Avaulta Mesh: Risk of Complications without Increased Benefits

Philadelphia, PAWomen who have had an Avaulta mesh implant say they have been harmed by the mesh, which is alleged to have been defectively designed. The Avaulta lawsuits are not the first involving transvaginal mesh products, some of which reportedly caused serious health problems for women. Bellwether trials involving the Avaulta mesh implant are expected to be heard in court in the next few months.

According to The Legal Examiner (5/8/13), the first of four federal trials involving the Bard Avaulta transvaginal mesh will begin in June 2013. In July 2012, a plaintiff was awarded $5.5 million in damages in her lawsuit against Bard, alleging the Avaulta mesh caused damage to her colon, requiring eight surgeries.

The four federal bellwether trials will be used by each side to determine the relative merits of the other side’s case, possibly allowing for a settlement of the lawsuits. Federal lawsuits involving the Bard Avaulta mesh have been consolidated for multidistrict litigation.

Other mesh products reportedly in litigation include Boston Scientific and Ethicon.

Concerns about the use of transvaginal mesh to repair pelvic organ prolapse and/or stress urinary incontinence resulted in the Food and Drug Administration (FDA) issuing a warning about use of mesh products. The warning (7/13/11) noted that complications associated with the use of transvaginal mesh to repair pelvic organ prolapse were “not rare” and that there was no evidence that the use of transvaginal mesh was more effective than other types of repair that did not involve mesh.

According to the FDA, a review of scientific literature from 1996 to 2011 showed that “transvaginal POP repair with mesh does not improve symptomatic results or quality of life over traditional non-mesh repair.” The FDA also found that complications associated with the mesh, including erosion of the mesh through the vagina, mesh shrinkage, pain, infection, bleeding and urinary problems, were all linked to the use of transvaginal mesh.

In other words, women who had the mesh implanted were possibly put at a risk of complications without having any greater benefit by using the mesh. In some cases, women required multiple surgeries to repair problems linked to mesh erosion. Not all of those surgeries were successful.

The Avaulta multidistrict litigation is MDL No. 2187 in the US District Court of the Southern District of West Virginia.