Panel Says Saline Implant Brand Safe
GAITHERSBURG, Md. (AP) _ Saline-filled breast implants break open at ``alarmingly high″ rates and require women to undergo repeated surgeries, but at least one brand is safe enough to continue selling as long as women are properly warned of the risks, a government advisory board decided late Wednesday.
About 130,000 American women received saline-filled breast implants last year even though the Food and Drug Administration has never declared these implants safe.
The implants sell because of a government loophole _ but the FDA recently decided they can only continue selling if manufacturers prove they truly are safe, and asked its scientific advisers to evaluate brands sold by California-based Mentor Corp. and two competitors this week.
In a 13-hour meeting Wednesday, about a dozen implant recipients emotionally urged that saline implants be banned. Some held up implants removed from their bodies that were blackened with fungus that had infected the moist implants, and blamed them for causing infections, excruciating breast pain or repeated surgeries.
``Only fools will call these risks acceptable,″ said Patricia Faussett of Henderson, Nev., who said her illnesses disappeared once her implants were removed.