Pelvic organ prolapse (POP) is one of the most common reasons for women to have surgery, with approximately 200,000 inpatient surgical procedures performed for POP in the U.S. each year.
A woman’s risk of requiring surgery for prolapse is approximately 10 percent. Of those who have surgery, 13 percent will require a repeat operation within five years and as many as 30 percent will undergo another surgery for prolapse or a related condition at some point during their life.
In the past several years, there was an increase in the use of synthetic and biologic mesh for transvaginal prolapse surgery. This was largely driven by the availability and marketing of commercially available pre-packed mesh products or “mesh kits” for prolapse.
Unfortunately, an increasing number of women report serious complications from transvaginal mesh used for prolapse that severely impact their quality of life.
In 2011, the U.S. Food and Drug Administration (FDA) issued a safety communication stating that the use of transvaginal mesh may put women at a higher risk of complications without increased benefit to their quality of life. This is what has sparked a large number of television commercials about the issue.
The most frequent complications noted in the FDA statement included infection, pain, urinary problems, vaginal scarring and recurrence of prolapse and/or incontinence. Another complication cited by the FDA was erosion, in which the mesh gradually dislodges from the vaginal wall where it was implanted and moves into the surrounding tissue and organs. Erosion is also called extrusion or exposure when the mesh protrudes from the opening of the vagina.
The FDA also noted some cases of vaginal scarring and mesh erosion led to a significant decrease in patient quality of life due to discomfort and pain, including painful intercourse (dyspareunia).
Incontinence Mesh uses similar graft material as Transvaginal Mesh (TVM), and patients can suffer from similar symptoms and effects postoperatively. However, the risk of these issues is much lower. The conclusions and recommendations of the FDA report do not apply to the use of synthetic mesh for treatment of stress urinary incontinence or abdominal or laparoscopic repair of pelvic organ prolapse (i.e. sacrocolpopexy) where the benefits of mesh are more clearly delineated and the risks are less.
Women who have transvaginal mesh implants may experience symptoms caused by the surgical procedure itself or from problems with the mesh. In transvaginal mesh removal surgery, physicians attempt to remove as much of the mesh as possible and repair the damaged tissue.
Subsequent surgery may be necessary to correct the original prolapse and/or any other serious complications from the mesh.
Because transvaginal mesh is considered a permanent implant, surgery to remove the mesh can be difficult and may increase a woman’s risk of additional complications or symptoms. Over time, the tissue grows into and around the mesh, so removing the mesh without damaging the surrounding tissue and organs is a delicate process.