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Public Health & Education | Some Physicians Cautious Over FDA Approval of Silicone Breast Implants

[Nov 27, 2006]

Some physicians after "poring over the fine print" of FDA's recent approval of silicone breast implants are finding reasons to caution patients about the surgery, and some are expecting many women not to switch from saline implants, the Los Angeles Times reports (Healy, Los Angeles Times, 11/27). FDA earlier this month approved the use of silicone breast implants manufactured by Santa Barbara, Calif.-based and Irvine, Calif.-based Allergan for breast reconstruction and cosmetic breast augmentation, but the agency limited cosmetic use to women ages 22 and older. Most breast implants, which often are given to women who have undergone a mastectomy to treat breast cancer, contain saline solution. Silicone breast implants were banned in 1992 because of safety concerns. The approval of Mentor and Allergan's application stipulates that the manufacturers inform women that the implants "are not lifetime devices" and that most recipients will need at least one additional surgery to replace or remove their implants. In addition, FDA is requiring both companies to conduct a study among at least 40,000 implant recipients over the next 10 years to determine the long-term safety and efficacy of the implants and provide the findings to the government. Women also will need to receive magnetic resonance imaging every two to three years to ensure the implants are not leaking (Kaiser Daily Women's Health Policy Report, 11/20). Diana Zuckerman, director of the National Research Center for Women and Families, said MRI testing typically costs between $1,500 and $1,800. In addition, health insurance does not cover silicone breast implants for cosmetic purposes. FDA also has said that subsequent monitoring and repeat surgery costs might not be covered by health insurance and might be more expensive than the initial surgery. "These young girls are often going into debt they can't really afford to get out of, and they're paying for something on installment they can barely afford," Zuckerman said. According to the Times, plastic and aesthetic surgeons are divided on the question of whether "silent ruptures," or breaks in a silicone implant that are not noticed by implant patients, need to be replaced for safety reasons. Walter Erhardt, chair of the American Society of Plastic Surgeons' public education committee, said that physicians "still don't have science that (a silent rupture) creates a harmful situation for the patients" and that FDA "hasn't addressed that either" (Los Angeles Times, 11/27).