Parker Waichman lawsuit claims Indiana woman suffered serious injuries due to defective transvaginal mesh deviceJun 20, 2012 | Parker Waichman LLP
An Indiana woman claims she has suffered serious and lifelong injuries due to several defective transvaginal mesh surgical devices.
The woman is being respresented by the national law firm of Parker Waichman LLP, which represents other victims of transvaginal mesh injuries across the U.S. In this lawsuit, filed in U.S. District Court for the Southern District of West Virginia, the woman claims to have been implanted with Perigee System with IntePro, Apogee System with IntePro, and Mentor Aris Trans-Obturator Tape in March 2007 as a treatment for stress urinary incontinence (SUI) and pelvic organ prolapse (POP).
Like many other women across the country who've received these and other similar devices since they were first approved by the Food and Drug Administration, she has suffered countless and endless injuries and likely faces a lifetime of revision surgeries, pain, and discomfort due to their defects that cause myriad internal injuries. The lawsuit filed on June 8 names American Medical System, Inc., Analytic Biosurgical Solutions, Mentor Corporation, Johnson & Johnson, Ethicon, Inc., Coloplast A/S, Coloplast Corporation, Coloplast Manufacturing and other companies who either manufactured, designed, or marketed the devices as Defendants.
The lawsuit blames these devices and others considered transvaginal mesh products for causing abrasions to human tissues, harboring infections, and becomimg embedded in the body. These devices were never thoroughly tested for use in these surgeries, instead they were rushed through the FDA's 510k fast-track approval system that allows medical devices and other pharmaceuticals to be rushed to the U.S. market because they are similar in design to a previously-approved product. The lack of evidence led surgeons to believe they were safe and effective treatments to SUI and POP, a condition suffered by millions of women annually.
And as a result, thousands of women like the Indiana woman represented in the lawsuit have realized they were not as advertised and now face lifelong unexpected medical costs due to revision surgeries and treatment of conditions like infections caused by the defective medical devices and a lifetime of probable pain and discomfort. The lawsuit seeks damages for "significant mental and physical pain and suffering, permanent injury, permanent and substantial physical deformity and loss of bodily organs," according to a release announcing the lawsuit from the firm.
Last year, the Food and Drug Administration announced it had received 2,874 adverse event reports caused by defective transvaginal mesh products. At the time of that July 2011 announcment, the agency stated that complications caused by transvaginal mesh are "not rare" and later last year, the agency's Obstetrics and Gynecology Devices Advisory Panel recommended all transvaginal mesh devices be reclassified as those which carry a high risk of injury.
At least 33 makers of transvaginal mesh implants have been ordered by the FDA to conduct post-market safety data that could determine their overall fate on the market. Earlier this June, Ethicon Inc. (a division of Johnson & Johnson) announced it would stop marketing its Prolift, Prolife + M, TVT Secur and Prosima system transvaginal mesh devices.