WASHINGTON (April 14)—An advisory panel to the U.S. Food and Drug Administration has voted 7-2 to conditionally approve the general sale of Mentor Corp.´s silicone-gel breast implants, the 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, Calif.-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.