One of the most serious problems caused by transvaginal mesh is called organ perforation. This occurs when the sharp edges of the mesh implant cut through tissues in the pelvic area and cut into other organs like the bladder or bowel.
Many women develop a condition known as pelvic organ prolapse (POP), in which the pelvic organs fall into the vagina. Sometimes these organs can drop so far down that they actually protrude through the opening in the vagina.
Women also may face stress urinary incontinence (SUI), which is the involuntary loss of urine during physical activities. Both prolapse and incontinence result from weak pelvic muscles.
Increasingly, doctors are turning to a newer approach of using transvaginal mesh to repair prolapses and incontinence. In 2010, about 75,000 had transvaginal mesh implanted to repair a prolapse, and 208,000 women had mesh implanted to fix incontinence problems. The additional support of the mesh was believed to lessen the chances of these problems recurring.
But instead of additional support, women have been forced to undergo additional surgeries after suffering from side effects such as erosion and organ perforation — in which the rough edges of the mesh puncture the vagina or nearby organs.
Tens of thousands of women have filed lawsuits, claiming the manufacturers of transvaginal mesh products failed to keep them safe.
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Pelvic Organ Prolapse Complications
The traditional method of correcting prolapse is a procedure known as colporrhaphy. An anterior colporrhaphy is performed when the bladder protrudes through the vagina, and a posterior colporrhaphy is performed when the rectum protrudes through the vagina.
An incision is made into the skin of the vagina, and the weakness in the fascia that is beneath the skin is identified. Fascia is the connective tissue that surrounds the muscles. The fascia is pulled away from the vaginal skin and is then folded over and sewed to provide support for the pelvic organs. There are risks to this type of surgery, including damage to other pelvic organs; however, there was only about a 1 percent chance for serious complications.
The main concern with colporrhaphy is that there is a 40 percent chance of the pelvic organ prolapse recurring. That is why surgeons turned to surgical mesh, which has long been used to fix hernias. Transvaginal mesh was believed to lessen the chances of the prolapse returning.
During transvaginal mesh surgery, a precut sheet of synthetic graft material is implanted through the vagina and sewn into place to provide continued support for the bladder, uterus and rectum.
While the transvaginal mesh does indeed provide additional support, it also results in higher rates of complications, including organ perforation.
Stress Urinary Incontinence Complications
When a small piece of mesh is used to support the bladder, it is called a bladder sling. Although these slings have significantly improved the treatment of stress urinary incontinence (SUI), the procedure also comes with the risk of organ perforation.
Introduced in the 1990s, bladder slings replaced the Burch procedure — which uses the patient’s own connective tissue to support the bladder and repair incontinence problems. Because of the problems associated with the mesh slings, doctors increasingly are returning to the Burch method.
Transvaginal Mesh and Organ Perforation
There are very few clinical trials investigating the risks associated with transvaginal mesh; however, some of those that have been conducted indicate there is a higher rate of organ perforation using this method.
In a 2011 study comparing the colporrhaphy and transvaginal mesh procedures, Swedish researchers studied 389 women with pelvic organ prolapse. Two hundred women underwent transvaginal mesh repairs, and 189 underwent colporrhaphy. All of the women had a prolapse in the anterior (front) vaginal wall.
The main outcome the researchers were looking for was a combination of either no prolapse or the position of the wall no more than one centimeter above the hymen, and no vaginal bulging 12 months after the surgery was performed.
What they found was that after one year, approximately 60 percent of the women treated with transvaginal mesh achieved the outcome, while only about 34 percent of the colporrhaphy patients achieved the goal.
|The complication rates were significantly higher for the transvaginal mesh group. They experienced a:|
|3.5 percent rate of bladder perforation.|
|12.3 percent rate of new stress urinary incontinence after surgery.|
|3.2 percent rate of follow-up surgery to repair mesh erosion.|
The Food and Drug Administration (FDA) issued a second warning about the problems with transvaginal mesh in July 2011. In that report, the agency noted that between 2008 and 2010, there were 2,874 reports of complications associated with prolapse and incontinence repairs using mesh. Organ perforation was among the most frequent complaints.
There were seven reported deaths between 2008-2010 associated with pelvic organ prolapse repairs. Three of the deaths were related to the mesh placement procedure (two bowel perforations, one hemorrhage).
The agency also concluded that after reviewing the existing literature regarding transvaginal mesh repairs, it doesn’t appear to have any benefits over the traditional surgical methods.
In early 2012, the FDA ordered 44 mesh companies to conduct three-year safety and effectiveness trials on their transvaginal products.