Breast implants, more guarantees for women who choose them for aesthetic purposes or after cancer

Breast implants, more guarantees for women who choose them for aesthetic purposes or after cancer

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Of 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 currently 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 obligatory 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” he 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 professionals who implant or remove breast prostheses on the national territory to record every single operation carried out, within three days from 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, monitor patients who have undergone prosthesis implantation both for aesthetic purposes and for reconstruction after cancer. So we can prevent complications and improve the clinical care management of any unwanted effects or unexpected long-term consequences. Second, thanks to this system we can track patients promptly in case of necessity. Third, collecting data is very useful for scientific study and research purposes, to evaluate theeffectiveness and safety of the devices in the short and long term».

The case of the defective Pip prostheses, in France 2011

Memory runs fast «Pip affair»: in 2011 in France around two thousand women had filed complaints 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, the French health authorities reported the increase in a particular form of blood cancerThe anaplastic large cell lymphoma (so-called BIA-ALCL), which appeared linked to several types of breast implants.

The alarm had been great, all over the world, and the fear of women even more. 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 does appears after repeated episodes of seroma (accumulation of serum around the capsule that lines the prosthesis) or when a severe capsular contracture (hard, fibrous membrane that lines 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 controls are therefore essential which are recommended to prosthesis wearers: 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 they have one average duration of 10-15 years – concludes de Fazio -. Is that they are “foreign bodies” so the organism reacts to their insertion trying to isolate them: the seroma (i.e. the formation of liquid in the area where the prosthesis was positioned), a local infection, 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, there are approximately 57,000 breast implants are sold on average every year (data 2011-2022): the 63% are implanted for aesthetic purposesThe 37% for reconstructive purposes. From the Ministry of Health database, in 2022, 613 accident reportslargely due to device failure.

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 cosmetic or reconstructive reasons, are class III medical devicesthe 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 for the long term, that is, for a period exceeding 30 days. For this reason they are classified as class III medical devices.

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April 2, 2024

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