Long term outcomes of Boston Scientific and American Medical System midurethral slings (MUS).

Abstract

Introduction: As a result of the 2017 Federal court of Australia order to hospitals for the records of all transvaginal mesh procedures pertaining to Johnson and Johnson devices, an audit list of all mesh procedures performed at our tertiary health service was obtained. This list also included Boston Scientific (BS) and American Medical Systems (AMS) devices, which enabled a review of our health service's experience with these products. Objective(s): We aim to evaluate the complications and readmissions related to BS and AMS MUS surgery. Method(s): Retrospective audit of patient files were conducted to identify the patient demographic, procedures performed, short or long-term complications and readmissions. Ethics approval: QA/73022/MonH-2021-247433. Result(s): From 2005 to 2017, 120 BS and 206 AMS MUS were reviewed (median age, 55 and 51 years). At time of review, time since surgery range from 1.5 months to 16 years. Forty five% and 53% were BS or AMS sling only procedures with the remaining being concomitant prolapse surgeries. The surgery was most often performed on an afternoon operating list and the average admission length was 2 nights for BS and 1 night for AMS slings. The most common intra-operative complication was bladder perforation (BS: 10 patients, 8%; AMS 6 patients 3%). The most common post-operative complication was temporary voiding difficulty (BS: 20 patients, 17%; AMS 28 patients, 14%), of which 55% and 82% resolved with outpatient trial of void. Post-operative urinary tract infection was identified in 3 BS (2.5%) and 2 (1%) AMS patients. 3 BS (2.5%) and 3 AMS (1.5%) patients required blood transfusion post-operatively, and 2 (1%) patients required ICU admission (of which 1 case was with concomitant surgery). 6 (5%) BS and 6 (3%) AMS patients required further admission for sling loosening or division for voiding dysfunction, of which 58% were retropubic slings. 3 (2.5%) BS patient and 2 (1%) AMS required mesh excision for asymptomatic exposure. 2 (2%) BS and 3 (1.5%) AMS patients required total mesh excision for pain (time to surgery: median 25 months, range 1 to 112 months). 10 patients (3%) had repeat mid-urethral or fascial sling for recurrent SUI (time to surgery: median 20 months, range 7 to 99 months). 2 patients had Bulkamid procedure. Conclusion(s): There is a low rate of adverse events requiring repeat surgery. Re-operative rates are comparable with the literature. A 5% rate of bladder perforation recognised and corrected intra-operatively may be due to the learning curve in a teaching hospital.