As the safety concerns and lawsuits over transvaginal surgical meshes mount, the FDA is preparing to reclassify the devices from class II to class III, meaning they would be subject to the rigorous premarket approval process rather than the easier 510(k) clearance.
"The FDA has identified clear risks associated with surgical mesh for the transvaginal repair of pelvic organ prolapse [POP] and is now proposing to address those risks for more safe and effective products," said William Maisel, deputy director of science and chief scientist at the FDA's Center for Devices and Radiological Health, in a statement. "If these proposals are finalized, we will require manufacturers to provide premarket clinical data to demonstrate a reasonable assurance of safety and effectiveness for surgical mesh used to treat transvaginal POP repair."
The FDA issued a proposed order and request for comment in Thursday's Federal Register. The proposed order lists a plethora of risks that the agency has identified including infection; vaginal bleeding; damage to blood vessels, nerves and connective tissue; and adverse tissue reaction caused by nonbiocompatible materials.
On top of that, there is little evidence that the products work better than the alternatives, the agency said. "The published literature reveals that, although transvaginal POP repair with mesh often restores anatomy, it has not been shown to improve clinical benefit over traditional non-mesh repair and, given the risks associated with mesh, the probable benefits from use of the device do not outweigh the probable risks," the FDA writes in the Federal Register.
As such, the reclassification would be the logical next step given the steady drumbeat of past FDA actions. In 2012, it ordered postmarket surveillance studies to address safety and effectiveness concerns regarding the transvaginal surgical mesh devices. And in 2011 it issued an updated safety communication warning that "serious complications associated with surgical mesh for transvaginal repair of POP are not rare." Between 2008 and 2010 the agency received 2,874 reports of complications with the devices for the treatment of POP and stress urinary incontinence, the 2011 notice says.
The devices have been a headache for their manufacturers, too. Also on May 1, Endo Health Solutions ($ENDP) announced that it will pay $830 million to settle 20,000 lawsuits, resolving a "substantial majority" of its vaginal mesh-related cases.
Last year, Johnson & Johnson's ($JNJ) Ethicon arm was ordered on appeal to fork over $11.1 million to resolve a vaginal mesh case involving its Dynacare Prolift transvaginal mesh device. And in February a U.S. magistrate judge ruled that J&J wrongly eliminated thousands of key documents relating to the products. Other companies including Boston Scientific ($BSX) and C.R. Bard ($BCR) also face a number of suits related to their own vaginal mesh implants, but rumors continue that some are seeking a settlement.
The reclassification decision would follow the request of the FDA's Obstetrics and Gynecology Devices Panel, which recommended that surgical mesh for transvaginal POP be reclassified into class II in September 2011. The FDA is also proposing to reclassify urogynecologic surgical mesh instrumentation from class I to class II, the Federal Register says.
Comments on the proposed order are due by July 30.
- read the release
- see the proposed order in the Federal Register
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