Please Tell Congress to Investigate the FDA Implant Advisory Panel

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Please Tell Congress to Investigate the FDA Implant Advisory Panel

CONRESS SHOULD INVESTIGATE THE FDA’s ADVISORY PANEL MEETING ON SILICONE BREAST IMPLANTS

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Was Safety Information Withheld From The Panel And The Public?

In April the FDA’s General and Plastic Surgery Devices Advisory Panel raised serious public health concerns about silicone breast implants. While the Advisory Panel voted against recommending approval for Inamed’s pre-market application (PMA), they voted for Mentor’s PMA. However, FDA scientists criticized the data from BOTH companies for failing to sufficiently respond to questions regarding the long-term safety of their products. Now, a recent New York Times article discloses new information that Mentor may have falsified its safety data. According to sworn depositions from former employees, Mentor withheld information

about high rupture rates from the FDA, so the public never had access to that information. (http://www.nytimes.com/2005/05/22/national/22implant.html?oref=login). Can we trust the safety data that Mentor is providing to the FDA? Congress must investigate whether pertinent safety information was kept from FDA scientists who evaluated the applications for the Advisory Panel and from the Advisory Panel members. WRITE CONGRESS TODAY and make sure they understand that this is what you want them to do. ************************************************************Click on the TAKE ACTION link and let Congress hear YOUR voice.************************************************************ MENTOR’S DATA MAY BE SUSPECT Two former Mentor employees have testified that the rates of rupture were significantly higher than reported to the FDA and that Mentor deliberately falsified reports, destroyed records, and hid physical evidence of implant problems. One employee testified that when an internal report indicated that the rupture rate of Mentor’s Siltex textured implants was 5 times higher than its smooth gel implants, the company ordered the report destroyed and fired the

employees who produced it. If Mentor destroyed data and distorted the rupture rates of the

Siltex textured implants – for which it now seeks FDA approval – then the data in its current application may be suspect. This concern about suppressing data that indicates problems is made worse by Mentor’s poor track record of follow-up in its studies – a poor track record that has already been well documented. *************************************************TAKE ACTION and TELL YOUR FRIENDS to act too.************************************************* ADVISORY PANEL COULD NOT REVIEW IMPORTANT DOCUMENTS From the late

1990’s through 2002, the FDA conducted a criminal investigation of Mentor Corporation. The results of that investigation were never made public by the agency. Because the investigation was conducted by the FDA’s Office of Criminal Investigations, FDA scientists and FDA Advisory Panel members who reviewed the pending Mentor application have not had access to documents that may expose serious flaws in the company’s data and even outright evidence of falsified data. The threshold for filing criminal charges is very high, as the agency needs to demonstrate criminal intent beyond a reasonable doubt. If the investigation revealed evidence that

Mentor suppressed information about problems with its breast implants, this information would be critically important for an accurate assessment of the company’s application for approval

even if the evidence did not support a criminal charge. The information collected by the FDA Office of Criminal Investigation may cast serious doubt on the integrity of Mentor’s data, and if it does, the FDA scientists and the Advisory Panel reviewing the application should have had access to it. The FDA must release the information from its criminal investigation of Mentor Corporation so that a determination can be made as to whether that information reflects on Mentor’s current application. In addition, Congress should conduct its own investigation of whether relevant safety information was withheld from the FDA scientists who evaluated the applications for the Advisory Panel and from the Advisory Panel members. Tell Congress To Support A Congressional Oversight Investigation Of The FDA’s Advisory Panel Meeting On Silicone Breast Implants. *********************TAKE ACTION NOW! *********************

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