Radiology highlighted: CBR member may be the Big Winner of the Euro Innovation in Health Award

We interviewed Dr. Eduardo Fleury, a radiologist associated with the College, Professor of Radiology of the undergraduate course in Medicine at Centro Universitário São Camilo, coordinator of breast imaging at IBCC Oncology and physician responsible for one of the 100 best initiatives of the Euro Innovation in Health Award , being selected among 1,650 other innovation initiatives by a highly qualified bank.

The new phase of the award consists of open voting for doctors on the Euro Award website (premioeuro.com.br), where the 11 finalist initiatives will be chosen. The criterion for classification is the highest number of votes. “I would be very happy to be able to represent my specialty in this final stage, and for this reason I count the votes to qualify”, he points out.

Also check out this short video prepared by Dr. Eduardo: https://www.youtube.com/watch?v=Yn6NpLltnRI&t=112s

Tell us a little about your initiative and how it came about.

I have worked at IBCC - Oncology for four years. I was invited to coordinate the hospital's breast imaging service. Since the beginning, we have implemented six lines of research in our area of activity registered in Plataforma Brasil, all original. As a result of these researches, we had a master's degree, a doctorate and a postdoctoral degree from doctors in our service. There were 21 articles published in international magazines and three awards at international congresses.

One of these works is the one that is competing for the Euro 2020 Prize. We describe a new disease related to breast implants, Silicone Induced Granuloma in the Breast Implant Fibrous Capsule, in English Silicone Induced Granuloma of Breast Implant Capsule - SIGBIC. We had a case of Anaplastic Large Cell Lymphoma (Breast Implant-associated Anaplastic Large Cell Lymphoma- BIA-ALCL) in 2017.

After three months, we had the second suspected case: the patient had all the MRI signs and clinical manifestations that led to the diagnosis BIA-ALCL. However, the biopsy result came negative, closing the diagnosis as capsular contracture. However, the patient had very relevant imaging changes, which were not compatible only with the histological diagnosis. It was requested to review the slides where silicone corpuscles were observed in the fibrous capsule associated with an inflammatory process and granulation tissue. The interesting thing is that the implant was intact.

Since then, we have decided to implement a protocol in our service to assess changes in breast implants by Magnetic Resonance Imaging (MRI), correlate with ultrasound, with clinical data and histological results. We found common MR findings in many patients, which were not yet described in the literature. We describe three MRI findings that were specific to the diagnosis:

  1. Black drop sign; 2. Mass with hypersignal in the T2 sequence; and 3. Late contrast enhancement. When together, they achieved great specificity. The three findings are original and described by our group.

As the findings were new, together with the Pathology Service of our hospital, we described original criteria for the histological classification of granulomas. We also correlated the histological findings with those found by imaging methods, all of which are original.

From the beginning, 4,665 women who underwent breast MRI examination in an observational, prospective study were evaluated. Of these, 1,535 had breast implants. When the findings were present, all patients in the initial phase for validation of the findings were submitted to percutaneous biopsy or capsulectomy.

Based on our findings and when correlating with the findings described in the BIA-ALCL literature, we question the origin and denomination of the BIA-ALCL. Our study has numerous similarities between the BIA-ALCL and the SIGBIC, both in terms of imaging methods, clinical presentation and histological findings. We speculate that both pathologies are caused by microscopic silicone leakage in healthy breast implants. They are due to an inflammatory response in the fibrous capsule by the foreign body, polydimethylsiloxone (PDMS), which alone is a structure that can be toxic in some patients. The immune response can vary in degrees, the more indolent the SIGBIC (polyclonal CD30 negaitvo) and the more aggressive the BIA-ALCL (monoclonal CD30 positive).


How has this initiative contributed to those involved?

At the beginning of the study, we observed that many patients who had the findings that MRI of SIGBIC had common clinical complaints, such as volumetric enlargement of the breasts, inflammatory process in the compromised breast, joint pain and skin rash. Many of these patients had no closed diagnosis, despite specific clinical complaints, and were treated by rheumatologists, dermatologists and allergists. Generally, complaints of origin to be clarified, of idiopathic origin, were considered, and empirical treatments were instituted without improvement.

At the same time, many patients met on social networks (such as Facebook) to report changes that were credited to breast implants, and called the changes Breast Implant Illness (BII). The reports of these patients were very similar to those described by our patients. When analyzing the MRI exams of some of these patients, we found the three characteristic signs of SIGBIC by MRI, inferring silicone leakage.

In addition to providing the diagnosis of the causative factor of this disease, the diagnosis of SIGBIC also acts in the management of these patients, where it is oriented when performing the replacement of the implant or its removal. When the option is withdrawn, it is recommended to perform a capsulectomy en bloc. We saw that, when there was a remnant of the fibrous capsule in these patients after surgery, many patients evolved with recurrence of the condition, often with very early intracapsular collections.

Until then, patients with complaints of changes related to breast implants, either had a diagnosis of BIA-ALCL or were considered to be normal evolutionary changes without a specific causal factor. However, today in the world we have only 700 cases of BIA-ALCL described in the literature (2 in our service), while we found 613 cases of SIGBIC (39.93% of cases) in our patients. The high prevalence of these findings in our population was something that caught our attention, and the diagnosis of SIGBIC helped the patients to choose the best management with the diagnosis made. Especially, we rule out the possibility of being of psychological origin, which haunted large parts of these patients. It is interesting, that the findings were validated in the other services in which I work, with the same incidence reported in the IBCC-oncology. We validated the results in a multicenter study.

Certainly, the most controversial part of the study is the questioning of the safety of silicone implants. We observed these changes in all types of silicone implants: saline, expanders, double-lumen, textured and smooth.


What are the challenges to put it into practice?

The challenges were enormous from the beginning of the study. First, because it is a new disease that was not described in the literature, with new specific findings for its diagnosis. As we have created specific nomenclatures, we are very reluctant to accept the findings of the requesting doctors. Second, without the help of plastic surgeons and pathologists, who encouraged us in research and provided all the support with surgical and histological information, the study would be impossible to validate.

Twice, we almost had to finish the work when the findings described by MRI were not confirmed by histology. As we describe new findings, false negative results were not desired. That is why the inclusion of three criteria to make the diagnosis of SIGBIC. These two cases were of patients from external services. We contacted the pathologists and requested the revision of the slides to search for silicone corpuscles. In both cases, silicone granulomas were found, which encouraged us to continue the study.

From the beginning, we linked silicone disease to the patients' immune response. This was a reason for fighting with some American surgeons who refuted the theory, especially in the development of the BIA-ALCL. Nowadays, these surgeons recognize the role of the immune system in the etiology of this disease following criteria similar to those proposed in our first studies.

As it is a new disease related to breast implants, an aesthetic and reconstruction procedure widely performed in our country, the initial acceptance was quite complicated. Strategically, we chose not to disseminate our results at the beginning of the study until the findings were validated. During this period, we submitted several articles in radiology, immunology, mastology and plastic surgery journals describing SIGBIC. It is worth mentioning that the first presentation of the theme was a panel at the Jornada Paulista de Radiologia 2017. Today we are quite sure of our findings, with the knowledge of the pathology from its formation to its treatment.

We also created a blog, sigbic.org, to facilitate communication with patients and doctors of other specialties, nonprofit.


And the idea of participating in the award, when did it come up?

IBCC- Oncology has its own research center, which encourages research at the institution. Today we develop artificial intelligence work for Radiology in the service. We developed three softwares for diagnosis of breast diseases that are already being used in our clinical practice. When the representative of Eurofarma, a pharmaceutical company that exclusively sponsors the award, communicated our study center about the award, we were encouraged by the board to participate. We chose the work on SIGBIC to represent us since it was the most robust work, with the largest number of publications, original, and that had a direct impact on the lives of patients.


How does it feel to have your initiative among the winners and the possibility of being the big winner?

The sensation is indescribable. When we start a survey, its initial objective is to contribute to the population that is being affected by it. An exchange is not expected, it is a one-way street. Our satisfaction is to know that we are contributing to improve the life of the population. Until then, the biggest reward is seeing your work cited and validated in other publications. This is perhaps the researcher's greatest recognition.

However, when you participate in an award for medical innovation, open to all doctors in the national territory, where there are 1,650 registered initiatives that pass through the sieve of an extremely graduated examining board, and your work is selected among the top 100, the sensation goes beyond any feeling of satisfaction. Especially for the duty done.

The new phase of the award consists of an open vote for the medical sector on the PREMIOEURO website, where the 11 finalist initiatives will be chosen. The criterion for classification is the highest number of votes. I would be very happy to be able to represent my specialty in this final stage, and for this reason I count the votes to qualify.

It is worth mentioning the quality of the works that were registered, especially those selected for this final phase. I believe that our work includes the requirements to reach the final due to originality, application in clinical practice, changes in the management of patients and the number of publications made.


How does the doctor analyze the role of doctors, in general, when it comes to innovation? And specifically about radiologists, how is this performance from your point of view?

I believe that the Brazilian doctor has innovation in the blood. We almost always have to work with much scarcer resources than in first world countries, there is a socio-economic constraint in order to develop work. However, this means that we have acquired enough creativity to overcome this economic barrier. We also have a factor that is paramount for research, which is the doctor-patient relationship in our country, where the patient has great confidence in our work. The collaborative character of Latinos also greatly facilitates the development of research, especially when it is multidisciplinary.

I always say that I was born a radiologist. I come from a family of doctors. My father is a radiologist. I grew up in the darkroom. Our specialty is fantastic. Before becoming a breast specialist, I am a radiologist. Virtually all hospitalized patients do at least one imaging study during the period of hospitalization. The radiologist is the main link between all specialties in multidisciplinary meetings. We have knowledge of anatomy, pathophysiology, histology and clinical manifestation of diseases. In a hospital like ours, we are present in the clinical routine, participating in multidisciplinary meetings, making diagnoses and discussing patients' behaviors and management. We received a lot of information. We are not nodulologists, but information hunters. It is with great satisfaction that I see a work like this having been conceived, developed and completed in the radiology report room.

In addition, when it comes to technology and artificial intelligence, we have the advantage of working with innovative and highly complex technologies, which makes us more adapted to current times.


In your opinion, what is the contribution of awards like this with regard to innovation in medicine?

Unfortunately, the incentive for research in Brazil is very embryonic. There is no incentive to encourage young people to follow this path. Researches are usually carried out with their own resources, and require a long period of dedication, with a return that is not measurable. Awards like this encourage young people to embark on this path of research, which is very important for the consolidation of our society in the international community.

Dr. Eduardo Fleury - Titular Professor of Radiology of the Graduate Course in Medicine at Centro Universitário São Camilo; Member of clinical staff of doctors at IBCC Oncology; Coordinator of breast imaging at IBCC Oncology; Post-Doctorate in Health Sciences by the Faculty of Medical Sciences of Santa Casa de São Paulo - FCMSCSP; PhD in Medicine (Tocoginecology) from the Faculty of Medical Sciences of Santa Casa de São Paulo - FCMSCSP; Titular member of the Brazilian College of Radiology (CBR); Specialist in Diagnostic Imaging by the Brazilian Medical Association (AMB); Graduated in Medicine at the ABC Medical School - FUABC. Member of the editorial board of European Radiology and European Radiology and reviewer of journals: European Radiology Experimental; American Journal of Roentgenology - AJR; Diagnostic and Interventional Radiology - DIR Journal; Magazine of the Brazilian Medical Association - RAMB.
EUROPEAN UNION: European Diploma in Breast Imaging (EDBI); Active Member of the European Society of Breast Imaging - EUSOBI; Active Member of the European Society of Radiology - ESR; Equivalence of Degree in Medicine by the Faculty of Medicine of the University of Minho - UMINHO.

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