Avaulta Mesh: Patients Are Not the Women They Once Were

Washington, DCAvaulta mesh is but one player in a women's health issue that, to some in the legal profession, represent a particularly alarming portfolio that sees many patients no longer existing as the women they once were.

Lawsuits involving the Bard Avaulta mesh implant have been consolidated in federal court in the Southern District of West Virginia. Lawyers and industry watchers have found that lawsuits appear to be on the rise since the US Food and Drug Administration (FDA) issued warnings against vaginal mesh products in July of last year.

While problems with the surgically implanted product—used to treat incontinence and pelvic organ prolapse (POP)—have been suspected and alleged for years, only recently did the FDA acknowledge that Bard mesh and its various cousins may not be the best treatment option related to the aforementioned issues. In the absence of an Avaulta mesh recall, the FDA announced in July that it is requiring all transvaginal (TVM) mesh manufacturers to devote the next three years to post-market testing.

The agency, however, appears unwilling to formally revoke approval of the mesh products, including Bard Avaulta mesh, for that indication.

TVM mesh grew out of a similar surgical mesh used successfully for decades to treat hernias. In theory, the product's use for women's unique health issues seemed to make sense. However, in practice, the indication for surgical mesh to treat incontinence and POP in women has been a bit of a crap shoot given the absence of intensive pre-market testing—testing not required under FDA guidelines governing new products that are substantially similar to those already on the market.

In practice, TVM mesh products—Bard mesh among them—have presented a myriad of health issues for women.

Among them: erosion of the mesh into the vagina causing pain, infection and in some cases injury to the woman's partner. For some patients, the mesh has affected intimacy with a spouse or partner. Some patients have suffered perforations of the bladder. The sensation of "pulling" within the abdomen while walking or bending has created mobility issues for some patients.

Ironically, with some patients for whom the Avaulta pelvic mesh was intended to resolve incontinence problems, symptoms of incontinence persisted. For these patients, not only was the incontinence problem not resolved, the patient is made to live with serious adverse reactions that for some have led to depression, separation and divorce.

Some patients undergo revision surgery. For others, depending upon how the Avaulta mesh system has migrated or broken down within the body, revision surgery is not possible—suggesting a permanent impact on quality of life.

While TVM lawsuits have been consolidated in federal court and will be handled by Chief Judge Joseph R. Goodwin, many an Avaulta lawsuit has been filed in state courts. Looking down the road, it will be interesting to see where the lawsuit tally stands—together with the FDA position following post-market testing—three years out.