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3 janvier, 2007 14:51

Kaiser Daily Women's Health Policy

Opinion

FDA Approval of Silicone Implants Example of Apparent 'Approve Now, Test Later' Policy, Opinion Piece Says

Although FDA's approval in November 2006 of silicone breast implants means "big money for easy surgery" for U.S. plastic surgeons, "women will become the experimental lab rats for these implants," Dallas-based surgeon Edward Melmed writes in a Los Angeles Times opinion piece (Melmed, Los Angeles Times, 1/3). FDA 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, 11/27/06). According to Melmed, "Most plastic surgeons vehemently deny any connection between health complaints and leaking silicone implants," but "I have seen a disturbing number of patients with symptoms -- including fatigue, short-term memory loss, joint and muscle pains, skin rashes disturbed sleep patterns, depression and hair loss -- that clear up when implants are removed." The same assurances that have been given that the "new generations" of silicone implants are less likely to rupture also were made "for every previous generation," Melmed writes, adding, "Apparently our government's policy has become 'Approve now, test later'" (Los Angeles Times, 1/3).

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