New York Woman Files Lawsuit Against Johnson & Johnson and American Medical Systems Alleging Transvaginal Mesh Implants Caused Permanent Damage
Lawsuit names Gynecare Prolift Total Pelvic Floor Repair System and Miniarc Precise Sling transvaginal mesh implants.Aug 10, 2012 | Parker Waichman LLP
Parker Waichman LLP, a national law firm dedicated to protecting victims injured by defective medical devices, has filed a lawsuit alleging that American Medical Systems’ Miniarc Precise Sling and the Gynecare Prolift Total Pelvic Floor Repair System manufactured by Johnson & Johnson’s Ethicon unit caused injuries in a New York woman. The suit was filed on July 12th in the U.S. District Court for the Southern District of West Virginia, Charleston Division (Case No. 2:12-cv-03132) 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).
According to the Complaint, the Plaintiff received the Gynecare Prolift Total Pelvic Floor Repair System and Miniarc Precise Sling in November 2007. The devices were implanted to correct her pelvic organ prolapse and stress urinary incontinence, but the lawsuit alleges that the mesh products caused the Plaintiff to suffer significant mental and physical pain and suffering, permanent injury, permanent and substantial physical deformity and the loss of her bodily organ system.
The lawsuit alleges that the Defendants were aware that the transvaginal mesh implants posed serious health risks, but chose to market them nonetheless. The suit claims that the mesh is defective because the material used reacts with the tissues of the body, which may lead to vaginal erosion, infection, extrusion, perforation, chronic pain and/or abscess.
In January, the U.S. Food and Drug Administration (FDA) asked 33 manufacturers, including Johnson & Johnson and American Medical Systems, to study the impact of transvaginal mesh on organ damage and other health concerns. The agency warned last summer that, contrary to their prior announcements, the complications associated with mesh implants are not rare.
In June, Johnson & Johnson said it would stop selling the Prolift, Prolift + M, TVT Secur and Prosima. The company has also asked the FDA to postpone the postmarket safety studies.
This is not the first that Johnson & Johnson has been criticized over the Prolift. The company began selling the mesh without FDA approval in 2005, under the justification that the device was similar enough to a previous product. The FDA asked Johnson & Johnson to stop selling the Prolift in 2007 when the agency discovered that the unapproved mesh was on the market. However, recent evidence indicates that J&J continued to sell the Prolift for nine months after the FDA ordered them to stop.
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