ObGyn and Urogynecologic Societies Issue Joint Opinion on Transvaginal Mesh Submitted by: Ennis & Ennis, P.A.
(OPENPRESS) December 9, 2011 -- On November 21, 2011, the American College of Obstetricians and Gynecologists (The College) and the American Urogynecologic Society (AUGS) issued a Joint Committee Opinion opining that due to the concerns about the safety and efficacy of the use of transvaginal mesh to treat pelvic organ prolapse (POP), it should be reserved for high-risk women for whom the benefit may justify the risk. Ennis & Ennis, P.A. explains that the Joint Committee also stressed the importance and urgent need for the development of a national registry to track the outcomes for all current and future patients who receive transvaginal mesh devices. Attorney Holly Ennis commented, "We support the Joint Committee's recommendation and feel that it is imperative that doctors cut back on the number of these procedures that they perform so that more women do not have to suffer the way our clients have."
In 2001, the U.S. Food and Drug Administration approved of surgical mesh for the repair of POP under the 510(k) process, which allows the device to be cleared for market as long as they are "substantially equivalent" to existing products.
In July 2011, the FDA issued a Safety Communication identifying 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." Similarly, Cheryl, Iglesia, M.D., former chair of The College's Committee on Gynecologic Practice, said, "Unfortunately some women will continue having pain even after corrective surgery because complete removal of the mesh may not be possible … in many cases, POP can be successfully treated without mesh and women and their doctors really need to weigh the risks and benefits before deciding on a course of action."
Several transvaginal mesh device manufacturers, such as American Medical Systems, Inc., C.R. Bard, and Johnson & Johnson, are the subject of current 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.
If you or a loved one has suffered from any of these injuries caused by a transvaginal mesh device, contact Ennis & Ennis, P.A. for a free nationwide confidential consultation toll free at 1-800-856-6405 or complete an online case evaluation form at www.ennislaw.com.
Ennis & Ennis, P.A. is a nationwide law firm with offices in Ft. Lauderdale, Miami and Washington D.C. that concentrates its practice in mass torts and represents individuals against pharmaceutical companies and medical device makers.
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Ennis & Ennis, P.A.
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