The use of implants in female pelvic floor reconstructive surgery. Short and long term efficacy and safety

Abstract: Pelvic floor reconstructive surgery (PFRS) has suffered from high recurrence rates ever since its birth. Implants were thus quickly employed, initially autologous grafts and allografts. Technological development led to the manufacturing of synthetic implants that were believed to provide the support needed during urinary incontinence and pelvic organ prolapse (POP) surgery. However, due to a surge of reported complications, the place of implants in PFRS remains the object of major debate. Evaluation of the long-term performance of the use of implants is critical, while efforts are made for the development of new techniques, like the single-incision slings (SIS), and new materials, like the porcine small intestinal submucosa graft (PSG).Study I is a three-year follow-up of a multicenter randomized controlled trial comparing the SIS Ajust® with conventional mid-urethral slings (MUS) for the treatment of stress urinary incontinence. Based on patient-reported outcomes, Ajust® is found to be equally effective and safe with MUS.Studies II and III utilize a register-based cohort of women to evaluate the long-term performance of MUS for the treatment of stress urinary incontinence. Ten years after surgery, MUS demonstrate good subjective results with a small decline in efficacy and acceptable complications profile. The retropubic approach displays higher long-term efficacy than the transobturator with no difference regarding safety. No difference is found between the two techniques for the application of MUS concerning dyspareunia or pelvic pain in a ten-year perspective.Study IV is a retrospective study examining the short-term complications and recurrence rates of POP surgery augmented with PSG. The relatively high recurrence rates do not suggest a clear benefit from PSG use, while pain and urinary tract symptoms hold a central position in the complications profile of PSG-augmented POP surgery.In conclusion, Ajust® appears to be equally effective and safe as MUS in a three-year setting. Retropubic slings show higher efficacy than transobturator at ten years while both techniques present good results with similar and acceptable profiles regarding complications, pain and sexual function. Finally, there are no clear benefits from the use of PSG in POP surgery.