Silicone implants for breast enlargement, FDA will approve one and turns down another

Main Category: Cosmetic Medicine / Plastic Surgery
Article Date: 16 Apr 2005 - 11:00 PDT

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'Silicone implants for breast enlargement, FDA will approve one and turns down another'

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An FDA panel has advised the approval of the use of one type of silicone implant for breast enlargement produced by the Mentor Corporation. It has turned down Inamed's implants. This follows the recommendations of an FDA panel.

Mentor's implant was approved because it ruptures less often. Mentor has to follow certain conditions. The company cannot start marketing yet.

Below is the press release from the Mentor Corporation:

FDA Advisory Panel Recommends Conditional Approval of Mentor Silicone Gel-Filled Breast Implants; Patient Advocates Hail Decision as Victory for Women Considering Breast Augmentation or Reconstruction

Mentor Corporation (NYSE:MNT), a leading supplier of medical products in the United States and internationally, today announced that an advisory panel to the U.S. Food and Drug Administration (FDA) determined that the Company's silicone gel-filled breast implants are safe and effective for use in breast reconstruction and augmentation patients. The 7-2 recommendation for approval, with a series of conditions stipulated by the FDA's General and Plastic Surgery Advisory Panel, represents a significant step towards full approval of Mentor's silicone gel-filled breast implants in the United States.

"This is a major victory for women who are considering the personal choice of breast implants," said Betsy Mullen, a patient advocate and founder, President & CEO of WIN Against Breast Cancer. "The panel clearly recognized what we've known for years. Silicone implants are a safe and important option for women who prefer the realistic feel and better appearance that these products offer."

The vote of the Advisory Panel was based primarily upon its review of Mentor's pre-market approval (PMA) application filed in December 2003 and on the company's PMA amendment filed in August 2004. This vote followed yesterday's Advisory Panel vote recommending against approval of Inamed Corporation's silicone gel-filled breast implant application. If the FDA follows both recommendations of its Advisory Panel, Mentor's Memory Gel(TM) products would likely be the only approved silicone gel-filled breast implants in the U.S.

Presently in the United States, silicone gel-filled breast implants are only available for women who are eligible and elect to participate in an FDA-approved continued access study for breast reconstruction and revision patients.

"This is good news for Mentor, and great news for doctors and patients," said Joshua H. Levine, President and Chief Executive Officer of Mentor Corporation. "If ultimately approved by the FDA, Mentor's Memory Gel(TM) breast implants will be a significant addition to the options for women seeking breast augmentation or reconstruction in the United States. The panel deserves a lot of credit for thoroughly examining the scientific data before reaching the same conclusion we have reached--that Mentor's silicone gel-filled breast implants are a safe and effective option for women."

Mentor is focused on providing smart and effective solutions for surgeons and the patients they serve. All of Mentor's silicone gel-filled breast implant products are filled with Memory Gel(TM), a proprietary silicone 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. More than 1,000,000 women in over 50 countries have received Memory Gel(TM) implants.

While Mentor currently markets saline-filled breast implants, its Memory Gel(TM) silicone gel-filled products provide an option for patients seeking a more realistic feel and appearance. "Mentor's gelatin-like, cohesive breast implants are designed to mimic the soft tissues of the human body," said Levine. "While the personal needs of each patient vary, experienced physicians are able to use Memory Gel(TM) products to provide both breast augmentation and reconstruction surgery patients a realistic breast contour."

"Most of my patients do significant research about breast implants, and then work closely with me and my staff to make an informed decision that meets their needs. These are patients who want to know that all of the safe options are made available to them," commented Dr. Scot Glasberg, a New York City plastic surgeon. "As a doctor, I look forward to the possibility of being able to provide Mentor's Memory Gel(TM) products as one of those options."

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 http://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," "would likely," "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.

Article adapted by Medical News Today from original press release.
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