Healthcare Industry News: breast implant
News Release - October 20, 2006
Mentor Receives Canadian Medical Device Licences with Terms and Conditions for Its Round and Contour Silicone Gel-Filled Breast Implants
For Use in Augmentation, Reconstruction and Revision SurgeriesSANTA BARBARA, Calif.--(HSMN NewsFeed)--Mentor Corporation (NYSE:MNT ), a leading supplier of medical products in the United States and internationally, today announced that it has been granted medical device licences with terms and conditions from the Therapeutic Products Directorate (TPD) of Health Canada to begin marketing and selling its round and contour MemoryGel(TM) breast implants in Canada for use in augmentation, reconstruction and revision procedures.
"The MemoryGel implant is a cohesive gel implant that more naturally mimics the breast when compared to saline implants," said Wayne Perron, M.D., F.R.C.S. (S.), a past President of the Canadian Society of Aesthetic Surgery. "MemoryGel implants are backed by strong science, and now Canadian women, in consultation with their plastic surgeons, can decide if this is the right choice for them."
The letter from the TPD noted that the information provided in support of the Company's applications was considered sufficient to issue a licence with conditions for each of the MemoryGel products under review. The terms and conditions include the following: continuation of the Core Study, conduct physician and patient focus groups regarding the format and content of the approved labeling, conduct a post-approval study, and conduct additional pre-clinical testing. The products will be available for patients undergoing reconstruction, augmentation, and revision procedures.
"We are very gratified that, after a thorough review of the clinical and scientific evidence, Health Canada has issued licences for MemoryGel breast implants," said Joshua H. Levine, President and Chief Executive Officer of Mentor Corporation. "In Canada, choices for women seeking breast augmentation and reconstruction had previously been limited. Mentor's MemoryGel breast implants will be a significant additional option for these women."
Mentor is focused on providing smart and effective solutions for surgeons and the patients they serve. All of Mentor's MemoryGel breast implant products contain a proprietary 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.
About Mentor Corporation
Founded in 1969, Mentor Corporation is a leading supplier of medical products for the global aesthetic market. The Company develops, manufactures and markets innovative, science-based products for surgical and non-surgical medical procedures that allow patients to retain a more youthful appearance and improve personal well-being. The Company's website is www.mentorcorp.com.
Safe Harbor Statement
This press release contains forward-looking statements regarding Health Canada regulatory actions, research and development activities, market, and product potential with respect to Mentor's MemoryGel silicone gel-filled breast implants. 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. 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 Report on Form 10-K, its Quarterly Report 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.
Source: Mentor
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