Settlement in Transvaginal Mesh Lawsuits Announced While FDA Looks at Stricter Classifications

Washington, DCA proposed settlement has reportedly been reached in Endo International Plc’s transvaginal mesh lawsuits. The settlement will resolve around 20,000 claims against the company, alleging women suffered serious side effects from the use of transvaginal mesh. A day before the settlement was announced, the FDA announced that the risk of transvaginal mesh complications warranted stricter safety requirements.

Bloomberg (5/1/14) reports that Endo has agreed to pay around $830 million to resolve approximately 20,000 claims linked to transvaginal mesh products made by American Medical Systems Inc, a unit of Endo. The lawsuits alleged that some of the transvaginal meshes eroded, causing incontinence and pain.

Endo still faces around 23,000 claims linked to transvaginal meshes, while other companies also face lawsuits.

News of the settlement came one day after the US Food and Drug Administration (FDA) announced possible changes to how transvaginal mesh products used to treat pelvic organ prolapse (POP) are classified. The FDA’s proposal recommends reclassifying the mesh from a class II (moderate risk) to a class III (high risk) and would require companies to submit an application for premarket approval so the FDA could evaluate the device’s safety and effectiveness.

“The FDA has identified clear risks associated with surgical mesh for the transvaginal repair of pelvic organ prolapse and is now proposing to address those risks for more safe and effective products,” said William Maisel, M.D., M.P.H., deputy director of science and chief scientist at the FDA’s Center for Devices and Radiological Health.

In its proposal, the FDA noted that mesh exposure (also known as mesh erosion or mesh extrusion) is the most commonly reported mesh-related complication, and can be life-altering for some women, as they may require repeated surgeries to remove the mesh.

“Mesh exposure can result in serious complications unique to mesh procedures and is not experienced by patients who undergo traditional repair,” the proposal’s authors wrote.

The FDA noted that in one study, around 10 percent of women suffered mesh exposure within 12 months of having the mesh implanted. Although not all of the side effects are unique to surgeries involving the mesh products, repeat surgery to treat complications appears to be highest in patients who received a transvaginal mesh, as opposed to a traditional surgery.

And, despite transvaginal mesh being an effective way to restore anatomy in pelvic organ prolapse patients, the FDA wrote that it is not more effective than traditional non-mesh repair, therefore, “given the risks associated with mesh, the probable benefits from use of the device do not outweigh the probable risks.”

The FDA’s proposal does not include surgical mesh used to treat stress urinary incontinence, nor transabdominal POP repair.