National register of breast prosthetic implants

Breast implants , commonly implanted for cosmetic or reconstructive reasons, are class III medical devices, the highest risk class, regulated by Legislative Decree No. 137 of August 5, 2022 and EU Regulation 745/2017 . The Ministry of Health, as the Competent Authority on medical devices in Italy, carries out careful and constant vigilance and market surveillance to ensure the safe use of breast implants in the post-marketing phase. Establishment of the National Registry and Regional and Provincial Registries To implement and strengthen control over Class III medical devices, Law 86/2012 established the National Registry, at the Ministry of Health, and the Regional and Provincial Registries of Breast Implants, at the relevant autonomous regions and provinces. From 2019 to 2021, the pilot phase of the National Registry took place. By Decree No. 207 of October 19, 2022 , published in the Official Gazette on January 18, 2023, the Regulations governing the operation of the National Registry were adopted, incorporating everything learned during the pilot phase. The purposes of the National Registry and the regional registries, each for their own areas of responsibility, are: clinical monitoring of the subject undergoing implantation, to prevent complications and improve clinical care management of any undesirable effects and outcomes at a distance timely traceability of patients in case of need epidemiological monitoring , for the purpose of study and scientific research in the clinical and biomedical field also with a view to the clinical evaluation of efficacy and safety of the device in the short and long term and planning, management, prevention of complications, control and evaluation of health care. With the entry into force of the Regulations, it becomes mandatory: for all health care professionals, who implant or remove breast implants in the national territory, to record every single surgical procedure performed, within 3 days from the date of its execution for distributors of breast implants, to transmit information, on a monthly basis, on every single device marketed in the Italian territory. Unless the act constitutes a crime, individuals operating in public and private facilities who fail to collect, update and transmit data to the registers are punished with appropriate administrative sanctions. The characteristics of the Italian Registry What makes the National Registry of Breast Prosthetic Implants as well as the regional and provincial registries unique is: the 'compulsory transmission of data the management of the national registry by a government institution, such as the Ministry of Health as the competent authority on medical devices in Italy the traceability of every single breast implant available on Italian territory, even when not implanted. Data and publications Since the year 2022, the Directorate General of Medical Devices and Pharmaceutical Service (DGDMF) has periodically produced Reports containing the results of the analysis conducted on the data collected in the registry. Specifically, in the year 2022, the Report "Pilot Phase" March 25, 2019 - August 31, 2021 was published, which contains the results of the processing carried out on the data collected during the "pilot phase." In the year 2024, the 2019-2023 Report was published in Italian and English verion containing the results of the analysis conducted on the data collected in the National Registry of Voluntarily-Fed Breast Prosthetic Implants until August 31, 2023. See: National Registry of Breast Prosthetic Implants. Report years 2019-2023, March 25, 2019 - August 31, 2023 Italian National Breast Implant Registry. Report: years 2019-2023 March 25th, 2019 - August 31st, 2023 Active Registries in the World The Breast Implant Registry is internationally recognized as an essential tool for enhancing surveillance and vigilance activities on this type of device, and the European Commission has asked member states to take all appropriate measures to encourage the establishment of registries thus contributing to an independent assessment of the long-term safety and performance of these devices ( European Regulation 745/2017 , Article 108). To date, there are few active breast implant registries in the international arena (See: Moving breast implant registries forward: Are they FAIR and Functional? , in JPRAS November 22, 2020) and in any case all established and managed by scientific societies in the field; they are not mandatory and achieve variable, but not complete coverage in the relevant territory. Accessing the RNPM How to access registries Consult Law No. 86 of 2012 Decree Law No. 179 of October 18, 2012 Decree of the President of the Council of Ministers of March 3, 2017 .