Fort Worth, Texas (PRWEB) December 12, 2011
Parker McDonald, P.C.reports on the recent Joint Committee Opinion released by The American College of Obstetricians and Gynecologists (ACOG) and the American Urogynecologic Society (AUGS) regarding the use of transvaginal mesh for the treatment of pelvic organ prolapse (POP). The Joint Committee recommended that the use of synthetic transvaginal mesh only be used for “high-risk women for whom the benefit may justify the risk.” Additionally, the committee called for the development of a national registry in order to track all patients who are implanted with transvaginal mesh.
In July of this year, the Food and Drug Administration (FDA) issued a warning for all patients who have received transvaginal surgical mesh.This warning came after the FDA identified 2,874 Medical Device Reports from January 1, 2008 to December 31, 2010. From these reports, 1,503 were associated with POP, and 1,371 were associated with stress urinary incontinence (SUI) repairs. AUGS President Matthew D. Barber, M.D., reported that “The incidence of POP continues to grow…More than 350,000 women undergo surgery for this condition in the US each year.”
Notably, the Obstetrics and Gynecology Devices Panel convened in September of this year regarding the safety and effectiveness of transvaginal mesh for POP and SUI. The FDA presented information which concluded that vaginal mesh for POP repair poses risks that are unique to mesh. These risks include vaginal mesh erosion, severe pain, organ perforation, and urinary problems. Corrective surgery is often required; however, former chair of ACOG's Committee on Gynecologic Practice, Cheryl B. Iglesia, M.D. explained that “Unfortunately, some women will continue having pain even after corrective surgery because complete removal of the mesh may not be possible.”
Transvaginal Mesh is currently a Class II medical device, meaning no clinical trials were required prior to market availability. At the September meeting, the FDA recommended these devices be reclassified to Class III, which would require pre-market approval.
The attorneys at Parker McDonald have decades of experience representing victims of defective drugs and medical devices. Parker McDonald is currently representing patients who have received a transvaginal mesh implant. If you or a loved one has undergone a transvaginal mesh surgical procedure, you may have a claim against the manufacturer, contact the attorneys at Parker McDonald today.
About Parker McDonald
Parker McDonald, P.C. offers comprehensive legal services for clients whose personal, business or property rights have been adversely affected. Built on years of trial experience, Parker McDonald lawyers are dedicated to a tradition of personal service and timely delivery of outstanding results. Parker McDonald has offices in Bedford, Fort Worth, Houston, Austin, and San Antonio.