Philadelphia Inquirer Examines Demand For Silicone Breast Implants Since FDA Approval

Main Category: Cosmetic Medicine / Plastic Surgery
Also Included In: Women's Health / Gynecology
Article Date: 05 Feb 2007 - 6:00 PDT

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The Philadelphia Inquirer on Wednesday examined the "resurgence" of silicone breast implants after FDA in November 2006 decided they were "reasonably safe" for breast reconstruction and cosmetic purposes (McCullough, Philadelphia Inquirer, 1/31). 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 the Inquirer, the "considerable risks of implants have never been clearer," but breast enlargement "has never been more popular" and silicone implants are expected to "corner that market." About 360,000 U.S. women in 2005 paid an average of $5,000 out of pocket for cosmetic breast augmentation. About 3.7 million U.S. women have had the surgery, the Inquirer reports (Philadelphia Inquirer, 1/31).

"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

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