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FDA Literature Review

The FDA determined that 1) serious complications are NOT rare contrary to 2008 public health notification, and 2) transvaginally placed mesh in POP does NOT conclusively improve clinical outcomes over traditional non-mesh repair.

From 2005 to 2010, Maude, the FDA Public Health Notification System, received more than 4000 reports of adverse events/ complications associated with surgical mesh devices used to repair POP and SUI. Between 2008 and 2010, there were seven reported deaths associated with POP repairs. Follow-up investigation on the death reports revealed that three of the deaths associated with POP repair were related to the mesh placement procedure (two bowel perforations, one hemorrhage).

FDA Reported Adverse Effects:

  • Mesh erosion (exposure, extrusion, or protrusion)
  • Pain
  • Infection
  • Bleeding
  • Dyspareunia (pain during sex)
  • Urinary problems
  • Organ (bowel bladder, blood vessel) perforation
  • Recurrent prolapse
  • Vaginal scarring/shrinkage caused by mesh contraction
  • Emotional distress
  • Decreased quality of life

FDA Literature Review

  • Patients who undergo POP repair with mesh are subject to mesh-related complications that are not experienced by patients who undergo traditional surgery with mesh
  • Adverse events associated with trans vaginally placed mesh can be life-altering for some women. Aftereffects (e.g., pain) may continue despite mesh removal.
  • Mesh-associated complications are not rare. The most common mesh-related complication experienced by patients undergoing trans vaginal repair with mesh is vaginal mesh erosion.
  • More than half of the women who experienced erosion from non-absorbable synthetic mesh required surgical excision in the operating room. Some women required two to three additional surgeries.
  • Mesh contraction, causing vaginal shortening, tightening and/or vaginal pain in association with trans vaginal POP repair with mesh, is increasingly reported in the literature.
  • New onset SUI has been reported to occur more frequently following mesh augmented anterior repair compared to traditional anterior repair without mesh.
  • Trans vaginal surgery with mesh to correct vaginal apical prolapse is associated with a higher rate of complication requiring reoperation compared to traditional vaginal surgery or sacral colpopexy.
  • Abdominal POP surgery using mesh (sacral colpopexy) appears to result in lower rates of mesh complications compared to trans vaginal POP surgery with mesh.

On April 29, 2014 the FDA issued two proposed orders suggesting that transvaginal mesh for repair of Pelvic Organ Prolapse be reclassified from a moderate-risk device (Class II) to a high-risk device (Class III) because the FDA had identified clear risks associated with surgical mesh for the transvaginal repair of pelvic organ prolapse.

As the FDA’s Deputy Director of Science and the chief scientist at the FDA’s Center for Devices and Radiological Health William Maiser, M.D M.P.H., observed “The FDA is now proposing to address those risks for more safe and effective products.” If these proposals are finalized, the FDA will require mesh manufacturers to provide premarket clinical data to demonstrate a reasonable assurance of safety and effectiveness for surgical mesh used to treat transvaginal POP repair.

In January 2016 the FDA determined that Pelvic Organ Prolapse devices are “high risk” (Class III) medical devices, subject to further testing for safety.  The FDA also released new recommendations for patients.

If you have experienced failure of transvaginal mesh, you may be eligible for financial compensation for lost wages, medical bills and other expenses. Please contact the attorneys at Levin Simes LLP today at 1 (888) 426-4156 or by filling out the form on this page for a free consultation.