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.

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 The descriptors in the Breast Imaging and Reporting Data System lexicon seem outdated for classifying the new generations of implants with cohesive gel, which hinders the diagnosis of device complications.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.

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.

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.

Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL): An Open Wound.

Since 2017, there have been an increasing number of reported cases regarding breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) in the literature. Although significant attention was dispensed for this relevant issue, there is no consensus on what the trigger points for disease development are. BIA-ALCL trigger point speculation includes textured breast implants, bacterial contamination, and genetic factors. However, little attention is given by the literature regarding gel bleeding and the toxicity of polydimethylsiloxane. This opinion-based article aims to report our experience in a prospective study of breast implants and share our knowledge regarding silicone-induced granuloma of breast implant capsule. LEVEL OF EVIDENCE V: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.

Silicone-Induced Granuloma of Breast Implant Capsule (SIGBIC): Histopathology and Radiological Correlation.

Currently, attention has been given to complications related to breast implants, especially due to the presence of anaplastic large cell lymphoma (ALCL) related to silicone implants. Many manuscripts attempt to associate silicone presence with clinical complaints reported by patients, while others try to demonstrate the mechanisms of silicone bleeding by permeability loss of breast implant surfaces. There also are reports of foreign body type reactions from implant fibrous capsule to silicone corpuscles. However, there seems to be no study that correlates the clinical, radiological, and histological correlations of these lesions. The objective of this review is to correlate radiological findings of silicone-induced granuloma of breast implant capsule (SIGBIC) from breast MRI (BMRI) scans and complementary findings of ultrasound (US) and positron emission tomography (PET) scan, and its histology originated from surgical breast implant capsulectomy. To make this correlation possible, we divided SIGBIC into three radiological findings: (1) intracapsular SIGBIC, (2) SIGBIC with extracapsular extension, and (3) mixed SIGBIC associated with seroma. Our experience demonstrates histological-radiological correlation in SIGBIC diagnosis. Knowledge of these findings may demonstrate its real importance in terms of public health and patient management. We believe that SIGBIC is currently underdiagnosed by lack of training, guidance, and management in our clinical practice.

Application of Breast Ultrasound Elastography to Differentiate Intracapsular Collection from Silicone-Induced Granuloma of Breast Implant Capsule Complementarily to Contrast-Enhanced Breast Magnetic Resonance Imaging.

BACKGROUND: To determine whether there is correlation between magnetic resonance imaging (MRI) findings and breast elastography to differentiate seroma/hematoma from silicone-induced granuloma of breast implant capsule (SIGBIC). METHODS: Prospective study of 99 patients with breast implants submitted to breast MRI during the period from February 1 to May 1, 2017. Patients who present MRI findings of seroma/hematoma or SIGBIC were submitted to a complementary ultrasound elastography study to evaluate the correlation of the results. The criteria adopted for the diagnosis of granuloma by MRI were heterogeneous hypersignal in the T2-weighted sequences, late contrast enhancement, and black drop sign. Lesions that did not enhance after the use of contrast were considered as seroma/hematoma. By elastography, the results were considered positive for granuloma when presented as hard lesions, whereas seroma/hematoma presented as soft lesions. RESULTS: Of the 99 patients evaluated, 15 were included in the study. Of the 15 patients, 9 had solid intracapsular MRI masses, whereas 6 presented collections without contrast enhancement. The complementary elastography study showed correlation with MRI results in all cases of SIGBIC and seroma/hematoma, being elastography able to differentiate lesions from solid to cystic. CONCLUSIONS: Elastography of intracapsular masses in breast implants presented results compatible with those found by MRI to differentiate solid lesions from collections.

Breast magnetic resonance imaging: tips for the diagnosis of silicone-induced granuloma of a breast implant capsule (SIGBIC).

Complications resulting from the placement of silicone breast implants are becoming more frequent in our clinical practice. This is due to the increase in breast aesthetic surgeries at the beginning of the century, where breast augmentation using silicone implants was the main intervention performed. Generally, studies that discuss the complications of breast implants are restricted to reports of intra- or extra-capsular ruptures, contractures and haematomas. Currently, much importance has been given to anaplastic large cell lymphoma (ALCL) as a more severe complication related to silicone implants. Recently, granuloma formation induced by silicone particle bleeding from intact breast implants has been described when the free silicone comes into contact with the fibrous capsule of the implant. Few studies have demonstrated the characteristics and diagnostic keys for this entity. The objective of this study is to present cases of SIGBIC diagnosed in our service and to discuss the main findings that allow its diagnosis. Teaching Points • Breast implants induce fibrous capsule formation at the periphery of the implant. • Gel bleeding is inherent in all types of silicone breast implants. • Gel bleeding induces silicone-induced granuloma of breast implants. • Main diagnostic tips: heterogeneous mass, black-drop sign and late enhancement.

Predictive values of BI-RADS(®) magnetic resonance imaging (MRI) in the detection of breast ductal carcinoma in situ (DCIS).

PURPOSE: The purpose of this study was to evaluate BI-RADS indicators in the detection of DCIS by MRI. MATERIALS AND METHODS: Prospective observational study that started in 2014 and lasted 24 months. A total of 110 consecutive patients were evaluated, who presented with suspicious or highly suspicious microcalcifications on screening mammography (BI-RADS categories 4 and 5) and underwent stereotactic-guided breast biopsy, having had an MRI scan performed prior to biopsy. RESULTS: Altogether, 38 cases were characterized as positive for malignancy, of which 25 were DCIS and 13 were invasive ductal carcinoma cases. MRI had a sensitivity of 96%; specificity of 75.67%; positive predictive value (PPV) for DCIS detection of 57.14%; negative predictive value (NPV) in the detection of DCIS of 98.24%; and an accuracy of 80.80%. CONCLUSION: BI-RADS as a tool for the detection of DCIS by MRI is a powerful instrument whose sensitivity was higher when compared to that observed for mammography in the literature. Likewise, the PPV obtained by MRI was higher than that observed in the present study for mammography, and the high NPV obtained on MRI scans can provide early evidence to discourage breast biopsy in selected cases.