'If ultimately approved by the FDA, Mentor's Memory Gel breast implants will be a significant addition to the options for women seeking breast augmentation or reconstruction in the United States.'

The 7-2 recommendation for approval, with a series of conditions stipulated by the FDA's General and Plastic Surgery Advisory Panel, represents a significant step towards full approval of Mentor's silicone gel-filled breast implants in the United States, says the company.

Same Panel Voted Against Approval of Inamed Implants

"This is a major victory for women who are considering the personal choice of breast implants," said Betsy Mullen, a patient advocate and founder, president and CEO of WIN Against Breast Cancer. "The panel clearly recognized what we've known for years. Silicone implants are a safe and important option for women who prefer the realistic feel and better appearance that these products offer."

The advisory panel's vote was based primarily upon its review of Mentor's pre-market approval (PMA) application filed in December 2003 and on the company's PMA amendment filed in August 2004.

The approval of the Mentor breast implants came in the wake of the same panel's 5-4 vote earlier this week against recommending approval of Inamed Corporation's silicone gel-filled breast implant application.

If the FDA follows both recommendations of its Advisory Panel, Mentor's Memory Gel products likely would be the only approved silicone gel-filled breast implants in the US, the company point out.

Currently Marketed in 50 Countries

Presently in the United States, silicone gel-filled breast implants are available only for women who are eligible and elect to participate in an FDA-approved continued-access study for breast reconstruction and revision patients.

"If ultimately approved by the FDA, Mentor's Memory Gel breast implants will be a significant addition to the options for women seeking breast augmentation or reconstruction in the United States," said Joshua H. Levine, President and Chief Executive Officer of Mentor Corporation.

All of Mentor's silicone gel-filled breast implant products are filled with Memory Gel, a proprietary silicone gel formulation that the company says "holds its shape but remains soft, resulting in a more realistic appearance."

By varying the ratio of the components of the gel, Mentor explains, it is able to provide a wide selection of products that address the full range of customers' needs. More than 1,000,000 women in over 50 countries have received Memory Gel implants, according to the company.