Biotech/Pharmaceuticals
Panel Says No to Cosmetic Silicone Implants
By Robert Steyer
TheStreet.com Staff Reporter
4/12/2005 6:39 PM EDT
A federal advisory committee late Tuesday afternoon rejected by a 5-4 vote the application by Inamed (IMDC:Nasdaq) to return silicone-gel breast implants to the U.S. market for cosmetic surgery.
The advisory committee said Inamed failed to provide "reasonable assurance" that the device is safe. The Food and Drug Administration will review the panel's findings. The FDA isn't bound by advisory panel recommendations, but it usually follows its lead.
The advisory panel's vote came after markets had closed; on the news, Inamed's stock was hammered in recent after-hours trade, sinking by $6.27, or 9.4%, to $60.14.
Silicone implants are permitted for a few procedures such as reconstructive breast surgery after mastectomies; but their use for cosmetic surgery has been blocked since 1992 because no company has been able to convince the FDA of its product's long-term safety.
The FDA permits saline-filled implants for cosmetic surgery. But many women say the silicone-gel implants have a more natural look and feel than do the salt-water-filled devices.
The advisory panel's vote came on the second of three days of hearings. The first day was devoted to public comments. The third day will be devoted to Mentor's (MNT:NYSE) application for a silicone-gel implant.
In regular trading, Mentor's stock closed unchanged at $34.56. In after-hours trading, the stock lost 56 cents, or 1.6%.
