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.
In France, on October 23, 2020, the Ministry of Health published issues new regulations with respect to the use of MUS in the treatment of female SUI. This legislation provided a framework for MUS procedure including patient information and counseling, learning curve for the procedures, and multidisciplinary teams (MDT) discussions including at least (but not limited to) a urologist and a gynecologist. The impact of such legislation on practice and ultimately on decreasing MUS-associated complications and morbidity are not known yet.
The carried out study aimed to make an inventory of the practices and the modifications generated by the publication of this act. French urologists and gynecologists replied to survey to collecting changes in practices since the publication of the new legislation.
The majority of the surgeons found this act useless, except the urogynecology MDT discussions of complex cases. In addition, this short-term assessment did not show major changes in daily practice which were already compliant with the current legislation regarding patient information consent and training. However, surgeons agreed complex cases (urethral erosions, multiple surgeries) should be referred to few experienced centers with multidisciplinary teams. The awaited label of SUI referral center has yet to be defined. The specific requirements including volume-load, surgeons' minimal experience, and training, case-complexity grading are sensitive and pending issues.
Finally, the reluctance of 61% of the surgeons to offer MUS procedures since the issue of the new legislation is alarming. While aimed to improve practice and decrease complications, this new legislation must not be an obstacle to patient management because of administrative constraints or fear of lawsuits.
Written by: Nicolas Hermieu, MD and Idir Ouzaid, MD, PhD, Department of Urology, Bichat Claude Bernard Hospital, Paris, France, University of Paris, Paris, France
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