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FDA says "not yet" to silicone gel breast implants; ASAPS comments.
2004 FEB 5 - (NewsRx.com & NewsRx.net) -- "The American Society for Aesthetic Plastic Surgery (ASAPS) respects the scientific inquiry and regulatory process that led the FDA [U.S. Food and Drug Adminstration] to its current conclusion not to allow silicone gel-filled breast implants back on the market right now," said Robert Bernard, MD, a White Plains, New York, plastic surgeon and president of ASAPS.
"The FDA has indicated that the scientific information presented so far has been helpful, but apparently believes that there are still questions that need to be answered about these products," he continued.
The FDA sent a decision letter to implant manufacturer Inamed, requesting amendment to their silicone gel breast implant premarket approval application, and the agency released a draft guidance on all breast implants that a spokesperson said was not meant to be "rules," but to give advice about what is required to establish that breast implants are safe and effective.
The FDA decision is unusual, according to the Society, because it is contrary to the October 15, 2003, FDA advisory panel recommendation for approval with conditions. The FDA decision does not affect saline-filled breast implants, approved by the FDA in May 2000, ...
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- Press release article from: PR Newswire January 6, 1992 700+ words
...TEMPORARY MORATORIUM ON SILICONE GEL BREAST IMPLANTS WASHINGTON, Jan. 6...moratorium on the use of silicone gel breast implants until new information...four manufacturers of silicone gel breast implants. The panel said that...