptured. Of those aged 10
to 17 years, 95.7 percent had ruptured. The FDA's own implant
rupture rate on microfiche illustrates this rupture rate.
The Food and Drug Commissioner, Dr. David Kessler wrote in the
Journal of the American Medical Association in 1993 that: Even
with a conservative rupture rate, some 75,000 of the 1 to 2 million
women (actually the number turned out to be only around 600,000,)
would be at risk for potentially serious adverse health effects.
That is NOT a safety standard that the FDA can accept.
Information provided by Silicone Sister
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