Are meshes dangerous for pelvic floor repair ? Why FDA recommendations are unsatisfactory.

Are meshes dangerous for pelvic floor repair ? Why FDA recommendations are unsatisfactory.

Are meshes dangerous for pelvic floor repair ? Why FDA recommendations are insufficient. SUMMARY OF RECOMMENDATIONS (for full data see article ) click to read full article For surgeons who do not currently perform transvaginal placement of surgical mesh for pelvic organ prolapse, but wish to begin performing this procedure: a. General knowledge should be documented either by completing a fellowship training program in Urogynecology, Female Pelvic Medicine and Reconstructive Surgery, or Female Urology or by completing adequate CME in pelvic anatomy and reconstructive pelvic surgery. b. Specific knowledge for a particular procedure should be obtained c. Skill may be documented by surgeons who have completed a Urogynecology, Female Pelvic Medicine and Reconstructive Surgery or Female Urology fellowship program via cases lists showing experience with transvaginal placement of surgical mesh for pelvic organ prolapse. Surgeons who do not have documentation of prior training with a specific transvaginal mesh prolapse procedure should be proctored on no fewer than 5 procedures or as many as is necessary to demonstrate that they can independently perform the specific procedure. d. Experience in treating women with pelvic floor disorders should be documented either by completing a fellowship training program in Urogynecology, Female Pelvic Medicine and Reconstructive Surgery or Female Urology or by demonstrating that they offer a full spectrum of surgical options for pelvic floor disorders and that surgery for pelvic floor disorders represents >50% of their surgical practice including a minimum of 30 surgical cases for pelvic organ prolapse annually. e. Demonstrate experience and privileges in nonmesh vaginal repair of prolapse including anterior colporrhaphy, posterior colporrhaphy, and vaginal colpopexy (eg, uterosacral or sacrospinous...

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