Complications and untoward effects of the tension-free vaginal tape procedure

OBJECTIVE: To report our experience with our first 350 cases of tension-free vaginal tape (TVT), specifically assessing intraoperative complications, postoperative morbidity, and untoward effects of the procedure. METHODS: Although increased numbers of reports have documented the efficacy of the TVT procedure, there are minimal data about the incidence of complications and how they are managed. We performed a retrospective review of all patients undergoing the TVT procedure over a 4-year period to report intraoperative complications (bladder perforation and excessive bleeding), postoperative complications (de novo urge incontinence, voiding dysfunction, erosion, nerve injury; urinary retention, hematoma formation), and incidence of reoperation either for voiding dysfunction or for recurrent incontinence. RESULTS: A total of 350 patients were included in the study. Fifty-five percent (194) of women underwent the TVT procedure in conjunction with other vaginal surgery, and 45% (156) underwent the TVT alone. Seventy women (20%) had previous antiincontinence surgery. Intraoperative complications included 19 bladder perforations in 17 patients (4.9%) and three cases of significant bleeding (0.9%). Postoperatively, 17 women (4.9%) had voiding dysfunction and 42 (12%) required anticholinergic therapy beyond 6 weeks. Recurrent urinary tract infections developed in 38 (10.9%), erosion or poor healing in three (0.9%), hematoma in six (1.7%), and nerve injury in three (0.9%). Twenty-eight (8%) underwent urethral dilation in the postoperative period for varied amounts of voiding dysfunction. Of these, 82% were either improved or were cured. Six women (1.7%) underwent a takedown of the TVT procedure for continued voiding dysfunction, and two of these (33%) developed recurrent stress incontinence. To date, two patients (0.5%) have undergone another procedure for recurrent or persistent stress incontinence. CONCLUSION: The TVT procedure is efficacious for the correction of stress incontinence. Our data show that it is a safe procedure with an acceptable complication rate when performed by surgeons who have experience with retropubic and transvaginal antiincontinence procedures. (Obstet Gynecol 2003;101:929-32. (C) 2003 by The American College of Obstetricians and Gynecologists).