On February 2, 2023, the Regulation for the establishment of the National Register of breast implantspublished in the Official Gazette on 18 January 2023.
The National Register of breast implants is fed with data from regional registers. Regions and autonomous provinces have 180 days from 2 February to set up regional and provincial registers. I enter the first August 2023 the National Registry of breast implants will receive data from every area of the territory.
Italy is the first country in the world that today has a register with mandatory feeding by the surgeons who implant or remove prostheses on the national territory.
Even the economic operators who distribute these devices in Italy are required to transmit the data relating to each single breast prosthesis marketed and intended to be implanted, both for aesthetic and reconstructive purposes.
Sanctions are envisaged for those who do not comply with the requirements in the manner and timescales defined by the Regulation.
The results of the analyzes carried out on the data collected by the register will provide important information for the scientific world of the sector and will allow research to be strengthened in terms of effectiveness and efficiency of breast implants.
The Ministry of Health can now count on a valid tool with which to implement supervision and surveillance activities on breast implants and enhance the safety of the implanted patient, recalling him if necessary.
Consult the National Register of Breast Implants page