In further response to the Safety Communication issued by the FDA in July 2011 regarding the use of vaginal mesh, the American College of Obstetricians and Gynecologists (The College) and the American Urogynecologic Society (AUGS) jointly state that the use of vaginal placement of synthetic mesh for the treatment of pelvic organ prolapse (POP) should be reserved for high-risk women for whom the benefits may outweigh the risks.1 The College and the AUGS also state that there is an urgent need for development of a national registry to track outcomes for all current and future patients who receive vaginal mesh implants.
The specific recommendations of The College and AUGS for use of vaginal mesh include the following1:
• Continued audit and review of outcomes and the creation of a surveillance registry for all current and future vaginal mesh implants.
• Outcome reporting for prolapsed surgical techniques defining success, complications, and total reoperation rates.
• Surgeon training for vaginal mesh placement specific to each device, including surgical experience with reconstructive surgery and thorough understanding of pelvic anatomy
• Rigorous comparative effectiveness trials of synthetic mesh and native tissue repair and long-term follow-up.
•Patient counseling about alternative native tissue repairs and the permanent nature of synthetic mesh, as well as discussion of the risks, benefits, and alternatives to the procedure.
• Limiting use of POP vaginal mesh repair to high-risk women for whom the benefit may justify the risk.
• Adoption of new mesh products and devices only with clinical long-term data demonstrating equal or improved safety and efficacy compared with existing products and devices.
Vaginal Mesh helpline lawyers are accepting cases on an individual basis for Transvaginal Mesh complications.
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