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Mentor to Present Long-Term Data Supporting Silicone Gel Breast Implants
Apr 13, 2005, 19:29, Reviewed by: Dr.
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"It's important to note that there are differences among breast implants as well as among the studies that support their safety and efficacy. We believe the advisory panel will weigh the scientific evidence and find that Mentor's silicone gel-filled implants are an important and safe option for women."
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By Mentor Corporation,
Mentor Corporation, a leading supplier of medical products in the United States and internationally, announced this evening that they are looking forward to presenting tomorrow, among other data, up to 12 years of evidence supporting the integrity of Mentor's Memory Gel(TM) silicone gel-filled breast implants. Mentor Corporation will be presenting to the General and Plastic Surgery Panel of the Medical Devices Advisory Committee on April 13, 2005, the third and final day of the advisory panel meeting.
"It's important to note that there are differences among breast implants as well as among the studies that support their safety and efficacy," said Joshua H. Levine, President and Chief Executive Officer of Mentor Corporation. "We believe the advisory panel will weigh the scientific evidence and find that Mentor's silicone gel-filled implants are an important and safe option for women."
Today, the General and Plastic Surgery Panel of the Medical Devices Advisory Committee voted 5 to 4 to recommend non-approval of Inamed's silicone gel-filled breast implants. The panel stated that Inamed failed to adequately address the issues outlined in the Food and Drug Administration's January 2004 Revised Guidance Document.
- Mentor Corporation
http://www.mentorcorp.com
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 can often be identified by words or phrases such as "anticipates," "scheduled," "expects," "intends," "plans," "predicts," "believes," "seeks," "estimates," "is confident," "may," "will," "should," "would," "could," "potential," "in the future," "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.
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