The “Implant Register Germany” has now begun trial operation and has received the first data on breast implants from clinics. The register was operational starting from March 31st and by January 1st, 2024, all healthcare facilities must report implant-related procedures involving breast implants to the registry. Patients with breast implants can expect high-quality implants and quick notification of any problems, according to Federal Health Minister Karl Lauterbach.
The implant register creates transparency and improves patient safety. The first expansion stage of the register focuses on breast implants and is carried out in collaboration with the German Society for Plastic, Reconstructive and Aesthetic Surgery (DGPRÄC) and the Working Group for Aesthetic, Plastic, and Reconstructive Operational Procedures in Gynecology (AWOgyn). The platform was set up by the state-owned D Trust GmbH and the Federal Information Technology Center (ITZBund) to ensure information security and data protection.
The establishment of the register in 2019 was regulated in the Implant Register Act (IRegG), and manufacturers are obliged to register their products in the product database. Patient consent is not required when medical institutions report data on the implants and their recipients, nor can affected individuals object or restrict the processing of their data. This has drawn criticism from data protection experts, and the European Parliament is currently correcting the regulations in the EU Commission’s draft for the European Health Data Space.
Clinics and practices can report implants via a web form in the telematics infrastructure, with the reporting procedure expected to be integrated into hospital information systems and practice management software in the medium term. Technical and organizational adjustments are ongoing, and the registration and authentication of clinics and practices will be converted to a mass-market procedure. The Federal Ministry of Health intends to present the draft for a register law in the autumn of this year, which aims to improve access to all existing medical register data in Germany for research and care.
