Makers of vaginal mesh implants have been asked by FDA to further study the rates of organ damage and other complications following allegations that the devices have harmed women. Such vaginal mesh products are used to treat incontinence and organ prolapse.

FDA has asked Johnson & Johnson, C.R. Bard, Covidien, Boston Scientific and several other companies to conduct three-year studies on the safety and effectiveness of the meshes. Patients have filed a number of lawsuits against manufacturers alleging the products have failed, leading to complications and even death.

An FDA expert panel met last fall to consider reclassifying the meshes as Class III. They originally had been cleared under the 510(k) process. The panel recommended reclassification, but FDA hasn't made its decision yet. 

"We need to change how we do our premarket evaluations of these products," said Colin Pollard, director of the FDA's obstetrics and gynecology devices branch, said at the time. "We think the current 510(k) paradigm doesn't work for these products because we don't think we know enough about the safety and effectiveness."

Groups like Public Citizen have even suggested a recall of all surgical mesh products made of non-absorbable synthetic material, typically used during transvaginal surgery because they offer no benefits and pose serious risks. However, FDA responded that "There's strong support in the clinical community that mesh serves a role for certain patients. Our goal is not to completely remove these products from the market," he said in a a media interview.