SANTA BARBARA, Calif.----April 3, 2006--Mentor Corporation, a leading supplier of medical products in the United States and internationally, today announced that it had filed its Pre-Market Approval (PMA) application with the U.S. Food and Drug Administration (FDA) for the Company's Contour Profile(R) gel breast implant products (CPG(TM)).
"Our CPG implants are market leading products in every country that they are available, and we are pleased to be in a position to seek approval for these products in the U.S. as well," commented Joshua H. Levine, President and Chief Executive Officer. "Their shape more closely imitates the natural breast, and would allow surgeons and their cosmetic and reconstructive patients to have more choices for breast surgery."
Mentor's silicone gel-filled breast implants, including the CPG products, are filled with MemoryGel(TM). "All of Mentor's MemoryGel implants are filled with a proprietary silicone gel formulation that holds its shape but remains soft, resulting in a realistic feel and appearance," said Levine. "Because the personal needs of each patient vary, we are committed to offering experienced physicians more MemoryGel products that would enable them to achieve the most realistic breast contour."
Mentor also remains in discussion with the FDA regarding the conditions for approval of the Company's MemoryGel round silicone gel breast implant PMA, including post-market patient monitoring. The Company submitted its PMA in December of 2003. 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 which Mentor must satisfy in order to receive FDA approval to market and sell silicone gel-filled breast implants in the United States. There can be no assurances with respect to the timing and outcome of the FDA's decision regarding approval.
About Mentor Corporation
Founded in 1969, Mentor Corporation is a leading supplier of medical products for the global healthcare market. The Company develops, manufactures and markets innovative, science-based products for the aesthetics, urologic specialties and clinical and consumer healthcare markets around the world. The Company's website is www.mentorcorp.com.
Safe Harbor Statement
All statements included or incorporated by reference in this release, other than statements or characterizations of historical fact, are forward-looking statements. These forward-looking statements are based on our current expectations, estimates and projections about our industry, management's beliefs and certain assumptions made by us. Forward-looking statements in this press release include but are not limited to those statements related to Mentor's belief that CPG products "would allow surgeons and cosmetic and reconstructive patients to have more choices for breast surgery," and our commitment to "offering experienced physicians more MemoryGel products that would enable them to achieve the most realistic breast contour." Forward-looking statements can also be identified by words such as "anticipates," "expects," "intends," "plans," "predicts," "believes," "seeks," "estimates," "may," "will," "should," "would," "could," "provide," "potential," "continue," similar expressions, and variations or negatives of these words. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. These forward-looking statements speak only as of the date hereof and are based upon the information available to us at this time. Such information is subject to change, and we will not necessarily inform you of such changes. These statements are not guarantees of future results and are subject to risks, uncertainties and assumptions that are difficult to predict. Therefore, our actual results could differ materially and adversely from those expressed in any forward-looking statement as a result of various factors.
The Securities and Exchange Commission filings of Mentor, including, without limitation, its Annual Reports on Form 10-K, subsequent quarterly reports on Form 10-Q, and recent Current reports on Form 8-K, discuss important risk factors that could contribute to such differences or otherwise affect its business, results of operations and financial condition. Mentor undertakes no obligation to revise or update publicly any forward-looking statement for any reason.