14 Dec 2004
WASHINGTON (Dec. 13)--The Food and Drug Administration tentatively has scheduled a meeting in April of its General and Plastic Surgery Devices Advisory Panel to consider the applications of Inamed Corp. and Mentor Corp. to sell silicone-gel breast implants in the U.S.
Inamed and Mentor sell silicone implants in more than 60 countries worldwide, but have been effectively banned from doing so in the U.S. since 1992. The advisory panel recommended lifting the ban in November 2003, but the agency ruled in January that there were too many unanswered questions about the rupture and leaking of the implants to allow their sale.
Besides seeking recertification of silicone implants, Inamed also seeks approval for sale of a new-generation implant that virtually nullifies the chances for rupture and leaking, the company said.
Press release from Inamed
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