“My wife has made an appointment to see her doctor—we are really concerned about this mesh,” says Jim, adding that his wife is suffering from more problems after the Transvaginal Mesh TVT Sling Procedure than she did before the surgery.
Jim and his wife are not the first couple to file a claim against Bard, the maker of Avaulta TVM. Bard lost the first personal injury lawsuit over its Avaulta mesh product and awarded $5 million to a California woman, Christine Scott, who claimed she was injured by Bard’s Avaulta Plus Device. Her husband was awarded $500,000 for loss of consortium. The couple blamed Avaulta mesh for injuries that included complete incontinence, chronic pain, inability to have sex, and eight surgeries to remove the mesh.
Many cases pending in the multidistrict litigation (MDL No. 2187) titled “In Re: C.R. Bard, Inc., Pelvic Repair Products Liability Litigation” allege painful injuries, including a risk of vaginal erosion caused by the mesh moving around. When that happens, it can tear through other tissue and damage other organs nearby such as the bladder or colon. Lawsuits also claim that the transvaginal mesh can cause infection, chronic pain and/or abscess.
Christine Scott’s case was not a part of an MDL, but there are currently four MDLs involving more than 1,000 cases against the major vaginal mesh makers, including C.R. Bard, American Medical Systems (AMS), Johnson & Johnson subsidiary Ethicon, and Boston Scientific.
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Another set of bellwether trial dates have been set in the continuing litigation over transvaginal mesh implants, including Avaulta. The first set of bellwether trials, which will involve C.R. Bard’s Avaulta vaginal mesh product, are scheduled for February 2013.
Given the recent FDA update warning that TVM complications were in fact not rare, and that there is no evidence that transvaginal mesh has any benefits over non-mesh methods used to treat pelvic organ prolapse or SUI, the odds are stacked against Bard.