Minnetonka, MNThere is rampant speculation that a tide of AMS transvaginal mesh lawsuits will flow amidst allegations the products caused infections, vaginal erosion, organ puncture and, in a handful of cases, death. And this isn't a lawyer talking, either. According to the Minneapolis / St. Paul Business Journal (The Business Journal 8/24/12) this is the position of the US Food and Drug Administration (FDA) itself.
To be fair, American Medical Systems Inc. (AMS) isn't the only manufacturer of the allegedly problematic mesh systems. Some 30 different manufacturers have been admonished by the FDA to undertake post-market studies of the transvaginal mesh, to better determine the safety and effectiveness of the controversial products. AMS mesh is one of those manufacturers so ordered.
AMS lawyers, and other legal professionals and plaintiffs investigating the problems associated with TVM mesh, make the point that in many such lawsuits, there is more than one person affected. To wit, while a woman may experience a basket of problems following AMS surgery, the woman's husband or partner may also be affected. Such was the case with a recent lawsuit involving another manufacturer, where the woman and her husband received separate awards—the woman due to her direct physical condition resulting from the implant, and a husband impacted by loss of sexual relations with his partner.
Many mesh patients have found they've had to give up intercourse due to the problematic mesh protruding through the vaginal wall, causing pain to both and risking injury.
The Business Journal noted that AMS legal is expected to face upwards of 1,900 lawsuits over AMS TVM products used to treat pelvic organ prolapse (POP) and incontinence in women. Its parent company, Endo Health Solutions Inc., purchased AMS last year.
The FDA, in ordering the various manufacturers to study their products post-market, is signaling the agency does not intend—at least for now—to order the products, AMS mesh among them, off the market. However, the regulator made its position clear when it suggested to doctors that use of TVM mesh should no longer be a preferred, 'first line' treatment, but rather should be relegated to the back of the pack and appropriate only for those patients for whom more traditional treatments for POP or incontinence, are ineffective.
The Business Journal notes that some doctors and advocate groups have called for a blanket recall of TVM products, including AMS transvaginal mesh. However, the publication noted that a spokesperson for Endo and AMS stated the companies remain committed to the business, and will respond to any AMS transvaginal mesh lawsuit, "as they come along."
Lawsuits stemming from alleged AMS transvaginal mesh injury could be interesting, if the outcome of a recent lawsuit against rival manufacturer C.R. Bard is any indication. At the end of July, a jury awarded a California woman $5 million. The jury also awarded $500,000 to her husband.
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