Surgical mesh is a medical device that is generally used to repair weakened or damaged tissue. In urogynecologic procedures, surgical mesh is permanently implanted to reinforce the weakened vaginal wall to repair pelvic organ prolapse or to support the urethra to treat urinary incontinence. Pelvic organ prolapse (POP) occurs when the tissues that hold the pelvic organs in place become weak or stretched. When POP happens, the organs bulge (prolapse) into the vagina and sometimes prolapse past the vaginal opening. More than one pelvic organ can prolapse at the same time.
Recent FDA releases have reported that use of Transvaginal Pelvic Mesh introduces unnecessary risks of serious side effects.
Facts about Transvaginal Pelvic Mesh:
- Initially, in 2008, the FDA called complications related to the use of mesh for such procedures rare.
- In July 2011, the FDA released an update stating that the complications associated with the mesh products are not rare.
- This report noted that “Mesh used in transvaginal POP repair introduces risks not present in traditional non-mesh surgery for POP repair. “
- The FDA also said that the Transvaginal Pelvic Mesh products used during POP surgery carried an increase risk of complications but “no evidence of greater clinical benefit such as improved quality of life.”
- These risks included severe pelvic pain, painful sexual intercourse or an inability to engage in sexual intercourse.
- The FDA announced that an outside panel of experts in obstetrics and gynecology will meet on Sept. 8-9, 2011, to discuss the safety and effectiveness of surgical mesh used to treat POP and stress urinary incontinence (SUI), a leakage of urine during physical activity.
- Several lawsuits have been filed around the nation alleging injury as a result of a Transvaginal Pelvic Mesh implant.
- The complaints often focus on the defendants’ failure to test and adequately warn of serious complications.
- On February 7, 2012, the Judicial Panel on Multi-District Litigation ordered that pelvic mesh cases filed against three major manufacturers, including American Medical Systems, Boston Scientific, and Johnson and Johnson, all be consolidated into MDLs in the Southern District of West Virginia before the Honorable Joseph Goodwin.
If you or a loved one have had surgery using the Transvaginal Pelvic Mesh, and suffered from erosion of mesh or mesh failure, have ongoing pelvic pain, dyspareunia, or chronic infections, find out how Johnson//Becker PLLC can help you. Fill out our case review form here on our website and submit it for a free consultation.