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FDA rules against lifting ban on breast implants
www.chinaview.cn 2005-04-13 09:07:07

   
An advisory panel to the US Food and Drug Administration (FDA) on Tuesday ruled against lifting a 13-year ban on the silicone breast implants manufactured by the Inamed Corp., saying the company failed to present convincing evidence to show the devices are safe enough.
 WASHINGTON, April 12 (Xinhuanet) -- An advisory panel to the US Food and Drug Administration (FDA) on Tuesday ruled against lifting a 13-year ban on the silicone breast implants manufactured by the Inamed Corp., saying the company failed to present convincing evidence to show the devices are safe enough.

    The panel of advisers voted 5 to 4 against recommending approval of Inamed's implants on the second day of a three-day scientific meeting held at Gaithersburg, Maryland, on whether to resume sales of silicone implants in the United States. Health concerns that leaking silicone could cause long term and disablingdiseases led to the imposition of a ban in 1992.

    The panel reviewed new data provided by Inamed after the FDA rejected a similar application from the company 15 months ago. The FDA, which has the final say, usually follows the opinion of its advisers.

    On Monday, the panel heard testimony both from women who linkedthe silicone implants to chronic, disabling illnesses and from others who said the devices were safe, and look and feel better than saline-filled ones now available in the United States.

    Silicone implants, which are widely available in other countries, have not been in studies linked with lupus, rheumatoid arthritis and other chronic diseases.

    The implants can lead to complications including breast pain. They can also break and require replacement operations.

    Inamed officials said the risks from the implants were "acceptably low" and more " related to the surgical procedure" thanthe nature of the device.

    Inamed's rival Mentor Corp. is also seeking to return silicone implants to the US market. The FDA panel will review Mentor's studies on Wednesday. Enditem

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