Watchdog Groups Call for a Transvaginal Mesh Recall Citing the Treatment for Pelvic Organ Prolapse Needlessly Exposes Patients to Serious Complications
Online PR News – 29-August-2011 – – Ennis & Ennis, P.A. strongly supports consumer advocacy group’s, Public Citizen, petition dated August 25, 2011 to the U.S. Food and Drug Administration (FDA) urging a recall of transvaginal mesh devices. The petition requests a ban on the marketing of the mesh products, an order to all manufacturers to recall the products, and a requirement that all future transvaginal mesh devices be classified as Class III devices (http://www.citizen.org/documents/Petition_to_Ban_Surgical_Mesh_for_Transvaginal_Repair_of_Pelvic_Organ_Prolapse.pdf).
While the FDA initially approved of transvaginal mesh devices to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI), they issued an updated advisory on July 13, 2011 reporting that there is little evidence that the mesh implants improve these conditions and that the devices actually expose the patients to a number of risks and complications that are not rare. Additionally, the transvaginal mesh devices are currently 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. Public Citizen’s petition noted that these mesh products “have been cleared for marketing based solely on in vitro bench and/or animal testing to confirm that engineering specifications are met.” In contrast, a Class III classification requires premarket approval, which is the most stringent type of device marketing application required by the FDA, including mandatory testing in well-designed studies with human subjects to assess whether they are safe and effective.
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.
Ennis & Ennis 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 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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