(PRWEB) September 03, 2011
Ennis & Ennis, P.A. reports that the U.S. Food and Drug Administration (FDA) is considering regulatory changes to the classification of surgical mesh devices used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). According to the FDA Executive Summary released yesterday, the FDA believes that “vaginal placement of surgical mesh for pelvic organ prolapse repair inherently introduces risks of complications that are unique to the mesh itself.” Next week the Obstetrics and Gynecology Devices Advisory Committee will discuss the risks associated with vaginal mesh used for POP repair and determine whether there is assurance of the safety of vaginally placed mesh for POP repair. The committee will also discuss the need for premarket and/or postmarket clinical data on these devices.
According to a Safety Communication dated July 13, 2011, the FDA has already identified surgical mesh placed transvaginally for POP repair as an “area of continuing serious concern”, as it is unclear that “transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk.”
Currently the mesh used for transvaginal POP repair is classified under Class II, which allows the devices to be cleared for market under the FDA’s controversial 510(k) approval process, as long as they are “substantially equivalent” to existing products. In contrast, Class III medical devices undergo the most stringent of testing prior to FDA market approval. The FDA reported that from 1992-2010, it has cleared 168 surgical mesh devices with urogynecologic indications under the 510(k) process; 83 with an SUI indication, 63 with a POP indication and 22 with both.
Several transvaginal mesh device manufacturers, such as American Medical Systems, Inc., C.R. Bard, and Johnson & Johnson, are the subject of recent lawsuits where the mesh devices have caused vaginal mesh erosion (also called exposure, extrusion or protrusion), pain, painful sexual intercourse (also called dyspareunia), infection, urinary problems, bleeding, organ perforation, recurrent prolapse, neuro-muscular problems, vaginal scarring/shrinkage and emotional problems.
While awaiting the outcome of this committee meeting, Attorney Holly Ennis recommends that all transvaginal mesh device patients with symptoms first seek medical attention. Then they should report the incident to the FDA by filing a voluntary report at http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm. Lastly, patients should seek the opinion of an experienced lawyer to explore their legal rights.
Ennis & Ennis, P.A. is offering FREE nationwide confidential consultations to all women who have a transvaginal mesh implant by calling toll free 1-800-856-6405 or by going to http://www.ennislaw.com and completing an online case evaluation form.
Ennis & Ennis, P.A. is a nationwide law firm with offices in Ft. Lauderdale, Miami and Washington D.C. Ennis & Ennis, P.A. specializes in mass torts and represents individuals against pharmaceutical companies worldwide as well as medical device makers.
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