7/28/05 – Mentor Press Release – Mentor Receives Approvable Notification From FDA for Its Silicone Gel-Filled Breast Implants
SANTA BARBARA, Calif.—(BUSINESS WIRE)—July 28, 2005—Mentor Corporation (NYSE:MNT), a leading supplier of medical products in the United States and internationally, today announced that it has received an “approvable letter” from the U.S. Food and Drug Administration (FDA) for the Company’s MemoryGel(TM) silicone gel-filled breast implants. The approvable letter stipulates a number of conditions which Mentor must satisfy in order to receive FDA approval to market and sell silicone gel-filled breast implants in the United States.
“We are very encouraged by this communication from the FDA, and view this letter as a positive sign for women and their surgeons that another option will soon be available,” said Joshua H. Levine, President and Chief Executive Officer of Mentor Corporation. “We thank the FDA and its Advisory Panel for the rigorous and objective review of our data and related science.”
“For more than a decade, choices for women seeking breast augmentation and reconstruction have been limited,” said Mr. Levine. “If ultimately approved by the FDA, Mentor’s Memory Gel(TM) breast implants will be a significant additional option for these women. Mentor is committed to making these important products available to women and will continue working with the FDA to address the approvable conditions.”
Previously, on April 13, 2005, the FDA’s General Plastic Surgery Devices Advisory Panel recommended Mentor’s MemoryGel(TM) breast implants for approval with conditions by a vote of 7 to 2. 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.
The conditions outlined in the approvable letter are generally consistent with the Advisory Panel’s deliberations. As is typical of FDA approvable processes, Mentor intends to engage in confidential discussions with the FDA to address these conditions, prior to the FDA’s final decision on approval.