FDA Warns about Transvaginal Mesh used in Pelvic Organ Prolapse and Urinary Incontinence Surgery

July 13, 2011

Today the U.S. Food and Drug Administration (FDA) issued a warning about complications with transvaginal placement of surgical mesh during surgery for pelvic organ prolapse (POP) and stress urinary incontinence (SUI).

Surgical mesh is a medical device permanently implanted in the body to repair or strengthen weak or damaged tissue.

According to the FDA, surgical procedures for pelvic organ prolapse and stress urinary incontinence that involve placement of surgical mesh through the vagina, called transvaginal mesh, offer no greater benefit than other surgical options and place women at even greater risk of complications.

The FDA first warned of complications with transvaginal mesh in 2008.

Doctors in the U.S. performed about 300,000 pelvic organ prolapse surgeries in 2010 with about 100,000 utilizing surgical mesh. In about 75,000 of those cases, doctors chose transvaginal mesh placement. Of 260,000 stress urinary incontinence surgeries in 2010, doctors used transvaginal mesh in 80% or 208,000 cases.

Thousands of women are reporting complications with transvaginal mesh, including “erosion” that causes exposure or protrusion of the surgical mesh from the vaginal tissue. During some surgeries, doctors punctured women’s organs with surgical tools during placement of the transvaginal mesh. Women are also experiencing pain, bleeding, infection, pain during sexual intercourse, urinary problems, recurrent organ prolapse, neuromuscular problems, vaginal scarring/shrinkage and emotional problems associated with this surgery. Many of these women have required additional medical care, surgeries and hospitalization to treat or remove the surgical mesh.

“The FDA is issuing this update to inform you that serious complications associated with surgical mesh for transvaginal repair of POP are not rare,” the FDA said in a communication to health care providers and patients who have received or are considering surgery involving transvaginal mesh.

According to an FDA report entitled Urogynecologic Surgical Mesh: Update on the Safety and Effectiveness of Transvaginal Placement for Pelvic Organ Prolapse, the agency received more than 2,800 reports of transvaginal mesh complications between 2008 and 2010 alone.

”There are clear risks associated with the transvaginal placement of mesh to treat POP,” said William Maisel, M.D., M.P.H., deputy director and chief scientist of the FDA’s Center for Devices and Radiological Health. “The FDA is asking surgeons to carefully consider all other treatment options and to make sure that their patients are fully informed of potential complications from surgical mesh. Mesh is a permanent implant — complete removal may not be possible and may not result in complete resolution of complications.”