TVT Sling and Arrows Over Transvaginal Mesh

Washington, DCLawyers representing transvaginal mesh plaintiffs note that mesh product primarily designed for use in the abdomen should never have been cleared for use in the pelvis without additional testing. However, that appears to have been the case. Today, according to the July 14 edition of the Boston Globe, upwards of 100,000 women receive the plastic mesh each year to treat pelvic organ prolapse (POP).

The latter is a condition that occurs when pelvic organs such as the bladder, uterus and bowel sag and descend into the vagina. Transvaginal mesh is often used to support those organs after they have been lifted out of the vagina and guided back into place. A TVT sling is effectively constructed out of the plastic mesh.

However, the US Food and Drug Administration (FDA), which approved the mesh for use in treating POP, has been getting an increasing number of adverse reports and now says that in most cases the prolapse condition can be successfully treated without the mesh.

Those reports run the gamut from urinary problems and bleeding to infections and painful intercourse. One health care worker who hails from New Hampshire articulated to the Boston Globe that since her transvaginal sling procedure in 2008, she is in constant pelvic pain, enduring frequent spasms.

Many women have been forced to undergo revision surgery to have the product removed in an effort to circumvent the transvaginal mesh complication. However, in some cases, when the mesh is so tightly interwoven with scar tissue, removal is not possible.

Dr. Jill Brown, a medical officer with the FDA, said in comments published in the Boston Globe that for women with a vaginal sling that can't be removed, their options are limited.

A further blight on the effectiveness and efficacy of the TVT sling procedure comes from the FDA's deputy director of the Center for Devices and Radiological Health. Dr. William Maisel told the Boston Globe that evidence studied by the FDA questions the clinical benefit of transvaginal mesh, adding that the product should not be routinely used for all POP repair work.

It was revealed that between 2008 and 2010, adverse event reports to the FDA have increased five-fold over 2005 to 2007. Among the adverse TVT mesh reports were three deaths. Studies available to the FDA have determined that approximately 10 percent of women having had the procedure experienced mesh erosion within a year of surgery. More than half of those women required additional surgery to remove the problematic trans vaginal mesh.