- Symptoms of transvaginal mesh failure include erosion of the mesh, pain, infection, bleeding, and/or urinary problems
- In 2010, approximately 75 thousand TVM surgeries were performed in the U.S. representing 40% of all transvaginal procedures that year
- From 2008 to 2010, there were 1500 reported cases of transvaginal mesh problems, a 5-fold increase from previous years
- The FDA has determined that women who received transvaginal mesh face additional heath risks.
WHAT IS TRANSVAGINAL MESH?
Surgical mesh is a type of netting used to provide external support to traumatized organs. Transvaginal mesh is implanted through the vagina and is used like a sling to provide support for the pelvic or lower abdominal organs. It is primarily used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). It is sometimes referred to as a bladder sling.
INJURIES, WARNINGS, AND THE FDA
On July 13, 2011, the FDA ordered new warnings for transvaginal mesh devices. As it turns out, the mesh tends to erode and break over time, resulting in recurrent infections, severe pelvic pain, painful intercourse, urinary and bowel dysfunction, and even organ perforation. Some partners have even been injured by the eroded mesh device during sexual intercourse.
This was not the first warning issued by the FDA. In October of 2008, they issued a Safety Alert about serious complications from transvaginal mesh devices. Corrective surgery is often required to remove the failed mesh. This surgery is much more complicated than the original surgery. Studies have shown that the transvaginal mesh carries more risks of injuries than other traditional surgical options without evidence of greater benefit or effectiveness.
“The FDA is issuing this update to inform you that serious complications associated with surgical mesh for transvaginal repair of POP are not rare. Recognize that in most cases, POP can be treated successfully without mesh thus avoiding the risk of mesh-related complications.”
During testimony before the FDA’s Obstetrics and Gynecology Devices Panel regarding non-absorbable synthetic surgical mesh for transvaginal repair of pelvic organ prolapse, Public Citizen called for a ban of such products due to high risk of serious complications, stating there were no clinically significant benefits from the mesh’s use, compared to other safer surgical methods.
In a letter dated August 19, 2011, Dr. Daniel Elliott, Assistant Professor of Urology at the Mayo Clinic, states:
“I strongly support Public Citizen’s petition to the Food and Drug Administration to ban the marketing of all currently available non-absorbable surgical mesh products designed and labeled for transvaginal repair of pelvic organ prolapse and to order all manufacturers to recall such products.
I am fully aware of the complications, which are too common, the management of complications, and their potentially lifelong ramifications. I have come to the conclusion that using mesh for transvaginal repair carries far more risk without any added benefit when compared with the standard surgical approaches without using mesh. I do not hold this view lightly. To quote Dr. William Mayo, founder of the Mayo Clinic, “The best interest of the patient is the only interest to be considered”.