Mississippi Woman's Lawsuit Alleges Serious Injury Due to Transvaginal Mesh Products Manufactured by American Medical Systems, Johnson & Johnson
The Plaintiff suffered adverse health consequences from American Medical Systems' Elevate Anterior and Apical System with Intepro Lite, Elevate Apical and Posterior System with Intepro Lite and Johnson & Johnson's Gynecare TVT System.Aug 30, 2012 | Parker Waichman LLP
Parker Waichman LLP, a national law firm dedicated to protecting the rights of victims injured by defective medical devices, has filed a lawsuit on behalf of a woman who was allegedly injured by three transvaginal mesh implants. The suit was filed on July 12th in the U.S. District Court for the Southern District of West Virginia, Charleston Division (Case 2:12-cv-03153) where it is one of many cases pending in the multidistrict litigation as part of the In Re: Ethicon, Inc. Pelvic Repair System Products Liability Litigation (MDL No. 2327). Ethicon, Inc., Ethicon Women’s Health and Urology, Gynecare, Johnson & Johnson and American medical Systems, Inc. have been named as Defendants.
According to the Complaint, the Plaintiff was implanted with the above mentioned devices in September 2009. The devices were implanted to correct her pelvic organ prolapse (POP) and stress urinary incontinence (SUI), the two conditions for which the products were approved. Pelvic organ prolapse is when the muscles of the pelvis are weakened, causing the organs to slip out of place and bulge into the vagina. Stress urinary incontinence is a condition that causes the involuntary release of urine during activities such as laughing or sneezing. Transvaginal mesh products are used to treat POP and SUI by providing additional support to the walls of the pelvis.
According to the lawsuits, however, the risks of the mesh devices far exceed any benefits. Allegedly, the material used in the mesh is not inert, meaning that it can react with the tissues of the body. As a result, the lawsuit claims that the products pose an unreasonable risk of vaginal erosion, infection, extrusion, perforation, chronic pain and/or abscess. The lawsuit is alleging significant mental and physical pain and suffering, permanent injury and permanent and substantial physical deformity on behalf of the Plaintiff.
The lawsuit also states that the devices were approved without adequate safety tests because they were approved through 510(k), a route that excuses the need for clinical testing if the manufacturer can show that the device is “substantially equivalent” to a previously approved product. Last September, an advisory panel to the U.S. Food and Drug Administration (FDA) recommended that transvaginal mesh be reclassified from “moderate” to “high” risk, a designation that would bar the devices from being approved through 510(k).
Last July, the FDA warned that complications associated with transvaginal mesh are not uncommon as once thought. The agency said that the devices may pose additional risks with no clear evidence of benefits compared to non-mesh methods of treating POP. In January, the FDA asked 33 manufacturers to conduct post market safety studies.
In June, Johnson & Johnson said they would no longer be selling the TVT Secur, Prolift, Prolift + M, and Prosima transvaginal mesh systems. The products are expected to be off the shelves by the first quarter of 2013.
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 yourlawyer.com. Free case evaluations are also available by calling 1-800-YOURLAWYER (1-800-968-7529).
Contact: Parker Waichman LLP
Gary Falkowitz, Managing Attorney