New York Woman Files Lawsuit Against American Medical Systems Claiming that the IntePro Transvaginal Mesh is Allegedly Responsible for Her Painful Injuries
The FDA has warned that transvaginal mesh may pose health risks while not having any clear benefits over non-mesh methods in treating stress urinary incontinence and pelvic organ prolapse.Jul 27, 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 New York woman who claims that her IntePro Large Pore Polypropelene Y-Sling caused adverse effects and bodily harm. Filed on July 12th in the U.S. District Court for the Southern District of West Virginia, Charleston Division (Case 2:12-cv-03110), the case is part of the multidistrict litigation as part of the In Re: American Medical Systems, Inc., Pelvic Repair System Products Liability Litigation (MDL No. 2325). American Medical Systems, Inc., has been named as the Defendant.
According to the Complaint, the Plaintiff, a woman from Monroe County, New York, was implanted with the IntePro Large Pore Polypropelene Y-Sling in September 2008. She received the transvaginal mesh in order to correct her stress urinary incontinence and pelvic organ prolapse, conditions for which the mesh was approved, marketed and sold. The lawsuit alleges that the Plaintiff suffered a number of health consequences as a direct result of the device, including significant mental and physical pain and suffering, permanent injury, permanent and substantial physical deformity and loss of her bodily organ system. The suit states that the transvaginal mesh is defective because it reacts with the tissues in the body. Among other things, this lawsuit alleges that this increases the risk of vaginal erosion, infection, extrusion, perforation, chronic pain and/or abscess.
Pelvic organ prolapse is a condition where the weakened muscles in the pelvis are unable to support its organs, causing them to bulge out of place and into the vagina. Stress urinary incontinence, on the other hand, is the involuntary release of urine during activities such as laughing or sneezing. These conditions, which are more common after childbirth, are supposed to be corrected with a transvaginal mesh implant. But according to the lawsuit, the risks associated with the use of this device outweigh the benefits.
Last July, the U.S. Food and Drug Administration (FDA) warned that public that transvaginal mesh may carry additional health risks while having little benefit over non-mesh methods. The agency’s announcement was based on 2,874 reports of complications received from 2008 to 2010. Common problems included mesh erosion, pain during sexual intercourse, urinary problems and organ perforation. Recurrent prolapse, emotional problems, neuro-muscular problems and vaginal scarring/shrinkage were also reported.
Last month, Johnson & Johnson said it would no longer sell four types of transvaginal mesh, including the Prolift, Prolift + M, TVT Secur and Prosima.
In January, the FDA asked 33 manufacturers, including American Medical Systems, C.R. Bard and Johnson & Johnson, to conduct post-market safety studies of transvaginal mesh.
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