The relationship between textured breast implants and anaplastic large cell lymphoma (or Alcl), a rare form of cancer, is more than likely. He established it in April it Scheer, the scientific committee that advises the European Commission on the subject of emerging health risks, in what represents the first confirmation of the danger (albeit minimal, it should be remembered) by a scientific body of international importance. Our Ministry of Health, however, reported a different conclusion. In fact, until yesterday on the ministry’s website it was read that Scheer’s report had established “the absence of scientific evidence regarding the possible correlation between the onset of this pathology and breast implants”.
An official complaint
An interpretation that prompted the scientific committee of the European Commission to send an official complaint to the Italian Ministry of Health, inviting it to be promptly corrected because the incorrect interpretation of the report’s conclusions “can cause damage to the health of European citizens”. Repubblica has contacted the Ministry of Health to ask for a comment, and we are awaiting a response. Meanwhile, on the website the sentence relating to the report has been changed: instead of “absence of scientific evidence” it now reads “absence of high levels of scientific evidence”.
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What could have misled the ministry technicians? In its reports, the Scheer’s panel of experts uses a scale with five levels of certainty to express the weight of the available scientific evidence. In our case, the final opinion of the experts speaks of a “moderate level of scientific evidence” supporting a causal link between textured prostheses (“rough” prostheses, more common in Italy and Europe than smooth ones) and lymphoma Alcl. A technical definition, which someone in the ministry may have misrepresented: moderate in this case is the fourth level of probability, above which there is only a “strong” level of evidence, which is practically equivalent to scientific certainty.
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“I can’t explain how they could have interpreted our conclusions so wrongly,” he tells a Salute Fabio Santanelli di Pompeo, Professor of Plastic Surgery at Sapienza in Rome who, together with 9 other world experts, evaluated 605 scientific researches to draft Scheer’s opinion on textured prostheses. “I knew that this incorrect information was circulating, and I had thought of a fake news, not an error on the Ministry’s website. What is certain is that it is an error that has put the health of Italian and European citizens at risk, preventing to make informed choices about their health “.
And he explains: “Our final opinion – he specifies – established exactly the opposite of what was reported by the Ministry of Health, and consequently by many national media: the correlation between textured prostheses and Alcl lymphoma is almost certain, there is strong epidemiological evidence and important clues on the underlying etiopathogenetic mechanisms. Speaking of a recently identified neoplastic pathology, a higher level of certainty is almost impossible, but already a moderate level of scientific evidence can, and must, direct the choices of the authorities towards the precautionary principle and consequently also those of doctors and patients “.
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Incidence greater than 67 times
According to Santanelli di Pompeo, in fact, the available data already in 2017 show a much higher incidence of Alcl in women who have breast implants: about 67 times higher than that of the general population, even more in 2020 or taking into consideration only the wearers of textured prostheses. It is also known the mechanism by which the local inflammation generated by textured prostheses can predispose to the onset of lymphoma. “Basically – explains Santanelli di Pompeo – what is missing in order to classify the evidence of the correlation as strong is the certainty of the etiological mechanisms with which the textured prostheses give rise to the inflammation that causes the tumor, but it is a small matter: not we know if it is the formation of a bacterial biofilm, if it is the friction caused by the rough surface, if they are toxic substances present in the prostheses or if instead the problem is the particulate coming off the device. For this we cannot say that the correlation is strong, but it does not mean that it is a simple possibility among many: that the textured prostheses can very rarely cause the appearance of an Anaplastic Large Cell Lymphoma is almost a certainty, and patients have the right to be correctly informed before decide to undergo surgery “.
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