Academic journal article Defense Counsel Journal

Silicone, Science and Settlements: Breast Implants and a Search for Truth

Academic journal article Defense Counsel Journal

Silicone, Science and Settlements: Breast Implants and a Search for Truth

Article excerpt

IN APRIL 1992, the U.S. Food and Drug Administration banned the further use of silicon breast implants, once the third most common form of plastic surgery in the United States, except for limited use in research settings. FDA Commissioner David Kessler stated that the ban was not imposed because the implants were known to pose a risk, but rather because the manufacturers had not fulfilled their legal responsibility of collecting data on the question.(1)

During the first two years following the FDA ban, more than 16,000 lawsuits were filed on behalf of women claiming injuries from their breast implants. Facing one product liability case after another, manufacturers, while maintaining that the devices are safe, eventually agreed to a class action settlement establishing a set aside fund of $4.25 billion. Some 440,000 women joined the class. action settlement, while more than 7,000 others opted out to file individual suits. The result was too many claims and too little money. The original manufacturer, Dow Corning, was drived into bankruptcy, and the remaining manufacturers - Bristol-Myers Squibb, Minnesota Mining and Manufacturing Co. and Baxter Healthcare Corp. - have entered into negotiations for a new settlement.

When the FDA made its decision in 1992, however, there had been no systematic studies of the adverse effects of breast implants.(2) The fact that implants occasionally leaked or ruptured, causing local problems, has been conceded by both manufacturers and researchers.(1) These include localized pain, scar formation, inflammation, enlarged lymph nodes, and misshapen breasts caused by shifting or hardening of the silicone gel.

There have been instances in which the silicone gel core material has escaped from the restrictive confines of the silicone rubber envelope, causing silicone to enter the body. There are two ways by which this can occur. First, the envelope of the breast implant can rupture. This is often caused by trauma to the area or closed capsulotomy. Second, research has shown that even in the absence of a rupture, the implant can "bleed," and minute quantities of the gel can move through the envelope and into the body.

These localized complications, however, have not been the basis of the public scare. Rather, it has been the allegation that the leaking silicone causes connective tissue and rheumatic diseases such as systematic lupus, rheumatoid arthritis and scleroderina. Because these are chronic disorders not easily diagnosed, and because they also may occur in women without breast implants, the postulated associations have been very difficult to evaluate.

Since the FDA action, numerous scientific studies have been done using a variety of epidemiological techniques. In the wake of what has become the "monster" of product liability cases, published medical studies have failed to find any correlation between silicone breast implants and any of the connective tissue diseases alleged. Nevertheless, lawyers representing women with implants have created an avalanche of litigation, and women have received awards.

This article addresses the scientific evidence that exonerates the silicone implants, the subsequent settlement and litigation that has seemed to fly in the face of the evidence, and the effect of the evidence on the new settlement and opt out litigation.

1995 HARVARD STUDY

Development of connective tissue disease in women with breast implants does not by itself constitute evidence that the implants caused the disease. Each year approximately 100 women with breast implants can be expected to develop lupus or scleroderma by chance alone.(4) Because these types of diseases may occur in women with and without breast implants, the only way to examine whether breast implants actually contribute to the diseases is to show that the incidence of disease is significantly higher among women with breast implants than in those without implants. …

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