Summary of FDA's approval of silicone breast implants

Nov 23 2006

Two editorials respond to FDA's approval on Friday of 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.

The agency also approved cosmetic use of silicone breast implants only for women ages 22 and older. The approval 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, according to Daniel Schultz, director of FDA's Center for Devices and Radiological Health. Silicone breast implants were banned in 1992 because of safety concerns, and most implants contain saline solution. Some critics of the approval have said some safety concerns have not been resolved (Kaiser Daily Women's Health Policy Report, 11/20).

• Chicago Tribune: FDA's approval is good for women who would like to have access to silicone breast implants for reconstructive or cosmetic purposes, and it is good "for anyone who thinks individuals should be free to assess risks and make their own choices," a Tribune editorial says. The approval comes about 15 years "too late for women who were deprived of a largely safe option because of fears that now turn out to be mostly groundless," according to the Tribune. "The important thing is that now women acting with ample information and the guidance of their doctors will be allowed to decide for themselves," the editorial says, concluding, "That's a positive development. A shame it's such a tardy one" (Chicago Tribune, 11/21).
  
  
• New York Times: Although silicone implant opponents called FDA's approval a threat to women's health, the agency made a "reasonable call" that will allow women and their physicians to make their own judgments, a Times editorial says. Many studies over the years have found that the main fears about silicone breast implants "were overblown," but "[t]hat does not mean they are risk free," the editorial says. FDA "heaped on enough caveats to give women ample reason to pause before leaping into cosmetic breast surgery," the editorial says, adding that the agency will need to be "vigilant" in enforcing the required post-marketing studies over the next 10 years (New York Times, 11/21).