The Evidence - Dow Chemical and Dow Corning

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The Evidence

Dow Chemical's direct involvement with Dow Corning's

products began in 1943, the year of Dow Corning's

incorporation, when Dow Chemical agreed to provide Dow

Corning with its technical expertise [including all

plans, specifications, formulas, data, and

information] and royalty free licenses under all

patents in the field of organo-silicon products. Dow

Chemical also agreed to supply Dow Corning with all

newly discovered technical information until 1958. Dow

Chemical also undertook responsibility for researching

the bioreactivity of silicone compounds on behalf of

Dow Corning 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 womanþs

body.

On another silicone track, Dow Chemical entered into a

secret agreement in the 1960's to develop a product

line of pesticides and insecticides from components of

the silicone gel used in Dow Corning's breast

implants.

In 1966 and 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. The first such agreement was on July 13,

1966, when Dow Chemical entered into a " secrecy

agreement...with Dow Corning Corporation on biological

properties of silicones. " On October 1, 1966, Dow

Chemical entered into a second " agreement... covering

research and development in the field of physiological

effects of certain organosilicon compounds. " On

February 1, 1967, Dow Corning entered into yet another

" joint research agreement with the Dow Chemical

Company pertaining to certain silicone products

designated as DC-555, DC-555A, and compounds derived

from and related thereto... " The two corporations also

reached

(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, wherein

in principle, the parties shall jointly share the

costs and shall share the profits and losses of any

commercialization. Finally, on December 5, 1967, Dow

corning 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 organosilicon

compounds. "

Pursuant to these agreements and for a period of nine

years, the Dow Bioscience Research Center performed

numerous experiments into the biological and

pharmacological effects of silicone components of

breast implants on animals and 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,[1] hearings were convened

by the FDA which resulted in the withdrawal of

silicone gel implants from the market in 1992.

Consistent with these involvements, the scientists of

Dow Chemical and Dow Corning shared a remarkable

community of interest, particularly between the

1965-1975 time frame. These scientists commonly and

frequently would exchange both knowledge and

experience with each other. They shared laboratories

and facilities to research the effects of low

molecular weight organosilicon compounds, like those

found in both Dow Chemicalþs DC-555 fluid and Dow

Corning's silicone get breast implants. Dow Corning

modeled its toxicology department after Dow Chemical's

laboratory pursuant to a letter by Dr. Groggin. In

1975, Dr. Lake, a Dow Corning scientist,

presented research showing that silicone was not

bio-inert at a joint conference between Dow Corning

and Dow Chemicalþs scientists. In fact, the need and

common interest of both corporations to study the

bioreactivity of organosilicon compounds was so great

that the exchange of scientists from one corporation

to the other occurred through the entire time Dow

Corning was in existence.

The relationship between Dow Corning and Dow Chemical

was further solidified in 1975 when the two

corporations entered into a Trademark Agreement.

Pursuant to that agreement, Dow Chemical admitted that

it has " controlled...the quality of its [Dow

Corning's] goods " since 1943. More specifically, the

agreement provided:

The products manufactured, distributed and sold --

shall 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

companiesþ premises. . . to examine the quality of

such products. In 1989, Dow Chemical agreed to perform

a " Good Laboratory Practices " audit on Dow Corning.

Finally, in 1990, Dow Corning reached an agreement

with Dow Chemical to advise and consult them in

toxicology laboratory practices and protocols.

In 1948, a seminal Dow Chemical research report was

published by two Dow Chemical employees, Dr. Rowe and

Dr. Spencer, in combination with a Dow Corning

employee, Dr. Bass, which declared silicone to be

" biologically inert. " This placed Dow Chemical in an

authoritative position as the leader in silicone

research.[2]

The importance of bio-inertness is well explained in

the August, 1994 supplement to Seminars in Arthritis

and Rheumatism:

Ideal biocompatible materials are devoid of

immunological, inflammatory, or toxic reactions,

resist deterioration of host tissues or the

biomaterial, limit alteration of host proteins, and

are noncarcinogenic. Silicone was promoted for

clinical application because it was thought to be

biologically inert. ( Borenstein, Toxicology of

Silicone). However, by the 1950's, Dow Chemical and

Dow Corning had performed studies which demonstrated

toxic hazards associated with Dow Corning silicone;

The

first known study was in September of 1954, when Dr.

Spencer of Dow Chemical reported that Dow Corning

silica (this silica being the beginning and end

product of silicone gel) had " quite a high order of

toxicity from dust inhalation. "

In March of 1955, Dr. T. K. Rowe of Dow Chemical

reported that Dow Corning Degussa Dust (fumed silica

added to the elastomer shell to strengthen the

implant) caused diffuse cellular infiltrates and

fibrocystic changes in the lungs and organs of

animals.

Dow Chemical learned specifically that the silicone

used in breast implants was not bio-inert in 1956 when

Dow Chemical studied the biological effects of

Octamethylcyclotetrasiloxane (D4). D4 became the

building block of the gel used in silicone breast

implants from the 1960's until they were taken off the

market in 1992. The 1956 study found that the

compound, if administered orally or by intramuscular

injection, led to traces of siloxane being found

throughout the bodies of laboratory animals. The study

also found the the compound caused a " slight initial

weight loss and moderate liver pathology.

A similar 1956 Dow Chemical study determined that D4

had a biological effect on the eye and that contact

would cause painful and transient irritation of the

conjunctival membranes. In fact, there were at least

nine separate Dow Chemical reports of test results on

Dow Corning Silicone Fluid. All of these reports

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 of the tests reported the biological

effects of Dow Corning Fluid 360, which is " chemically

the same silicone formula utilized in many aspects of

breast implants. "

In 1956, Dow Chemical initiated a research project

with University of Miami, on behalf of Dow Corning.

Dow Chemical negotiated the price of the project and

determined what testing would be performed. When the

test results found that a Dow Corning silicone

compound entitled 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 retests indicated the deposits found

in the rats' livers represented silicone, not fat.

Although the final report published by the University

of Miami referenced several employees at Dow Chemical,

no mention was made of the Z- 4141 compound. .

In 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. "

In 1961, Dow Chemical tested Dow corning Fluid and

found a 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. "

In 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. Also in 1970, 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. "

In 1975, Dr. Lake's study, which showed significant

silicone bioreactivity, was presented to a joint

conference between Dow Corning and Dow Chemical

scientists. This research was never published.

Finally, in 1976, employees from Dow Corning and Dow

Chemical studied the effect of implantation on the

physical properties of silicone rubber. The study

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 from the above studies that Dow

Chemical knew as early as the 1950's that the silicone

used in breast implants was not biologically inert,

neither Dow Chemical nor Dow Corning ever published

the results of any of this research. In fact, Dow

Chemical indicated just the opposite to 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, product inserts indicated that

silicone breast implants were " nonreactive to body

tissue. " The General and Plastic Surgery Devices

Panel, in a letter to the FDA which contains public

information, declared that " . . . although one

pathologist has 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. "

Conclusion

Dow Chemical had responsibility for researching the

bioreactivity of silica and silicone compounds used in

Dow Corning breast implants. Dow Chemical knew as

early as the 1950's that silicone and silica used in

Dow Corning's breast implants was bioreactive,

immunogenic, toxic and inflammatory when introduced

into the human body. The company did nothing to advise

the public of these hazards or to stop the sale,

despite the fact that Dow Chemical had the right to

control and in fact controlled the quality of the

products manufactured and sold by Dow Corning.