The FDA has recently issued a press release announcing that the makers of surgical mesh products used to treat pelvic organ prolapse (POP) must reclassify the devices as Class III, or high risk medical devices.

Because of transvaginal mesh complications, manufacturers will also have to receive premarket approval (PMA) to continue selling the product.

Dr. William Maisel, deputy director of science and chief scientist for the FDA’s Center for Devices and Radiological Health, said “These stronger clinical requirements will help to address the significant risks associated with surgical mesh for repair of pelvic organ prolapse. We intend to continue monitoring how women with this device are faring months and years after surgery through continued postmarket surveillance measures.”

What is Pelvic Organ Prolapse?

Pelvic Organ Prolapse (POP) is when weakened pelvic floor muscles in women, often weakened by childbirth or aging, allow the organs in the pelvis such as the bladder or uterus descend into the vagina.

It is a serious problem that causes pelvic pain, urinary issues and complications with intercourse.

Over 40% of women over age 60 have some form of POP according to a 2002 study in the American Journal of Obstetrics and Gynecology.

Surgical mesh was approved in 2002 as a Class II or moderate risk option for treating women with POP. However, soon after, thousands of reports reporting transvaginal mesh complications poured in to the FDA.

Transvaginal Mesh Complications

In 2008 the FDA warned the medical community and the public transvaginal mesh complications that could include such symptoms as severe pelvic pain, infection, bleeding, organ perforation, urinary problems and vaginal scarring.

Other transvaginal mesh complications include mesh erosion, device failure and organ prolapse.

Three years later, a second warning by the FDA reported that such adverse events are not rare but that one of the most common transvaginal mesh complications is the erosion of the mesh through the vagina.

This serious condition may take several surgeries to fix.

Subsequently, the manufacturers of transvaginal mesh products have been hit with thousands of lawsuits. By 2014, there were nearly 60,000 pending transvaginal mesh lawsuits.

But according to the recent press release by the FDA, if manufacturers want to continue to make surgical mesh products, they have a 30-month deadline to submit a premarket approval.

Transvaginal mesh procedures are becoming increasingly popular even though the FDA has issued several warnings about safety. In fact, POP-related surgeries in New York have increased by 44.7 percent from 2008 to 2011 according to a June 2015 study.

Over 300,000 POP surgeries are performed annually in the U.S., a 1 billion dollar business. Mesh procedures, despite the increasing warnings of transvaginal mesh complications, are not the only way to resolve pelvic organ prolapse.

The American Academy of Family Physicians reports that some POP symptoms can be regulated with Kegel exercises. More severe pelvic organ prolapse can be treated with a washable and removable device called a pessary.

Other safer surgical methods of resolving POP are also available.

The assistant director for science at the FDA’s Center for Devices and Radiological Health, Dr. Diane Mitchell said, “Postmarketing data indicate that repair of POP with surgical mesh is no more effective than POP repair with sutures alone, particularly for certain types of prolapse.”

In essence, the FDA’s announcement indicates that unless the manufacturers of transvaginal mesh products and adequately document the safety of the devices, the product will be off of the market by 2019. Until then, they are listed as a high risk.