The FDA recently issued a warning regarding the use of TransVaginal Mesh, to cover side effects ranging from vaginal mesh erosion (a serious and very painful complication that may lead to splitting of skin or tissue), infection, pelvic organ prolapse, and urinary incontinence. Serious complications from vaginal mesh devices have been observed from almost a dozen different medical device manufacturers.
The warning followed a clinical trial, in which a higher than acceptable percentage of women with the vaginal mesh device suffered vaginal erosion within 3 months of surgery. According to one report, about 10% of women experienced mesh erosion within a year after surgery. This figure includes both synthetic mesh and biologic types. Mesh problems tend to develop at least a month after surgery, as opposed to the immediate recovery period.
What is Vaginal Mesh and what are the problems?
There are four types of surgical mesh: non-absorbable polyester or polypropylene, absorbable synthetics, animal tissues, and combinations of the above. Most GYN and female urology surgeries use the polyester or polypropylene type of mesh. Manufacturers are required to report adverse outcomes linked to their products. The FDA has recently disclosed 1,105 reports of possible problems with mesh used for prolapse repair, and in the last three years there have been an additional 2,874 adverse reports according to the FDA.
According to a just-published FDA report, the most common problems occurred when mesh was used for repair of prolapse. The most common adverse side effects of TransVaginal Mesh include:
- Erosion or protrusion of the mesh from the soft tissues
- Pain, including pain with intercourse
- Infections in the area of the mesh
- Urinary tract problems
- Bleeding from the mesh site
- Damage to nearby organs
TransVaginal mesh is a material that stretches across the vaginal wall providing support for damaged tissue and is one option for treatment of pelvic organ prolapse or stress urinary incontinence.
While implantation of this surgical mesh has proven to be an effective treatment for some patients, the FDA alerted consumers of possible complications to such treatment after reports stated that 9 surgical mesh manufacturers had submitted over 1,000 reports over a three-year period, of postsurgical complications.
Blood Transfusion, abscess drainage, intravenous therapy or additional surgery are common treatment options for TransVaginal Mesh complications. Although the FDA did determine causation or what factors placed certain patients at a higher risk for complication, many physician have speculated that age, as well as estrogen levels, were all possible indicators for risk of erosion.