The National Breast Implant Registry, established in 2012 by Law no. 86 of June 5, 2012 under the aegis of the Italian Ministry of Health, has the following purposes:

  • clinical monitoring of the patient undergoing implantation in order to prevent complications and improve clinical care management of any undesirable effects and long-term outcomes
  • timely tracing of patients in case of need
  • epidemiological monitoring in order to enhance study and scientific research in clinical and biomedical fields, also with the aim to: evaluate performance and safety of the device in the short and long term; plan, prevent or manage complications; control and evaluate healthcare services.


The entry into force of the Regulation (Decree No. 207 of October 19, 2022) on 2 February 2023 made the Registry mandatory. This means that:

  • all healthcare professionals who implant or remove breast implants in the national territory must register within 3 days from date of surgery every single surgical procedure performed.
  • distributors of breast implants must register, on a monthly basis, every single device marketed on the Italian territory.


To access data collection platform click here.

For more information on the Registry click here.