Technical Solutions found to install the German Mandatory Breast Implant Registry
Author(s): von Fritschen U, Schiltz D, Prantl L, Fricke A.
Background: Despite numerous attempts, sound data on long-term implant performance is lacking for almost every aspect of implant based procedures of the breast. Various scandals highlighting insufficient trackand- trace functions led the German Government in accordance with new EU-requirements to engage in a comprehensive device registry.
Objectives: This article aims to provide information about the challenges of implant registries to provice high evidence data and the complex structural and regulatory requirements implementating a mandatory registry
Methods: We analysed the current limitations of studies and other international registries and developed solutions to overcome these setbacks
Results: Insufficient inclusion rates and inability to verify adhearance, lack of funding, privacy issues and inefficient research methodologies, turned out to be the most common.
Conclusion: To assure longitudinal assessment of every implant-based procedure, a mandatory approach was identified as the most reasonable way. Beside limitations of personal privacy rights, extensive legislative and procedural requirements were to be met. We describe our approach, obstacles encountered, and strategies to inform future registries on structural requirements.