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FDA Schedules Advisory Panel Hearing for Mentor's Silicone Gel-Filled Breast Implant PMA.


SANTA BARBARA, Calif. -- Mentor Corporation (NYSE NYSE

See: New York Stock Exchange
:MNT See molecular nanotechnology. ), a leading supplier of medical products in the United States and internationally, today announced that it has been notified by the U.S. Food and Drug Administration (FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
) that the Company's silicone gel-filled breast implant breast implant, saline- or silicone-filled prosthesis used after mastectomy as a part of the breast reconstruction process or used cosmetically to augment small breasts.  PreMarket Approval premarket approval Medical devices A scientific and regulatory review by the FDA to ensure the safety and effectiveness of a Class III device, before its approval for marketing. See Advisory panel, Medical device.  (PMA PMA (papillary-marginal-attached),
n a system of epidemiologic scoring of periodontal disease devised by Schour and Massler in which the symbols denote the areas involved in gingival inflammation.

PMA Progressive muscular atrophy
) application will be reviewed by an FDA Scientific Advisory Panel, scheduled for the Spring of 2005.

"We believe that the data from our core clinical study, together with the supplemental data we have provided, support the safety and effectiveness of these products. Mentor has a long heritage of innovation in surgical devices and patient care, and has been able to meet the increasingly sophisticated needs of physicians and evolving needs of patients," commented Joshua H. Levine, President and Chief Executive Officer. "We look forward to being able to offer an additional choice to women exploring options in breast augmentation and reconstruction."

Mentor filed the fifth and final module of its silicone gel-filled breast implant PMA in December 2003. In January 2004, the FDA issued revised guidelines for companies seeking to gain approval for silicone gel-filled breast implants Breast Implants Definition

Breast implantation is a surgical procedure for enlarging the breast. Breast-shaped sacks made of a silicone outer shell and filled with silicone gel or saline (salt water), called implants, are used.
. In August 2004, Mentor submitted an amendment to its PMA that focused on providing additional information outlined in the new January 2004 revised guidance document and on answering other questions raised by the Agency.

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 Aesthetics franchise includes prosthetic pros·thet·ic
adj.
1. Serving as or relating to a prosthesis.

2. Of or relating to prosthetics.



prosthetic

serving as a substitute; pertaining to prostheses or to prosthetics.
 mammary mammary /mam·ma·ry/ (mam´ah-re) pertaining to the mammary gland, or breast.

mam·ma·ry
adj.
Of or relating to a breast or mamma.



mammary

pertaining to the mammary gland.
 implants for breast augmentation and reconstruction, and lipoplasty products for body contouring. Mentor's Urologic Specialties franchise includes surgical slings for the treatment of urinary stress incontinence urinary stress incontinence
n.
Leakage of urine as a result of coughing, straining, or sudden movement.
, brachytherapy seeds for the treatment of prostate cancer prostate cancer, cancer originating in the prostate gland. Prostate cancer is the leading malignancy in men in the United States and is second only to lung cancer as a cause of cancer death in men. , prosthetic implants for the treatment of erectile dysfunction and disposable surgical urology implants. The Company's Clinical and Consumer Healthcare franchise includes catheters and other products for the management of urinary incontinence and retention.

Mentor employs approximately 2,000 people around the world and is headquartered in Santa Barbara, California Santa Barbara is a city in California, United States. It is the county seat of Santa Barbara County, California. As of the 2000 census, the city had a total population of 92,325. , with manufacturing and research operations in the United States, France, the Netherlands and the United Kingdom. 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 such as "anticipates," "expects," "intends," "plans," "predicts," "believes," "seeks," "estimates," "may," "will," "should," "would," "could," "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.
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No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2004, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1USA
Date:Dec 6, 2004
Words:624
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