TVM Mesh Breakthrough Not What Patients Bargained For

Washington, DCThere remains a continuing debate surrounding pelvic mesh and—specifically, for some—the Bard Avaulta mesh implant. At one time the pelvic mesh, or transvaginal mesh (TVM), was considered a breakthrough treatment for pelvic organ prolapse. For some women, however, the term "breakthrough" takes on an entirely different meaning.

Prolapse is a condition whereby organs begin to descend toward the walls of the vagina. TVM mesh was developed as a sling, after a fashion, to help hold wayward organs in place. However, while the procedure has proven useful for many women, just as many it seems have complained of severe pain from a mesh that has been likened to a window screen with raw edges. Scar tissue is designed to weave into the edges and help hold the mesh in place.

Some women, however, have complained of intense pain and perforation of the vaginal wall. More than one TVM patient has noted that their partner experienced the sensation of "something sharp" while in the throes of intercourse.

One Bard mesh patient submitted to an online blog that she had consented to the Avaulta mesh in 2007. Her doctor had offered assurances the product was reliable and had never experienced a failure.

It failed—causing the woman much pain and suffering. A second surgery was required to adjust the mesh, and even though a complete hysterectomy was performed, the mesh is still in place as a permanent part of the patient's anatomy four years later.

Another patient indicated back in August of this year that she had been scheduled for TVM pelvic mesh, "but after researching the use of synthetic mesh, I am calling it off."

At one time pelvic mesh lurked just under the radar of the US Food and Drug Administration (FDA), with the agency taking the stance that problems with the mesh were "rare" That's not the case now, after having reportedly received thousands of adverse events related to the TVM mesh.

"It is not clear that transvaginal POP (Pelvic Organ Prolapse) repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk," the FDA said in a statement in July of this year.

Meanwhile Public Citizen, the well-known consumer advocacy group, provided testimony to the FDA's Obstetrics and Gynecology Devices Panel in September. According to a summary of Public Citizen's presentation and petition appearing on the organization's official web site, Dr. Michael Carome reminded the Administration that Public Citizen petitioned the FDA the month prior to place a ban on the marketing "of all currently-available non-absorbable surgical mesh products specifically designed and labeled for transvaginal repair of POP because these devices offer no clinically significant benefits in comparison to surgical repairs for POP performed without placement of surgical mesh; and (b) have high rates of serious complications."

Public Citizen has petitioned the FDA to order "all manufacturers of these mesh products to recall them, and…

"Require that any such mesh product that is proposed for marketing in the future be classified as a class III device and be approved for marketing only under a premarket approval application (PMA) that includes data from well-designed, prospective clinical trials that provide a reasonable assurance that the surgical mesh product is safe and effective."

In the meantime, according to a recent issue of the West Virginia Record, two patients have launched lawsuits against an obstetrician and gynecologist in West Virginia citing adverse reactions after receiving the Bard Avaulta mesh.