Healthcare Industry News:  Mentor Corp 

Devices FDA

 News Release - November 17, 2006

Mentor Receives FDA Approval to Sell Its MemoryGel(TM) Breast Implants; Announces Conference Call to Discuss Approval

SANTA BARBARA, Calif.--(HSMN NewsFeed)--Mentor Corporation (NYSE:MNT ), a leading supplier of medical products for the global aesthetic market, announced today that the U.S. Food and Drug Administration (FDA) has approved for sale the Company's MemoryGel(TM) 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(TM) 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(TM) 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(TM) 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 Mentor is focused on providing effective product solutions for surgeons and the patients they serve. All Mentor's MemoryGel(TM) 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.

Conference Call

Mentor Corporation has scheduled a conference call for Monday, November 20, 2006 regarding this announcement. You may listen to the live web cast at 8:30 a.m. EST on Monday, November 20, 2006 or the archived call at, Investor Relations site under "Conference Calls". Those interested in listening to a recording of the call may dial (888) 225-1540 at 10:30 a.m. EST on November 20, 2006 until Midnight EST December 1, 2006.

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

For free video content about Mentor MemoryGel(TM) breast implants, media can log onto to preview and request video. You can receive broadcast-standard video digitally or by tape from this site.

Safe Harbor Statement

This press release contains forward-looking statements regarding FDA regulatory actions, research and development activities, market, and product potential with respect to Mentor's MemoryGel(TM) 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 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.

Source: Mentor Corp

Issuer of this News Release is solely responsible for its content.
Please address inquiries directly to the issuing company.

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