Fwd: criminal investigation of Mentor

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The FDA has started a criminal investigation of Mentor Corporation, regarding their breast implants. Two stories are below.

Best wishes,

Zuckerman, Ph.D.PresidentNational Research Center for Women & Families1701 K Street, NW, Suite 700Washington, DC 20006(202) 223-4000www.center4research.org

FDA Week, January 24, 2006

FDA Criminal Investigation Shop Looks Into Breast Implant AllegationsFDA's Office of Criminal Investigation is interviewing people about therupture data that Mentor submitted to FDA on its textured siliconebreast implants, sources say. One of at least two interviewees include aformer Mentor employee who last year alleged the company hid rupturedata from the agency. It is unclear if the OCI is on a fact finding mission or pursuing aformal investigation. An FDA spokesperson would neither confirm nor denyan investigation is underway. Sources say an OCI investigator asked those interviewed about rupturedata that Mentor gave FDA as part of a multi-product approval package.The investigator also asked general questions about the company'spractices, the sources say. The former Mentor employee spoke with OCI Dec. 19 in FDA's Dallasoffice. A Mentor spokesperson says the company has given FDA all rupturecomplaints from product evaluations, warranties, clinical studydepartments or any other source. Mentor has told FDA Week in the pastthat it remains confident that its product will be approved, and pointsout in a company statement that the former employee was indicted by aTexas district attorney for stealing Mentor implants and selling them oneBay.

In a letter to FDA last November, the former Mentor employee allegedthat Mentor hid rupture data from FDA. "The textured silicone gel breast implants made by Mentor have a designflaw that results in a higher rupture rate than [the company's] smoothshell implants," the former employee wrote. "That higher rupture ratehas not been accurately reported to the FDA."The former employee told OCI investigators of hearing conversationswhile at Mentor that warranty claims for the textured implant were muchhigher than the number of defects doctors reported, the former employeetells FDA Week. The former employee also reports telling OCI that thecompany may have categorized leaks under other defects like jointfailures or patch failures. The former employee worked in Mentor's research and developmentdepartment and stresses to FDA Week that this division is not privy toproduct quality data. The former employee told OCI of hearing that thecompany hid data from another employee who transferred from productevaluation to research and development, the former employee says. The OCI investigator may interview this employee, sources say. Textured implants are made with two layers of silicone to prevent theprosthesis from moving around, the former employee explains to FDA Week.Over time, the rubbing between the two layers can result in tinyfractures and lead to ruptures. The texturing process is used to make some saline implants as well,which Mentor already has on the market.The former employee also alleged in the letter to FDA that Mentor mayhave misled patients by supplying doctors with sample implants that usea low-bleed patch that leaks less than those used in surgery (see FDAWeek, Dec. 16). Previously, FDA Week reported that FDA thinks thecompany likely did nothing wrong by giving doctors a demonstrationimplant that is different from the one used in surgery unless Mentorpurposely misled patients. Sources close to the investigation say the demonstration models do notappear to be the focus of the OCI investigation. Drug lawyers say it is unusual for the OCI to investigate a company thatis not involved in product diversion or counterfeiting. "It's significance is that they've decided that [the accusations] areserious enough to dedicate resources to," one drug lawyer said. Another drug lawyer points out that the Department of Justice does nothave to approve cases that OCI brings. Instead, OCI can bring the casedirectly to a U.S. Attorney General, which bypasses some bureaucracy,the lawyer says. Breast implants are also the subject of a Senate health committeeinvestigation.Last year, Sen. Mike Enzi's (R-WY) committee started looking intofinancial conflicts on the FDA advisory committee that recommendedMentor's implants be approved for general use. A committee spokespersonsays the panel is also taking into account the former employee'saccusations. Other legislators also have talked to the former employee,sources say. Silicone implants currently are only available to women who need themfor reconstructive surgery, but they have been widely used nonetheless.Opponents of the product say even small silicone leaks caused by cracksor ruptures could be harmful to women. Mentor wants to put its silicone implants on the market for general use.The company last summer received an "approvable" letter from FDA formarketing the product. FDA stated it would approve the device if thecompany meets certain conditions. FDA and Mentor are not allowed to talkabout these conditions.--Catharine Richert------------------------------------------

WASHINGTON, Jan 25 (Reuters) - A consumer activist and a former Mentor Corp. (MNT.N: Quote, Profile, Research) 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: Quote, Profile, Research) 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. Continued ...

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. Such patches seal the opening through which the silicone gel is placed in the implant. Mentor said in December those allegations were "wrong" and that the engineer had been indicted for stealing implants from the company and trying to sell them. The engineer said he directed the investigators to others to contact about allegations regarding rupture rates. 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