A Nationwide Analysis of Complications Associated With the Tension-Free Vaginal Tape (TVT) Procedure

Abstract

This study presents a series of all patients in Finland who underwent the tension-free vaginal tape (TVT) procedure for urinary stress incontinence before the end of 1999. Data regarding numbers of operations and complication rates were collected via questionnaires sent to the 38 hospitals whose staff were trained to perform TVT. The process for teaching this operation was carefully planned. First, urogynecologists from four of the five university hospitals in Finland underwent an extensive training program held at the fifth hospital, where this procedure was developed. Each doctor was approved to perform the procedure only after the main instructor visited his or her facility and observed the local team at work through several TVT operations. The university hospital-based urogynecologist was authorized to train local gynecologists after successfully performing 20 TVT operations with no major problems in 6 months of follow-up. Eventually, a TVT-certified urogynecologist was on the staff at all central and local hospitals in Finland. In all, there were 1455 TVT operations performed in Finland by the end of 1999. The overall rate of complications was 255 per 1000 procedures, including 206 per 1000 in university hospitals, 253 per 1000 in central hospitals, and 283 per 1000 in local hospitals. In the 1455 cases, there were five major complications that required laparotomy (case of arterial bleeding, two undetected bladder perforations, one vesicovaginal fistula, and one case of severe urinary retention) and 362 minor complications that necessitated some form of intervention. Intraoperative blood loss greater than 200 ml was noted in 27 patients (incidence 19/1000). Five cases resolved with minimal vaginal packing. Manual compression, intravenous tranexamic acid, and/or blood transfusion were required in three women. One woman underwent laparotomy for arterial bleeding behind the symphysis with removal of the TVT tape. Bladder perforation occurred in 56 women (38/1000). In 39 cases, the injury was recognized by cystotomy. The TVT needle was removed and reinserted in 36 of these; in 2 others interruption of the operation was required. One perforation was so near the urethral orifice that the TVT tape had to be removed. Nine perforations were noted after the TVT needle had been pulled through the bladder, requiring removal of the tape in two cases and partial removal (behind a midline cut) with reattachment of new tape in seven cases. In six women, the injury to the bladder was not recognized at the time of surgery. The TVT tape had to be partially or wholly removed in all of these patients. Injury of the epigastric vessel injury, which was treated with simple ligation, occurred in one patient. One woman sustained an injury of the obturator nerve that caused her to limp and led to adhesion formation at the Achilles tendon. Surgical evacuation was required for treatment of vagina hematoma in one patient, and the TVT procedure was interrupted in another patient because of a urethral lesion. Postoperatively, 34 women experienced complete urinary retention, with only 1 persisting beyond 3 months (incidence 23/1000). Minor voiding difficulties were reported by 111 patients (incidence 76/1000), 108 of whom resolved spontaneously or with conservative treatment. Two patients were treated by cutting the TVT tape at the midline, and one resolved after 4 months of repeated catheterization.