(PRWEB) June 13, 2012
Cohen, Placitella & Roth has just received reports that Ethicon, Inc. ("Ethicon"), a subsidiary of Johnson & Johnson ("J&J"), has advised the Food and Drug Administration ("FDA") it will stop commercializing in the United States several pelvic mesh products intended to treat pelvic organ prolapse ("POP") and stress urinary incontinence ("SUI"): the TVT-Secur Sling system, the Prosima Pelvic Floor Repair System, and the Prolift and Prolift +M Pelvic Floor Repair Systems.
“We are extremely pleased to hear that Johnson & Johnson will stop selling some of its vaginal mesh products. It is clear that these products are dangerous and pose significant risks," says Jillian Roman, an attorney with C/P/R. "Johnson & Johnson’s decision is, however, only a small comfort to the thousands of woman whose lives have forever changed because of these products. We look forward to obtaining justice and compensation on behalf of our clients who have suffered devastating injuries as a result of vaginal mesh products.”
Ethicon will also be revising the product labeling for the Gynecare Gynemesh system to restrict the indication for use to abdominal sacrocolpopexy procedures only. Ethicon's decision to cease commercialization of these products follows the hundreds of lawsuits filed in the centralized pelvic mesh litigation in the Superior Court of New Jersey, where the first bellwether trial is set for November 5, 2012, as well as the recently created Ethicon MDL in the Southern District of West Virginia. Christopher M. Placitella, a shareholder of C/P/R, serves on the Plaintiffs' Steering Committee in the federal litigation, In re: Ethicon, Inc., Pelvic Repair System Products Liability Litigation (MDL No. 2327); the federal litigation is pending in the U.S. District Court for the Southern District of West Virginia before Judge Joseph R. Goodwin. Jillian A. S. Roman, an attorney with C/P/R, serves as Plaintiffs' Co-Liaison Counsel in In re Pelvic Mesh/Gynecare Litigation, the centralized litigation pending in the Superior Court of New Jersey before Judge Carol E. Higbee.
Notably, Ethicon has also requested that the FDA place on hold its existing orders that Ethicon conduct postmarket studies on these POP and SUI products. Ethicon was ordered by the FDA in January 2012 to conduct these postmarket surveillance studies, along with several other pelvic mesh manufacturers. In total, the FDA issued 88 postmarket study orders to POP product manufacturers and 11 postmarket study orders to SUI product manufacturers.
The orders were issued as part of the FDA's continuing assessment of the safety and efficacy of mesh devices, and as the FDA considers reclassifying surgical mesh products from Class II to Class III devices. Class III devices, unlike Class II, require a premarket approval application, or PMA, demonstrating the safety and effectiveness of the product.
Transvaginal placement of surgical mesh has received significant attention following the FDA's October 20, 2008 Public Health Notification warning consumers and health practitioners about serious complications associated with the procedure, and the FDA's July 13, 2011 revision of its previous safety communication to inform the community that serious complications associated with surgical mesh for transvaginal repair of POP are not rare. In September 2011, the FDA's Obstetrics & Gynecology Devices Advisory Committee held two days of meetings regarding the risks and benefits of the use of surgical mesh for POP and SUI treatment.
The FDA has estimated that 30 to 50% of women may experience POP in their lifetime, and hundreds of thousands of woman in 2010 alone underwent surgery to repair POP and SUI conditions. From 2008 to 2010, the FDA received thousands of adverse event reports associated with mesh used for POP repair. Frequently reported complications from these mesh products include mesh exposure or protrusion through the vaginal tissue, also known as erosion, mesh concentration or shrinkage, chronic pain and infection. Many side effect victims have been forced to undergo at least one revision surgery to remove portions of the mesh product, and the side effects suffered by victims can be permanent and debilitating.