FDA Increases Scrutiny on Transvaginal Mesh Products

On January 4, 2016, the FDA took action to address the safety risks of transvaginal mesh repair of pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Transvaginal mesh has been the subject of controversy for years, as the FDA has received thousands of reports of problems, including organ perforation, infection, and bleeding.

Surgical mesh is a type of plastic-like netting that surgeons use to shore up weakened or damaged tissue. In women with POP, a condition in which the organ protrudes or “falls” into the wall of the vagina, surgeons use the mesh to support and hold the dropped organ and tissues back into place. Serious complications, however, have raised concerns that repair with mesh is more dangerous than traditional repair without it.

Thus, after much research and analysis, the FDA recently required manufacturers to conduct additional clinical studies on these products, and has reclassified the devices from class II (moderate risk) to class III, which indicates high-risk.

FDA Has Watched Mesh for Years

The FDA has been watching the developments with transvaginal surgical mesh for years, now. Back in 2008, they warned that they’d received over 1,000 reports of adverse events associated with these devices, identifying surgical mesh for transvaginal repair of pelvic organ prolapse (POP) as “an area of continuing serious concern.”

In July 2011, they updated their previous warning to inform patients and physicians that complications associated with surgical mesh were not rare, and that it was not clear that repairing POP with mesh was more effective than traditional non-mesh repair. They noted that between 2008 and 2010, they received nearly 3,000 additional reports of complications with surgical mesh devices used to repair POP and SUI, with problems including erosion of the mesh through the vagina, pain, infection, bleeding, pain during intercourse, organ perforation and urinary problems.

In September 2011, the administration held a subcommittee meeting to discuss the safety and effectiveness of vaginal mesh. The panel concluded that the safety of these medical devices was not well established, that more clinical studies were needed, and that manufacturers should conduct more trials to better explain the risks and benefits.

FDA Raises Safety Requirements for Transvaginal Mesh

Progress has been slow, but the FDA has finally taken meaningful action to protect public safety. According to their press release, their first order was to reclassify mesh used for transvaginal repair from class II to class III. The FDA proposed this change back in May 2014, “based on the tentative determination that general controls and special controls together are not sufficient to provide reasonable assurance of safety and effectiveness for this device.”

They then issued a second order requiring that manufacturers submit a premarket approval (PMA) application to support the safety and effectiveness of their products. Many transvaginal mesh products were previously approved through the FDA’s fast-track 510(k) process, which didn’t require clinical studies—only that the companies prove their products were significantly similar to other devices already on the market.

This change will force companies to prove that their products are safe and effective through the FDA’s most rigorous vetting process. Manufacturers will have 30 months to comply with the new requirements.

According to the Wall Street Journal, companies that make transvaginal mesh kits have already faced losses in court as women seek compensation for serious injuries. In 2014, Endo International PLC settled 20,000 transvaginal mesh lawsuits for $830 million, and in April 2015, Boston Scientific Corp settled about 3,000 cases for $119 million. Johnson & Johnson stopped selling some of it’s transvaginal mesh products in 2012.