"It’s a long learning curve, and you have to continue with an adequate volume and know how to do a proper dissection," he said. "You need about 25 to 50 cases to have a level of expertise, which is consistent with the surgical literature. We know that’s true of total laparoscopic hysterectomy as well."
In its joint communication, ACOG and AUGS recommended that surgeons placing vaginal mesh undergo training specific to each device, have experience with reconstructive surgical procedures, and have a thorough understanding of pelvic anatomy.
Based on the current limited data, the two groups said there is a "small, but significant group" of patients who experience permanent or life-altering sequelae as result of the transvaginal mesh placement.
In its updated July 2011 safety report, however, the Food and Drug Administration said that serious complications related to POP transvaginal mesh repair "are not rare," and that the procedure "may expose patients to greater risk" than traditional nonmesh repair.
The FDA’s Obstetrics and Gynecology Devices Panel subsequently called for postmarket studies to evaluate current products, and recommended that new vaginal mesh products for POP repair not be approved through the less rigorous Class II 501(k) process, but reclassified as Class III to ensure that premarket clinical studies are conducted.
Law firms are aggressively litigating cases against transvaginal mesh manufacturers, with commercials soliciting new clients airing on local television in Las Vegas throughout the AAGL meeting. American Medical Systems, which also manufactures the Apogee and Perigee mesh products, is one of several companies to be named in at least six ongoing multidistrict litigations.
Dr. Stanford said the current data are reassuring, and that there were no significant differences between women with or without uterine preservation in quality of life scores on the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire-12 (PISQ-12), Pelvic Floor Incontinence Questionnaire-7 (PFIQ-7), and Pelvic Floor Distress Inventory (PFDI).
Dr. Stanford disclosed a research grant from study sponsor American Medical Systems, maker of the Elevate system.