January 1, 1970 · FLEMING | NOLEN | JEZ, L.L.P.
A new bill, HR 3847, has been pending in the House since February. Its purpose is to give the FDA enhanced authority when approving new medical devices. Specifically, it would permit the FDA to reject a manufacturer’s application for a new medical device that is designed or modeled on a previously recalled medical device. Doesn’t common sense support this premise? Logically, one would believe that any medical device that is designed and predicated on an earlier recalled medical device would be problematic – raising questions about safety. One would assume that new medical devices designed and predicated on earlier recalled devices would not be cleared or approved for use in patients. However, that is not the case.
Many medical devices on the market today are cleared through the FDA’s 510k process. This process allows a manufacturer to seek clearance by claiming the new medical device is substantially equivalent to an earlier cleared medical device. Ironically, the new devices are cleared even if they are modeled on earlier devices that were subject to recall because they harmed patients.
A number of transvaginal surgical mesh products are designed and predicated on previously recalled products. One specific product is Protogen mesh used to correct pelvic organ prolapse. It was approved in 1997 and recalled two years later because it harmed patients. Despite this fact, since 1999 numerous transvaginal mesh products modeled after Protogen were cleared through the 510k process. If this proposed law was in place then those products would not be on the market today and many women would not have been harmed.
Common sense along with the FDA’s July 2011 safety alert about the various mesh products supports passing this new law.