Transvaginal Mesh Bowel & Bladder Perforations
Among the risks of using transvaginal mesh for repairing POP is the risk of bladder and bowel perforations. Rates of bladder perforation were 3.5 percent in a group of women undergoing mesh-repair for pelvic organ prolapse (POP) compared to 0.5 percent in a group of women undergoing traditional POP surgery in a study reported in a recent issue of the New England Journal of Medicine.
The FDA said that between 2008 and 2010, seven deaths had been reported as being associated with POP repairs. Of those deaths, two were related to bowel perforation. The perforations can occur during the insertion of the mesh.
Other Complications of POP Surgical Mesh Operations
In 2010, approximately 300,000 women in the United States had surgery to repair POP. From Jan. 1, 2008, to Dec. 31, 2010, there were 1,503 reports of adverse events associated with POP surgical repairs. This was more than a five-fold increase in the number of adverse events associated with pelvic organ prolapse that were reported in the previous three years.
The FDA said that it is difficult to determine the exact cause or causes of the increase. "Regardless," the agency said, "the FDA believes the overall increase in the number of serious adverse event reports is cause for concern."
Organ perforation was among the most frequent complications reported to the FDA from the use of surgical mesh devices for POP repair. Other complications included:
- Vaginal mesh erosion (This is also called exposure, extrusion or protrusion.)
- Painful sexual intercourse (known as dyspareunia)
- Urinary problems
Because of the high number of complications and because using surgical mesh transvaginally for POP does not seem to have better outcomes than traditional abdominal surgery for treating POP, the FDA is considering making regulatory changes to improve the understanding, safety and effectiveness of these devices.
The agency recommends that women who are thinking about having surgery for POP need to understand the risks associated with transvaginal POP repair and should be made aware that having mesh surgery can increase the risk for needing more surgery because of mesh-related complications.
Following surgery, the FDA said, patients should:
- Continue with annual and routine follow-up care
- Understand they do not need to take any action if they are satisfied with their surgery and are not having complications or symptoms
- Notify their doctors if they develop symptoms or complications, including persistent vaginal bleeding or discharge, pelvic or groin pain and/or pain with sex
- Let their doctors know if they have surgical mesh, in particular if they are planning to have another related surgery or other medical procedures
- Be sure to ask their surgeon at the next medical checkup if surgical mesh was used for their POP procedure if they don't know
Contact a Transvaginal Mesh Injury Lawyer Today
If you've suffered injuries such as bladder and bowel perforations, you might be eligible for financial compensation. To schedule a free case review with a qualified transvaginal mesh perforations attorney about your rights, please contact us today.