Mentor seeks marketing approval for gel-based implants

By Elaine Rigoli

Tampa, Fla., April 3 - Mentor Corp. announced Monday that it has filed its Pre-Market Approval application with the Food and Drug Administration for Contour Profile breast-implant products.

Mentor's silicone gel-filled breast implants are filled with MemoryGel, a proprietary silicone gel formulation that holds its shape but remains soft, resulting in a realistic feel and appearance, officials said in a news release.

Mentor said the company remains in discussion with the FDA regarding the conditions for approval for MemoryGel, including post-market patient monitoring.

The company submitted its PMA in December 2003, and in April 2005, Mentor received a recommendation for approval, with conditions, by an FDA advisory panel.

In July 2005, the company received an approvable letter from the FDA that stipulated a number of conditions that Mentor must satisfy in order to receive FDA approval to market and sell silicone gel-filled breast implants in the United States, the release said.

Santa Barbara, Calif.-based Mentor develops products for the aesthetics, urologic specialties and clinical and consumer health care markets.

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