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Panel rejects breast implant application.
Byline: Frank Nelson
Apr. 13--Inamed Corp., the Goleta-based breast implant maker, has failed to convince federal health advisers that the time is right to allow silicone-gel-filled implants back onto the market.
Thirteen years after most such implants were banned, a Food and Drug Administration advisory panel voted 5-4 on Tuesday to reject the manufacturer's request to reintroduce them. The panel cited lingering questions about safety and durability.
"Obviously we're disappointed," said Dan Cohen, Inamed spokesman and vice president, who added that the company still believes in the data it presented and thinks it has a strong case.
Today, Inamed rival and the nation's other major implant maker, Santa Barbara-based Mentor Corp., will try to change the panel's mind as it seeks FDA approval for its own silicone implants. The panel is expected to render a decision this afternoon.…
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Source: HighBeam Research, Panel rejects breast implant application.
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