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Coloplast Vaginal Mesh Lawsuits Join West Virginia MDLs

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On February 7, 2012, the U.S. Judicial Panel on Multidistrict Litigation (JPML) signed an order that transferred three pending vaginal mesh Multidistrict Litigations (MDL) into a fourth. The combined litigation is located in the Southern District of West Virginia, and includes lawsuits against American Medical Systems (AMS), Boston Scientific, Ethicon, and C.R. Bard – all manufacturers of vaginal mesh products used to treat pelvic organ prolapse and stress urinary incontinence.

In an order signed August 6, 2012, the JPML has added another vaginal mesh to the Southern District of West Virginia. Judge Joseph R. Goodwin, who manages the other MDLs, will be managing the new one as well, which includes claims against transvaginal mesh manufacturer Coloplast Corp.

A sixth transvaginal mesh MDL is also proceeding in the Middle District of Georgia, and involves claims against Mentor ObTape.

FDA Warns of Transvaginal Mesh Complications

Women who file transvaginal mesh lawsuits typically claim that the manufacturers failed to adequately warn of the risks. These women were implanted with mesh products to help support pelvic organs that have dropped into the vaginal wall because of muscles weakened and stretched by multiple childbirths, surgeries, and obesity. Sling mesh products are also used to help control urinary incontinence caused by prolapsed organs.

In July 2011, the FDA released a public safety communication warning physicians and patients of complications reportedly due to implantation with transvaginal mesh. The FDA received thousands of reports of women experiencing severe pelvic pain, erosion, extrusion, infections, bleeding, continued urinary problems, and painful sexual intercourse. The FDA added that these complications were not rare, and that it was not clear whether pelvic organ prolapse with mesh was more effective than traditional repair without mesh.

Coloplast Products Named in Lawsuits

According to their website, Coloplast develops products and services “to make life easier for people with deeply personal and private medical conditions.” The company has a special focus on surgical urology, developing surgical devices for both men and women. For women, Coloplast markets products to treat pelvic organ prolapse and to control urinary incontinence.

The August 6 order by the JPML centralized 13 Coloplast pelvic mesh lawsuits into West Virginia. All plaintiffs allege that the company’s products caused serious injuries. The products at issue in these lawsuits, Novasilk, Exair, Suspend, and Axis, are used to treat pelvic organ prolapse by supporting weakened pelvic muscles.

Consolidation into one court helps conserve resources, increase efficiency, and reduce the risk of duplicative discovery or conflicting rulings from other courts. Each lawsuit retains its individual nature, however, and will be returned to its original court for trial after pre-trial proceedings are complete.