History of Breast Implant Regulation
Silicone gel–filled implants, introduced in the US in 1962, were classified as moderate-risk (Class II) medical devices when Congress passed the 1976 Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act.17 In the 1980s, concerns regarding the safety of breast implants led to extensive studies. Data from the FDA’s surveillance systems and published case reports led the FDA to upgrade silicone breast implants to a Class III device (presenting “a potential unreasonable risk of illness or injury”), which requires premarket approval.16
In 1992, the FDA removed silicone breast implants from the market for primary augmentation purposes due to persistent concerns about patient safety. From 1992 to 2006, silicone breast implants remained available only for breast reconstruction after mastectomy, correction of congenital deformities, or replacement of existing implants.17 Women who agreed to undergo breast augmentation with silicone gel–filled implants were enrolled in safety studies conducted by the implant manufacturers. Saline implants remained on the market with no limitations on use, but additional studies on these implants were also ordered.
In 1999, the Institute of Medicine (IOM) released a report, “Safety of Silicone Breast Implants,”18 which more clearly delineated the complications associated with silicone gel–filled implant use. The authors concluded that local complications, including implant rupture and capsular contracture, were the primary associated safety issues. Furthermore, the authors of the IOM report found no causal relationship between silicone gel–filled implants and systemic diseases, such as autoimmune disorders or cancer.2,18
In 2006, the FDA restored approval of silicone gel–filled implants, based largely on core studies conducted by the implant manufacturers.15,19,20 “Despite frequent local complications and adverse outcomes,” it was noted, “the FDA determined that the benefits and risks of breast implants were sufficiently understood for women to make informed decisions about their use.”17 The FDA required the manufacturers to continue with several postapproval studies.15
The complications and adverse outcomes most frequently observed in these studies were capsular contracture, reoperation, removal of implant, and implant rupture.17 Revision and reconstruction surgeries typically have higher complication rates than do primary augmentation surgeries.2