opinion

Pelvic Floor Reconstruction – Quo Vadis ? Should the Actual Development in the Anglo-American Countries Change our Strategy?

Heinz Koelbl

Department of Gynecology, University of Vienna, Währinger Gürtel 1190 Vienna, Austria

*Corresponding author Heinz Koelbl, Department of Gynecology, University of Vienna, Währinger Gürtel 1190 Vienna, Austria

Received Date: 26 October, 2022

Accepted Date: 08 January 2023

Published Date: 12 January 2023

Citation: Koelbl H (2023) Pelvic Floor Reconstruction – Quo Vadis ? Should the Actual Development in the Anglo-American Countries Change our Strategy?. J Urol Ren Dis 08: 1301. DOI: https://doi.org/10.29011/2575-7903.001301

Introduction

February 12, 2019: The FDA convened an advisory committee meeting to share the available evidence and seek expert opinion on how to evaluate the risks and benefits of these devices. The committee was asked to provide scientific and clinical input on assessing the effectiveness, safety, and benefit-risk of mesh placed transvaginally in the anterior vaginal compartment, as well as identifying the appropriate patient population and physician training needed for these devices. As there was no sufficient reply of the manufacturers on April 16, 2019, the FDA ordered all manufacturers of surgical mesh intended for transvaginal repair of anterior compartment prolapse (cystocele) to stop selling and distributing their products immediately. The FDA has determined that the manufacturers, Boston Scientific and Coloplast, have not demonstrated reasonable assurance of safety and effectiveness for these devices, which is the premarket standard that now applies to them since the agency reclassified them into class III (high risk) in 2016 (FDA 2019) [1].

This was definitively not a scientifically based decision, but, had a more or less paramedical history in other English speaking countries:

  • December 2017 de facto ban on vaginal mesh use for pelvic organ prolapse NICE conclusion / joint RCOG/BSUG statements UK , since June 2018 they were officially „banned“ !
  • January 2018 ban on vaginal mesh for prolapse and single incision(mini) slings for SUI in Australia
  • Ban the surgical mesh for any pelvic operations - New Zealand Medicines and Medical Device Safety Authority (Medsafe), de facto in Ireland as well. These decisions on the british isles were provoked by actions of the public in their local parliaments and BBC, that with three prime time transmissions in the TV produced a public motion resulting in a complete refusal of all alloplastic materials by the patients. Even though in the medical community there is no doubt at all about midurethral slings politics and thus the public mixes up everything (Figure1).

 

Figure 1: From JAMA: showing a midurethral sling and talking about meshes for prolapse !.

  • in the Netherlands since 4 years there is a contract with the government that only certified , specialized centers with regular audits are allowed to use meshes – their use went down to < 1% (Figures 2-4) [2].

 

Figure 2: Development of anti-incontinence surgery in England . conventional procedures have gradually disappeared, suburethral slings decreasing dramatically, revival of intraurethral injections [3].

 

Figure 3: History of alloplastic materials being introduced very quickly with small patient series – basic research started nearly 20 years later.