FDA Issues New Warnings About Risks of Vaginal Mesh

Warning that the risks outweigh the benefits of the transvaginal placement of surgical mesh, the Food and Drug Administration (FDA) advised potential patients to fully consider all options and risks before undergoing the procedure to correct pelvic organ prolapsed (POP) or stress urinary incontinence (SUI). Among the risks of transvaginal mesh (TVM) is the possibility of hospitalization and/or a second surgery to repair or remove the mesh.

Vaginal prolapse, or pelvic organ prolapse (POP), occurs when surrounding pelvic organs protrude into the vaginal area as a result of weakened vaginal walls. Vaginal mesh surgery, or specifically the transvaginal placement of surgical mesh, is one option available to women suffering from POP to repair vaginal prolapse. Surgical mesh is permanently implanted in the vagina to strengthen the body's own weakened support system. Pennsylvania product liability attorneys are seeing instances of complications resulting from TVM.

The FDA recently reported two major issues with transvaginal mesh: contraction and erosion. Contraction is the shortening of the vaginal mesh and has been linked to vaginal pain and tightening. Erosion is the most-reported complication of transvaginal mesh, and can require more than one surgery to correct. Some women have had several corrective transvaginal mesh surgeries to repair erosion, but the procedures have not been successful.

Possible Uses of Transvaginal Mesh

Vaginal mesh surgery has been used to correct the following disorders:

  • Cystocele: the collapse or prolapse of the bladder into the vagina
  • Rectocele: the collapse of the rectum into the vagina
  • Stress Urinary Incontinence (SUI): involuntary loss of urine when women cough, sneeze, laugh and/or jump.

The FDA's recent warnings report that the use of vaginal mesh has not been shown to be more effective than alternative treatments but its use does carry a higher risk of complications.

Known Complications Associated with Transvaginal Mesh

Adverse events related to the use of transvaginal mesh have continued to increase since 2005. From 2005-2007, approximately 1000 adverse events related to transvaginal mesh were reported. From 2008-2010, an additional approximately 3000 reports of complications related to transvaginal mesh were reported.

Problems that can occur as a result of the transvaginal placement of surgical mesh include:

  • Projection of the mesh through the soft tissues;
  • Bleeding and/or infection;
  • Urinary tract problems;
  • Perforation of the bladder, rectum, or surrounding blood vessels;
  • Erosion of vaginal tissue;
  • Additional surgeries may be required and sometimes the problem still isn't corrected; and
  • Pelvic or groin pain, and/or pain during intercourse.

According to Dr. William Maisel, chief scientist and deputy director of the 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."

But one consumer advocacy group, Public Citizen, doesn't think the FDA is going far enough and is calling for the formal recall of transvaginal mesh. Public Citizen petitioned the FDA to ban marketing of transvaginal mesh, order manufacturers to recall all transvaginal mesh products and to classify transvaginal mesh as a Class III device. Pennsylvania medical device defect attorneys are also pushing for the rights of patients who've been injured by complications from transvaginal mesh.