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November 17, 2006 source: American Academy of Cosmetic Surgery

FDA allows silicone breast implants back on market WASHINGTON (CNN) - The FDA is allowing silicone breast implants to be sold again, 14 years after they were removed from the market by the same agency over questions of safety. The approved silicone implants are made by two companies, Inamed Aesthetics, now a part of Allergan, and Mentor. In 1992, then-FDA Commissioner Dr. David Kessler took silicone breast implants off the market, citing concerns over their safety, including how often they ruptured in a woman's body and whether leaking silicone could lead to diseases as some women claimed. After the ban, the implants were available only to women in clinical trials who needed them after surgery, especially after breast cancer. At that point, lawsuits over the products drove one of the manufacturers, Dow Corning, into bankruptcy. Since then, most studies have failed to link the implants to serious or chronic diseases such as cancer and lupus, but questions remained over how often the implants rupture and what happens if the silicone enters the body. In a meeting before an FDA advisory committee in April 2005, Inamed said its implants have a 14 percent likelihood of rupturing over a 10-year period. Mentor conducted a three-year study and said the rupture rate at that point was negligent. To help answer questions on long-term safety, the FDA is requiring Inamed and Mentor each to study 40,000 women for 10 years to assess potential health problems. ###

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