title: [Concept for a National Implant Registry to Improve Patient Safety].
abstract: Since the introduction of silicone implants, several events have led to considerable uncertainty among the patients, public, and users. So far, however, the necessary steps to significantly improving patient safety have not been taken in any of these cases. Requiring stricter approvals for medical devices, improving monitoring by the regulatory authorities and the revision of the Medical Devices Directive are all initial steps in the right direction towards a change in policy, but are insufficient as an early warning system. After the introduction of registers was announced in the coalition agreement, the German Society of Plastic, Aesthetic and Reconstructive Surgeons (DGPRÄC), in close consultation with the Ministry of Health, has developed a concept which is presented here. The need for a uniform and legally binding central register for breast implants is fully supported by the entire medical profession. According to the concept presented by the DGPRÄC, three data qualities would be applicable: Safety data (mandatory), physician information (voluntary) and research data (optional, except if safety related). The public authorities are creating a unified, secure entry portal for all professional associations concerned. This register is based with the professional associations, and from there the mandatory security data will be forwarded to the public authorities. Decoding of the identity of the patient and doctor would only occur in specifically defined emergency situations such as product recalls. Automated tools in the security database provide early detection of problems, so that rapid clarification is possible in consultation with the professional associations, manufacturers and possibly patients. This concept as proposed by the DGPRÄC has thus far been very positively received in all discussions between the various parties concerned.
authors.affiliation: Abteilung für Plastische, Hand- und Wiederherstellungschirurgie, Universitätsklinikum Regensburg, Regensburg.
authors.forename: L
authors.initials: L
authors.lastname: Prantl
authors.affiliation: Chefarzt der Klinik für Plastische und Ästhetische Chirurgie, HELIOS Klinikum Emil von Behring GmbH, Berlin.
authors.forename: U
authors.initials: U
authors.lastname: von Fritschen
authors.forename: J
authors.initials: J
authors.lastname: Liebau
authors.affiliation: Geschäftsführer, Ethikkommission an der Universität Regensburg.
authors.forename: J
authors.initials: J
authors.lastname: von Hassel
authors.affiliation: Univ.-Klinik für Plastische, Rekonstruktive und Ästhetische Chirurgie Innsbruck, A.ö. Landeskrankenhaus Innsbruck, Medizinische Universität Innsbruck, Innsbruck.
authors.forename: E M
authors.initials: EM
authors.lastname: Baur
authors.affiliation: Klinik für Plastische, Ästhetische, Hand- und Wiederherstellungschriurgie, Hochschule Hannover, Hannover.
authors.forename: P M
authors.initials: PM
authors.lastname: Vogt
authors.affiliation: Abteilung für Handchirurgie, Plastische Chirurgie und Ästhetische Chirurgie am Klinikum der Universität München (LMU): a) Campus Großhadern, München; b) Campus Innenstadt, München.
authors.forename: R E
authors.initials: RE
authors.lastname: Giunta
authors.affiliation: Direktor der Plastisch und Handchirurgischen Klinik, Universitätsklinikum Erlangen, Friedrich- Alexander-Universität Erlangen-Nürnberg, Erlangen.
authors.forename: R E
authors.initials: RE
authors.lastname: Horch
mesh_terms: D019928:Breast Implantation; D018427:Breast Implants; D006801:Humans; D061214:Patient Safety; D012042:Registries