Mentor Receives FDA Approval To Sell Its MemoryGel Breast Implants

Santa Barbara, CA — Mentor Corporation, a supplier of medical products for the global aesthetic market, announced recently that the U.S. Food and Drug Administration (FDA) has approved for sale the Company's MemoryGel™ silicone gel-filled breast implants with post-approval conditions. The products are indicated for women undergoing breast reconstruction and for women who are at least 22 years old undergoing breast augmentation.

"At this historic moment for Mentor, we would like to recognize with gratitude the dedication of the patients, nurses, and surgeons who have participated in the studies that provided the clinical and scientific support for this approval," said Joshua H. Levine, President and Chief Executive Officer of Mentor Corporation. "Over the past 14 years we have remained devoted to returning MemoryGel implants to the U.S. market, and we are pleased to be able to provide women seeking breast augmentation and reconstruction with important new options."

The post-approval conditions and other requirements associated with the FDA's approval include the following: continue the ongoing Mentor Core Study through 10 years, provide physician training to access the device, conduct a large post-approval study for 10 years, complete additional device failure studies, conduct a focus group with patients on the format and content of the approved labeling, utilize a formal informed decision process with patient labeling, cease new enrollment in the Mentor Adjunct Study, and implement device tracking.

For more than a decade, U.S. women seeking breast augmentation have been limited to using saline implants. "Many women prefer the appearance and feel that Mentor's MemoryGel implants provide, and with the help of their doctor, they can now make that informed choice," said Maurice Nahabedian, M.D., Associate Professor of Plastic Surgery, Georgetown University.

In April 2005, the FDA's General and Plastic Surgery Devices Advisory Panel recommended approval for Mentor's MemoryGel implants by a vote of 7 to 2, based on its review of Mentor's Pre-Market Approval (PMA) application, filed in December 2003, the Company's PMA amendment, filed in August 2004, and more than 10 years of science related to silicone gel-filled breast implants referenced in those submissions.

The risks and complications associated with breast augmentation and reconstruction procedures are described in detail in FDA approved physician and patient labeling and can be obtained on www.memorygel.com. Mentor is focused on providing effective product solutions for surgeons and the patients they serve. All Mentor's MemoryGel breast implants are made of a proprietary silicone gel formulation that holds its shape but remains soft, resulting in a more natural look and feel.

SOURCE: Mentor Corporation