Government advisers have recommended that silicone breast implants be returned to the U.S. market, though with restrictions on how easily women can get them.If you would like to receive late breaking news on health issues covered by AXcess News then you need to subscribe.
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April 14, 2005 (AXcess News) Washington - Government advisers have recommended that silicone breast implants be returned to the U.S. market, though with restrictions on how easily women can get them.
By a 7-2 vote Wednesday, A U.S. Food and Drug Administration panel said the Mentor Corporation had proved its product safe.
On Tuesday, the panel recommended the FDA reject a similar application by rival implant manufacturer Inamed, saying the company failed to prove its devices are less likely to rupture today than a decade ago.The panel also recommended the FDA attach several conditions if it approves the Mentor product, including requiring hands-on training for surgeons inserting the implants, and keeping a registry of breast implant recipients.
Citing health concerns caused by implant ruptures, the FDA banned the devices in 1992 -- except for reconstructive surgery patients and breast cancer survivors.
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