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

• What is already known on this subject? 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.

• What do the results of this study add? 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.

• What are the implications of these findings for clinical practice and/or further research? 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.

Keywords:

• Pelvic organ prolapse
• pelvic reconstructive surgery
• pelvic floor disorders
• surgical mesh
• complications

Acknowledgments

We would like to express our gratitude to the patients who participated and the staff at Centre for Advanced Reproductive Endosurgery (C.A.R.E.) who supported this study. This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.

Author contributions

Daniel Wong: Project development, Data Collection, Manuscript writing.

To Valerie: Data Collection.

Alan Lam: Project development, Manuscript writing.

The first draft of the manuscript was written by Daniel Wong and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.

Disclosure statement

No potential conflict of interest was reported by the author(s).