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FDA PANEL RECOMMENDS BREAST IMPLANTS REMAIN ON THE MARKET

      FDA PANEL RECOMMENDS BREAST IMPLANTS REMAIN ON THE MARKET
    SANTA BARBARA, Calif., Nov. 15 /PRNewswire/ -- INAMED Corp. (NASDAQ: IMDC) today announced that a Food and Drug Administration (FDA) advisory panel voted unanimously to recommend that the company's silicone gel-filled breast implants  remain on the market while more safety data is gathered and evaluated by the agency.  The FDA will consider this recommendation in January 1992, when the agency is scheduled to issue a final decision on the approval of a Pre-Market Approval (PMA) application originally submitted by the company's subsidiary, McGhan Medical Corp., in July 1991.
    Although the FDA is not obligated to abide by the panel's recommendations, the agency generally accepts and follows such recommendations.
    Earlier in the meetings, the advisory panel concluded that the original PMA submitted by McGhan Medical had failed to provide sufficient data concerning the safety of the implants.  However, the panel said it did not find any conclusive evidence that the products were unsafe.  In a Nov. 14 Dow Jones report, one of the panel members indicated that he would recommend approval of the PMA on the condition that McGhan Medical complete post-implant research and additional follow-up studies.  He said, "The information in this PMA, taken as a whole, provides reasonable assurance as to the safety and efficacy of the product."  The same panel member also expressed concern that in its review of silicone gel-filled prostheses, the FDA panel "may be establishing a threshold of safety beyond what is reasonable."
    INAMED's Chairman Donald K. McGhan concurred with the assessment provided by the panel member, but stated that the company will continue to cooperate with the FDA in providing research data and additional information which will assist the agency in making an informed decision in January.  Since the original PMA submittal, McGhan Medical has provided further information to the FDA in response to certain deficiencies identified by the agency in September.
    The Wall Street Journal reported today that FDA Commissioner Dr. David Kessler closed the hearings by reassuring women who currently have implants and those who may be considering the devices.  "I don't believe there is any reason for undue alarm," he said.
    INAMED Corp. is a medical device company with 13 operating subsidiaries in the United States and Europe.  The company develops, manufactures and markets medical devices for the plastic and reconstructive, bariatric and general surgery markets.  The company reported sales of over $35.7 million for the year ending Dec. 31, 1990, a 37 percent increase over sales during 1989.
    -0-                 11/15/91
    /CONTACT:  Donald K. McGhan, chairman of INAMED Corp., 805-684-6277; or Jimmy Caplan of Market Makers, 805-569-6919, or Rick Eisenberg of Eisenberg Communications, 212-496-6828, both for INAMED/
    (IMDC) CO:  Inamed Corp. ST:  California IN:  MTC SU: SE-EH -- LA005 -- 1682 11/15/91 15:55 EST
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Publication:PR Newswire
Date:Nov 15, 1991
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