New York, New York (PRWEB) May 24, 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 Colorado woman allegedly injured by transvaginal mesh products manufactured by American Medical Systems, Inc. The suit was filed on May 21, 2012 in the U.S. District Court for the Northern District of California (Case No. 3:12-cv-02613-RS).
According to the complaint, the Plaintiff, a Pueblo County, Colorado resident, received American Medical Systems' Perigee System with InteXen LP and the Apogee Systen with InteXen LP on May 19, 2010 to treat her pelvic organ prolapse and stress urinary incontinence. As a result, and as alleged in the Complaint, she has sustained significant mental and physical pain and suffering, permanent injury, permanent and substantial physical deformity, loss of bodily organ systems, and has undergone or will undergo corrective surgery or surgeries. According to Parker Waichman LLP, American Medical Systems received approval for their transvaginal mesh products through the U.S. Food and Drug Administration’s (FDA) 510(k) process, which allows devices to be sold without any formal review, provided that the product is deemed “substantially equivalent” to similar devices marketed before May 28, 1976.
The lawsuit alleges that the manufacturer knew or should have known that the transvaginal mesh products could cause complications such as vaginal erosion, infection, extrusion, perforation, chronic pain and/or abscess prior to marketing the devices to the public.
Dozens of transvaginal mesh lawsuits against American Medical Systems have already been consolidated in a multidistrict litigation (MDL No. 2325) in the U.S. District Court for the Southern District of West Virginia. Proceedings will take place before Judge Joseph R. Goodwin.
Between January 1, 2008 and December 31, 2010, the FDA received 2,874 reports of injuries associated with transvaginal mesh, including vaginal erosion, pain, infection, bleeding, painful sexual intercourse, urinary problems and organ perforation. On July 13, 2011, the FDA announced that such complications associated with transvaginal mesh products are not rare. Furthermore, the agency stated that it is uncertain whether such devices provide any benefit over traditional non-mesh procedures used to treat pelvic organ prolapse and stress urinary incontinence, and may actually pose greater risks. The announcement amends the agency’s previous position in October 2008, when it stated that complications were potentially serious, but uncommon. [fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm]
Last September, the FDA’s Obsterics and Gynecology Devices Advisory Panel recommended that transvaginal mesh products be reclassified from moderate risk to high risk. Such a designation would prevent the devices from going through the 510(k) process and require formal clinical testing as a prerequisite for approval.
In January 2012, the FDA ordered 33 manufacturers, including American Medical Systems, Johnson & Johnson and Boston Scientific, to conduct post-market studies assessing the impact of transvaginal mesh products on organ damage and other associated problems. [fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/UroGynSurgicalMesh/default.htm]
Parker Waichman LLP continues to offer free lawsuit consultations to victims of transvaginal mesh. 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 http://www.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: http://www.yourlawyer.com or call 1-800-LAW-INFO (1-800-529-4636).
Contact: Parker Waichman LLP
Gary P. Falkowitz