Why Is the Baker Classification Inadequate for Classifying Silicone Implant Fibrous Capsules?

Baker's clinical classification is adopted as the gold standard for grading complications related to silicone implants. Despite being widely used for this purpose, the classification has several limitations, highlighting subjectivity, reproducibility, and interobserver agreement. In this technical report, we aim to present the reasons for the inadequacy of the Baker classification for breast implants and the main factors contributing to false-negative results using recent theories of surface tension of fluids and gel bleeding. We also present an alternative classification proposal using magnetic resonance imaging of the breasts.

Comparative analysis of ultrasound-guided percutaneous biopsy of native kidneys in children and adults using the free-flank supine antero-lateral decubitus positioning.

PURPOSE: Ultrasound-guided percutaneous biopsy (USPB) of the native kidneys is the preferred diagnostic method for several nephrological conditions in both adult and pediatric populations. Conventionally, native kidney biopsies are conducted with patients in the prone position (PP). However, an alternative approach involving the supine oblique antero-lateral position (SALP) has been explored, particularly for individuals who are obese, elderly, or critically ill. METHODS: This study aimed to assess the feasibility and outcomes of USPB performed in SALP with a Free-Flank setting (FF-SALP) in pediatric patients (Group A) compared to adults (Group B). Data from kidney biopsies conducted between 2008 and 2021 were gathered. The study focused on the safety and the prevalence of biopsy samples containing a minimum of 10 glomeruli, histopathological yield in both groups. RESULTS: Complication rates were low in both groups (5.6% vs. 3.7%; p = 0.454), without major complications noted. The pediatric group achieved a significantly higher mean number of glomeruli per biopsy compared to the adult group (20.6 ± 12.3 vs. 15.7 ± 9.4; p < 0.001). However, when evaluating the minimum threshold of 10 glomeruli (76.3% vs. 68.5%; p = 0.072) and histopathologic yield (95.3% vs. 93.5%; p = 0.408), no differences were observed between groups. CONCLUSION: USPB of native kidneys in the FF-SALP position is a safe and effective method for tissue sampling in patients with parenchymal disease. It demonstrated comparable diagnostic yields and complication rates in the pediatric and adult populations, providing advantages in terms of airway management, making it particularly useful for pediatric patients that require general anesthesia.

Breast silicone implants' pericapsular impairment: current underdiagnosed status.

Many complications related to silicone implants have been reported recently, from clinical symptoms manifestations to association with some specific types of cancer. During the early 2010s, it was believed that implants were biocompatible and inert to the human body and that gel bleeding/leakage events were rare and without repercussions for the human body. However, at the end of 2010s, several studies pointed out that gel bleeding was more frequent than previously believed, and the pathogenic potential of free silicone should not be ignored. The Food and Drug Administration recommends performing magnetic resonance imaging in asymptomatic patients 5-6 years after implant placement. The descriptors in the Breast Imaging and Reporting Data System lexicon seem outdated for classifying the new generations of implants with cohesive gel, which hinders the diagnosis of device complications. In this review, supported by our research data publications related to silicone implants for 6 years on a prospective study protocol, most of them being original articles, we summarized the main complications observed in clinical practice and discuss the impact of these changes on patients' outcomes focusing on the pericapsular space.

A multicentre single arm phase 2 trial of neoadjuvant pyrotinib and letrozole plus dalpiciclib for triple-positive breast cancer.

Current therapies for HER2-positive breast cancer have limited efficacy in patients with triple-positive breast cancer (TPBC). We conduct a multi-center single-arm phase 2 trial to test the efficacy and safety of an oral neoadjuvant therapy with pyrotinib, letrozole and dalpiciclib (a CDK4/6 inhibitor) in patients with treatment-naïve, stage II-III TPBC with a Karnofsky score of ≥70 (NCT04486911). The primary endpoint is the proportion of patients with pathological complete response (pCR) in the breast and axilla. The secondary endpoints include residual cancer burden (RCB)-0 or RCB-I, objective response rate (ORR), breast pCR (bpCR), safety and changes in molecular targets (Ki67) from baseline to surgery. Following 5 cycles of 4-week treatment, the results meet the primary endpoint with a pCR rate of 30.4% (24 of 79; 95% confidence interval (CI), 21.3-41.3). RCB-0/I is 55.7% (95% CI, 44.7-66.1). ORR is 87.4%, (95% CI, 78.1-93.2) and bpCR is 35.4% (95% CI, 25.8-46.5). The mean Ki67 expression reduces from 40.4% at baseline to 17.9% (P < 0.001) at time of surgery. The most frequent grade 3 or 4 adverse events are neutropenia, leukopenia, and diarrhoea. There is no serious adverse event- or treatment-related death. This fully oral, chemotherapy-free, triplet combined therapy has the potential to be an alternative neoadjuvant regimen for patients with TPBC.

Fundamentals of Breast Implant Illness and Device Imaging.

The past six decades of silicone breast implant history encompass manufacturing secrecy, regulatory laxity, inadequate informed consent, clever advertising, overly simplistic research methodology, diverse and controversial opinions, changing social patterns, safety issues, information ambiguity, speculation, and deception. This review addresses the verifiable clinical, radiological, and pathological aspects of these devices, particularly with regard to silicone bleeding. This information can favorably assist practitioners and radiologists facing diagnostic challenges encountered in patients with silicone breast implants.

Magnetic resonance classification proposal for fibrous capsules in breast silicone implants.

OBJECTIVE: To propose a new classification system for evaluating fibrous capsules around silicone implants using magnetic resonance. METHODS: We retrospectively evaluated 90 consecutive patients who underwent breast MRI scans at a single center from February to March 2022. All patients with silicone implants and contrast dynamic sequences were included. Two radiologists classified the fibrous capsules according to the proposed classification in four grades. Interobserver variability was calculated for the final score. For comparison purposes, the inter-rater agreement of background parenchymal enhancement and the amount of fibroglandular tissue were also calculated. RESULTS: Reader 1 classified 2 (2.2) fibrous capsules as grade 1, 7 (7.8) as grade 2, 18 (20.0) as grade 3, and 63 (70.0) as grade 4, whereas reader 2 classified 1 (1.1), 9 (10.0), 24 (26.7), and 56 (62.2) fibrous capsules, respectively, for each grade. The interobserver agreement for fibrous capsule classification was moderate (ĸ = 0.65). The inter-rater agreement of background parenchymal enhancement and amount of fibroglandular tissue were fair: ĸ = 0.50 and ĸ = 0.44, respectively. CONCLUSION: Our study proposes classifying FC by MRI in patients with SI to standardize the description and classification of the findings with good interobserver agreement.

Management of Non-Mass Enhancement at Breast Magnetic Resonance in Screening Settings Referred for Magnetic Resonance-Guided Biopsy.

Rationale and Objectives: According to the Breast Imaging and Reporting Data System (BI-RADS), one of the main limitations of MRI is diagnosing the non-mass enhancement (NME). The NME lesion is challenging since it is unique to the MRI lexicon. This study aims to report our experience with NME lesions diagnosed by MRI referred for MRI-guided biopsies and discuss the management and follow-up of these lesions. Materials and Methods: We retrospectively evaluated all MRI-guide breast biopsies. We included all patients referred for NME breast MRI-guided biopsy in screening settings. All patients had a negative second-look mammography or ultrasonography. We correlated the distribution and internal enhancement pattern (IEP) of the NME lesions with histology. Invasive ductal carcinomas (IDC) of no special type and ductal carcinoma in situ (DCIS) were considered malignant lesions. Results: From January-2018 to July-2021, we included 96 women with a total of 96 lesions in the study. There were 90 benign and 6 malignant lesions with DCIS prevalence (5/6 cancers). The most frequent benign lesion type was fibrocystic changes. There were no NME lesions with diffuse or multiple area distribution features referred to MRI-guided biopsy. The positive-predictive values (PPV) were respectively 0.0%, 2.5%, 9.0%, and 11.0% for linear, focal, regional, and segmental distribution describers, and 0.0, 3.0%, 7.9%, and 50% for homogenous, heterogeneous, clumped, and clustered-ring enhancement patterns. Conclusion: We observe the high potential risk for malignancy in the clustered-ring enhancement followed by the clumped pattern. Segmental distribution presented the highest predictive-positive values.

Case Report: Evidence of Migratory Silicone Particles Arising From Cohesive Silicone Breast Implants.

Background: Silicone implants have been used since the 1960s for aesthetic purposes and breast reconstructions. During this period, many women have reported up to 40 similar symptoms, including fatigue, the emergence of autoimmune diseases, Raynaud Phenomenon, arthritis, arthralgias, and hair loss, among others. However, most of the time, these symptoms are neglected by doctors across different specialties and are most often considered a psychosomatic disease. Since 2017, many women suffering from the same complaints have formed social media groups to report their histories and subsequently describe the disease as Breast Implant Illness (BII). The phenomenon of gel bleed and silicone toxicity is known and accepted in literature, but silicone migration into the extracapsular space is still poorly demonstrated, due to the difficulty of monitoring its particles and access to patient data. Methods: This work demonstrated the presence of silicone through pathological examination in post-explant breast capsules and in the synovial tissue of the right wrist, detected with special Modified Oil Red O (MORO) staining in a patient with a history of BII. The pathological results were compared to the breast MRI imaging files. Results: The MRI images show the permeability change of the implant shell diagnosed as a water-droplet signal. It was also possible to diagnose the gel bleeding as the silicone-induced granuloma of breast implant capsule (SIGBIC) in both implants. Silicone gel bleed and migration of silicone were detected with MORO staining in and outside the capsule and in the synovial tissue of the right wrist. Conclusion: In this case study, we showed that silicone migration is possible via cohesive silicone gel breast implant leakage. The accumulation of silicone in the synovial tissue of the right wrist suggests local silicone toxicity and defects.

Tumor remnant after silicone implant en bloc capsulectomy: The magnetic resonance role.

Recently, there has been an increase in surgeries to treat silicones implant complications. These procedures are generally related to diseased fibrous capsules, with capsular contracture the most common clinical manifestation. However, patients often do not undergo a magnetic resonance imaging (MRI) scan for the explant surgical programming to access the fibrous capsule status and avoid residual diseased tissue. The accuracy of MRI to assess fibrous capsule breast neoplasm remnants depends on the surgical time. The ideal time for the evaluation is up to 72 h after the surgery when the repaired tissue starts to appear. Up to 2-3 weeks after surgery, MRI can provide information on the presence of a residual tumor. After this period, the presence of scar tissue and granuloma impairs the analysis. This communication discusses the role of MRI in evaluating residual fibrous capsules in the postoperative period.

Silicone exposure associated with breast papillary lesion: A case report.

We described a breast papillary lesion related to silicone breast implant exposure. The case report is in accordance with our initial publication, where we proposed that silicone particles may trigger a process of reverse morphogenesis in pericapsular tissue resulting in metaplasia of the epithelial cells. The relationship between breast metaplasia and silicone implants is still little discussed in the literature. Our current study is based on evidence obtained from the files of a patient with a six-year-old history of silicone breast implant, which resulted in a diagnosis of a papillary lesion after a percutaneous breast biopsy. Currently, the main complications related to implants reported in the literature are intra- and extra-capsular ruptures, capsular contracture, and the most severe, breast implant-associated anaplastic large cell lymphoma. However, another complication not yet widely accepted in the literature is breast implant illness, resulting from silicone induced granuloma of breast implant capsule. Many medical specialists are skeptical about silicone disease potential and argue the lack of scientific evidence to support its existence. We believe that presenting these findings and the appropriate discussion of the results should contribute to a better understanding of the pathologies related to breast implants. It is worth mentioning that the safety of breast implants must be questioned.

Screening a Solitary Dilated Duct in the Breast: A Pictorial Essay.

A solitary dilated duct visualized by mammography is a rare event. According to the latest edition of BI-RADS® it is classified as category 4. This series of cases shows complementary ultrasound of a solitary dilated duct can reduce false-positive results on mammography.

Side effects in breast implants related to radiotherapy in breast cancer reconstructive surgery.

Breast reconstructive surgery with silicone implants is routinely one of the techniques performed immediately after a mastectomy and before adjuvant radiotherapy. Implant shell degradation may result in gel bleeding that can trigger capsular disease. The silicone corpuscle in contact with the implant fibrous capsule can promote an inflammatory reaction, identified as silicone-induced granuloma which is, related to clinical complaints referred to as breast implant illness. This short communication aims to demonstrate and discuss the impact of radiotherapy's side effects on patients with post-mastectomy reconstructive breast surgery with silicone implants followed by adjuvant radiation therapy.

The Breast Tumor Microenvironment: Could Silicone Breast Implant Elicit Breast Carcinoma?

Complications related to breast implants have received much attention recently. Breast implant-associated anaplastic large cell lymphoma, silicone-induced granuloma of breast implant capsule, and breast implant illness are the main complications reported in the medical literature. However, the literature contains limited evidence regarding the possibility of silicone implants eliciting breast carcinoma. In this manuscript, we propose a theory in which the immune response to silicone breast implant gel bleeding acts as a triggering point for tumor oncogenesis in breast tissue. This hypothesis is derived from our findings of a case of invasive and undifferentiated medullary carcinoma in a patient with a silicone breast implant. The following concepts have been used to support this theory: 1) silicone bleeding from intact breast implants; 2) metaplasia: an adaptation to injury and precursor to dysplasia and cancer; 3) T-cell dysfunction in cancer immunity; 4) inhibitory cells in the tumor microenvironment (TME); 5) morphogenesis and bauplan; and 6) concepts underlying medullary carcinoma. We propose that the inflammatory process in response to silicone particles in the pericapsular glandular tissue favors the development of cellular mutations in specialized epithelial cells. This reverse morphogenesis could have resulted in breast carcinoma of the medullary type in the present case.

Impact of radiomics on the breast ultrasound radiologist's clinical practice: From lumpologist to data wrangler.

OBJECTIVE: The study aims to assess the impact of radiomics in the clinical practice of breast ultrasound, to determine which lesions are undetermined by the software, and to discuss the future of the radiologist's role. METHODS: Consecutive analyses of 207 ultrasound masses from January 2018 to April 2019 referred for percutaneous breast biopsy. Breast masses were classified using dedicated ultrasound software (AI). The AI software automatically classified the masses on a scale of 0-100, where 100 is the most suspicious. We adopt the histology results as the gold standard. The cut-off point of malignancy by radiomics was determined, with ±10 % of margin error according to the Youden's index. We considered these lesions as undetermined masses. The performance of the AI software and the radiologist classification was compared using the area under roc curves (AUROC). We also discuss the impact of radiologist validation of AI results, especially in undetermined lesions. RESULTS: Of the 207 evaluated masses, 143 were benign, and 64 were malignant. The Youden's index was 0.516, including undetermined masses with a varied range of 10 % (0.464-0.567). Twenty-one (14.58 %) benign and twelve (19.05 %) malignant masses were in this range. The best accuracy performance to classify masses was the combination of the reader and AI (0.829). The most common undetermined masses in AI were fibroadenoma, followed by phyllodes tumor, steatonecrosis as benign. Whereas, low-grade, and high-grade invasive ductal carcinoma represents the malignant lesions. CONCLUSIONS: Artificial Intelligence has a reliable performance in ultrasound breast masses classification. Radiologist validation is critical to determine the final BI-RADS assessment, especially in undetermined masses to obtain the best classification performance.

Synchronous breast implant associated anaplastic large cell lymphoma (BIA-ALCL) and silicone induced granuloma of breast implant capsule (SIGBIC): What to learn.

We recently described silicone induced granuloma of breast implant capsule (SIGBIC) as an implant capsule illness related to intact silicone breast implants. The precursor to SIGBIC development is gel bleeding/shedding from the implant shell/interior content. Currently, although the literature widely discussed the pathogenesis of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), the trigger point for its development is still a black-box. In this case report, we report a 46-year-old woman with SIGBIC diagnosis in her right breast and BIA-ALCL in her left breast, diagnosed with ultrasound and breast magnetic resonance. Microscopy confirmed silicone bleeding from the implant surface/ content. The imaging findings reported that SIGBIC and BIA-ALCL were similar; however, BIA-ALCL had an intracapsular collection.

Silicone Induced Granuloma of Breast Implant Capsule (SIGBIC) diagnosis: Breast Magnetic Resonance (BMR) sensitivity to detect silicone bleeding.

OBJECTIVE: To evaluate the sensitivity (S) of BMRI to detect silicone gel bleeding in a prospective observational study, including consecutive patients referred for BMRI scan. METHODS: From January 2017 to March 2018, we evaluated patients with breast implants referred for BMRI in a prospective observational study. For SIGBIC diagnosis, we adopted three new original imaging features: black drop signal; T2* hyper signal mass; and delayed contrast enhancement, considered as irrevocable signs to detect gel bleeding (GB). Histology confirmed the presence of a silicone corpuscle in breast implant capsular specimens. The accuracy of BMRI SIGBIC findings to predict GB was determined. We also compared SIGBIC diagnosis criteria to those features proposed by the BI-RADS léxicon, considered as equivocal findings. RESULTS: 208 patients had SIGBIC diagnosis at BMRI, and the histology confirmed GB in all cases. There were no false-positive results. Compared to the BI-RADS equivocal findings (S = 0.74), SIGBIC criteria had better sensitivity for GB diagnosis. CONCLUSION: SIGBIC diagnosis has high sensitivity to predict GB by the three irrevocable BMRI features described by the authors. We suppose GB is underdiagnosed in clinical practice by BI-RADS features. TRIAL CERTIFICATION: Study protocol: Plataforma Brasil CAAE: 77215317.0.0000.0072.

Breast elastography: diagnostic performance of computer-aided diagnosis software and interobserver agreement.

OBJECTIVE: To determine the best cutoff value for classifying breast masses by ultrasound elastography, using dedicated software for strain elastography, and to determine the level of interobserver agreement. MATERIALS AND METHODS: We enrolled 83 patients with 83 breast masses identified on ultrasound and referred for biopsy. After B-mode ultrasound examination, the lesions were manually segmented by three radiologists with varying degrees of experience in breast imaging, designated reader 1 (R1, with 15 years), reader 2 (R2, with 2 years), and reader 3 (R3, with 8 years). Elastography was performed automatically on the best image with computer-aided diagnosis (CAD) software. Cutoff values of 70%, 75%, 80%, and 90% of hard areas were applied for determining the performance of the CAD software. The best cutoff value for the most experienced radiologists was then compared with the visual assessment. Interobserver agreement for the best cutoff value was determined, as were the interclass correlation coefficient and concordance among the radiologists for the areas segmented. RESULTS: The best cutoff value of the proportion of hard area within a breast mass, for experienced radiologists, was found to be 75%. At a cutoff value of 75%, the interobserver agreement was excellent between R1 and R2, as well as between R1 and R3, and good between R2 and R3. The interclass concordance coefficient among the three radiologists was 0.950. When assessing the segmented areas by size, we found that the level of agreement was higher among the more experienced radiologists. CONCLUSION: The best cutoff value for a quantitative CAD system to classify breast masses was 75%.