Dear ACR BI-RADS committee members 

 

I respectfully come through this open letter to make some remarks regarding the BI-RADS lexicon new edition, which will come into force from the year 2023 in its sixth edition, preliminarily made available by the Society of Breast Imaging (SBI) in the form of a brochure with the title of “BI-RADS: THE NEXT EDITION.” 

There is no reference to changes in the lexicon in this preliminary version concerning silicone implants. 

The contribution of the BI-RADS lexicon to the improvement of our specialty is indisputable. There is no doubt that BI-RADS has changed how we report on breast studies. Standardizing reports makes it possible to improve the reproducibility and auditing of radiology services and facilitate communication between physicians. BI-RADS is a successful case extended to other radiology specialties. We are model enthusiasts. 

I have been a radiologist since 2000, board-certified, with a doctorate and postdoctoral degree in Medicine, Researcher, and Graduate Professor in Diagnostic Imaging. 

Since 2017, we have developed a research protocol regarding silicone breast implants. Our group accompanies women with silicone implants from imaging studies, including MRI and Ultrasonography, through clinical follow-up, biopsies when necessary, and, finally, explant surgery or implant replacement. We follow up and monitor these patients. During this period, we accumulated vast material from more than 4,000 patients. We correlated the clinical conditions, the imaging findings, the histological alterations of the fibrous capsules, and the microscopy of the implants removed from the patients. This material supported our publications in digital libraries, easily accessed over the internet at PUBMED. All data are available in public repositories and accessible upon request from authors. 

We observed changes related to silicone implants that did not have compatible descriptors in the BI-RADS lexicon during the study. Our study protocol describes the possibility of MRI to diagnose silicone gel bleeding in silicone breast implants without evident signs of rupture at MRI, described as silicone induced granuloma of breast implant capsule (SIGBIC). Our group follows up with the patients diagnosed with SIGBIC during the period of diagnosis. Our current data demonstrate that the diagnosis of SIGBIC serves as a marker for these women. When present, the findings indicate a compromised fibrous capsule by silicone. Women diagnosed with SIGBIC are more likely to develop complications related to their implants, where the imaging diagnosis facilitates the monitoring and management of these patients. It is worth mentioning that other findings associated with SIGBIC and gel bleeding gel were still objects in our publications. 

Our studies followed all research protocols. We made a theory, which generated a validation study and confirmed the applicability in clinical practice. 

Until 2015, we ignored these findings, and our reports followed the descriptors proposed by the BI-RADS lexicon. However, we observed that with the new generations of silicone implants, especially with cohesive gels and surface alterations, the lexicon descriptors have become inefficient in classifying them. By strictly following what the lexicon recommends, we limit the diagnosis for our patients regarding silicone implants and Breast Implant Illness (BII). 

Given the strong evidence of the correlations of clinical manifestations, changes presented in imaging methods, surgical findings, and microscopic evaluation of the implants in 2019, we decided to introduce our SIGBIC findings in our reports, under our responsibility. Since then, we have helped diagnose and manage countless patients worldwide, most with a diagnosis of Silicone Disease and who did not have the diagnosis of their pathology. These patients complain about the discredited of conventional medical practice regarding their pathology. Our results in this period encouraged us to continue reporting our findings. Silicone disease is real, and the improvement of patients with the diagnosis after the explant is surprising. 

When we ignored the changes in the implants in the imaging methods until the year 2015, it was forgivable not to carry out the diagnosis. Since we have tools to perform the diagnosis, and we do not report the findings because there is no formal recommendation from our medical entities, the non-description of the findings can be interpreted as negligence or omission, under the Hippocratic Oath. To paraphrase Joshua Ferris: “It is forgivable to say nothing out of ignorance; it is inexcusable to remain silent once awereness dawn”. 

Due to the current circumstances, we came through this open letter to position the ACR that we will continue using the proposed terms in our practice if the BI-RADS Committee does not provide a descriptor alternative. An extensive scientific production supports our descriptors. 

We strongly recommend radiologists training to correct describe, classifify, and report the silicone capsules changes.  

We make ourselves available to present and discuss our findings to improve our specialty and offer the best diagnosis for our patients. 

 

Prof. Dr. Eduardo de Faria Castro Fleury