The Ministry of Health has announced the establishment of the National Register of Breast Implants which will collect data relating to all breast implants implanted in Italy: this will allow total traceability of the devices and improve patient safety.
"The register was born from an incident: the one that occurred in 2010, when problems were encountered with some prostheses containing silicone that did not comply with the regulations" - recalled Achille Iachino, head of the general directorate of medical devices and of the pharmaceutical service of the ministry of Health - At the time, the greatest criticality was not so much the system's ability to intervene to correct the problem of the device, but traceability and the possibility of identifying women". With the establishment of the register, this can no longer happen: from 2023 it will become in fact, it is mandatory for both public and private healthcare facilities to deposit information relating to each operation involving the implantation and removal of breast implants.
After a pilot phase that began in 2019, the Registry was released on 19 October.
Publication in the Official Gazette is expected in the next few weeks: from that moment, the Regions will have 6 months to start the widespread collection of data.
The Register, said the president of the Istituto Superiore di Sanità Silvio Brusaferro, will improve "the safety of treatments, because it allows us to know, deepen and evaluate the effectiveness of the prostheses we implant, bearing in mind that their duration has also become an aspect important with the lengthening of the average life".
The hope, he added, is "to extend the register to all types of prostheses that are becoming available".
In Italy every year about 42,000 people receive a breast prosthesis.
37% of the implants are for reconstructive purposes, for example after an operation to remove a tumor or for trauma or malformations;
63% of implants are for aesthetic reasons.
Schillaci, the only breast prosthesis registry in the world
“A unique supervisory and surveillance tool on the international scene”.
Thus the Minister of Health Orazio Schillaci defined the new "National Register of Breast Prosthetic Implants", presented this morning to the Ministry of Health.
The register will allow the collection of all data relating to breast implants marketed and implanted in Italy.
“The register has peculiar characteristics - added Schillaci - In fact, it makes it compulsory for doctors and health professionals to enter the data relating to each implanted prosthesis and each removal operation.
Furthermore, its management is in the hands of the Ministry of Health with a guarantee of independence in the collection and reading of data.
This does not happen in the world, where the registers are most often managed by scientific societies and the data entered voluntarily”.
For the minister, the new tool "will be useful for the industry sector which will be able to improve the effectiveness, performance and biocompatibility of devices, for the scientific world and, above all, for patients".