Guest guest Posted January 25, 2006 Report Share Posted January 25, 2006 Note: forwarded message attached. Bring words and photos together (easily) with PhotoMail - it's free and works with . http://today.reuters.com/investing/financeArticle.aspx?type=governmentFilingsNews & storyID=URI:urn:newsml:reuters.com:20060125:MTFH37788_2006-01-25_23-18-48_N25250349:1 Print this article Close This Window US FDA investigators said asking about Mentor CorpWed Jan 25, 2006 6:19 PM ET By Richwine WASHINGTON, Jan 25 (Reuters) - A consumer activist and a former Mentor Corp. <MNT.N> employee said on Wednesday they had been interviewed by U.S. criminal investigators about the company's experimental silicone breast implants. Zuckerman, president of the National Research Center for Women & Families, told Reuters she spoke last Friday with investigators from the Food and Drug Administration's (FDA) Office of Criminal Investigations. Zuckerman, who has questioned the long-term safety of silicone implants, said she was asked in part to recount allegations from former or current Mentor employees who had told her the company failed to accurately report the difference in rupture rates between smooth and textured implants. Mentor said in a statement: "We have not been notified by the FDA of an investigation regarding that issue." A former Mentor employee also said in an interview he was questioned by an FDA criminal investigator in December. He spoke to Reuters on condition of anonymity. FDA spokeswoman Bro said she could not confirm or deny whether the FDA had launched a criminal probe of Mentor. Mentor and rival Inamed Corp. <IMDC.O> are seeking FDA approval for silicone breast implants. The FDA has told both companies it would approve the implants for sale if certain conditions are met. The conditions have not been disclosed. Zuckerman said FDA investigators asked her about allegations from three former and one current Mentor employee who had contacted her. The investigators asked in part about charges that Mentor did not report rupture rates for the implants accurately. "That's one thing I know interested (the investigators), the idea that the rupture rate is higher than has been reported," Zuckerman said. Zuckerman said she had no way of knowing whether any of the allegations were true. Mentor said the company had reported all rupture complaints to the FDA and that its Texas manufacturing facility had been audited annually by the FDA and international regulators since 1999. "This FDA audit included a review of the complaint reporting process and no issues with that process were identified," the company said. The former Mentor employee, an engineer who said he was interviewed in December, said he also spoke at the same time with two officers from the FDA's Office of Compliance, which makes sure companies follow device regulations. The former employee said he was questioned about his charges that Mentor used a "low-bleed" patch for the implants that women try on externally for size, while a higher-bleed patch was used in devices put into women's bodies. ~~~~~~~~~~~~~~~~~~~~~~~ Ilena RosenthalDirector, Humantics Foundation for Womenwww.BreastImplantAwareness.org Quote Link to comment Share on other sites More sharing options...
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