Risks Associated with Surgical Transvaginal Mesh
Transvaginal Mesh for Pelvic Organ Prolapse and Stress Urinary Incontinence Associated with Erosion, Infections & Urinary Problems
Surgical mesh is a metallic or polymeric screen used in the repair of vaginal wall prolapsed to add support and to reduce the risk of recurrence, particularly for women with recurrent prolapsed or with congenital connective tissue disorders (such as Ehlers-Danlos or Marfan’s syndromes). Mesh can be placed either transvaginally (through the vagina) or transabdominally (through the abdomen). It is also used for surgical repair of Stress Urinary Incontinence (SUI).
In October of 2008, the FDA issued a Public Health Notification regarding adverse events related to the urogynecologic use of surgical mesh, but cited them as rare. The most frequent complications included erosion through vaginal epithelium, infection, pain, urinary problems, and recurrence of prolapse and/or incontinence. There were also reports of bowel, bladder, and blood vessel perforation during insertion. In some cases, vaginal scarring and mesh erosion led to a significant decrease in patient quality of life due to discomfort and pain, including dyspareunia.
On July 13, 2011, after a search of its Manufacturer and User Device Experience (MAUDE) database as well as its own systematic review of the scientific literature in regards to POP and SUI surgical mesh safety and efficacy, the FDA issued an Updated Safety Communication. The updated alert warns that surgical placement of mesh through the vagina, specifically to repair POP, may expose patients to greater risk than other surgical options. The FDA determined that 1) serious adverse events 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. The FDA plans to convene an advisory panel of experts September 8-9, 2011 to discuss these findings and the types of clinical studies necessary to better asses the risks and benefits of using mesh to treat POP and SUI.
Adverse Event Reporting through MAUDE
In the Oct. 20, 2008 FDA Public Health Notification, the number of adverse events reported to the FDA for surgical mesh devices used to repair POP and SUI for the previous 3-year period (2005 – 2007) was “over 1,000.” Since then, from Jan. 01, 2008 through Dec. 31, 2010, the FDA received 2,874 additional reports of complications associated with surgical mesh devices used to repair POP and SUI, with 1,503 reports associated with POP repairs and 1,371 associated with SUI repairs.
Between 2008 and 2010, there were seven reported deaths associated with POP repairs. Followup 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). Four deaths were due to post-operative medical complications not directly related to the mesh placement procedure.
FDA Literature Review Safety Findings:
- Patients who undergo POP repair with mesh are subject to mesh-related complications that are not experienced by patients who undergo traditional surgery without mesh.
- Adverse events associated with transvaginally placed mesh can be life-altering for some women. Sequelae (e.g., pain) may continue despite mesh removal.
- Mesh-associated complications are not rare. The most common mesh-related complication experienced by patients undergoing transvaginal POP repair with mesh is vaginal mesh erosion. Based on data from 110 studies including 11,785 women, approximately 10 percent of women undergoing transvaginal POP repair with mesh experienced mesh erosion within 12 months of surgery.
- 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 transvaginal 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.
- Transvaginal surgery with mesh to correct vaginal apical prolapse is associated with a higher rate of complication requiring reoperation and reoperation for any reason 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 transvaginal POP surgery with mesh, with the median vaginal mesh erosion rate reported at 4 percent within 23 months of surgery.