Pelvic organ prolapse is a common gynaecological problem. Surgical techniques to repair prolapse have been constantly evolving to reduce the recurrence of prolapse and need for reoperation. Grafts made of synthetic and biological materials became popular in the last decade as they were intended to provide extra support to native tissue repairs. However, serious complications related to use of synthetic meshes have been reported and there is increasing medico-legal concern about mesh use in prolapse surgery. Some mesh products already have been withdrawn from the market and the FDA has introduced stricter surveillance of new and existing products. Large randomized studies comparing mesh with non-mesh procedures are lacking which creates uncertainty for the surgeon and their patients.The small cohorts of the RCTs available with short follow-up periods just allow the conclusion that the mesh repair can be helpful in the short to medium term but unfortunately are not able to prove safety for all patients. In particular, current clinical reports cannot define for which indication what material may be superior compared to non-mesh repair.Quality control through long-term individual and national mesh registries is needed to keep a record of all surgeons using mesh and all devices being used, monitoring their effectiveness and safety data. Meshes with better biocompatibility designed specifically for use in vaginal surgery may provide superior clinical results, where the reduction of complications may allow a wider range of indications.
Keywords: Biological graft; Medicines and Healthcare products Regulatory Agency; Pelvic organ prolapse; U.S. Food and Drugs Administration; synthetic Mesh.
© The Author(s) 2015.