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Prevention of complications related to the use of prosthetic meshes in prolapse surgery: guidelines for clinical practice

https://doi.org/10.1016/j.ejogrb.2012.09.001Get rights and content

Abstract

The objective of the study was to provide guidelines for clinical practice from the French College of Obstetrics and Gynecology (CNGOF), based on the best evidence available, concerning adverse events related to surgical procedures involving the use of prosthetic meshes. French and English-language articles from Medline, PubMed, and the Cochrane Database were searched, using key words (mesh; pelvic organ prolapse; cystocele; rectocele; uterine prolapse; complications; adverse event; sacral colpopexy; extrusion; infection).

As with any surgery, recommendations include perioperative smoking cessation (Expert opinion) and compliance with the prevention of nosocomial infections (regulatory recommendation). There is no evidence to recommend routine local or systemic estrogen therapy before or after prolapse surgery using mesh, regardless of the surgical approach (Grade C). Antibiotic prophylaxis is recommended, regardless of the approach (Expert opinion). It is recommended to check for pre-operative urinary tract infection and treat it (Expert opinion). The first procedure should be undertaken under the guidance of a surgeon experienced in the relevant technique (Grade C). It is recommended not to place a non-absorbable synthetic mesh into the rectovaginal septum when a rectal injury occurs (Expert opinion). Placement of a non-absorbable synthetic mesh into the vesicovaginal septum may be considered after suturing of a bladder injury if the suture is considered to be satisfactory (Expert opinion).

If a synthetic mesh is placed by vaginal route, it is recommended to use a macroporous polypropylene monofilament mesh (Grade B). It is recommended not to use polyester mesh for vaginal surgery (Grade B). It is permissible to perform hysterectomy associated with the placement of a non-absorbable synthetic mesh placed by the vaginal route but this is not routinely recommended (Expert opinion). It is recommended to minimize the extent of the colpectomy (Expert opinion).

The laparoscopic approach is recommended for sacral colpopexy (Expert opinion). It is recommended not to place and suture meshes by the vaginal route when a sacral colpopexy is performed (Grade B). It is recommended not to use silicone-coated polyester, porcine dermis, fascia lata, and polytetrafluoroethylene meshes (Grade B). It is recommended to use polyester (without silicone coating) or polypropylene meshes (Grade C). Suture of the meshes to the promontory can be performed using thread/needle or tacks (Grade C). Peritonization is recommended to cover the meshes (Grade C). If hysterectomy is required, it is recommended to perform a subtotal hysterectomy (Expert opinion).

Implementation of this guideline should decrease the prevalence of complications related to surgical procedures involving the use of prosthetic meshes.

Introduction

Genital prolapse surgery is accompanied by a significant improvement in quality of life and a reduction of symptoms [1], [2], [3] (Level of evidence 1 (LE1) – see below). In the short term, the use of a non-absorbable synthetic mesh reduces the risk of anatomic recurrence of the cystocele [1], [2], [3], [4] (LE1). This has been shown, in particular, for the case of women operated for prolapse recurrence [5] (LE2). The placement of meshes exposes the patient to specific risks, however, which in some cases is severe. The aim of the present study was to establish a critical review of the literature related solely to the complications of genital prolapse surgery, and to make guidelines for clinical practice in order to minimize the prevalence of these complications. We do not address the issue of the indication for the placement of meshes in prolapse surgery, nor that of the choice between vaginal or abdominal routes.

Section snippets

Materials and methods

The objective of the study was to provide guidelines for clinical practice from the French National College of Obstetrics and Gynecology (CNGOF).

This study is based on an exhaustive review of the literature (PubMed, Medline, Cochrane, EMBASE) related to meta-analyses, randomized trials, controlled studies and large non-controlled studies, published on the subject up until May 2011, using the following keywords: mesh; pelvic organ prolapse; cystocele; rectocele; uterine prolapse; complications;

Results

The Dindo classification of surgical complications [6] is not specific to prolapse surgery. The classification recently published by the IUGA (International Urological Association) and the ICS (International Continence Society) is specific to prolapse surgery [7].

Choice of surgical route

Laparoscopic sacral colpopexy is associated with anatomic results which are comparable with sacral colpopexy via laparotomy, with less perioperative bleeding, a shorter hospital stay, and a lower rate of parietal complications (LE3) [27], [94], [95]. There is no randomized trial. The preferred route for sacral colpopexy is that of laparoscopy (Expert opinion).

The rates of vaginal mesh exposure are significantly greater if the sacral colpopexy mesh is sutured and inserted by the vaginal route

Conclusion

The application of these recommendations should allow the best available knowledge concerning genital prolapse surgery to be disseminated, in order to minimize its risks and consequences. Information for patients concerning these risks has been recently underlined by the US Food and Drug Administration [110]. The present paper is different from the paper of Deffieux et al. [111] since we have focused on recommendations that should be useful internationally, and furthermore, data have been

Working group

At the time of the preparation and editing of these recommendations, the expert editors (VL, DS, LS), the president (FP), the other members of the working group (AA,PM) and the methodologist (XD) declare that they have not been, and are not, consulted by any urogynecological prosthesis manufacturing firms. They also declare that they do not hold any patents relating to urogynecological equipment available on the market. They also declare that they do not own shares in these companies and do not

Acknowledgements

We wish to thank those who proofread these recommendations. Their pertinent remarks have led to the enrichment of this study: Arnaud Fauconnier, Georges Bader, Malik Boukerrou, Laurent Bresler, Jean Luc Brun, Michel Cosson, Emile Darai, Jean-Valère Deffarges, Renaud de Tayrac, Philippe Ferry, Xavier Fritel, Martine Herry, Jean Philippe Lucot, Alain Pigné, Loïc Marpeau, Georges Mellier, Delphine Salet Lizee, Vincent Villefranque, Peter von Theobald, Hervé Fernandez, François Devianne, Christophe

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