Inamed Gains FDA Nod

This is the same panel of medical experts that recommended approval of Mentor's silicone gel implant by a 7-2 vote.

The panel suggested a number of conditions, such as restricting the sale of implants to board-certified plastic surgeons who complete special training and to patients who sign documents showing they understand that the implants could rupture. The panel also said Mentor should prepare a patient registry to examine the implants' long-term health effects and to conduct a clinical study that would assess the implant's rupture rate over 10 years.

After the advisory committee backed Mentor's product and opposed Inamed's implant, angry Inamed executives began discussing their application with the FDA, asking the agency to override the panel's recommendation.

Analysts say cosmetic surgery will represent the lion's share of silicone gel implant sales in the U.S. Both companies sell silicone gel implants in foreign markets, and both sell saline, or salt water-filled, implants for cosmetic and other uses in the U.S. The implant companies and plastic surgeons say women prefer the silicone gel implants because they have a more natural look and feel than the saline implants.

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