FDA Advisory Panel Recommends Conditional Approval of Mentor Silicone Gel-Filled Breast Implants

U.S. Food and Drug Administration (FDA) determined on Apr. 13, 2005, that the Mentor’s silicone gel-filled breast implants are safe and effective for use in breast reconstruction and augmentation patients. 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 .

“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 & 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.”

ASPS and ASAPS are optimistic that the FDA will follow the panel’s recommendation. “By doing so, Mentor can move forward to reintroduce silicone implants as an option for American women. Organized plastic surgery is enthusiastic about working with the manufacturer to ensure women’s health and safety,” said ASAPS President-Elect Mark Jewell, MD. “Plastic surgeons are committed to helping women make informed choices about their health care based on all the available and accurate information about these devices.”

The vote of the Advisory Panel 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. This vote followed yesterday’s Advisory Panel vote recommending against 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(TM) products would likely be the only approved silicone gel-filled breast implants in the U.S.

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

Mentor is focused on providing smart and effective solutions for surgeons and the patients they serve. All of Mentor’s silicone gel-filled breast implant products are filled with Memory Gel(TM), a proprietary silicone gel formulation that holds its shape but remains soft, resulting in a more realistic appearance. By varying the ratio of the components of the gel, Mentor 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(TM) implants.

On April 12, the FDA advisory panel issued in a 5-4 vote a “non-approvable” recommendation to Inamed’s application for approval of its silicone breast implants. The panel encouraged Inamed to address its remaining concerns and then request panel re-review of its application for approval. “We are hopeful that a similar favorable recommendation will be issued in the near future to Inamed if it can satisfy the FDA’s remaining concerns,” said Dr. Jewell.

An increasing number of women are choosing breast augmentation to enhance their appearance. According to ASAPS, nearly 335,000 women chose breast augmentation in 2004. More than 62,000 women had breast reconstruction in 2004, according to ASPS. Breast reconstruction has been proven in numerous studies to have many psychological and physical benefits for women who have undergone a mastectomy.

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