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An Indiana couple has filed a product liability lawsuit over problems with a Caldera Medical Desara vaginal sling, which caused the wife to experience severe complications similar to those that have been linked to several transvaginal mesh products.
The complaint (PDF) was filed by Kimberly Durham and her husband, Morris, in the U.S. District Court for the Southern District of West Virginia on June 8.
Durham indicates that she received a Caldera Desara sling on October 15, 2007, and alleges that the she suffered serious bodily injuries, mental and physical pain and suffering, including vaginal pain and painful sexual intercourse, as a result of complications with the sling.
According to the lawsuit, the Caldera Medical Desera vaginal sling was defectively designed and the manufacturer failed to adequately warn about the risk of problems following use of the sling during transvaginal surgery.
The Desara sling contains material that is not inert, reacting to human tissues and bodily functions in ways that adversely affect a patients health, according to allegations raised in the complaint. Durham also alleges that the mesh harbors infections and can migrate from its original location, becoming embedded in human tissue.
Durham is suing the manufacturers for negligence, breach of warranty, manufacturing and design defects, as well as failure to warn. Her husband has brought a claim for loss of consortium, and the couple seeks compensatory damages, as well as punitive damages in the lawsuit.
The case joins a growing number of vaginal sling lawsuits that have been filed throughout the United States over problems with similar products made by a number of different companies, including American Medical Systems (AMS), C.R. Bard, Boston Scientific and Ethicon.
The Desara sling was manufactured and sold by Caldera Medical, but AMS was included as a defendant in Durham’s lawsuit because the mesh utilized design elements and technology designed and owned by AMS, resulting in royalties based on sales of the system.
Transvaginal mesh products are used to support organs during repair of pelvic organ prolapse (POP) and female stress urinary incontinence (SUI). However, problems with the bladder slings and vaginal mesh have been linked to reports of the mesh eroding through the vagina, causing severe pelvic pain, infection and other complications.
Public awareness about the risk of the complications from vaginal mesh increased last year, after the FDA issued warnings in July 2011 about an growing number of adverse event reports associated with the products, indicating that the agency has been unable to find any evidence that products used for repair of pelvic organ prolapse provide any benefit over other available means of treatment.