Summary

Urogynecology prostheses include all medical implants used in women for the treatment of urinary incontinence or genital prolapse.

This therefore includes sub-urethral tapes, the best known of which is the Tension-free vaginal tape (TVT), but also prostheses placed in contact with the vagina, used for the treatment of genital prolapse (“descend of organs”). Although these two types of implantable medical devices share a similar material (non-resorbable plastic material such as polypropylene), their indications are quite different, as is the quantity of material used (three to ten times greater to treat a prolapse).

Their use was questioned during the scandal of the implant files and during lawsuits in the US. After several withdrawals of materials from manufacturers (ams, ethicon gynecare, boston scientific), the HAS after reanalysis of the files of the remaining manufacturers did not authorize the use of synthetic prostheses presented for the cures of vaginal genital prolapse. More recently, two decrees have specified the use of sub-urethral strips and more recently of prostheses used in promontofixations. Similarly, the analysis by the HAS of the files of manufacturers who submitted a file for these products has drastically limited the number of manufacturers who can still market their products in these indications.

At the same time, the European Community has launched new regulations that are much more demanding in terms of constraints on medical data and market monitoring for manufacturers in order to obtain the CE mark.

This article will briefly review the respective place of the various medical devices in terms of therapeutic indication in the treatment of urinary incontinence in women and genital prolapse. We will review the conditions of regulatory use of these devices following the evolution of the legislative texts.

These scandals and regulatory changes have altered patients’ confidence in these devices, which are sometimes rejected outright. They will durably modify clinical practice by returning to older and poorly evaluated autologous techniques and will force a stronger collaboration around file discussion meetings for multidisciplinary decisions for most treatments.