The suit states that the mesh is defective in the sense that it can harbor infection, migrate from location of implantation, abrade tissue, become embedded and is overall inappropriately designed for use in the female pelvis.
New York, NewYork (PRWEB) July 02, 2012
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 Virginia woman who was implanted with the Gynecare Prolift Posterior Pelvic Floor Repair System and suffered serious injuries, allegedly due to the defective device. The suit was filed on June 8th in the U.S. District Court for the District of New Jersey (Case No. 3:12-cv-03582-FLW-TJB). The lawsuit names Ethicon, Inc., Ethicon Women’s Health and Urology and parent company Johnson & Johnson as Defendants.
According to the complaint, the Plaintiff is a woman from Manassas, Virginia who received the Gynecare Prolift Posterior Pelvic Floor Repair System in January 2007. The device was implanted to treat pelvic organ prolapse and stress urinary incontinence, conditions for which the mesh is approved. The lawsuit alleges significant mental and physical pain and suffering, permanent injury, permanent and substantial physical deformity and loss of bodily organ system. The suit also claims that the Plaintiff has undergone or will undergo corrective surgeries.
The lawsuit claims that the Defendants were aware that the transvaginal mesh caused defects, but marketed the device nonetheless. According to the complaint, the material used in the mesh is not inert, and can therefore react with the tissues in the body. Among other things, the suit states that the mesh is defective in the sense that it can harbor infection, migrate from location of implantation, abrade tissue, become embedded and is overall inappropriately designed for use in the female pelvis. As a result, the product allegedly causes:
- vaginal erosion
- chronic pain and/or abscess
The suit notes that transvaginal mesh implants were approved through the 510(k) route. This process allows devices to be sold with little to no clinical testing, so long as it is deemed “substantially equivalent” to a previous device. Last September, the U.S. Food and Drug Administration’s (FDA’s) Obstetrics and Gynecology Devices Advisory Panel said that transvaginal mesh should be reclassified as “high-risk”, which would prevent the devices from going through 510(k). In January, the agency said it was considering the Panel’s recommendation, and asked 33 manufacturers to conduct post market studies to analyze the impact of the meshes on organ damage and other relevant health issues.
Last July, the FDA warned that, contrary to previous notions, complications associated with transvaginal mesh are “not rare.” The agency also stated that there is little proof demonstrating meshes’ superiority over non-mesh methods, adding that the devices may pose additional risks.
Johnson & Johnson and its subsidiary Ethicon recently decided to stop selling the Prolift, along with three other types of transvaginal mesh products. According to Bloomberg Businessweek, the Prolift, Prolift + M, TVT Secur and Prosima mesh systems will be off the market by first quarter of 2013. The company has asked the FDA for permission to stop “commercializing” the products and requested 120 days to inform consumers and healthcare professionals.
In the past, Johnson & Johnson had issues concerning the marketing of Prolift. According to Bloomberg, the Prolift was launched in 2005, but the FDA was unaware of the device until 2007. The company said it did not need to have the device approved by the agency since it was similar to the Gynecare Gynemesh, which was already on the market. The FDA, however, did not agree. The agency did not approve the Prolift until May 2008.
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.
Free case evaluations are also available by calling 1 800 LAW INFO (1-800-529-4636).
For more information regarding transvaginal mesh lawsuits and Parker Waichman LLP, please visit: yourlawyer.com or call 1-800-LAW-INFO (1-800-529-4636).
Parker Waichman LLP
Gary Falkowitz, Managing Attorney