Efficacy and safety of pelvic organ prolapse surgery with porcine small intestinal submucosa graft implantation

Vasileios Alexandridis,Pia Teleman,Martin Rudnicki

doi:10.1016/j.ejogrb.2021.10.011

Abstract

ObjectiveThe ideal implant material for the surgical repair of pelvic organ prolapse in women is yet to be found. This retrospective study aims to evaluate a porcine small intestinal submucosa (SIS) graft (Surgisis™). Study designWe reviewed the medical records of women that were operated upon for pelvic organ prolapse using implantation of SIS graft and we examined the short-term complications and recurrence rates. ResultsA total of 155 surgical procedures were reviewed. SIS graft was placed in the anterior, posterior and middle compartments in 93 (60%), 71 (45.8%) and 13 (8.4%) cases, respectively. At three-month follow-up, 22.6% of anterior graft repairs displayed anatomical recurrence (POP-Q stage ≥ 2), compared to 4.8% of posterior and none of the middle compartment graft repairs. During the three postoperative months, 56% of the women were recorded with complications, mostly urinary retention (19%) and pain (12%). The incidence of grade III complications was 5.3%. Persistent complications at three months were observed in 28% of all cases. Logistic regression analysis showed that previous prolapse surgery at the same compartment was a significant predictor for recurrence of prolapse after SIS graft application, whereas lower age, smoking and longer duration of surgery were significant predictors for the development of complications. Younger women had higher risk of developing pain postoperatively. ConclusionPain and urinary tract symptoms hold a central position in the complications profile of SIS graft-augmented prolapse surgery. The relatively high recurrence rates do not suggest a clear benefit from SIS graft use.

Highlights

The use of implants in pelvic organ prolapse (POP) surgery has long been debated, with little consensus regarding their place in women’s modern health care
No patients had been operated with any other type of mesh or graft and no concurrent incontinence surgery was performed in any case
In 134 cases (86.5%) small intestinal submucosa (SIS) graft was applied in one compartment, in 20 cases (12.9%) in two compartments and in one case (0.6%) SIS graft was applied in all three compartments

Summary

Introduction

The use of implants in pelvic organ prolapse (POP) surgery has long been debated, with little consensus regarding their place in women’s modern health care. Many devices and materials have been evaluated [1] with sometimes encouraging preclinical findings but often disappointing clinical results [2]. Xenografts are thought to address existing challenges by striking the right balance between material integration and endurance [5]. Previous limited clinical studies have not been able to show consistent advantages of xenograft use [6,7,8] but there is evidence of significant diversity among the different types of xenografts, precluding their treatment as a homogenous group [9]

Methods

Results

Conclusion