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FDA May Classify Surgical Mesh Devices as High Risk

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Transvaginally implanted devices used in surgeries to address prolapsed organs and incontinence fail to lead to better outcomes than non-mesh repair and should be reclassified as posing a high risk to patients, according to a Food and Drug Administration staff recommendation released today. Like many other problematic medical devices, transvaginal mesh devices never went through the full FDA approval process, but rather were were approved through the streamlined 510(k) process used to evaluate products similar to those already approved. The 510(k) process itself is under review by the FDA.

In July, the U.S. Institute of Medicine urged the FDA to abandon the 510(k) process and require device makers to prove that each new product is safe and effective on its own merits. Such a policy may have saved 90,000 DePuy ASR hip implant patients a lot of misery. According to FDA data, last year alone, about 300,000 women underwent surgical procedures to repaire prolapsed organs. The FDA now advises such women to be aware of risks of mesh erosion, pain, and urinary incontinence, and to have annual check-ups after surgery. In a safety warning released by the FDA in July, the agency reported receiving 1,503 reports of complications associated with mesh from January 2008 to December 2010.

If the FDA changes the risk classification to "high," transvaginal mesh device manufacturers like Johnson & Johnson and Boston Scientific may be required to conduct post-market studies and submit additional data to regulators to keep their products on the market. Public Citizen is urging the FDA to not only reclassify the devices, but to also recall surgical mesh devices.

Since we are in the midst of a presidential cycle, don’t be surprised to see massive donations by medical device manufacturers and pharmaceutical companies to candidates who will be asked to advocate for a weakened FDA. You may recall Newt Gingrich in 1994 advocating for privatizing the FDA (i.e., having the big pharma and the device manfufactureres regulate themselves). Donations to anti-consumer state Supreme Court justices will also be on the uptick.