by Vera Martinella
The national register which collects data relating to all devices implanted in Italy is now active. Their traceability is thus ensured and the safety of those who carry them is improved. In our country 57 thousand are sold per year
It was established by law in 2012 and, after 12 years, it is now finally active: the National registry of breast prosthetic implants it became operational in 2023 and to date it collects the implantation or removal operations of each breast prosthesis carried out in almost all of Italy. «Almost all» because the national register is fed with data arriving from regions and autonomous provinces and only Basilicata is missing, which has not yet started its own regional register.
Despite the long process, our system is a model to follow for other countries: «We are among the first in the world: our Registry is the only mandatory one and the only one managed by the highest national authority on health (the ministry of Health, ed.), two decisive elements for the vastness and objectivity of the data collected” clarifies Stefania de Fazio, president of the Italian Society of Reconstructive-Regenerative and Aesthetic Plastic Surgery (Sicpre).
The three objectives of the Registry
The ministry has made one available technological platform where specialists can (and must) record the surgical procedure performed.
In practice, with the entry into force of the Regulation it becomes mandatory for all healthcare workers who implant or remove breast implants on the national territory to record every single operation carried out within three days of the date of execution. Furthermore, distributors of breast implants must transmit information, on a monthly basis, on every single device marketed in Italy.
For what reason? «The objectives of the Registry are essentially three – replies de Fazio -: first, to monitor patients who have undergone prosthesis implantation both for aesthetic purposes and for reconstruction after a tumor. In this way we can prevent complications and improve the clinical care management of any unwanted effects or unexpected consequences in the long term. Second, thanks to this system we can track patients promptly if necessary. Third, collecting data is very useful for scientific study and research purposes, to evaluate the effectiveness and safety of devices in the short and long term over time and on many people.”
The case of the defective Pip prostheses, in France 2011
Memory runs quickly to the “Pip affair”: in 2011 in France around two thousand women filed a complaint against the Pip (Poly implants prothesis) company accused of producing defective prostheses using poor quality material (the same used to seal cracks in taps and showers). Then, in 2015, French health authorities reported the increase in a particular form of blood cancer, anaplastic large cell lymphoma (so-called BIA-ALCL), which seemed linked to different types of breast implants.
The alarm was great, all over the world, and the fear of women even more so. Especially those who wore prostheses after having undergone a mastectomy for breast cancer. At the time it was very difficult (in some cases impossible) to track down the women who had to remove the implants “offending”, with the current Italian registry it would be a quick and simple operation.
Anaplastic lymphoma: what is known today
«As for the rare cases of lymphoma, today it is estimated that they occur in three patients out of 100 thousand – explains Paolo Veronesi, director of the Senology Program and of the Surgical Senology Division of the European Institute of Oncology in Milan -. It is not yet entirely clear why the tumor develops, but we know that it generally appears after repeated episodes of seroma (accumulation of serum around the capsule that lines the prosthesis) or when there is severe capsular contracture (hard and fibrous membrane that covers the prosthesis), mostly in wearers of “textured” prostheses with a rough surface. And if the disease is diagnosed early, surgical treatment is sufficient, which consists of completely removing the breast implants with the capsule that covers them.” In addition to the Register, the checks recommended to prosthesis wearers are therefore fundamental: usually one ultrasound scan per year and, in doubtful cases, we proceed with magnetic resonance imaging.
Prosthetics are not eternal
«Finally, we must remember that prostheses are not eternal, but have an average lifespan of 10-15 years – concludes de Fazio -. And which are “foreign bodies” for which the organism reacts to their insertion by trying to isolate them: the seroma (i.e. the formation of liquid in the area where the prosthesis was positioned), a local infection, a capsular contracture or rupture of the prosthesis are events that can occur. As always in medicine, complications are possible.”
57 thousand prosthetics every year in Italy
In Italy, based on surveillance activities carried out at the General Directorate of Medical Devices, approximately 57,000 breast prostheses are sold on average every year (2011-2022 data): 63% are implanted for aesthetic purposes, 37% for reconstructive. The Ministry of Health database shows, in 2022, 613 accident reports, largely due to device breakage.
Public or private health workers who, in the exercise of their activity, detect an accident with any medical device, and therefore also with breast implants, are required to notify the Ministry of Health. All patients, following the implantation of a breast prosthesis, are issued a label containing the name of the manufacturer, the code, the batch and the serial number of the device. Copies of this label are attached to the operating report: if you lose the tag, by requesting a copy of the medical record, you will find all the data that identifies the implanted device.
Important to know
Breast implants, commonly implanted for aesthetic or reconstructive reasons, are class III medical devices, the highest risk class, regulated by Legislative decree 5 August 2022, n. 137 and from EU Regulation 745/2017.
The classification takes into account the invasiveness of the device, its
dependence on an energy source (active device) and duration
of contact time with the body. Breast implants are invasive devices because they are intended to remain in the body long-term, i.e. for more than 30 days. For this reason they are classified as class III medical devices.
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April 2, 2024
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