Toronto, ONWith lawsuits over transvaginal mesh ricocheting across both the US and Canada, a noted health writer for a major Canadian newspaper says it's time to bring transvaginal mesh complication out of the shadows and into the spotlight.
Andre Picard, writing in The Globe and Mail (5/8/12), notes there about 25,000 surgical procedures each year for stress-urinary incontinence (SUI), and another 5,000 for pelvic-organ prolapse (POP) in Canada. To that end, Picard reports, more than 30 percent of POP procedures and a full 90 percent of SUI surgeries involve the insertion of vaginal mesh, also known as transvaginal tape sling (TVT sling) to hold everything in place after things like ligaments, muscles and even skin fail over time and are no longer capable of doing the job of holding wayward organs in place.
While transvaginal mesh remains effective for the majority of patients for whom it is used, the emergence of serious TVT side effects in many patients has prompted both Health Canada and the US Food and Drug Administration (FDA) to take a cautionary stance against the product.
Some of the real-life transvaginal mesh complications encountered by women are heartbreaking, according to Picard, who tracked the stories of two plaintiffs involved in a class-action transvaginal mesh lawsuit in Canada. Both women had been suffering from incontinence issues, and were assigned TVT mesh to hopefully fix the problem.
It didn't work for one, and fostered debilitating pain for both, Picard reports. One plaintiff developed chronic leg pain allegedly from the mesh and had to give up her job in the nursing profession due to her newfound inability to stand for long periods. Another plaintiff found the mesh resolved her bladder problem, but left her with serious leg pain.
There are other women with equally compelling transvaginal sling stories. One patient reports constant burning pain from her knees to her navel. Another is now on long-term disability due to the pain allegedly caused by the vaginal sling she received in 2010.
Some women, according to Picard, report suicidal thoughts as a means to escape the pain.
Picard notes that such a compelling problem has largely gone unrecognized due to a largely silent media reluctant to address issues involving the nether regions. When the CTV News Network recently did a story on transvaginal mesh, the floodgates opened.
One patient complained that her vaginal sling had loosened and pierced her vaginal wall. Another reported bits of purple mesh fiber expelled in her urine. Picard notes that the particular mesh used in a TVT sling procedure is designed to latch to the body, so removal after the fact due to complication is nearly impossible.
July will be the first anniversary of the FDA's most recent warning letter to physicians, in which the federal regulator cautioned "serious complications associated with surgical mesh for transvaginal repair of POP are not rare." In language that Picard notes is rather damning towards transvaginal mesh, the FDA went on to say that "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."
The manufacturers of TVT mesh—the defendants in many a transvaginal mesh lawsuit—refer back to the skill of the surgeon as a factor, together with the fact mesh remains effective for the majority of patients regardless of the FDA's position that a transvaginal tape sling may no longer be the best treatment option. The manufacturers also point to the FDA's own approvals protocol, which excuses manufacturers from the need for substantive testing if a product is similar to one already on the market and used successfully.
To that point, mesh has been used for decades to repair abdominal hernias. However, mesh utilized for a vaginal sling has been seen as increasingly problematic.
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