The National Breast Implants Registry was established by the Italian Ministry of Health with the national law n. 86 of 2012. In the same year, the Law Decree n. 179 effectively blocked its immediate launch, as it required the Registry to be accomplished through the publication of a Decree of the President of the Council of Ministers (DPCM), which took place only in 2017.
The Department of Medical Devices and the Pharmaceutical Service of the Ministry participated in the process of formulating the DPCM and at the same time began to study this type of device in depth to better understand its market and create a solid network with all the stakeholders: regional authorities, scientific societies and distributors of breast implants.
At the beginning of 2017, Italian national institute of health (ISS) and the Ministry of Health started a collaboration on this project, since ISS, over the years, has acquired a considerable experience in the development of the Italian Arthroplasty Registry (RIAP).
How is RNPM organized?
The key elements in the architecture of an implantable prostheses’ registry are the definition of the data to be collected and the design of the information flow.
The data collected must be those essential to achieve the objectives of the registry: certain personal data, strictly anonymized to guarantee privacy but pivotal for the patient’s recall; clinical data on patient’s medical history and the diagnosis that led to the intervention; the nature of the procedure performed and the surgery technique used; the device’s identification data.
Designing a data flow that would allow to collect data of all the interventions, both in reconstructive and aesthetic surgery, was a very important step. The situation with breast implants is completely different compared to orthopedic prostheses. Only a small minority (1-2%) of approximately 200,000 orthopaedic implant surgeries per year is performed outside of public or accredited private hospitals monitored by the National Health Service. On the contrary, of 51,000 breast implant surgeries per year, 67% are not traceable by official data flow.
In order to be able to track all the implants, it was therefore necessary to change the approach and start registering all the prostheses distributed throughout the national territory and link them to patients afterwards. This was made possible thanks to the great collaboration of all the distributors who have uploaded on the project’s platform called “Dictionary” all the devices marketed in Italy with the identification codes for better traceability. The distributors also periodically report to which clinic or hospital the implants were sold and then implanted.
In this way, the surgeon does not have to enter any code when implanting a prosthesis. Therefore, transcription errors cannot occur.
This approach allows the Ministry to constantly check whether for all the prostheses sold, the registration form and link to the patient have already been completed and, if necessary, recall the non-compliant institutions.
These features, together with the obligation of law, make the Italian Breast Implants Registry a system unequalled in the world, to date.