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Shezad Malik MD JD
Shezad Malik MD JD
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Study: Vaginal Mesh for Prolapse Repair Provides No Benefit

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According to new published research, transvaginal mesh placement provides no benefits when used for pelvic organ prolapse repair. In a study published in the Obstetrics and Gynecology journal, researchers found that the use of vaginal mesh does not increase good outcome for surgical prolapse repair when compared to more traditional treatments.

Trans Vaginal Mesh AttorneyGeorgetown University researchers halted the study due to the high rate of serious injuries associated with use of vaginal mesh. The study involved 65 women, 33 of whom received vaginal mesh to treat pelvic organ prolapse (POP) and 32 who underwent traditional vaginal prolapse surgery.

The women were followed for three years and the program stopped early because of a 15.6% mesh exposure rate, where the mesh eroded into the vagina.

Three women who received a vaginal mesh implant had to undergo another operation when their prolapse returned. None of the women who received traditional vaginal prolapse surgery had to undergo re-operation.

Researchers found that there was no difference in the quality of life for women who received the mesh versus those who did not. This finding raises questions as to whether the benefits outweigh the risks.

FDA Concerns About Vaginal Mesh Prolapse Surgery

In July 2011, the FDA said that nearly 3,000 reports of problems with vaginal mesh were received by the agency between January 2008 and December 2010, including cases where the mesh eroded through the vagina, causing severe and debilitating injuries.

In early 2012, the FDA sent a letter to several mesh manufacturers, ordering that they conduct additional studies and trials to evaluate the safety of transvaginal mesh products.

Controversial FDA 510(k) Process

Many of these vaginal mesh products were approved through the FDA’s 510(k) system, which permitted the manufacturers to begin selling the devices without conducting rigorous pre-market studies. The FDA opened the door to “me too” like products, which flooded the market without adequate testing and research. Products were approved as long as the manufacturer could demonstrate that it was “substantially equivalent” to other products on the market.

Trans Vaginal Mesh Lawsuits

More than 30,000 women across the U.S. have filed lawsuits against the manufacturers of transvaginal surgical mesh, alleging that the companies did not properly research or design the products, and failed to adequately warn about the risk of complications.

In the federal court system, 6 different multidistrict litigation (MDLs) have been set up in the Southern District of West Virginia for lawsuits filed against Johnson & Johnson’s Ethicon unit, as well as C.R. Bard, American Medical Systems (AMS), Boston Scientific, Coloplast Corp., and Cook Medical.

All of the complaints involve allegations that women suffered severe complications from vaginal mesh products implanted for repair of pelvic organ prolapse (POP) or female stress urinary incontinence.