Silicone implant ban
The silicone implant ban refers to the regulatory restrictions imposed by the FDA on the use of silicone gel-filled breast implants for cosmetic surgery, initiated in 1992. This action followed growing concerns about health issues associated with ruptured silicone implants, which had been increasingly linked to reports of illnesses among women. Initially, the FDA required manufacturers to validate the safety of these implants, but the data provided was deemed inconclusive, leading to the restriction of their use solely for reconstructive purposes as part of research studies.
Despite the ban, silicone implants remained popular, with millions of women having undergone the procedure by the 1990s. Legal battles emerged as many women sought compensation for alleged health problems, prompting one major manufacturer, Dow Corning, to file for bankruptcy. In subsequent years, extensive reviews of scientific studies found no evidence linking silicone implants to severe health risks, though issues like capsular contracture and implant rupture were recognized as potential complications. Despite the findings, the FDA's ban on silicone implants for cosmetic use remains in place, reflecting ongoing debates and uncertainties surrounding their safety. Further research is still encouraged to address lingering concerns associated with undetected ruptures and long-term risks.
On this Page
Subject Terms
Silicone implant ban
The Event As a result of health concerns, the U.S. government declares that breast implants cannot be filled with silicone
Date 1992
When the Food and Drug Administration (FDA) banned silicone implants, it created enormous distrust of the health care industry. Thousands of women sued manufacturers for damages.
In 1976, the FDA enacted the Medical Devices Amendment, requiring that all medical devices be approved for safety and effectiveness. A grandfather clause exempted devices already in use unless their safety was questioned. Silicone breast implants, in use for over ten years, were therefore exempt.
In 1988, following reports of illness linked to ruptured implants, the FDA required the four manufacturers of implants to prove the safety of silicone implants, giving them three years to conduct studies and compile data. In 1992, Dow Corning provided data from 329 studies. The FDA found the results inconclusive and banned the use of implants for cosmetic surgery. Only women undergoing reconstructive surgery for breast cancer, breast injuries, or deformities could receive silicone-filled implants, and then, only as part of a research study.
Impact
By the 1990’s, cosmetic breast surgery had become popular, as more than 1.5 million women in the United States had received silicone implants. Thousands of women who believed their implants caused disease, such as cancer and autoimmune disorders (rheumatoid arthritis and lupus), sued the manufacturers for billions of dollars in settlements. Dow Corning filed for bankruptcy to settle claims.
In 1997, Congress instructed the Department of Health and Human Services to examine safety issues related to silicone implants. Scientists from numerous medical specialties reviewed all available studies and concluded that there is no evidence that silicone implants cause cancer, autoimmune diseases, diseases specific to implants, birth defects, or danger to a developing fetus.
Problems associated with implants are local to the implant and areas affected by the surgery. The greatest risk of silicone implants, compared with saline implants, is an increased incidence of capsular contracture (scar tissue formed by the body). All implants result in some degree of contracture, but, in some women, the appearance and feel of the breast is so altered that surgical correction is required. Breast implants do not last forever and will rupture eventually. When rupture is detected, surgery, with the usual risk of hematoma and infection, is required to replace the implant. Rarely, rupture results in silicone gel escaping into tissue near the breast and becoming encapsulated by the body, resulting in a lump in the chest, armpit, or arm. Surgical correction requires removal of the implant and escaped silicone. Although radiation therapy can cause an increase in capsular contracture, mammography or other X rays have no adverse effects on implants.
Subsequent Events
Subsequent research has failed to show a causal relationship between silicone implants and disease, but uncertainty and controversy continue. It is possible that an undetected rupture could result in long-term risks. More research is indicated and the FDA ban remains in effect.
Bibliography
Grigg, Martha, et al. Information for Women About the Safety of Silicone Breast Implants. Washington, D.C.: National Academy Press, 1999.
Stewart, Mary White. Silicone Spills: Breast Implants on Trial. Westport, Conn.: Praeger, 1998.
Zimmerman, Susan. Silicone Survivors: Women’s Experiences with Breast Implants. Philadelphia: Temple University Press, 1998.