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FDA Orders Vaginal Mesh Makers to File PMAs

The U.S. FDA is tightening regulatory requirements for transvaginal meshes, which have turned into lawsuit magnets amid safety problems.

Boston Scientific Obtryx II mesh
Boston Scientific's mesh products include the Obtryx II. (Image courtesy of Boston Sci)

Chris Newmarker

Transvaginal mesh devices used to treat pelvic organ prolapse will now be regulated in the U.S. as high-risk devices, with manufacturers required to submit a PMA submission, which requires data from a pivotal study.

FDA on Monday issued two orders related to the devices. One order reclassifies the devices as high-risk Class III devices, versus the previous moderate-risk Class II devices. The second order requires a PMA application for such devices.

Manufacturers with devices still on the market--including Boston Scientific, Coloplast, ACell, and Endo International's Astora Women's Health (previously the women's health business of AMS)--have 30 months to submit a PMA, according to FDA.

The PMA requirement would make pelvic mesh products substantially more expensive to produce. The studies required for PMA submissions can costs millions of dollars as they often require hundreds of patients--typically randomized across multiple clinical settings. In addition, PMA applications are often thousands of pages long.

The FDA's orders only apply for meshes used to repair pelvic organ prolapse, not other indications such as treating stress urinary incontinence or abdominal repair of pelvic organ prolapse. Still, they represent a recognition on FDA's part that more regulation is needed. (Here's a roundup of 10 unsafe medical devices that have hit the market over the years.)

"These stronger clinical requirements will help to address the significant risks associated with surgical mesh for repair of pelvic organ prolapse," William Maisel, MD, chief scientist for the FDA's Center for Devices and Radiological Health, said in a news release.

"We intend to continue monitoring how women with this device are faring months and years after surgery through continued postmarket surveillance measures," Maisel said.

Vaginal mesh devices were supposed to treat urinary incontinence. But FDA from 2008 through 2010 received reports of thousands of serious complications, including mesh erosion through the vagina, pain, infection, bleeding, pain during sexual intercourse (dyspareunia), organ perforation, and urinary problems.

And then the lawsuits came pouring in, with hundreds of millions of dollars in settlements paid out. In September, Coloplast announced plans to pay nearly nearly half a billion dollars to settle vaginal mesh lawsuits. Endo in 2014 announced it was settling 20,000 claims to the tune of about $830 million. And Boston Scientific--which has conditional settlement agreements for about 6000 of the more than 30,000 claims it is facing--increased its cash reserves for the case by $457 million during the third quarter of 2015, chief financial officer Daniel Brennan said during an earnings call transcribed by Seeking Alpha.

Johnson & Johnson's Ethicon subsidiary, which discontinued sales in 2012, settled more than 100 vaginal mesh lawsuits in 2015.

As late as 2008, FDA was maintaining that surgical mesh complications might be serious--but they were also rare, according to ProPublica. By July 2011, FDA was changing its tune, saying the complications were "not rare."

FDA issued safety communications in 2008 and in 2011, and ordered manufacturers in January 2012 to conduct postmarket surveillance studies.

Organizations such as the National Center for Health Research and Patient, Consumer, and Public Health Coalition have recommended that the mesh be upclassified to Class III.

The FDA had proposed changing the classification of the devices last year

Brush up on your medical device quality assurance and risk management knowledge at MD&M West, February 9-11 at the Anaheim Convention Center in Anaheim, CA.

Chris Newmarker is senior editor of Qmed and MPMN. Follow him on Twitter at @newmarker.

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