According to PRWeb Newswire (6/14/13), May 31 was the date that Atlantic County Superior Court Judge Carol E. Higbee issued an Amended Bellwether Scheduling Order with regard to lawsuits filed against C.R. Bard, one of some 33 manufacturers of transvaginal mesh. The Order puts in motion the first trial against C.R. Bard alleging transvaginal mesh complication, now set to begin September 23 of this year as part of In re: Pelvic Mesh Litigation/Bard, No. L-6339-10.
Before that trial has the chance to begin, another trial is slated for this summer in federal court. In just a couple of weeks, on July 8, the first federal action trying a transvaginal mesh lawsuit will commence in the C.R. Bard multidistrict litigation, In re: C.R. Bard, Inc., Pelvic Repair Systems Products Liability Litigation - MDL No. 2187, U.S. District Court, Southern District of West Virginia.
TVT mesh has quickly evolved from a savior to a scourge for hundreds, if not thousands, of patients. Women who have borne children often discover, at middle age and combined with the ravages of time, that abdominal organs will drift, or prolapse, into the pelvic area and press against the uterus (POP). Incontinence (SUI) is also a common, if unrelated, condition.
Previous treatment has involved harvesting a woman’s own tissue for the creation of a sling, which is stitched into place by way of invasive surgery to hold migrating organs at bay. However, borrowing from the successful use of mesh in abdominal hernia procedures, medical device manufacturers and surgeons developed a less-invasive procedure involving the placement of mesh inserted into the placement area through a small incision, then deployed in the abdomen. The new procedure was initially hailed as a breakthrough that would speed healing time and preserve hospital resources.
The reality for scores of women has been transvaginal mesh complication. Mesh has been found to migrate away from the initial deployment area, sometimes pressing into and through the vaginal wall, or becoming hopelessly entangled with internal organs that makes removal virtually impossible. The US Food and Drug Administration (FDA) has since suggested that use of the TVT sling procedure may no longer necessarily represent the safest and optimum way to treat POP and SUI, and has ordered all 33 manufacturers of the vaginal sling to conduct post-market studies to gauge the ongoing safety and efficacy of their products.
Meanwhile, lawsuits alleging TVT side effects keep coming. According to court records, 550 lawsuits naming C.R. Bard as a defendant were pending in Atlantic County Superior Court as of June 8 of this year.
Pharmaceutical and medical device giant Johnson & Johnson is also intertwined in the transvaginal tape sling debacle through its Ethicon subsidiary. Nearly 3,000 trans vaginal mesh lawsuits alleging complications with Ethicon vaginal sling products are pending in a multi-district litigation in Atlantic County (In re: Pelvic Mesh/Gynecare Litigation, No. 6341-10).
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Numerous patients have sought a reversal to their TVT sling procedure, either through surgery to adjust the troublesome device or an outright removal of the mesh. Some women, for whom removal is not possible, are made to face a lifetime of pain and suffering. Their lives are never the same.
Three other TVT sling litigations also pending in the Southern District of West Virginia: In re: American Medical Systems, Inc., Pelvic Repair Systems Products Liability Litigation - MDL No. 2325; In re: Boston Scientific Corp., Pelvic Repair Systems Products Liability Litigation - MDL No. 2326; and In re: Ethicon, Inc. Pelvic Repair Systems Products Liability Litigation - MDL No. 2327.