Meanwhile, women's groups and health advocates are demanding that transvaginal mesh (TVM)—including the Bard Avaulta mesh implant—be pulled from the market.
The US Food and Drug Administration (FDA), however, has not signaled a looming Avaulta mesh recall. What it has done, however, is send out a series of signals that translate to grave concern about the mesh products, and their efficacy and effectiveness for women suffering from incontinence or pelvic organ prolapse (POP). The latter two conditions affect women later in life, and are especially true for women who have borne children.
The Bard mesh—not unlike mesh used to repair abdominal hernias—is inserted through the vagina and is intended to hold organs which tend to sag into the uterus over time in place. However, countless women have found the mesh to impact and erode tissue, with sharp edges migrating into the vagina. The result can range from pain and lack of mobility to a loss of intimacy with a partner.
After reviewing adverse reaction reports over a three-year period from January 2008 to December 2010, the FDA in August of last year decreed that transvaginal mesh products were a high risk to patients and, thus, not the best treatment option. However, rather than mandate an Avaulta pelvic mesh recall (and a similar recall of product from other manufacturers), the FDA this past January required manufacturers to conduct studies related to organ damage and complications from TVM mesh.
No fewer than 31 manufacturers are affected.
READ MORE BARD AVAULTA TVM LEGAL NEWS
Various lawsuits involving a host of different manufacturers have been consolidated federally before US District Court Judge Joseph R. Goodwin of the US District Court, Southern District of West Virginia in Charleston. However, Bloomberg reports there are about 600 cases alleging Bard mesh caused injury—and the first case to go to trial before Judge Goodwin will be an Avaulta lawsuit, set to be heard February 5 of 2013.
Bard also faces many an Avaulta lawsuit in state court as well.