The FDA has recently warned that serious complications associated with surgical mesh for transvaginal repair of POP are not rare. These injuries may require multiple surgeries, which still may not-cure long-term complications. These side effects may be permanent despite corrective surgery. This is a change from what the FDA previously reported on Oct. 20, 2008. Furthermore, it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk. This Safety Communication provides updated recommendations for health care providers and patients and updates the FDA’s activities involving surgical mesh for the transvaginal repair of POP.
The FDA’s literature review found that erosion of mesh through the vagina is the most common and consistently reported mesh-related complication from transvaginal POP surgeries using mesh. Mesh erosion can require multiple surgeries to repair and can be debilitating for some women. In some cases, even multiple surgeries will not resolve the complication.
Vaginal mesh is also known as transvaginal mesh, pelvic mesh, tape, or sling which is most commonly used to treat Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI). Transvaginal mesh is implanted through the vagina, and designed like a hammock or sling to support weakened, sagging pelvic muscles — a complication of pregnancy that affects hundreds of thousands of women.
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. The mesh is produced by several manufacturers and has been used in tens of thousands of surgical procedures in the United States. But TVM has been linked to serious health complications that can often require painful and invasive revision surgeries to correct.
One of the more serious side effects of the transvaginal mesh implant is the possibility of erosion. Erosion is the gradual moving of the device through the vaginal wall and sometimes into surrounding organs. Erosion can cause serious complications, including damage to the bladder and bowel and intense pain. When erosion occurs, patients often require additional surgeries to correct the problem. Thousands of women who have had these devices surgically implanted have experienced negative side-effects and medical complications. Some minor transvaginal mesh side effects include pain during intercourse, and urinary tract infections. More serious side effects of transvaginal mesh include erosion of the mesh, infections in the area of the mesh, and damage to nearby organs.
Vaginal mesh side effects may include:
- Pain, including pain with intercourse
- Infections in the area of the mesh
- Urinary tract problems
- Multiple occurrences of pelvic organ prolapse
- Vaginal scarring
- Perforated bladder, perforated bowel or perforated blood vessels
- Mesh erosion into the vagina
- Organ injuries
Thousands of bladder sling lawsuit have been filed by women have had a transvaginal mesh implant, vaginal sling, bladder sling or vaginal mesh surgically implanted to treat pelvic organ prolapse. Now, these women are reporting a multitude of serious side effects caused by the very medical devices that were supposed to help them. Leading manufacturers of vaginal mesh and bladder slings like Bard, AMS, Ethicon, Boston Scientific, UGYTEX, Coviden, and others are preparing to settle these vaginal mesh lawsuits as more studies come out showing the dangers and side effects of vaginal mesh and bladder slings. Millions of dollars in vaginal mesh settlements have already been awarded to plaintiffs. Skilled surgeons have had mishaps with the tools used to implant Transvaginal Mesh, which is why the FDA has warned them to be diligent. However, diligence does not always prevent the complications that can occur.