Product News and Recalls

Vaginal mesh study halted because of health risks

One criticism that plaintiffs in widespread lawsuits have leveled against transvaginal mesh implants is that the devices were approved without clinical testing.

According to a story in the New York Times, researchers actually did attempt a clinical test, but had to discontinue it early because so many participants were suffering potentially dangerous complications.

Transvaginal mesh implants are sling-like devices meant to treat urinary incontinence and pelvic organ prolapse. The lawsuits are based on their tendency to fail and cause health problems, including severe pain, infection and organ perforation.

The devices were approved without clinical testing because of a loophole in the U.S. Food and Drug Administration process that requires approval of medical devices based on their alleged similarity to previously approved products. Mesh implants were originally used to treat hernia – placed in a different part of the body by a different process. And the implants were approved despite the fact that an earlier version was pulled from the market because of safety concerns.

The New York Times refers to a trial in which 65 women with prolapse were randomly assigned to undergo surgical repair either with vaginal mesh or with a procedure called colpopexy that uses the patient’s own ligaments to support the sagging muscles.

More than 15 percent of the patients who received the mesh suffered erosion, a potentially serious complication in which the skin splits and the mesh protrudes. Researchers stopped the trial, which began in 2007, in August 2009.

If you have a vaginal mesh implant, you should consult with a doctor if you have any ongoing symptoms or health concerns. If you have significant injuries, you should also consult with a mesh lawyer to discuss your legal rights.

See the story here:

http://www.nytimes.com/2010/10/26/health/research/26complications.html?_r=0