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Panel gives mixed recommendations on silicone implants.(News)
GAITHERSBURG, MD. -- After more than a decade, silicone gel-filled breast implants could soon be back on the market and widely available for women undergoing reconstructive, augmentation, and revision surgery.
Last month, the Food and Drug Administration's General and Plastic Surgery Devices Panel recommended approval of silicone implants made by the Mentor Corporation by a vote of 7-2. The panel's approval came with a list of nine conditions.
The positive vote was surprising. The day before, the same panel had voted 5-4 against approving silicone breast implants made by the Inamed Corporation, although that company had presented somewhat longer follow-up data than did Mentor.
A very low rupture rate at 2 years and evidence indicating that the Mentor implants may have an average lifetime of about 25 years helped sway the panel in favor of approval. Those voting against approval of the Mentor and Inamed implants cited the need for longer patient follow-up.
Joseph LoCicero III, M.D., professor and chair of the department of surgery at the University of South Alabama, Mobile, said he was "much more comfortable" with the rupture data on the Mentor implants, and agreed with the other panelists supporting approval that there was "reasonable assurance" that they were safe.
Stephen Li, Ph.D., president of a medical device testing company in Sarasota, Fla., said that Mentor had done the best possible fatigue testing of its implants. Another reason Dr. Li said he voted for the Mentor implants, but not Inamed's, was that Mentor's rupture rate at 2 years was "extremely low."
Those who voted against approval for both the Mentor and Inamed implants said longer follow-up of patients was still needed. Panelist Amy Newburger, M.D., a dermatologist from Scarsdale, N.Y., said that information on Mentor's rupture rates was not adequate, since data on MRIs used to determine silent rupture rates had been collected only twice, which made it difficult to estimate long-term rupture rates.
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Source: HighBeam Research, Panel gives mixed recommendations on silicone implants.(News)