Breast Implant: Dow Chem. Responsible ?

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Breast Implant: Dow Chem. Responsible ?

USSW NEWS

United Silicone Survivors of the World

October 1996

Offical Journal - International Circulation

Breast Implants: Is Dow Chemical Responsible ?

SOURCE - The Consumer Law Page (The Law

Firm)

By - Access@...

- phone: (408) 289-1776

- Fax: (408) 287-1776

Part 1

1943

Dow Corning Incorporation formed;

- Dow Chemical agreed to provide;

- technical expertise; plans, specifications,

formulas, data, and information

- Royalty-free licenses under all patents in the field

of organo-silicone products

- supplied Dow Corning with all with all newly

discovered technical info until 1958

- undertook the responsibility for researching the

bioreactivity of silicone compounds and continued to

do so until as late as 1992

Dow Corning relied on Dow Chemical's expertise in the

silicone field to such an extent that Dow Corning did

not perform a single study on a breast implant before

an implant was inserted into a woman's body.

1960's

Dow Chemical entered into a secret agreement to

develop a product line of pesticides and insecticides

from components of the silicone gel used in Dow

Corning's breast implants.

1966-1967

Dow Chemical and Dow Corning entered into a series of

express joint agreements for the purpose of research,

development, evaluation and commercialization of

biologically active silicone compounds.

- july 13, 1966, Dow Chemical entered a 'secrecy

agreement...with Dow Corning on biological properties

of silicones'

- october 1, 1966, Dow Chemical entered into

'agreemnet..covering research and development in the

field of physiological effects of certain

organo-silicon compounds'

- february 1, 1967, Dow Corning entered 'joint

research agreement with Dow Chemical company

pertaining to certain silicone products designated as

DC-555; DC-555A, and compounds derived from and

related thereto..'

- (a) joint development agreement relating to the

physiological effects resulting from ingestion or

injection into the systems of animals or men of

particular physiologically active silicones, wehrein

in principle, the parties shaal jointly share the cost

and shall share the profits and losses of any

commercialization.

- december 5, 1967, DowCorning entered into an

agreement 'with the Dow Chemical Company providing for

joint research, development, evaluation and

commercialization programs on the physiological

effects upon the systems of animals or man of

physiological active organo-silicon compounds.

For a periode of 9 yeras the Dow Bioscience Center

performed numerous experiments into the biological and

pharmacological effects of silicone compounds of

breast implants on animals an humans. Research from

these joint enterprises produced results that

silicones were not bio-inert. This research was never

published. When the first evidence of silicone

bioreactivity was discovered in the California trial

of Hopkins v. Dow Corning, hearings were convened by

the FDA which resulted in the withdrawal of silicone

gel implants from the market in 1992.

1965-1975

Scientists (Dow Corning and Dow Chemical) commonly and

frequently exchanged knowledge and experience. Shared

facilities to research the effects of low molecular

weight organo-silicon compounds, like those found in

both Dow Chemicals DC-555 fluid and Dow Cornings

silicone gel breast implants. Dow Corning modeled its

toxicology department after Dow Chemicals laboratory

(letter from Dr. Groggin)

- 1975, Dow Corning scientist, Dr. robbert Lake,

presented research showing that silicone was not

bio-inert at a joint conference between Dow Corning

and Dow Chemicals scientists. An exchange of scientist

from one corporation to the other occured through the

entire time Dow Corning was in existence.

- 1975, Dow Corning and Dow Chemical entered into a

trademark Agreement. Dow Chemical admitted that it has

" controlled...the quality of its [Dow Cornings] goods "

since 1943. The agreement also provided - products

manufactured, distributed and sold, shaal be of a

nature and quality that is acceptable to Dow Company.

When requested, associate companies shall.. submit

specimens of its products to Dow Company and shall

permit inspection of associate companies premises..to

examine the quality of such products.

1989

Dow Chemical agreed to perform a " Good Laboratory

Practice " audit on Dow Corning

1990

Dow Corning reached an agreement with Dow Corning to

advise and consult them in toxicology laboratory

practises and protocols

1948

A seminar Dow Chemical research report was published

by two Dow Chemical employees, Dr. Rowe, and Dr.

Spencer, incombination with Dow Corning employee, Dr.

Bass, which declared silicone to be " biologically

inert " . This placed Dow Chemical in an authoritative

position as the leaer in silicone research.

1994

Seminars in Arthritis and Rheumatism explain

bio-inertness importance.

- ideal biocompatible materials are devoid of

immunological, inflammayory, or toxic reactiosn,

resist deterioration of host tissues or the

biomaterial, limit alteration of host proteins, and

are noncarcinogenic. Silcione was promoted for

clinical application because it was thought to be

biologically inert. ( Borenstein, Toxicology of

Silicone).

Part 2 -

Safety Breast Implants: Dow Studies

1950

Dow Chemical and Dow Corning had performed studies

whch demostrated toxic hazards associated with Dow

Corning silicone.

1954-september

Dr. Spencer of Dow Chemical reported that Dow Corning

silica (this silica being the beginning and end

prodcut of silicon gel) had " quite a high order of

toxixity from dust inhalation "

1955 - march

dr. T.K. Rowe of dow Chemical reported that Dow

Corning Degussa Dust (fumed silica added in the

elastomer shell to strengthen the implant) caused

diffuse cellular infiltrates and fibrocystic changes

in the lungs and organs of animals

1956

Dow Chemical learned that silicone used in breast

implants was not bio-inert when Dow Chemical studied

the biological effects of Octamethyleyclotetrasiloxane

(D4). D4 became the building block of the gel used in

silicone breast implants from the 1960s until they

were taken off the market in 1992. The 1956 study

found that the compound, if afministered orally or by

intramuscular injection, led to traces of siloxane

being found thorughout the bodies of laboratory

animals. The study also found the compound caused a

" slight initial weight loss and moderate liver

pathology " .

1956

A Dow Chemical study determined that D4 had a

biological effect on the eye and that contact would

cuase painful and transient irritation of the

conjunctival membranes. There were 9 seperate Dow

Chemical reports of test results on Dow Corning

Silicone Fluid. All indicate some irritation to the

eyes and skin. One particular report indicates the

silicone fluid caused hyperemia, edema, and general

skin rawness in all cases. Some tests reported the

biological effects of Dow Corning Fluid 360, which is

" chemically the same silicone formula utilized in many

aspects of breast implants " .

1956

Dow Chemical initiated a research project with the

University of Miami, on behalf of Dow Corning. Dow

Chemical determined the cost and what testing would be

performed. When the results found that a Dow Corning

silicone compound, Z-4141, caused fat or silicone

deposits in the livers of laboratory rats, Dow

Chemical (not Dow Corning) retested the results. The

results of these re-tests indicated the deposits found

in th rats' livers represented silicone, not fat.

Although a final report published by the University of

Miami referenced several employees at Dow Chemical, no

mention was made of the Z-4141 compound.

1957

Dow Corning sent Dow Chemical reports that Dow Corning

200 Fluid was " absorbed through the skin by the

adrenal and kidneys of a rabbit " .

1961

Dow Chemical tested Dow Corning's Fluid and found

substantial difference in the fluid when it was heat

treated. Specifically, the fluid caused death in all

but one of the rats, apparently because of " irritation

of the respiratory tract " .

1970

Dow Chemical discovered that Dow Corning 360 Fluid

caused spontaneous death in several rats, pulmonary

deposition and vacuoles (cavities) to develop in the

liver, heart, kidney, spleen, pancreas, ovary, adrenal

and stomach mucosa.

1975

Dr. 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 " .

1976

Employees of Dow Corning and Dow Chemical studied the

effects of implantation on the physical properties of

silicone rubber. The sutdy found that the subcutaneous

implantation (as is performed in mammary augmentation

or reconstruction) changed the physical properties of

medical grade silicone rubber.

Although it is clear that Dow Chemical knew as early

as the 1950's that silicone used in breats implants

was not biologically inert, neither Dow Chemical and

Dow Corning ever published the results of any of this

research. In fact, Dow chemical indicated just the

opposite in the public - that silicone was bio-inert

and safe for human use. In 1954 and again in 1959, Dow

Chemical promoted the suitability of silicone products

for medical uses. In october of 1974 products inserts

indicated that silicone breast implants were

" nonreactive in body tissue " . The General and Plastic

Surgery Devices Panel, in a letter to the FDA which

contains public information, declared that " although

one pathologist had been widely quoted as claiming

that he has found silicone in various organs of the

body, we are not aware of any other medical

professional who has observed this phenomenon " .

Finally, in 1992, the CEO of Dow Chemical,

Popoff, declared that Dow Corning's breast implants

were " beyond reproach " .