This week, in the Health Breast newsletter (here the link to register for free) we return to talk about breast implants and the possible increased risk of a very rare form of lymphoma that has only been associated with implants with a rough surface.
We do this because there is a certain buzz: companies are developing the sixth generation of prosthetics and funding research. And one of these – conducted by none other than MIT in Boston, in collaboration (among others) with the MD Anderson Cancer Center in Houston – has just been published in the pages of an important scientific journal, Nature Biomedical Engineering.
For the first time, the way in which the cells of the immune system react to the implantation of different types of silicone breast implants has been analyzed: the results show that those with a rougher surface give rise to a greater local inflammatory state which can result in this particular lymphoma. Rough textured implants were introduced in the 1980s and today are the most widely used for breast reconstruction after cancer, as they are generally considered to be better than smooth ones.
What does lymphoma have to do with prostheses
We speak of “anaplastic large cell lymphoma associated with breast implants” (BIA-ALCL, acronym for Breast Implant-Associated Anaplastic Large Cell Lymphoma), because it develops right next to the implant. This lymphoma affects T lymphocytes, which are cells of the immune system. It is not an aggressive disease: it proceeds slowly and, if caught early, almost always resolves with the “en bloc” removal of the prosthesis and periprosthetic capsule, even if chemotherapy or radiotherapy are sometimes required.
Furthermore, as mentioned, the incidence is very low: in the USA, for example, where 400,000 prostheses are implanted every year, about 450 cases have been registered since 2010, while in Europe today there are 468. “In reality However, 95% of implants implanted in the US have a smooth surface and, if we consider only women with rough or very rough prostheses, the probability of lymphoma occurring increases, ranging from 1 case every 86,000 to 1 every 2,300 women , depending on the type of prosthesis, “he points out Fabio Santanelli di Pompeo, director of the Plastic Surgery Operating Unit of the Sant’Andrea Hospital and professor of plastic surgery at the “Sapienza” University of Rome: “This must be said not to generate alarmism, which is not justified, but because it is It is important that women know that there is a possible risk, so that they are also correctly informed of the type of prosthesis that has been – or will be – implanted, that the activation of the breast implant register is finally completed. small entity, does not bring any advantage: all women, and even more so patients who put a prosthesis after a tumor, must have the information to evaluate the risks and benefits. In particular, in their case the genetic predisposition to tumors could increase , according to the Memorial Sloan Kettering Cancer Center in New York, this risk is up to 1 case for every 335 women with prostheses “.
History
Here is a brief summary of the story that has brought us this far. The first suspicions of a possible association between rough implants and anaplastic large cell lymphoma occurred in 2011, when the US Food and Drug Administration reported that an abnormal number of cases involved the area around the breast implant in women who had performed a aesthetic or reconstructive surgery. Later, in 2016, the World Health Organization recognized and defined this particular and very rare form of implant-associated lymphoma.
Breast implants and lymphoma, 13 models withdrawn in France
by GIULIA TONIUTTI AND TIZIANA MORICONI
In 2017, in Europe, the Scientific Committee on Health Environmental and Emerging Risks (SCHEER) of the European Commission recommended that scientific societies conduct a more in-depth assessment since, given the low incidence, the data did not allow for a risk assessment. Meanwhile, France has been moving on its own since 2011, with a surveillance program promoted by the Direction générale de la santé, and since April 2019 it has banned 13 models of rough prostheses. The rest of the world would follow her just three months later.
Breast implants related to lymphoma risk withdrawn worldwide
by MARIA TERESA BRADASCIO
What the latest European report says and the Italian “discrepancy”
The last chapter of the story dates back to last March, when SCHEER published a new report. The conclusions? Today we can say that there is a causal link between the implantation of textured breast implants and the development of BIA-ALCL, with a “moderate degree of evidence”. Yet, to date, the website of our Ministry of Health reports that “the Scientific Committee on Health Environmental and Emerging Risks (SCHEER), again questioned on the safety of breast implants in relation to the BIA-ALCL problem, declares the absence of scientific evidence regarding the possible correlation between the onset of this pathology and the prosthesis mammary“.
Faced with this confusion, it is legitimate to ask: is there evidence of an increased risk or not? “It should be emphasized – comments Santanelli – that the moderate grade, 4th on a scale of 5 degrees, is the strongest that can be assigned on the basis of the primary epidemiological evidence alone”, explains Santanelli di Pompeo, who collaborated in the drafting of the document: “The team in charge of SCHEER worked for 18 months with six selected experts from all over the world to arrive at this conclusion. While knowing the role of genetic predisposition and, at the cellular level, the pathogenetic mechanism of chronic inflammation, that what is still missing is the explanation of what exactly causes this inflammation that can trigger the development of lymphoma “.
Breast implants and cancer development: minimal risks, but patient records are needed
by Simone Valesini
The MIT studio
The new study attempts to shed light on this very aspect. The names of the scientists involved are important: the senior author is Robert Langer, a chemical engineer at MIT in Boston, one of the main financiers of the Moderna company (yes, that of the vaccine for Covid-19), and who also owns shares in the company that sponsored the research, Establishment Labs.
The experiments were conducted on animal models (rabbits and mice), reproducing miniature breast implants from 5 commercially available models, and in vitro tests were performed on cell lines. The results were then crossed with the analyzes carried out on tissues taken from patients who had developed BIA-ALCL. The prosthesis models considered ranged from a smooth to a micro-textured surface with “tips” of just 4 microns (thousandths of a millimeter) in height, up to a heavily textured surface (with “tips” of 80 microns).
Researchers observed that the surface of a prosthesis can strongly influence the immune response and that, by acting on the architecture, this response can be modulated to minimize inflammation and the formation of fibrotic tissue. The less rough the surface, the better for the tissues that receive it, although the slightly rough texture (4 microns) was less pro-inflammatory than the smooth one. Much remains to be understood, however, about how the immune system orchestrates its response to the prosthesis.
The next steps
“There is great interest – concludes Santanelli di Pompeo – and our research group at Sapienza is also conducting an independent study in this area at the Istituto Superiore di Sanità, funded by various manufacturers of competing prostheses. with comparable results that will be published shortly. In the meantime, the message for patients who have implants is not to be alarmed, but simply to pay a little more attention to the onset of possible symptoms such as enlargement of one of the two breasts which may be due to the formation of a seroma, possibly talk to experienced doctors and continue to do the normal checks “. New updates are expected for next October, when the third edition of the World Consensus Conference on BIA-ALCL will be held in Rome, organized by Santanelli himself together with one of the authors of the new study, Mark Clemens, dell’MD Anderson Cancer Center.
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