FDA Warns of Serious Complications Associated with Transvaginal Mesh

July 13, 2011

The FDA has warned surgeons to consider options other than transvaginal mesh for pelvic organ prolapse. Studies have revealed that about 10 percent of women with the implant experience erosion of the mesh within 12 months of surgery, and half of those required additional surgery for removal of the mesh. In some circumstances, the mesh was so intertwined with scar tissue that removal was impossible.

Transvaginal mesh is used to surgically treat pelvic organ relapse and stress urinary incontinence. More than 100,000 women each year are implanted with the plastic mesh, but the FDA states most women can be treated successfully without mesh.

Problems associated with mesh include painful sexual intercourse, infections, urinary problems, overall discomfort, and bleeding, usually caused by the mesh eroding through the stitched tissue or from skin contracting tightly around it.

The agency first warned about problems with transvaginal mesh in 2008, when it reported that the implant was associated with "rare" problems. The warning was expanded in 2009.

Serious Problems Linked to Transvaginal Mesh

June 13, 2009

The FDA announced that it had received more than 1,000 adverse reports over a three year period involving transvaginal mesh used in surgical repair of pelvic organ prolapse and stress urinary incontinence. An agency warning featured the story of a woman who learned, just four weeks after surgery, that the surgical mesh had eroded, requiring surgery for resection of the exposed mesh and closure of eroded tissue.

Adverse reports included problems of pain, infection, mesh erosion (into vagina, bowel and bladder), and recurrence of prolapse or incontinence.