Regulatory Focus™ > News Articles > FDA Orders Surgical Mesh Manufacturers to Study Risks

FDA Orders Surgical Mesh Manufacturers to Study Risks

Posted 05 January 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) issued a safety communication yesterday warning consumers about problems associated with surgical mesh implants and ordering manufacturers of the devices to conduct new studies in light of those safety concerns.

The mesh, used to treat pelvic organ prolapse and stress urinary incontinence, has been associated with pain, infections, urinary problems, bleeding and discomfort. 

FDA said that it has received more than 1,500 adverse event reports related to the use of the mesh for pelvic organ prolapse repair between 2008 and 2010-a 500% increase over ADEs received between 2005 and 2007.

The studies proposed by the FDA would follow patients for approximately three years to better assess the risks associated with the devices, said FDA Center for Devices and Radiological Health Deputy Director for Science Bill Maisel, MD.

The postmarket studies are a preferred option for industry, which is otherwise faced with the prospect of having the devices re-classified as a "high-risk" Class II/III device that would necessitate premarket studies. The devices are currently cleared using the FDA's 510(k) program, which only requires that the devices be found to be "substantially equivalent" to previously cleared mesh devices.



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