Size Does Matter: Long-term Efficacy and Safety of Minimesh in Transvaginal Pelvic Organ Prolapse Repair

Abstract Objectives: The Food and Drug Administration banned the use of transvaginal mesh for pelvic organ prolapse (POP) repair due to safety and efficacy concerns. The present study aimed to evaluate the safety and efficacy of a novel lightweight minimesh (SERATOM ® MN) for transvaginal repair of significant primary or recurrent POP. Materials and Methods: A cohort study of 134 consecutive patients (mean age: 61.7 ± 9.4 years, range: 46–88) who underwent transvaginal minimesh repair (SERATOM ® MN) for Stage III or IV POP was retrospectively analyzed. At 10 years postoperatively, a telephone survey was conducted to assess long-term outcomes. The mean postoperative follow-up was 9.8 ± 0.45 years (range: 9.4–10.9 years). A comparison was made between 99 (73.9%) patients who underwent primary mesh-assisted POP repair versus 35 (26.1%) patients who underwent mesh-assisted surgery for recurrent POP. Primary outcomes comprised postoperative complications, POP recurrence rate, and subjective long-term satisfaction. Results: The mean duration of surgery and blood loss was 30.8 min and 32.4 ml, respectively. Most patients (98.5%) were discharged on the day of surgery or the day after. There were no significant intra- or early postoperative complications, except for one case of postoperative perineal hematoma that was managed conservatively. Of the initial 134 patients, 110 (82%) were available for long-term follow-up. There were no mesh erosions. De novo dyspareunia occurred in 6.4%. Rates of recurrent POP repair were similar among patients who had mesh-assisted repair after previous pelvic surgery (23.3%) and those who had primary mesh-assisted repair (15%). Conclusion: Transvaginal SERATOM ® MN minimesh is a safe, effective, and durable surgical option for significant POP repair.