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Einsatz von synthetischen Band- und Netzimplantaten bei der Behandlung von Belastungsinkontinenz und Descensus genitalis der Frau

Stellungnahme des Arbeitskreises Urologische Funktionsdiagnostik und Urologie der Frau der Akademie der Deutschen Gesellschaft für Urologie

Use of synthetic slings and mesh implants in the treatment of female stress urinary incontinence and prolapse

Statement of the Working Group on Urological Functional Diagnostics and Female Urology of the Academy of the German Society of Urology

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Zusammenfassung

Beginnend mit einer 2011 erschienenen Sicherheitswarnung der US Food and Drug Administration (FDA) für transvaginale Netzimplantate zur Behandlung des Descensus genitalis der Frau wegen zahlreicher Berichte über Komplikationen wie Infektion, chronische Schmerzen, Dyspareunie, Vaginalarrosion, Schrumpfung und Arrosion in andere Organe wurden zwischenzeitlich nahezu alle Industrieprodukte vom Markt genommen. Großbritannien, Australien und Neuseeland weiteten entsprechende Warnungen und Verbote sogar auf die Implantation midurethraler Schlingen/Bänder (TVT, TOT) aus. Angesichts dieser aktuellen internationalen Kontroversen in Bezug auf die Verwendung von implantierten Materialien zur Behandlung der Belastungsinkontinenz und des Descensus genitalis und dem Fehlen klarer Richtlinien für die Verwendung von Biomaterialien soll die Stellungnahme des Arbeitskreises Urologische Funktionsdiagnostik und Urologie der Frau Klarheit schaffen. Die Stellungnahme erfolgt in Anlehnung an den SCENIHR-Bericht der „European Commission’s Scientific Committee on Emerging and Newly Identified Health Risks“, dem „Consensus Statement of the European Urology Association and the European Urogynaecological Association on the Use of Implanted Materials for Treating Pelvic Organ Prolapse and Stress Urinary Incontinence“ und unter Beachtung relevanter EAU- und nationaler Leitlinien und der Stellungnahme der Arbeitsgemeinschaft für Urogynäkologie und Plastische Beckenbodenrekonstruktion (AGUB e. V.). Darüber hinaus werden Empfehlungen für den künftigen Umgang mit Implantaten von Bändern und Netzen für die Behandlung der Belastungsinkontinenz und des Descensus genitalis aus Sicht der Urologie gegeben.

Abstract

Due to a safety alert issued by the US Food and Drug Administration (FDA) in 2011 for transvaginal mesh implants to treat female prolapse as a result of numerous reports of complications such as infection, chronic pain, dyspareunia, vaginal erosion, shrinkage and erosion into other organs nearly all industrial products have been withdrawn from the market in the meantime. The United Kingdom, Australia, and New Zealand extended warnings and prohibitions even on the implantation of midurethral slings (TVT, TOT). In view of these current international controversies regarding the use of implanted materials for the treatment of stress incontinence and prolapse and the lack of clear guidelines for the use of biomaterials, the opinion of the Working Group on Urological Functional Diagnostics and Female Urology should provide clarity. The Opinion is based on the SCENIHR Report of the “European Commission’s Scientific Committee on Emerging and Newly Identified Health Risks”, the “Consensus Statement of the European Urology Association and the European Urogynaecological Association on the Use of Implanted Materials for Treating Pelvic Organ Prolapse and Stress Urinary Incontinence” and in compliance with relevant EAU and national guidelines and the opinion of the Association for Urogynaecology and Plastic Pelvic Floor Reconstruction (AGUB eV). In addition, recommendations are given for the future handling of implants of slings and meshes for the treatment of stress incontinence and prolapse from a urologic viewpoint.

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Abbreviations

ASC:

abdominale Sakrokolpopexie

BI:

Belastungsinkontinenz

DG:

Denscensus genitalis

MUS:

midurethrale Schlingen

PP:

Polypropylen

RCT:

randomisiert kontrollierte Studie

RP:

retropubisch

SSF:

vaginale sakrospinale Fixation

TO:

transobturatorisch

TVN:

transvaginale Netze

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Author information

Authors and Affiliations

  1. Urologische Klinik, Evangelisches Krankenhaus Oberhausen, Virchowstr. 20, 46047, Oberhausen, Deutschland

    K. Höfner

  2. Urologische Abteilung, Marien-Hospital Erwitte, Erwitte, Deutschland

    C. Hampel

  3. Neuro-Urologie/Urologie Universitätsklinikum Bonn und Neuro-Urologie, Neurologisches Rehabilitationszentrum der Godeshöhe e. V., Bonn, Deutschland

    R. Kirschner-Hermanns

  4. Abteilung Urologie, Universitätsspital Basel, Basel, Schweiz

    S. H. Alloussi

  5. Urologische Klinik und Poliklinik der Ludwig-Maximilians-Universität München, Campus Großhadern, München, Deutschland

    R. M. Bauer

  6. Urologische Klinik, Fürst-Stirum-Klinik Bruchsal, Bruchsal, Deutschland

    S. Bross

  7. Klinik für Urologie, Andrologie und Kinderurologie, Klinikum Weiden/Kliniken Nordoberpfalz AG, Weiden i. d. Oberpfalz, Deutschland

    T. Bschleipfer

  8. Klinik für Urologie und Nephrologie, Helios Klinikum Niederberg, Velbert, Deutschland

    M. Goepel

  9. Urologische Klinik und Poliklinik, Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Mainz, Deutschland

    A. Haferkamp & T. Hüsch

  10. Zentrum für Kontinenz und Neuro-Urologie, Kliniken Maria Hilf GmbH Mönchengladbach, Mönchengladbach, Deutschland

    A. Kaufmann

  11. Institution Neuro-Urologische Ambulanz, Univ. Klinik f. Urologie Innsbruck, Innsbruck, Österreich

    G. Kiss

  12. St.-Antonius Hospital, Klinik für Urologie und Kinderurologie Eschweiler, Eschweiler, Deutschland

    J. Kranz

  13. Universitätsklinik und Poliklinik für Urologie, Universitätsklinikum Halle (Saale), Halle (Saale), Deutschland

    J. Kranz

  14. Klinik für Urologie, Kinderurologie und Urologische Onkologie, St. Antonius-Hospital Gronau, Gronau, Deutschland

    M. Oelke

  15. Neuro-Urologie, Schweizer Paraplegiker-Zentrum Nottwil, Nottwil, Schweiz

    J. Pannek

  16. Urologische Klinik, Inselspital, Universitätsspital, Universität Bern, Bern, Schweiz

    J. Pannek

  17. KontinenzZentrum Hirslanden Zürich, Zürich, Schweiz

    A. Reitz

  18. Urologische Klinik, Landesklinikum Korneuburg, Korneuburg, Österreich

    M. Rutkowski

  19. Sarasota, FL, USA

    W. Schäfer

  20. Urologie Turmstraße (Gemeinschaftspraxis), Berlin Mitte/Moabit, Deutschland

    H. Schulte-Baukloh

  21. Urology Department, Healthpoint Hospital, Abu Dhabi, Vereinigte Arabische Emirate

    S. Schumacher

  22. Urologiezentrum Alter Markt, Kiel, Deutschland

    C. Seif

  23. Kontinenzzentrum Südwest, Schwarzwald-Baar Klinikum Villingen-Schwenningen, Villingen-Schwenningen, Deutschland

    D. Schultz-Lampel

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  1. K. Höfner
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  2. C. Hampel
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  3. R. Kirschner-Hermanns
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  4. S. H. Alloussi
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  5. R. M. Bauer
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  6. S. Bross
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  7. T. Bschleipfer
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  9. A. Haferkamp
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  12. G. Kiss
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  19. H. Schulte-Baukloh
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  22. D. Schultz-Lampel
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Corresponding author

Correspondence to K. Höfner.

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Interessenkonflikt

C. Hampel, S.H. Alloussi, S. Bross, M. Goepel, A. Haferkamp, A. Kaufmann, G. Kiss, J. Kranz, M. Oelke, J. Pannek, A. Reitz, M. Rutkowski, W. Schäfer, H. Schulte-Baukloh, S. Schumacher, C. Seif und D. Schultz-Lampel geben an, dass kein Interessenkonflikt besteht. K. Höfner gibt Beraterhonorar für Boston-Scientific an. R. Kirschner-Hermanns gibt Vorträge und Studien für Repha GmbH und Training und Vorträge für Laborie an und ist CEO and Founder der MEC-ABC Medical Care and Product Development in Aachen-Bonn-Cologne GmbH. R. Bauer gibt Honorar für Beratung und Vorträge bei AMI, Boston Scientific und Promedon an. T. Bschleipfer gibt Honorare für Beratung und Vorträge für Serag Wiessner und Dahlhausen an. T. Hüsch gibt Reisekostenübernahme von Boston Scientific an.

Für diesen Beitrag wurden von den Autoren keine Studien an Menschen oder Tieren durchgeführt. Für die aufgeführten Studien gelten die jeweils dort angegebenen ethischen Richtlinien.

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Höfner, K., Hampel, C., Kirschner-Hermanns, R. et al. Einsatz von synthetischen Band- und Netzimplantaten bei der Behandlung von Belastungsinkontinenz und Descensus genitalis der Frau. Urologe 59, 65–71 (2020). https://doi.org/10.1007/s00120-019-01074-y

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