The Food and Drug Administration (FDA) ended a 14-year ban of silicone gel-filled breast implants on Friday, even as it acknowledged side effects including “the hardening of the area around the implant, breast pain, change in nipple sensation, implant rupture, and the need for additional surgery”. Many groups, including the National Organization for Women (NOW) and Public Citizen, are concerned about the approval, questioning the threat that silicone implants may still pose to women’s lives.
The FDA reported that its decision was based on reviews of breast implant manufacturers Allergan (formerly Inamed) and Mentor, independent investigations, and an advisory panel that heard public comments. In October, a former Mentor employee raised questions about the investigations, claiming that the company withheld information about dangerous side effects when reporting to the FDA. The New York Times reports that studies have found that the majority of silicone implants will “rupture at some point;” one study found that 69 percent of women with silicone breast implants had a rupture. Dr. Daniel Schultz, director of the FDA Center for Devices and Radiological Health, warned that ruptures may be “silent,” meaning that they could occur without a woman knowing that anything was wrong. For this reason, women should know that “breast implants are not lifetime devices There is a likelihood [women with silicone implants] will require additional surgery,” Schultz said.
The implants will likely be popular among the 300,000 American women who undergo breast augmentation or reconstruction annually because of the silicone’s more natural look and feel compared to saline implants, the Los Angeles Times reports. They are about twice as expensive, and the full cost of follow-up care and future surgeries for silicone implants cannot be estimated.
The FDA will require post-approval studies of the implants, requiring manufacturers to follow 40,000 women for 10 years following the surgery. Susan F. Wood, former head of the FDA’s Office of Women’s Health, said this process illustrates the limited set of data on which the FDA is basing its decision, according to the Los Angeles Times. NOW President Kim Gandy said of the decision, “It is impossible for women to give informed consent for implants if the information they are receiving is inaccurate or incomplete the very real possibility that women and their children will be exposed to grave health risks is a serious matter.”
