Mid-urethral sling (MUS) is the first-line surgical treatment for stress urinary incontinence (SUI) with urethral hypermobility after the failure of pelvic floor muscle training. Around 13.6% of women will undergo surgery for SUI during their lifetime. In 2018 in France, 37.000 MUS implantation procedures were performed. This surgical management has demonstrated its effectiveness with a strong improvement in the quality of life of patients while presenting a good safety profile. Nevertheless, a cumulative 5-year complications rate was reported in up to 9.8% of patients. Minor complications are usually managed with conservative measures. However, major complications including erosion, pain, dysuria, infection) lead to re-intervention in up to 2.2% of cases. Consequently, authorities in Western countries have advocated for a thorough evaluation of the medical devices currently available and used for the surgical treatment of SUI and pelvic organ prolapse surgery. In the United Kingdom, the National Institute for Health and Care Excellence (NICE) has prohibited synthetic devices for the treatment of pelvic organ prolapse by vaginal approach in 2017. Similarly, in the United States, the Food and Drug Administration (FDA) has banned these devices in 2019. In both countries, the use of colposuspension and fascial slings for surgical SUI treatment is recommended by national guidelines while the cautious use of MUS remains allowed.

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