Den Stein ins Rollen gebracht hatte der so genannte „PIP-Skandal“. Als 2010 bekannt wurde, dass die französische Firma Poly Implant Prothèse (PIP) Brustimplantate mit minderwertigem, nicht zugelassenem und vor allem brüchigem Industriesilikon befüllt hatte und Tausende Frauen, auch in Deutschland, sich deswegen noch einmal operieren lassen mussten, da wurde schnell klar: Für Medizinprodukte hoher Risikoklassen wie Implantate braucht es strengere Vorschriften und vor allem eine bessere Überwachung; 2014 dann erklärte der damalige Bundesgesundheitsminister Hermann Gröhe (CDU): „Implantateregister können uns helfen, die Sicherheit der Produkte und die Qualität der Patientenversorgung weiter zu verbessern.“
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