What Dow Knew..&..When Dow Knew It

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Thanks Lea!

What Dow Knew.. & ..When Dow Knew It

Fact Long Suppressed About The Dangers of Silicone!

Dow Corning's full culpability in the silicone

breast implant controversy is not widely known. For

decades the company chose to keep secret a series of

warning signals about silicone, and made misleading

and false statements to the women who received

implants.

The original Dow Corning sales pitch, in a

brochure entitled " Facts About Your New Look, "

promised a lifetime of safety and satisfaction.

Silicone breast implants were advertised as benign and

chemically inactive.

In fact, Dow Corning had no substantial evidence of

safety, but had plenty of evidence that silicone

implants were a high-risk product.

The beginning of the story goes back 60 years!!!

1950's-- Silicone injections are banned in Japan

because of dangerous side effects, including

immunological problems.

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. (1)

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. (2)

1960's-- California and Nevada pass laws against

silicone injections, classifying them a criminal

offence.

1961 -- As Dow Corning prepares to market the

first silicone breast implants the company is advised

by its own Center for Aid to Medical Research that

silicone will bleed through a silicone bag and be

absorbed into human tissue.(3) Silicone leaking from

implants can be equivalent to injections of silicone

into the body.

1962-- Alarmed about the health dangers posed by

silicone, the FDA issues strict new regulations

governing silicone injections.

1963-- Dow Corning begins selling silicone breast

implants under the trade name " Silastic " without

long-term testing or monitoring of the women who

receive them. No mention whatsoever is made of

possible health risks, and because the silicone is

contained inside a " protective " bag the breast

implants are not within the purview of the FDA

regulations.

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.

(4)

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

substance. (5)

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.

1968-- When silicone bags are implanted into dogs

the silicone leaks out and is dispersed throughout

their systems, according to another secret study for

Dow Corning. (6)

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. (7)

1972-- Dow Corning pharmacologist, Don ,

notes in an internal memo that economic considerations

are constraining research into the biological

applications of silicone. Dr. later quits in a

falling-out with the company over the lack of

research.(8)

1975-- Numerous plastic surgeons complain to Dow

Coming that its newly redesigned silicone implants

appear oily and seem to be leaking even before they

are surgically inserted. (9) Some surgeons report that

the implants appear to have been soaked in Mazola oil.

(10) One Dow Corning executive instructs company

salesmen to wash and towel-dry the implants before

displaying them to surgeons, thus concealing the

leakage problem. (11)

1975-- Dow Corning employees are compelled to

edit a training video for plastic surgeons when

implants rupture during the filming of the video.(12)

1976-- Talcott, a senior Dow Corning

materials engineer, quits in a dispute over the safety

of silicone implants. He will later tell a news

reporter, " The manufacturers and surgeons have been

performing experimental surgery on humans. " (13)

1976-- A Dow Coming internal study reveals that

the lining of silicone implants loses strength even

when sitting on a shelf. (14)

1976-- A Dow Corning technical-services

specialist, Art Rathjen, complains in a letter 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.(15)

1977-- A Dow Corning marketing executive, Chuck

Leach, tells a gathering of the International Society

of Plastic Surgeons that Dow Coming has a study

underway on the possible seepage of silicone from

breast implants. Mr. Leach says later he had his

fingers " crossed " at the time. (16) In fact, no such

study existed.

1978-- Dow Coming represents in a patient

brochure that " laboratory studies " prove that implants

should " last a lifetime. " At the same time, Dow

Corning is receiving numerous complaints of

spontaneous rupture from surgeons and sales

representatives. Another senior Dow Corning engineer

writes to his superiors about implanits: " 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'? " (17)

1980-- The chief of biomaterial safety for Dow

Coming, Boley, tells a private physician it is

highly improbable a woman's onset of lupus is

connected to her silicone breasts. Mr. Boley claims

the implants have been proven safe in " extensive "

testing, although three years later he will admit the

opposite, saying there is " no valid long-term implant

data to substantiate the[irl safety,. " (18)

1984-- The first woman with autoimmune disorder

recovers damages. Stern was awarded $1.5 million

in punitive damages. Dow Corning was found fraudulent,

having misrepresented animal studies.

1985-- In an internal report by Boley and

other Dow Corning scientists, the company concludes

that the preponderance of available data suggests that

silicone can produce immune-mediated diseases. (19) At

the same time Dow Coming continues to state publicly

there is no evidence that silicone causes disease.

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. The Food and Drug

Administration rules that breast implants should be

classified high risk and mandates that manufacturers

produce safety data.

1991 -- A San Francisco jury finds against Dow

Corning in a lawsuit charging the company with fraud,

negligence and product liability for not disclosing

information about the dangers of breast implants. The

plaintiff in the suit is nn Hopkins, a woman with

implants who developed a painful, arthritic-like

condition.

1992-- The FDA limits the future sales of

silicone implants after the " safety " data produced by

the manufacturers is ruled patently inadequate--there

are no clinical studies. Under the new rules, implants

can be sold only as part of supervised clinical

studies. FDA Commissioner Kessler cites a

70-percent rupture rate as one of the problems with

implants.

1993-- For the first time Dow Coming acknowledges

that silicone may not be inert, revealing that

complaining researchers found a possible link between

silicone and immune-systern disease in a study on

laboratory rats. The chief medical officer for Dow

Corning, Dr. Myron on, is quoted as saying, " It

clearly raises my concern that silicone gel might

cause immune-system disease. " (20 & 21)

1994-- Lawsuits are filed against Dow Coming by

plastic surgeons who claim the company damaged their

medical reputations by misrepresenting the quality of

implants.

1995-- A judge rules that Dow Corning's parent

company, Dow Chemical, can be held liable in lawsuits

involving silicone implants. Dow Coming files for

bankruptcy protection.

(1) Request for Applications Testing on Dow Coming

Silica, " Sept. 1, 1954 (TDCH- 1-55)

(2) " The Physiological Assimilation of Dow Coming 200

Fluid. " by Chenoweth, 1956.

(3) Letter from Ethel Mullison, staff associate, Dow

Coming Center for Aid to Medical Research, to Dr.

Cronin, Jan. 24, 1961.

(4) Letter from Harry Dingman to Food and Drug

Administration. Nov.7, 1964 (M35009-012) 'The

Physiological Assimilation of Dow Coming 200 Fluid, "

1956.

(5) " Siliconoma: Another Cutaneous Response to

Dimethylpolysiloxane, " by Ben-Hur, 1965.

(6) Letter from E. Hobbs, toxicologist, to Dr.

Raffkin, Squibb Institute for Medical Research, Oct.

6, 1968.

(7) Two-year study with Silastic Memory Implants

TX-202A and TX202B in Dogs. " April 20, 1970 (F462-483)

(8) Deposition of Don

(DCC 16001173-16001178).

(9) Memo to Dow Coming mammary task force from

Talcott, senior engineer, May 15, 1975.

(10) Deposition of Dumas (KKA 119771-119774)

(11) Memo to Dow Coming sales staff and other company

officials from Tom Salisbury, May 16, 1975.

(12) Deposition (M190200-190202)

(13) " Breast Implants: What did the Industry Know, and

When? " Business Week, June 1, 1991

(14) Deposition (T 21431-2144)

(15) Memo to A.E. Bey and C.W. Lentz, Dow Corning

managers, from Art H. Rathjen, June 8, 1976

(16) Memo to Bob Levier, Dow Corning implant products

PXG, from Leach, March 31, 1977

(17) Memo from Farnk to Milt Hinsch, March 2,

1978

(18) Letter from F. Boley, senior group

leader, Health Core Group Reseach, Down Corning, to

ph R. Connelly, M.D., Buffalo, N.Y., April 23,

1980, and memo to J. and C. Jakubczak, Dow

Corning managers,Sept. 15, 1983

(19) Report by Boley et al, Feb. 19, 1985

(KMM386 643-695)

(20) " Dow Corning Reveals: Study Shows Possible Immune

System Link, " Midland Daily News, March 19,1993, p.1.

(21) " Informed Consent, " by A. Byrne,

McGraw-Hill, 1996