New York, New York (PRWEB) June 05, 2012
Parker Waichman LLP, a national law firm dedicated to protecting the legal rights of people injured by defective medical devices, is reporting that Ethicon Inc., a division of Johnson & Johnson, has decided to withdraw four of its transvaginal mesh devices, including its controversial Gynecare Prolift product, as well as its Prolift+ M, TVT Secur and Prosima systems, from the U.S. market. In a letter filed with U.S. District Judge Joseph Goodwin, Ethicon stated that it would seek U.S. Food and Drug Administration (FDA) approval to stop "commercializing" the four transvaginal mesh products, and will advise healthcare providers to select alternative treatments for their patients. However, the company is not recalling any products that have already been sold or implanted [http://www.bloomberg.com/news/2012-03-21/j-j-sold-vaginal-mesh-implant-without-u-s-regulatory-approval.html .
Currently, Ethicon and Johnson & Johnson are named in some 600 lawsuits pending in a multidistrict litigation in the U.S. District Court for the Southern District of West Virginia before Judge Goodwin. All of the lawsuits allege that the companies’ transvaginal mesh devices used in pelvic organ prolapse (POP) and stress urinary incontinence (SUI) repair surgeries caused women to suffer serious complications, including vaginal erosion, inflammation, infection, chronic pain and organ damage (In re: Ethicon, Inc., Pelvic Repair System Products Liability Litigation - MDL No. 2327).
The Gynecare Prolift product, one of the transvaginal mesh devices named in the letter, was sold by Ethicon for three years without approval from the FDA. According to a report from Bloomberg News, Ethicon did not apply for FDA approval of the device prior to its 2005 introduction, ostensibly because it was similar to a previously-approved product, leading the company to believe premarket clearance was not needed. It was not until 2007, when Ethicon cited Gynecare Prolift as the predicate in the 510(k) application for another transvaginal mesh product, Prolift+M, did the FDA learn that it was being marketed. At that time, the agency informed Johnson & Johnson and Ethicon that it would require a 510(k) application for the Gynecare Prolift device. The FDA cleared both the Gynecare Prolift transvaginal mesh product and the Prolift+M device in 2008, according to Bloomberg. [http://www.bloomberg.com/news/2012-03-21/j-j-sold-vaginal-mesh-implant-without-u-s-regulatory-approval.html
About Transvaginal Mesh
In October 2008, the FDA announced that it had begun a safety review of transvaginal mesh products, after receiving more than 1,000 reports of complications related to the use of the devices in the surgical repair of POP and SUI. In July 2011, the FDA announced that it had received an additional 1,503 reports of transvaginal mesh complications associated with POP repairs and an additional 1,371 reports associated with SUI repairs. The most common side effects reported to the FDA included erosion through the vaginal tissue, pain, infection, bleeding, pain during intercourse, organ perforation during placement, and urinary problems. The FDA also emphasized that POP transvaginal mesh complications are not rare, a change from the position it took in 2008. [http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm
On September 8 and 9, 2011, the FDA's Obstetrics and Gynecology Devices Advisory Panel met to discuss the safety of transvaginal mesh devices in POP repair. Though no formal vote was taken, the majority of outside medical experts on the panel backed the FDA's proposal to reclassify transvaginal mesh devices as high risk, which would make such devices ineligible for the agency's 510(k) protocols. In January 2012, the FDA directed the makers of transvaginal mesh products, including Johnson & Johnson and Ethicon, to conduct post-market safety studies of their products in order to enable the agency to better understand the safety and effectiveness profiles of these devices. [http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/UroGynSurgicalMesh/default.htm
Parker Waichman LLP continues to offer free lawsuit consultations to victims of transvaginal mesh injuries. If you or a loved one experienced complications following POP and SUI surgery with transvaginal mesh, please visit the firm's transvaginal mesh injury page at http://www.yourlawyer.com. Free case evaluations are also available by calling 1 800 LAW INFO (1-800-529-4636). Specific information on Gynecare Prolift and other Johnson & Johnson/Ethicon transvaginal mesh products can be accessed [here.
For more information regarding transvaginal mesh lawsuits and Parker Waichman LLP, please visit http://www.yourlawyer.com or call 1-800-LAW-INFO (1-800-529-4636).
Parker Waichman LLP
Gary Falkowitz, Managing Attorney