Dow Corning

Dow Corning Corp. was established in 1943 as the joint venture between Dow Chemical and Corning Glass to produce silicones for commercial purposes. Later, Dow Corning gained notoriety for its manufacture of the controversial silicone breast implants. In 1992, after thousands of lawsuits and several multimillion dollar jury awards, Dow Corning discontinued the manufacture of its silicone implants and filed bankruptcy in 1995. A Mayo Clinic study published in the New England Journal of Medicine in June of 1994 showed that there was no difference between women with silicone implants and those without with respect to the incidence of connective-tissue disease. Twenty other large-scale clinical studies have also shown no correlation between silicone and any other disease. This case highlights several social issues: corporate responsibility for the safety of their products, scientific studies versus public opinion, and patient safety versus patient choice.

Dow Corning silicone breast implants were first made available to plastic surgeons in 1964 along with silicone chin and testicular prostheses. Since that time numerous companies both domestic and international have manufactured implants. It is estimated that over 1 million American women now have silicone breast implants.

In the 1960s, the implants were not subject to any government regulations. In 1976, Congress gave the U.S. Food and Drug Administration (FDA) authority to regulate all medical devices. Because implants had [Page 619]been on the market for 15 years, they were “grandfathered” in and classified as “Class II” devices, meaning that they did not need testing to remain on the market.

In the 1980s, women with silicone implants reported certain patterns of illness, including severe joint and muscle pain, fatigue, and weight loss. It was alleged that leaky silicone bags were responsible for various autoimmune disorders such as rheumatoid arthritis, lupus erythematosus, and scleroderma, the latter being a disease in which the body's immune system attacks its own connective tissue. Because of these concerns, the FDA reclassified silicone implants as “Class III” in 1986. Thereafter, all manufacturers of the silicone implants were ordered to file Premarket Approval Applications (PMAAs), backed by valid scientific data to prove the safety and effectiveness of their devices. The PMAAs were due by 1991 at which time the FDA would have 180 days to review the data and rule. The FDA's advisory panel composed of experts from various fields, including plastic surgery, oncology, epidemiology, internal medicine, immunology, radiology, pathology, toxicology, as well as industry and consumer groups, complained of a lack of hard scientific data. The symptoms the women who brought lawsuits complained of were not uncommon in the general population. For example, connective-tissue disease strikes 1% of all women. The percentage of women who suffer from connective-tissue disease with implants is statistically indistinguishable from the population at large and thus impossible to distinguish coincidence from causation. Furthermore, not only does silicone appear to be chemically inert, but silicone from a ruptured implant will remain trapped inside a fibrous capsule of scar tissue. After studying the data submitted by the various manufacturers the panel ruled that the manufacturers had failed to prove that their devices were safe; neither was there evidence that they were harmful. The FDA could not vouch for the safety of implants without more clinical research. The panel advised the implants to be made available to women on a limited basis.

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