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Mentor's silicone breast
implants get FDA OK Thu Jul 28, 2005 4:59
WASHINGTON, July 28 (Reuters) - Silicone gel-filled breast implants won conditional approval to return to the broad U.S. market after a 13-year ban on Thursday when U.S. health officials backed a version made by Mentor Corp. (MNT.N: Quote, Profile, Research) The U.S. Food and Drug Administration said the device maker must satisfy a number of conditions before it receives final approval to sell the implants. FDA officials said they would not make the conditions public. "Federal law and regulations prohibit the government from discussing the specific contents of the letter," the agency said. Mentor said the conditions were "generally consistent" with recommendations from an expert FDA advisory panel that met earlier this year. Shares of the Santa Barbara, California-based firm were halted in after-hours trading after closing down 84 cents, or 1.87 percent, at $44.20. It was not immediately clear what the decision meant for competitor Inamed Corp. (IMDC.O: Quote, Profile, Research), which had also sought approval for its implants. Dan Cohen, Inamed's vice president for global corporate and government affairs, said he was not aware that the FDA had made any decision about his company's silicone implants. Shares of Inamed, which is being bought by Medicis Pharmaceutical Corp., closed down 28 cents at $71.41 ahead of the Mentor announcement. The United States banned silicone breast implants for most women in 1992 amid allegations that leaking silicone caused disabling, long-term illnesses such as rheumatoid arthritis and lupus. In April, an FDA advisory panel voted 7-2 to recommend approval of Mentor's silicone implants and 5-4 against sales of Inamed's implants. © Reuters 2005. All Rights Reserved. Up to the Minute: News Articles about Silicone Gel Implants
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Up to the Minute: News Articles about Silicone Gel Implants
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