(PRWEB) June 19, 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 woman who suffered injuries after receiving transvaginal mesh implants. The suit alleges that these products created an unreasonable risk and directly caused her injuries. The lawsuit was filed on June 8th in the U.S. District Court for the Southern District of West Virginia, Charleston Division (Case No. 2:12-cv-01954) and 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 designed, manufactured or marketed the products as Defendants.
According to the Complaint, the Plaintiff, a woman from Columbus, Indiana, was implanted with the Perigee System with IntePro, Apogee System with IntePro and Mentor Aris Trans-Obturator Tape in March 2007 to treat her stress urinary incontinence (SUI) and pelvic organ prolapse (POP), conditions for which the devices are intended and approved. As a result of these defective products, the lawsuit alleges, she has suffered from significant mental and physical pain and suffering, permanent injury, permanent and substantial physical deformity and loss of bodily organs. The suit also states that the Plaintiff has undergone or will undergo one or more corrective surgeries.
The lawsuit also points out that transvaginal mesh devices were approved via the 510(k) process, meaning that they did not require any sort of formal review for approval. The suit thus alleges that transvaginal mesh implants pose dangerous and unreasonable risks due to numerous defects. The complaint further alleges, among other things, that the material used reacts with and abrades human tissues, harbors infections, becomes embedded and is inappropriately designed for use in the female pelvis. The defendants are accused of misrepresenting the products as safe and effective.
In 2008, the U.S. Food and Drug Administration (FDA) issued a Public Health Notification in response to over 1,000 reports of complications linked to transvaginal mesh, noting that the side effects appeared serious, but rare. Reports included erosion, pain, infection, bleeding, pain during intercourse, organ perforation during placement and urinary problems. Last July, the FDA announced that it had received an additional 2,874 adverse reports associated with the devices. This time, the agency stated that the complications are “not rare,” pointing out that it is unclear whether or not transvaginal mesh provides any benefit over non-mesh procedures and may expose patients to greater risks. [http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm
Last September, the FDA's Obstetrics and Gynecology Devices Advisory Panel recommended that transvaginal mesh implants be reclassified from moderate risk to high risk. The new designation would eliminate the product’s ability to go through the 510(k) process and mandate clinical evidence to supports its safety and efficacy. In January, the FDA asked 33 manufacturers to conduct post market studies assessing the impact of transvaginal mesh on organ damage and other related issues. [fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/UroGynSurgicalMesh/default.htm]
Earlier this month, Johnson & Johnson announced that it would stop selling four transvaginal mesh products, including the Prolift, Prolife + M, TVT Secur and Prosima systems. According to Bloomberg, the devices are expected to be off the market by the first quarter of 2013. The company has also asked the FDA for 120 days to inform its consumers and healthcare professionals about the decision. [bloomberg.com/news/2012-06-04/j-j-tells-judge-it-will-stop-selling-vaginal-mesh-implant.html]
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 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).
Contact: Parker Waichman LLP
Gary Falkowitz, Managing Attorney