The Report

Breast cancer, more than 9 out of 10 implants inserted immediately after mastectomy

For aesthetics Campania is at the top while Lombardy attracts more patients for 'curative' purposes: the geography of operations in the National Register of Breast Implants as a prelude to the Single Register of all medical devices expected by the end of the year

by Barbara Gobbi

 (AdobeStock)

6' min read

Translated by AI
Versione italiana

6' min read

Translated by AI
Versione italiana

Ninety-two per cent of breast prostheses in the reconstructive field - i.e. mostly following a neoplasm - were implanted in Italy immediately after a conservative mastectomy, i.e. with skin and nipple sparing. This is the most relevant data for patients, among those lined up in the National Register of Breast Prosthesis Implants - officially established in 2012 but active since 2023 - and of which the 2023-2025 Report was presented at the Ministry of Health. A fundamental compass for verifying safety - thanks to full traceability of implants on real-world data - and costs in terms of evidence-based healthcare planning. "This registry shows how we were the first in Europe to try to track these devices all along the way, also with a view to monitoring public spending. This should not be understood as a limitation but as a possibility to spend better, which frees up and therefore generates resources,' stressed Daria Perrotta, State Accountant General.

Schillaci: tests for the efficiency of the SSN

Elements that Health Minister Orazio Schillaci wished to highlight: 'The register of breast prosthetic implants is a feather in the cap of our healthcare system,' he emphasised. 'Italia is the only country to have made it compulsory to enter data, and this gives us a complete and homogeneous picture. Data collection takes place in real time, which allows us to be constantly updated. A guarantee of safe patient care,' he pointed out, 'but also a tool for monitoring effectiveness and efficiency and a support for innovative and evidence-based health planning. The data show more than 68,000 surgical operations, and almost 56 per cent for reconstructive purposes,' the minister summarised, 'while the rest for aesthetic purposes. The numbers give the measure of our health welfare and also of its ability to guarantee fair access to treatment. The Report shows that in the reconstructive field, when there is a breast neoplasm, in 92% of cases the prosthesis is implanted immediately after a conservative mastectomy. A figure that reflects the effectiveness of cancer screening: with these tests, timely diagnoses are increasing and also the recourse to demolition-conservative surgery and breast reconstruction at the same time. For patients who do not have to undergo a new operation at a later date, this equates to a better quality of life and greater psychological well-being. In short, this is a fact of clear efficiency of our health service and respect for people'.
The Report nevertheless reveals a rate of passive mobility that is "still too high in the southern regions, up to 85% of operations carried out outside the region," the minister warned, however: there are territories where action must be taken to guarantee equal access to care.

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To the Device Register

The register on breast prostheses - with compulsory compilation and 'real time' with 80 thousand patients now under close clinical monitoring and more than 141 thousand surgical procedures under careful study and over 137 thousand prostheses already implanted - is a sort of 'dress rehearsal', at the basis of the 'Single National Register of Implantable Medical Devices' bill - the text of which will monitor the 500 thousand existing implantable medical devices that cater for an expenditure of 7 billion - as Health Undersecretary Marcello Gemmato announced, "has been hinged in the Senate and we hope to dismiss it by the end of the year". "We intend to promote a governance model: the Single Register of Implantable Devices will bring about an important paradigm shift that will allow us to monitor what is being done in healthcare facilities and to be able to intervene in the event of anomalies and inefficiencies. The role of the Regions will also be fundamental in the implementation of the IT platform, and we will have to continue along this path,' explained Francesco Saverio Mennini, Head of the Department of Planning, Medical Devices, Drugs, and Policies in Favour of the NHS.

Data

Between 1 August 2023 and 31 December 2025, 68,776 surgical procedures were registered. Of these, 55.7 per cent were performed for reconstructions and 44.3 per cent for cosmetic purposes. A total of 66,796 operations involved the implantation of a breast implant, while 1,980 operations involved removal. The total number of implants was 112,924, while 33,605 implants were removed. In the reconstructive field, in 71.1% of cases, implantation was performed following a diagnosis of breast neoplasia, mainly after mastectomy with skin and nipple sparing. In the presence of a breast neoplasm, in 92% of cases the prosthesis was implanted immediately after a conservative mastectomy: 'a figure - the ministry noted - that reflects the effectiveness of screening and the increase in early diagnosis that favours conservative demolition surgery and breast reconstruction in a single time'.

The geography of plants

37.4 per cent of the operations were performed in public facilities, 33.6 per cent in private facilities - where breast augmentation is mostly performed for aesthetic reasons - and 29.0 per cent in accredited private facilities. Two-thirds of implants are therefore performed in public facilities.
The map of Italia is coloured differently when looking at the different implant purposes: for cosmetic surgery, it is Campania (followed by Lombardy and Lazio) where the largest number of operations for aesthetic purposes are performed; while for the reconstructive part, Lombardy is at the top, attracting the most patients (Lazio is second) and mostly from the South and the Islands. From Basilicata and Molise, we only go to Lazio, Campania and Apulia, and there is 100 per cent passive mobility: all patients are forced to go to other regions for both aesthetic and reconstructive post-mastectomy operations. Campania, which has the highest number of operations, has the lowest mobility rate.

We are talking about different populations: on the one hand, we are talking about patients who want to increase the volume of their breasts (77%) or restore their shape and volume. And they return to the operating theatre, in 32% of cases, because they are not satisfied with the result. This is followed by the two most frequent phenomena of capsular contracture and implant rupture.

Post-cancer interventions

For reconstructive reasons, one mostly goes to the operating theatre following a diagnosis of breast cancer or because the patient has a high risk of developing breast cancer (prophylactic mastectomy) or if one wants to correct chest wall deformities that have also involved the breast. If Lombardy is the first pole of attraction (and the lowest for passive mobility), it is from the Islands that the largest share of patients arrives here. Reconstruction is supported by the National Health Service, but in Campania, Sicily and Lazio there is a large private presence. The register also tells us that in 71% of cases the prosthesis is implanted because there is a breast tumour: it becomes a useful tool to understand the evolution of assistance and the quality of care.
There are more than 53,000 new diagnoses of breast cancer in 2024 alone, and if we look at the analysis of the Sdo flow over the last 10 years, there has been a progressive reduction in partial breast demolitions over time, against a doubling of mastectomies, which have gone from 8% in 2010 to 16% in 2024. This means that if we have women who have a high number of mastectomies and the survival rate is 88% at 5 years, and today there are more than 925,000 women diagnosed with cancer, it becomes essential that the National Health Service guarantees them a good quality of life with a new image and a new body. When one speaks of demolition treatment, therefore, one cannot but think of reconstructive treatment. And in fact the latter has increased over time: in 98% of cases, (in fact 'the') patients are reconstructed precisely with breast implants, hence the importance of having a compulsory register with which to monitor the recipients of implants and oversee their safety. Although mastectomies have increased, it is also true that 92 per cent of reconstructions performed today in Italy after breast cancer take place immediately after conservative mastectomies: which means that on the territory 'we are working well,' the ministry warns, 'and that early diagnosis and screening is working. Because if a woman can undergo a conservative mastectomy, it also means being able to carry out immediate reconstructions with better aesthetic results.

Half life with chemo and radio

Then the Breast Implant Register says that after reconstruction women return for capsular contracture and rupture, and here comes the first data, chemo and radiotherapy condition the duration of implantation for the onset of capsular contracture. While patients who implant the prosthesis for aesthetic purposes return for capsular contracture after ten years, for post-cancer women the re-entry occurs after not even five years. A critical element that is being further investigated. "What we are doing is not just collecting data but transforming them into value for patients, moving from intuition to knowledge and from fragmentation to systemic vision. Analysing and reading this data better means taking better care of people,' clarified Antonella Campanale, medical director of the DG Medical Devices, Pharmaceutical Service and Safety of Care of the Ministry of Health.

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