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Beckenbodenchirurgie

Rechtliche Implikationen der Implantation von Fremdmaterialien

Pelvic floor reconstructive surgery

Medico-legal implications with implantation of alloplastic materials

  • Medizinrecht
  • Published:
Der Gynäkologe Aims and scope

Zusammenfassung

Selten hat eine neue Operationstechnik weltweit so schnell Eingang in die klinische Routine erfahren, ohne dass zu Beginn prospektive Studien zu Sicherheit und Effektivität als Basis diese Strategie untermauert hätten. Nach dem Erfolg der suburethralen Bänder, die mittlerweile millionenfach implantiert wurden, stehen Netze zur Behandlung von Deszensus und Prolaps zur Verfügung, wobei mit der Zeit neue, bis dahin völlig unbekannte Komplikationen in relevanter Zahl beobachtet wurden. In den USA haben diese Komplikationen bei dem sehr eigenen Rechtssystem zu einer Flut von Klagebegehren (>60.000 nur 2014) geführt, die mittlerweile für den Einzelfall Schadenssummen von >10 Mio. US-Dollar erstritten haben. Diese Entwicklung sollte für Deutschland trotz sicher unterschiedlicher ärztlicher Strategien und guter chirurgischer Ausbildung zu einer sorgfältigen Indikationsstellung und Zentralisierung der Eingriffe Anlass geben.

Abstract

Rarely new surgical strategies have been accepted so rapidly in clinical routine worldwide, without available prospective studies proving safety and effectivity. After the success of midurethral slings, having been implanted in millions, alloplastic meshes are available for the treatment of prolapse with new, so far unknown complications in relevant frequency. In the USA with their own medico-legal system there is a flood of litigations (>60,000 in 2014) for singleton cases with compensations of >10 million $. Even though medical strategies and surgical skills might be different in Germany this development should encourage for strict indications and centralization in pelvic floor centers.

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Authors and Affiliations

  1. Urogynäkologie, Universitäts-Frauenklinik, Ferdinand-Sauerbruch-Straße 1, 17475, Greifswald, Deutschland

    Eckhard Petri

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  1. Eckhard Petri
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Correspondence to Eckhard Petri.

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Interessenkonflikt

E. Petri gibt an, dass kein Interessenkonflikt besteht.

Dieser Beitrag beinhaltet keine von den Autoren durchgeführten Studien an Menschen oder Tieren.

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Redaktion

H.G. Bender, Düsseldorf

B. Neuroth, Düsseldorf

E. Schumann, Göttingen

A. Strauss, Kiel

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Petri, E. Beckenbodenchirurgie. Gynäkologe 49, 709–714 (2016). https://doi.org/10.1007/s00129-016-3905-2

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  • DOI: https://doi.org/10.1007/s00129-016-3905-2

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