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Transvaginal Mesh Trials Begin on Several Fronts
The first transvaginal mesh multi-district litigation (MDL) case is set for trial on February 5, 2013 and names American Medical Systems as defendant.
Nearly 300,000 women received transvaginal mesh implants and/or bladder slings in 2010 alone as they were a popular treatment for pelvic organ prolapse (POP) and stress urinary incontinence. (SUI) Traditionally, these problems were treated with surgery using the patient’s own tissue to support the organs. Although the medical community quickly touted transvaginal mesh implants as a low-risk breakthrough, the FDA states that, “it is not clear that transvaginal POP repair with mesh is more effective that traditional non-mesh repair in all patients with POP and the treatment, “may expose patients to greater risks.” Such risks include: erosion and extrusion of the mesh through vaginal tissue, perforation of pelvic organs bowels and blood vessels, vaginal bleeding and scarring, pelvic pain, particularly during intercourse, chronic infections and urinary incontinence. Unfortunately, for many women there is virtually no way to undo the harm caused by the mesh. Multiple surgeries may be required to attempt to remove the mesh and often it cannot be totally removed as it imbeds itself into the muscle and surrounding tissue.
In July 2011 the FDA issued a public safety warning regarding these products. At least 10 percent of women implanted with transvaginal mesh experience severe complications within the first year of the surgery. Many require multiple surgeries to remove and/or repair internal damage caused by the mesh. Such complications have led hundreds of women to file suits against the multiple manufactures of mesh products claiming insufficient testing and studies were performed prior to approval by the FDA. Some of the primary manufacturers of these defective products are:
American Medical Systems: Elevate, Apogee, Perigee
Boston Scientific: Pinnacle, Uphold
Caldera Medical: Ascend Anterior, Ascend Posterior
Johnson & Johnson: Gynecare Prolift, Gynecare Prosima, Gynecare
C.R. Bard, Inc.: Avaulta, Pelvisoft, BioMesh, Pelvilace, Pelvitex, Pelivicol Acellular Collagen Matrix
As there are hundreds of women across the country who have filed similar lawsuits based on the damages caused by transvaginal mesh, the multidistrict litigation judicial panel transferred the cases filed in various federal courts across the country to one court, the U.S.District Court for the Southern District of West Virginia to help process these claims more efficiently. The Honorable Judge Joseph R. Goodwin has been assigned to handle the litigation involving the following defendants: American Medical Systems, Inc. (MDL No. 2325), Boston Scientific Corp. (MDL No. 2326), C.R. Bard, Inc., ( MDL No. 2187), Ethicon, Inc (MDL No. 2327) and Coloplast (MDL No. 2387). A sixth MDL was established for claims against Johnson & Johnson pertaining to the defective Mentor ObTape in the U.S. district Court for the Middle District of Georgia before Judge Clay D. Land. Additionally, there are hundreds of state court claims pending in New Jersey against Johnson & Johnson involving the Gynecare Prolift.
Ennis & Ennis, P.A. continues to offer free, nationwide, confidential consultations to anyone who was injured by a transvaginal mesh device by calling toll free 1-800-856-6405 or by going to www.ennislaw.com and completing an online case evaluation form.