Silicone breast implant cases

DATE: 1977-1999

THE EVENT: Women throughout the United States filed individual and class-action lawsuits against the manufacturers of silicone gel-filled breast implants, alleging that injuries and illnesses resulted when the products ruptured or leaked. Suits filed during the 1990s led to huge monetary awards for damages to women who claimed injury from silicone breast implants, often because the manufacturers had concealed safety information from implant recipients.

SIGNIFICANCE: Numerous scientific studies of silicone breast implants have shown that there is no significant link between such implants and the diseases experienced by the plaintiffs who brought lawsuits against the manufacturers, but these cases nonetheless resulted in the largest proposed product liability settlement in American legal history. In addition, the beginning of federal regulation of medical devices in the United States may be attributed to the silicone breast implant cases.

The first silicone gel-filled breast implant was introduced in 1962. By 1964, Dow Corning Corporation, the largest manufacturer of such implants, had established its Medical Products Division in order to market silicone breast implant products. Between 1962 and 1991, nearly two million women had received silicone breast implants in North America alone. Of these women, 80 percent received the implants for cosmetic reasons; the remaining 20 percent received the implants as part of breast reconstruction surgery following mastectomies.

As increasing numbers of breast augmentation surgeries were performed, problems with silicone implants began to become evident, including hardening and occasional rupture; cases of enlargement of the lymph nodes in implant sites were also observed. At the same time, some recipients of silicone implants began to develop an array of more serious disorders that they suspected were related to the implants. Some recipients developed systemic connective-tissue diseases, including scleroderma, systemic lupus erythematosus, rheumatoid arthritis, and other nonspecific autoimmune ailments. The silicone breast implant lawsuits focused on the alleged link between the silicone implants and connective-tissue diseases.

Background

The first suit, which was filed in 1977, resulted in a $170,000 settlement against Dow Corning. In Hopkins v. Dow Corning Corporation (1991), a found that the plaintiff’s mixed connective-tissue disease was linked to her ruptured silicone breast implants and awarded the plaintiff $7.3 million. The bulk of that award ($6.5 million) can be attributed to the jury’s desire to punish the conduct of Dow Corning, which had concealed its knowledge that its silicone implants could leak and failed to disclose the adverse results of animal testing the company had conducted.

In response to Hopkins and other cases, certain manufacturers of breast implants and their suppliers set aside funds of $4.25 billon to deal with potential legal suits. The fund was used as the basis for a global settlement whereby women who had received implants were given a deadline to decide whether they would join a class-action suit that guaranteed a settlement of $200,000 to $2 million if they agreed not to litigate or would litigate separately. Despite the settlement offer, 12,359 individual lawsuits were filed against Dow Corning by the end of 1993. In 1995, Dow Corning filed for Chapter 11 bankruptcy protection, which halted all pending litigation.

In 1997, a jury in the first class-action suit against Dow Chemical, which owned half of Dow Corning, found that the company had fraudulently concealed the dangers of silicone and failed to investigate properly the health risks associated with silicone implants. Facing the bankruptcy of Dow Corning, the plaintiffs agreed in 1998 to an offer of $3.2 billion to settle numerous injury claims; this step allowed Dow Corning to emerge from bankruptcy proceedings. Given the scientific evidence, most silicone breast implant cases after 1998 did not result in awards of punitive damages, but juries still concluded that the manufacturers were liable for concealing and failing to warn recipients.

The Scientific Evidence Presented

To establish that silicone breast implants constitute a risk factor for the development of immune system-related disorders, epidemiological studies must show that recipients of these implants as a distinct group develop these disorders at a higher rate than do women without implants or any normal population of women. The first such study, the results of which were published in 1994, failed to demonstrate any such heightened risk or increased development of disorders, and statistical analyses continue to demonstrate that no evidence exists of any causal link or association between breast implants and any of the individual connective-tissue diseases, all connective-tissue diseases combined, or any other autoimmune conditions.

As most commentators have observed, insufficient scientific evidence exists to support the conclusion that the silicone breast implants caused the alleged injuries. Evidence is too sparse even to support the argument that the implants increased the likelihood of the recipients’ developing these conditions. For example, one study noted that patients with insulin-dependent diabetes and those who depend on dialysis have increased exposure to silicone because silicone accumulates in their bodies. In these individuals, no systemic illnesses or any illnesses similar to those experienced by women with the silicone implants developed; thus, these illnesses are probably not attributable to silicone.

It is extremely difficult to establish a causal link involving illnesses and a product. In Livshits v. Natural Y Surgical Specialties, Incorporated (1991), the plaintiff was initially able to demonstrate a “cause-and-effect” link, but later the court substantially reduced the award of damages when the of the plaintiff’s was disqualified. The expert had testified that the plaintiff’s silicone implant had caused an acceleration of the cancer that occurred in the plaintiff’s breast. A study published in June, 1992, however, revealed that silicone was linked only to connective-tissue sarcomas that appeared in limited numbers in rodent species susceptible to cancer. The court found this study to be clear evidence that the silicone implant did not cause the acceleration of the plaintiff’s cancer and therefore reduced the plaintiff’s award.

Some commentators still adhere to their belief that the implants caused the disorders sustained by these women. They argue that scientific evidence may show no link between silicone breast implants and specific classic autoimmune diseases, but the research has not addressed possible connections of the implants to atypical autoimmune diseases or the severe complications that arise locally at the sites of implants.

No definitive scientific evidence has shown whether removing silicone breast implants changes the course of connective-tissue diseases. One study found some improvement in seven of twelve patients after the removal of implants, but no firm conclusions can be drawn from this small sample.

The Food and Drug Administration’s Response

In 1976, in response to public pressures regarding the lack of safety testing of silicone breast implants, the Medical Devices Amendment was added to the Federal Food, Drug, and Cosmetic Act. This amendment required the U.S. Food and Drug Administration (FDA) to review and approve new medical devices for safety. It had no effect on silicone breast implants, however, as they had already been on the market for almost fifteen years.

For years, the FDA failed to act on growing concerns related to breast implants, allowing manufacturers, in essence, to regulate themselves. In 1988, the FDA classified the implants as Class III devices, which meant that manufacturers were required to provide detailed data as to product safety and design. The data, however, were not due until 1991, at which point the FDA concluded that many manufacturers had submitted insufficient safety data and requested more. In 1992, after hearings before two independent advisory committees, the FDA placed a moratorium on the use of silicone gel-filled breast implants other than in research because of inadequate data on their safety. In 2006, silicone implants received FDA approval for use in breast reconstruction in women of any age and in breast augmentation (often cosmetic) in women twenty-two years or older.

In 2021, the FDA updated its safety requirements for breast implants, mandating that health care providers and health facilities inform patients of the risks of the implants. Only doctors and facilities that agree to provide this information to patients are legally allowed to provide breast implants.

Bibliography

Angell, Marcia. Science on Trial: The Clash of Medical Evidence and the Law in the Breast Implant Case. New York: W. W. Norton, 1997.

Bar-Meir, Eran, Michael Eherenfeld, and Yehuda Shoenfeld. “Silicone Gel Breast Implants and Connective Tissue Disease: A Comprehensive Review.” Autoimmunity 36 (June, 2003): 193-197.

Janowsky, Esther C., Lawrence L. Kupper, and Barbara S. Hulka. “Meta-analyses of the Relation Between Silicone Breast Implants and the Risk of Connective-Tissue Diseases.” New England Journal of Medicine 342, no. 11 (2000): 781-790.

"Risks and Complications of Breast Implants." US Food and Drug Administration, 14 Dec. 2023, www.fda.gov/medical-devices/breast-implants/risks-and-complications-breast-implants. Accessed 18 Aug. 2024.

Stewart, Mary White. Silicone Spills: Breast Implants on Trial. Westport, Conn.: Praeger, 1998.

U.S. Food and Drug Administration. “Silicone Gel-Filled Breast Implants Approved.” FDA Consumer Magazine, January/February, 2007.