Lieff Cabraser Civil Justice Blog
FDA Classifies Transvaginal Mesh As High Risk

FDA Classifies Transvaginal Mesh as High-Risk due to Serious Complications from Surgery

The U.S. Food and Drug Administration (FDA) has reclassified the surgical mesh device utilized for transvaginal repair of pelvic organ prolapse (“POP”) and other conditions in women as a high-risk (class III) product. Previously, the agency classified the product as moderate-risk (class II).

Manufacturers of the pelvic mesh or bladder sling product have been given thirty months to submit a premarket approval (PMA) application with regard to the mesh’s safety and effectiveness.

Between 2005 and 2010, nearly 4,000 injuries were reported to the FDA in connection with surgeries involving the pelvic mesh devices, along with an additional 1,500 reports of complications arising in the past three years. As of early 2015, more than 70,000 patients have filed lawsuits against pelvic surgical mesh manufacturers, including American Medical Systems, C.R. Bard Inc., Boston Scientific Corp. and Johnson & Johnson.

The most common complications and side effects of these plastic surgical mesh devices include:

  • Erosion of vaginal tissue;
  • Lower back pain;
  • One or more surgeries to repair or remove mesh;
  • Pain during intercourse;
  • Perforations of the bowel, bladder or blood vessels;
  • Urinary problems; and
  • Vaginal bleeding, infections, pain (unrelated to intercourse), and scarring.

“These stronger clinical requirements will help to address the significant risks associated with surgical mesh for repair of pelvic organ prolapse,” stated William Maisel, M.D., M.P.H., deputy director of science and chief scientist for the FDA’s Center for Devices and Radiological Health. “We intend to continue monitoring how women with this device are faring months and years after surgery through continued postmarket surveillance measures.”

Transvaginal Mesh Injury Attorneys at Lieff Cabraser

Lieff Cabraser represents over 300 women nationwide who have suffered serious complications and injuries arising from transvaginal mesh. As of early 2016, we are in all phases of litigation and settlement on these cases. Learn more about Vaginal Mesh/Bladder Sling complications and lawsuits and the legal rights of injured patients.