FDA Finalizes Tougher Stance on Transvaginal Mesh

Marie Thibault

FDA is taking a stricter approach to surgical mesh used in transvaginal repair of pelvic organ prolapse (POP), issuing two final orders reclassifying the devices from Class II to Class III and requiring manufacturers to submit PMA applications showing safety and effectiveness. 

The orders follow numerous reports of adverse events and thousands of lawsuits filed against the devices in recent years. POP is a relatively common condition in women that takes place when the pelvic organs are no longer held in place by the pelvic floor. Sometimes caused by childbirth, POP can cause pelvic organs like the bladder to extend out of the vagina and may cause symptoms such as incontinence or pain during sexual intercourse. Surgical mesh was first cleared for this indication in 2002 as a Class II moderate-risk device, according to FDA.

"These stronger clinical requirements will help to address the significant risks associated with surgical mesh for repair of pelvic organ prolapse," William Maisel, MD, MPH, deputy director of science and chief scientist for CDRH, said in an agency press announcement. "We intend to continue monitoring how women with this device are faring months and years after surgery through continued postmarket surveillance measures."

FDA noted in its announcement that there are five manufacturers selling surgical mesh for use in transvaginal POP repair. These manufacturers will have 30 months—until July 5, 2018—to submit their PMA application. Any manufacturer looking to introduce new surgical mesh for transvaginal POP repair will first need to submit a PMA application for approval. 

FDA originally proposed the PMA requirement and reclassification in May 2014. 

This week's final orders cap off years of FDA communication on the issue. The agency published safety communications in 2008 and 2011 about increasing adverse event reports and held an advisory panel in September 2011 to gather expert recommendations. That panel's findings led to FDA's decision to reclassify the devices as Class III.

As explained in the FDA reclassification order, "FDA is reclassifying these devices based on the determination that general controls and special controls together are not sufficient to provide reasonable assurance of safety and effectiveness for this device. In addition, in the absence of an established positive benefit-risk profile, FDA has determined that the risks to health associated with the use of surgical mesh for transvaginal POP repair identified previously present a potential unreasonable risk of illness or injury."

In January 2012, FDA notified transvaginal mesh manufacturers that they must run postmarket surveillance studies on safety and effectiveness.

Manufacturers have been dealt tens of thousands of lawsuits related to transvaginal mesh. Ethicon counted 44,400 plaintiffs at the end of September while Boston Scientific noted over 30,000 cases or claims linked to transvaginal mesh for stress urinary incontinence and POP as of early November. In May 2015, a Delaware state court awarded $100 million in damages to a female plaintiff against Boston Scientific, but that was later reduced to $10 million.

Marie Thibault is the associate editor at MD+DI. Reach her at [email protected] and on Twitter @medtechmarie. 

[Image courtesy of STUART MILES/FREEDIGITALPHOTOS.NET]