Silicone Breast Implants Are Unsafe, Despite FDA Approval, Opinion Piece Says

Main Category: Women's Health / Gynecology
Also Included In: Cosmetic Medicine / Plastic Surgery
Article Date: 06 Feb 2007 - 12:00 PDT

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Despite FDA's recent approval of silicone breast implants, there still are "considerable risks that women must consider before walking into the operating room," Edward Melmed, a Dallas-based plastic surgeon, and Judy Norsigian, executive director of Our Bodies Ourselves, write in a Boston Globe opinion piece (Melmed/Norsigian, Boston Globe, 2/2). FDA in November 2006 approved the use of silicone breast implants manufactured by Santa Barbara, Calif.-based Mentor 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, 2/1). According to Melmed and Norsigian, FDA made its "endorsement" of the implants "without adequate safety assessments." In addition, the medical community "does not have a clear picture of how many women have become sick due to a leaking implant," the authors write. "[T]here is little evidence to support" some plastic surgeons' claims that the implants "will break and leak far less often," Melmed and Norsigian write, adding that silicone that leaks into the lymph nodes "poses greater risks than leaking saline." Requiring silicone manufacturers to conduct a study on the implants' long-term effects after the approval is the "greatest indicator that the FDA has proceeded too quickly," according to the authors. They add, "Should we not understand the long-term risks before sending a product to market?" Melmed and Norsigian write that women are "essentially the experimental lab rats into whom the so-called new and improved 'fifth generation' of silicone will be implanted," concluding that women considering the implants "need to be fully aware of the lack of data showing these implants are safe" (Boston Globe, 2/2).

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