What are the safety concerns about use of surgical mesh to treat pelvic floor disorders?

Each type of mesh procedure carries its own risks and benefits.

In 2008, the Food and Drug Administration (FDA) warned of potentially serious complications associated with surgical mesh placed through the vagina to treat POP and SUI. Then, in 2011, the FDA stated that serious complications associated with surgical mesh for transvaginal repair of POP are not rare. The agency also said that it's not clear whether surgical mesh for transvaginal repair of POP is more effective than traditional nonmesh repair in people with POP, and that transvaginal repair with mesh might expose women to greater risk.

Research has shown that surgical mesh for transvaginal repair of POP can cause complications such as mesh erosion, pain, infection, bleeding, pain during sex, organ perforation and urinary problems. Many of these complications require additional treatment, including surgery.

Treating SUI with a mesh sling also can cause complications, including mesh erosion, infection and pain. However, research suggests that the complications are infrequent and less severe than are complications associated with surgical mesh for transvaginal repair of POP, and rarely require follow-up surgery.

What are the FDA's current recommendations regarding the use of surgical mesh to treat pelvic floor disorders?

The FDA has issued two proposed orders to address the health risks associated with surgical mesh for transvaginal repair of POP. If finalized, they would reclassify surgical mesh for transvaginal repair of POP from a moderate-risk device to a high-risk device. They would also require manufacturers to submit a premarket approval application for the agency to evaluate safety and effectiveness.

The proposed orders do not involve the mesh sling treatment for SUI or transabdominal mesh treatment for POP.

What questions should I ask before seeking a mesh treatment for a pelvic floor disorder?

If you're considering treatment for a pelvic floor disorder that involves surgical mesh, be sure to have your health care provider explain all of your options, as well as their possible risks and benefits. In particular, be aware of the risks associated with surgical mesh for transvaginal repair of POP, such as the need for additional surgery due to mesh-related complications.

Aug. 09, 2014 See more In-depth