Transvaginal mesh implants are intended to treat pelvic organ prolapse, but even the U.S. Food and Drug Administration has said the risks associated with the implants can outweigh its benefits.
Thousands of women have suffered complications from surgical transvaginal mesh placed through the vagina. Some of the risks patients with mesh face are the implant protruding out of the vaginal tissue—a complication called erosion—pain, infection and bleeding. Perforation is another risk and is caused by tools used in the mesh placement, WebMD reported. Other women have also reported experiencing urinary problems due to the mesh.
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In 2010, at least 100,000 POP repairs were done using surgical mesh—75,000 of which were transvaginal mesh, WebMD reported.
The FDA has said previously that it could not find any evidence that transvaginal mesh was a better treatment option for patients with POP than other methods.
“We do not see conclusive evidence that using mesh for the transvaginal approach to pelvic organ prolapse improves clinical outcomes anymore than transvaginal procedures that do not use mesh,” said William Maisel, MD, the deputy center director for science at the FDA’s Center for Devices and Radiological Health in Silver Spring, Md. “These devices appear to expose patients to greater risks. Mesh is a permanent implant, and complete removal may not be possible and may not result in complete resolution of complications.”
The FDA said in a July 2011 statement that serious complications associated with mesh devices were not rare. In fact, thousands of women reported complications to the agency in just a two-year period.
Thousands of women are also suing mesh manufacturers for the damage the devices have caused. Many of these lawsuits have been consolidated and are moving forward in state and federal courts.