Breast Implants

Types of Breast Implants

Over the past 100 years, various materials have been implanted in patients seeking to augment their breast size and shape, including ivory, glass, rubber, sponges, paraffin, Teflon, and silicone. Most patients receiving breast implants fall into two groups: women seeking augmentation for cosmetic reasons and women seeking reconstruction following mastectomy. Other patients include girls or women with congenital “deformities” and patients seeking male-to-female gender reassignment surgery. Breast implants are soft sacs with a silicone shell, filled with either saline liquid or silicone gel, which are surgically implanted into the breast. Women undergoing breast reconstruction after mastectomy may choose among these manufactured implants or can use their own body tissue to reconstruct a breast via either TRAM flap or free flap methods. In the first technique, skin and fat from the lower abdomen is moved to the chest to create a breast shape. In the latter approach, abdominal tissue is surgically removed and then reattached via microsurgery to create a breast.

A Brief History of Silicone Breast Implants

The use of silicone to enlarge women's breast size originated in Japan, shortly after World War II, when Japanese prostitutes, seeking to meet American servicemen's reputed preference for larger breasts, used injections of liquid silicone (among other substances) to augment their breast size. Women who underwent silicone breast injections experienced serious complications, including scarring, infections, disfigurement, and migration of the injected silicone to other body parts. The first contemporary breast implant was created in 1961 by two plastic surgeons, Frank Gerow and Thomas Cronin, by encasing silicone gel inside a thin silicone envelope, thereby preventing migration and its associated problems. In 1962, Timmie Jean Lindsay became the first woman to receive a silicone-gel-filled implant. Silicone was already used in other medical devices without evidence of serious risks and thus was well received by plastic surgeons. The “Cronin Implant” was patented, albeit without formal clinical trials or safety testing, with rights assigned to the Dow Corning Corporation.

As silicone-filled implants gained popularity among women in the 1970s and 1980s as a way of augmenting breast size, they also came under increasing public scrutiny. In 1976, the Medical Device Amendment (MDA) to the Federal Food, Drug, and Cosmetic Act was passed, giving the FDA authority to regulate medical devices, including implants. Already on the market for 15 years, breast implants were “grandfathered” in under the amendment, such that manufacturers were not required to provide the FDA with scientific evidence of product safety and effectiveness, and the devices remained available to women without restriction. However, the 1980s and early 1990s were marked by increasing concern about potential health risks associated with silicone breast implants. Sidney Wolfe of the Public Citizen's Health Research Group began raising concerns about connections between breast implants and cancer risk and accused Dow Corning Corporation, a leading breast implant manufacturer, of withholding and suppressing information regarding potential leaks and ruptures of their implants. In December 1990, the news show Face to Face With Connie Chung aired a program about the possible dangers of silicone breast implants, and by June 1992, a total of 14,259 adverse reactions were reported to the FDA by breast implant recipients. Thousands of lawsuits were filed against Dow Corning, including one by Marcia Stern in 1984 and one by Mariann Hopkins in 1991, both of whom won claims that silicone breast implants cause systemic autoimmune disease. These lawsuits eventually resulted in a $4.3 billon global settlement against implant manufacturers to offer compensation to any woman with diseases or symptoms associated with breast implants. As a result of this settlement, Dow Corning Corporation filed bankruptcy in 1995.

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