FDA Issues Warning over Vaginal Mesh Implants Such As Avaulta TVM

Washington, DCThe US Food and Drug Administration recently issued a warning about the use of vaginal mesh implants such as C.R. Bard's Avaulta TVM, which has been the subject of lawsuits in the past.

According to a release from the federal agency, there are complications that have been associated with the transvaginal placement of surgical mesh to treat Pelvic Organ Prolapse (POP), as well as Stress Urinary Incontinence (SUI).

The FDA noted that over the past three years, it has received more than 1,000 reports from manufacturers of surgical mesh dealing with complications associated with the devices implanted to treat the conditions.

The most common complications reported by the manufacturers included erosion through vaginal epithelium, urinary problems, pain, infection and recurrence of prolapse or incontinence, the FDA stated. Additionally, however, there were some reports of bladder, bowel and blood vessel perforation when the device was inserted.

Often, the problems that led to pain and discomfort were reported to have decreased the quality of life for patients, according to the FDA. This likely had to do with the fact that the treatment options for most of the complications typically involved extra surgery, blood transfusions, IV therapy or drainage of abscesses.

While the FDA reported that characteristics of patients that had an increased risk for complications from the mesh implants were not yet determined, potential factors could include overall patient health, the size and shape of the mesh, and the actual material used in the making of the mesh, the agency said.

The new warnings from the FDA come after a lawsuit was filed in April by at least 85 women claiming C.R. Bard's Avaulta TVM device they received caused them serious pain and problems that cannot be repaired.

According to the Atlanta Journal-Constitution, the lawsuit, which was filed in US District Court in Atlanta, Georgia, is just the latest lawsuit to be leveled against C.R. Bard over its Avaulta product, which is marketed as a treatment for POP.

"The mesh appears to be moving from where it was originally put," an attorney representing the plaintiffs told the news source. "It curls, tearing nerves and doing significant damage. When they go in to try to repair it and take it out, they [surgeons] generally can't get the arms [of the support system] out."

Scott Lowry, a spokesman for Bard, told United Press International that when Avaulta was approved by the FDA in 2005, it included warnings about all of the reported complications.

"Physicians around the country continue to recommend these products, believing they provide significant benefit to the majority of patients receiving them," Lowry told the news provider.