On July 13, 2011, the Food and Drug Administration issued a warning to women regarding serious complications that have been reported resulting from the use of transvaginal mesh to repair pelvic organ prolapse (POP).
This is the second FDA warning on this issue in the last 3 years. The surgical procedure involving mesh is commonly referred to as a bladder sling or pelvic sling.
POP occurs when supporting structures for pelvic organs including the bladder, uterus, and rectum weaken or stretch and the organs bulge (prolapse) into the vagina. Symptoms associated with POP can include pain, difficulty urinating, incontinence, problems with intercourse, etc.
The FDA estimates 30-50 percent of women may develop POP in their lifetimes, although only a small percentage actually have symptoms. In the last 10-15 years, some doctors have used transvaginal (through the vagina) placement of surgical mesh to support the vaginal wall to help alleviate the bulging of the organs into the vagina.
The problem with this procedure, however, is that it can result in serious complications that may be irreversible. Between 2008 and 2010, thousands of women have reported complications from this surgery to the FDA.
The most commonly reported complications include erosion of the mesh through the vagina causing pain, infection, bleeding, pain during intercourse, organ perforation and urinary problems.
The FDA has now reported that there is no clear evidence that the use of transvaginal mesh is better than other types of surgery and, furthermore, that the use of mesh may expose patients to greater risks than conventional surgery.
Consumer groups, including The Public Citizen, have placed transvaginal mesh on their “Do Not Use” list. The mesh used in these procedures has been manufactured by many different companies and includes mesh products known as Bard Avaulta, Ethicon Gynecare Gynemesh, Prolene Mesh, Prolift, TVT sling, AMS Sparc, Elevate, Apogee, Perigee, Monarc sling systems, and others.
Even though the significant risks associated with these procedures have been known for some time now, both the mesh manufacturers and, frequently, physicians have not been properly advising patients about them. The results for some women have been catastrophic.
If you have had problems with a transvaginal surgical mesh repair of POP, you should do two things.
First, notify the FDA of the problem by filing a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
Second, contact an experienced medical malpractice attorney to discuss your problem and potential legal options. We would be happy to provide you with a free consultation.