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)
- 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.