FDA panel approves one silicone implant application, rejects another

Washington-An advisory panel to the US Food and Drug Administration has voted 7-2 to conditionally approve the general sale of Mentor Corp.'s silicone-gel breast implants, a day after it voted 5-4 to reject lifting the ban on Inamed Corp.'s silicone implants.

"This is good news for Mentor, and great news for doctors and patients," said Joshua Levine, president and ceo of Mentor, in a statement.

The panel agreed to recommend approval of Mentor implants to the FDA on condition that the Santa Barbara, California-based company meets certain conditions, such as agreeing to another FDA review in five years and continuing a major study of silicone implants through the first 10 years of their public use.

Inamed ceo Nicholas Teti said he found the panel´s approval of Mentor implants inconsistent with its rejection of his company's devices, but added he looked forward to addressing these inconsistencies with the panel.

The full FDA-which rejected an earlier panel recommendation to lift the 13-year ban on silicone implants-has 90 days to rule on the Mentor petition.