Complications associated with transobturator sling procedures.
This study aims to determine the complications associated with trans-obturator slings as reported to a national database. We required "MAUDE", a database that collects reports of complications associated with medical devices and which is maintained by the Food and Drug Administration. We searched for complications associated with three different, commercially available trans-obturator slings. We then tabulated the results by type of complication, by date of occurrence, and by type of sling. Between January 2004 and July 2005, 140 reports of 173 complications associated with trans-obturator tapes were reported to the MAUDE database. Previously unreported injuries, such as obturator nerve injuries, large blood losses (>or=600cc), and ischiorectal fossa abscesses, were documented. Serious complications occur with the trans-obturator tape systems, but the rates are unknown due to database limitations. The type of complication appears to differ between devices and this may reflect different implantation systems and different polypropylene mesh formulations. Improved tracking of device complications is necessary to maximize patient safety.
Boyles
Sarah Hamilton
SH
Urogynecology & Reconstructive Pelvic Surgery, OHSU Center of Excellence in Women's Health, L466, 3181 SW Sam Jackson Park Rd, Portland, OR 97239, USA. hamilsar@ohsu.edu
Edwards
Renee
R
Gregory
William
W
Clark
Amanda
A
D005260:Female; D006801:Humans; D011183:Postoperative Complications / Q000453:epidemiology*; D053825:Suburethral Slings; D014549:Urinary Incontinence / Q000601:surgery*