Ten-year surgical complications and mesh erosion of transvaginal Elevate™ mesh for management of pelvic organ prolapse.

Abstract

This study aims to review the surgical complications and mesh erosion with a cohort of patients who underwent Elevate™ mesh repair. This was a single-centre, retrospective study of women undergoing Elevate™ mesh reconstruction between 2006 and 2016. Women who presented with symptomatic prolapse of stage II or above were enrolled. The study outcomes were intra-operative and peri-operative complications (including mesh complications) at six weeks, one year and five years reporting with a standardised communicable method-the International Urogynecological Association (IUGA)/International Continence Society (ICS) scale and the Clavien and Dindo Classification. A total number of 350 women had Elevate™ mesh insertion. The mesh exposure rate was 1.1% and the surgical complication rate in our series was low and self-limiting (2% were Dindo grade 3). With the low morbidity and mesh-related complications, Elevate™ mesh should be at least kept as an alternative treatment of pelvic organ prolapse. Impact statement<b>What is already known on this subject?</b> Transvaginal mesh repair surgery was popular to treat advanced pelvic organ prolapse 10 years ago. However, after announcement of the Food and Drug Administration (FDA) public notification regarding mesh-related complications, particularly mesh exposure, use of transvaginal mesh and its safety have been scrutinised. Despite the increasing challenging and difficult medico-legal climate, several studies on second generation mesh kits, such as Elevate™ have shown favourable outcomes with low complication rates including our group.<b>What do the results of this study add?</b> In this paper, the surgical complications and mesh erosion of Transvaginal mesh was reported in a quantified communicable method-the International Urogynecological Association (IUGA)/International Continence Society (ICS) scale and the Clavien and Dindo Classification. This is significant because it is the largest case studies from a single centre with 350 patients.<b>What are the implications of these findings for clinical practice and/or further research?</b> This study well demonstrated using a standardised way to classify mesh exposure and peri-operative complications which is lacking in the past, while majority studies only focus to discuss on surgical outcome instead of complications. This may make a spark for future research analysis.