14.04.2005 02:34:00
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Inamed Comments on FDA Advisory Panel Recommendations
Business Editors/Healthcare Editors
SANTA BARBARA, Calif.--(BUSINESS WIRE)--April 13, 2005--Inamed Corporation (Nasdaq:IMDC), a global healthcare company, today commented on a decision by the General and Plastic Surgery Advisory Panel of the U.S. Food and Drug Administration (FDA) to recommend approval of Mentor Corporation's premarket approval (PMA) application to market the company's gel-filled breast implants in the United States.
Nicholas Teti, Chairman, Chief Executive Officer and President of Inamed, released the following statement with respect to today's FDA Panel decision to approve Mentor's PMA:
"Inamed views today's Panel decision as curious and inconsistent with the decision reached by the Panel yesterday on Inamed's PMA -- we look forward to working with Dr. Crawford and FDA staff on addressing these inconsistencies."
Inamed experienced both a positive vote in 2003 and a close negative vote yesterday on its PMA, and understands that the FDA has to continue its review process, and a Panel vote is not determinative of ultimate product approval.
Inamed's Style 410 cohesive gel-filled breast implants are the subject of a separate PMA and were not part of the PMA under consideration yesterday by the Panel.
Inamed manufactures and sells gel-filled implants internationally in more than 60 countries. For more than a decade, gel-filled implants in the U.S. have been restricted to patients undergoing reconstruction or revision surgery and who are also participating in clinical studies.
About Inamed Corporation
Inamed (Nasdaq:IMDC) is a global healthcare company with over 25 years of experience developing, manufacturing and marketing innovative, high-quality, science-based products. These products include breast implants for aesthetic augmentation and for reconstructive surgery; a range of dermal products to treat facial wrinkles; and minimally invasive devices for obesity intervention, including the LAP-BAND(R) System for morbid obesity. The Company's web site is www.inamed.com.
Forward-Looking Statements
This press release contains, in addition to historical information, forward-looking statements. Such statements are based on management's current estimates and expectations and are subject to a number of uncertainties and risks that could cause actual results to differ or differ materially from those described in the forward-looking statements. Inamed is providing this information as of April 13, 2005 and expressly disclaims any duty to update information contained in this press release.
This press release contains additional forward-looking statements, including, without limitation, Inamed's anticipated product development program. These forward-looking statements involve risks and uncertainties, which could cause actual results to differ materially from those expressed or implied here. Readers are referred to the documents filed by Inamed with the Securities and Exchange Commission, specifically the most recent reports which identify important risk factors that could cause actual results to differ from those contained in the forward-looking statements.
The information contained in this press release is a statement of Inamed's present intention, belief or expectation and is based upon, among other things, the existing regulatory environment, industry conditions, market conditions and prices, the economy in general and Inamed's assumptions. Inamed may change its intention, belief or expectation, at any time and without notice, based upon any changes in such factors, assumptions or otherwise. Inamed undertakes no obligation to review or confirm analysts' expectations or estimates or to state publicly any revisions to any forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
By including any information in this press release, Inamed does not necessarily acknowledge that disclosure of such information is required by applicable law or that the information is material.
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CONTACT: Inamed Corporation Declan Daly Executive Vice President and Chief Financial Officer 805-683-6761
KEYWORD: CALIFORNIA INDUSTRY KEYWORD: GOVERNMENT CONSUMER/HOUSEHOLD MEDICAL DEVICES PRODUCT SOURCE: Inamed Corporation
Copyright Business Wire 2005
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