FDA (April 2019) ordered manufacturers of synthetic mesh for the treatment of Pelvic Organ Prolapse (POP) to discontinue sale and distribution in the US. ACOG responded with a Practice Advisory, which emphasizes that the FDA order applies only to mesh placed vaginally for POP and does not apply to (1) transvaginal mesh for SUI or (2) sacrocolpopexy (abdominal placement). POP is considered ‘benign’, but symptoms can seriously impact quality of life, affecting defecatory, voiding and sexual function.
Posterior Wall Prolapse
Anterior Wall Prolapse
It is imperative that local hospitals and health systems establish and strictly enforce robust processes to both/credential and audit surgeons with specific expertise, experience, training and skill to perform these procedures. AUGS has developed, and published credentialing guidelines for transvaginal mesh surgery for pelvic organ prolapse and sacrocolpopexy for the treatment of pelvic organ prolapse.
ACOG Practice Bulletin 214: Pelvic organ prolapse
AUGS: Update on FDA Announcement on Transvaginal Mesh for Prolapse
FDA takes action to protect women’s health, orders manufacturers of surgical mesh intended for transvaginal repair of pelvic organ prolapse to stop selling all devices
Cochrane Review: Surgery for women with anterior compartment prolapse. Cochrane Database of Systematic Reviews
Incidence and Management of graft erosion, wound granulation, and dyspareunia following vaginal prolapse repair with graft materials: a systemic review. Systematic Review Group of the Society of Gynecologic Surgeons.
AUGS Position Statement on Restriction of Surgical Options for Pelvic Floor Disorders, March 26,2013
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