BIA-ALCL and BIA-SCC: Updates on Clinical Features and Genetic Mutations for Latest Recommendations.

Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) and Breast Implant-Associated Squamous Cell Carcinoma (BIA-SCC) are emerging neoplastic complications related to breast implants. While BIA-ALCL is often linked to macrotextured implants, current evidence does not suggest an implant-type association for BIA-SCC. Chronic inflammation and genetics have been hypothesized as key pathogenetic players, although for both conditions, the exact mechanisms and specific risks related to breast implants are yet to be established. While the genetic alterations in BIA-SCC are still unknown, JAK-STAT pathway activation has been outlined as a dominant signature of BIA-ALCL. Recent genetic investigation has uncovered various molecular players, including MEK-ERK, PI3K/AKT, CDK4-6, and PDL1. The clinical presentation of BIA-ALCL and BIA-SCC overlaps, including most commonly late seroma and breast swelling, warranting ultrasound and cytological examinations, which are the first recommended steps as part of the diagnostic work-up. While the role of mammography is still limited, MRI and CT-PET are recommended according to the clinical presentation and for disease staging. To date, the mainstay of treatment for BIA-ALCL and BIA-SCC is implant removal with en-bloc capsulectomy. Chemotherapy and radiation therapy have also been used for advanced-stage BIA-ALCL and BIA-SCC. In-depth characterization of the tumor genetics is key for the development of novel therapeutic strategies, especially for advanced stage BIA-ALCL and BIA-SCC, which show a more aggressive course and poor prognosis.

Unnecessary Explantation of IDEAL IMPLANT Structured Saline Breast Implants Prompted byRadiologic Misdiagnosis of Rupture.

ABSTRACT: The unique dual-lumen and baffle design of the IDEAL IMPLANT Structured Saline breast implant gives it specific advantages over both silicone gel-filled and the original saline-filled implants. This internal baffle structure also gives it an appearance on various radiologic imaging studies that may be misinterpreted as a rupture because of similarities to the well-known radiologic appearance of a ruptured silicone gel implant. Patients may present with various misinterpreted imaging studies, highlighting the need for plastic surgeons and radiologists to be familiar with the normal appearance of the intact IDEAL IMPLANT and be able to distinguish it from a ruptured IDEAL IMPLANT. The radiology findings must be correlated with the clinical findings, or an intact IDEAL IMPLANT misdiagnosed as ruptured, may cause unnecessary patient worry, and may prompt unnecessary surgery for removal or replacement.

Screening the Implant-Augmented Breast with Digital Breast Tomosynthesis: Is Tomosynthesis Necessary for Non-implant-Displaced Views?

OBJECTIVE: To determine cancer visualization utility and radiation dose for non-implant-displaced (ID) views using standard protocol with digital breast tomosynthesis (DBT) vs alternative protocol with 2D only when screening women with implant augmentation. METHODS: This retrospective cohort study identified women with implants who underwent screening DBT examinations that had abnormal findings from July 28, 2014, to December 31, 2021. Three fellowship-trained breast radiologists independently reviewed examinations retrospectively to determine if the initially identified abnormalities could be visualized on standard protocol (DBT with synthesized 2D (S2D) for ID and non-ID views) and alternate protocol (DBT with S2D for ID and only the S2D images for non-ID views). Estimated exam average glandular dose (AGD) and associations between cancer visualization with patient and implant characteristics for both protocols were evaluated. RESULTS: The study included 195 patients (mean age 55 years ± 10) with 223 abnormal findings. Subsequent biopsy was performed for 86 abnormalities: 59 (69%) benign, 8 (9%) high risk, and 19 (22%) malignant. There was no significant difference in malignancy visualization rate between standard (19/223, 8.5%) and alternate (18/223, 8.1%) protocols (P = .92), but inclusion of the DBT for non-ID views found one additional malignancy. Total examination AGD using standard protocol (21.9 mGy ± 5.0) was significantly higher than it would be for estimated alternate protocol (12.6 mGy ± 5.0, P <.001). This remained true when stratified by breast thickness: 6.0-7.9 cm, 8.0-9.9 cm, >10.0 cm (all P <.001). CONCLUSION: The inclusion of DBT for non-ID views did not significantly increase the cancer visualization rate but did significantly increase overall examination AGD.

Self-reported systemic symptoms among women with breast implants.

Around 2,500 women receive a breast augmentation with silicone-based implants yearly in Denmark. A number of these women report various uncharacteristic systemic symptoms, which they attribute to the breast implants, including impaired cognition, joint pain, etc. This condition has been termed "breast implant illness" and is currently not a recognised diagnosis. The correlation between the patient's self-reported symptoms and breast implants has not been established and there is limited evidence that surgery has any effect. In this review, the current literature on the topic has been reviewed.

The influence of a previous implant-based breast reconstruction on postoperative sensation of the deep inferior epigastric artery perforator flap.

BACKGROUND: Implants and DIEP flaps have different outcomes regarding postoperative breast sensation. When compared to the preoperative healthy breast, implant-based breast reconstruction (IBBR) negatively influences postoperative breast sensation. However, it is currently unknown whether a prior IBBR also influences postoperative sensation of a replacing DIEP flap. The goal of this cohort study is to evaluate the influence of an IBBR on the postoperative sensation of a replacing DIEP flap. METHODS: Women were included if they received a DIEP flap reconstruction after mastectomy, with or without prior tissue expander (TE) and/or definitive breast implant. Sensation was measured at four intervals in 9 areas of the breast with Semmes-Weinstein monofilaments: T0 (preoperative, implant/no reconstruction), T1 (2-7 months postoperative, DIEP), T2 (± 12 months postoperative, DIEP), Tmax (maximum follow-up, DIEP). Linear mixed-effects models were used to investigate the relationship between an implant/TE prior to the DIEP flap and recovery of breast sensation. RESULTS: 142 women comprising 206 breasts were included. 48 (23.3%) breasts did, and 158 (76.7%) breasts did not have a TE/IBBR prior to their DIEP. No statistically significant or clinically relevant relationships were found between a prior implant/TE and recovery of DIEP flap breast sensation for the flap skin, native skin, or total breast skin at T1, T2, or Tmax. There were also no relationships found after adjustment for the confounders radiation therapy, BMI, diabetes, age, flap weight, follow-up, and nerve coaptation. CONCLUSIONS: An implant/TE prior to a DIEP flap does not influence the recovery of postoperative breast sensation of the DIEP flap.

Major Clinical Adverse Events of Breast Implant in the Manufacturer and User Facility Device Experience Database.

OBJECTIVE: Search the Manufacturer and User Facility Device Experience database to collect information on adverse events of breast implant. We analyzed the local complications and the breast implant illness (BII) of silicone breast implants, as well as saline breast implants separately, aim to provide a reference for women who want to breast augmentation. MATERIALS AND METHODS: The Manufacturer and User Facility Device Experience database was queried for events reports related to the breast implant between July 1, 2012, and June 30, 2022. Event year and reporting year were summarized. Patient problem was collected and analyzed to distinguish between local complications and BII. RESULTS: A total of 108,728 adverse events in the past 3 years were analyzed, silicone breast implants accounted for 62.1% and saline breast implants accounted for 37.9%. The most common local complication of women receiving silicone breast implants was "Capsular Contracture," accounting for 48.73%. However, the incidence of "capsular contracture" in women who received saline breast implants was only 17.49%. The most common BII was "fatigue/weakness" in both women receiving 2 different breast implants, 17.20% in women receiving silicone breast implants and 24.71% in women receiving saline breast implants. Of note, in all the reports, there was a wide variation in the timing of reporting as compared with the timing of the adverse event. CONCLUSIONS: Although the adverse events of breast implant cannot completely be determined from this study, we provide a reference for women who want to get breast implants, so that they can choose breast implants more carefully. In addition, a better understanding of BII may allow them to think further about whether the benefits of breast implants outweigh the risks.

Altered Foreign Body Response at the Posterior Surface Compared to the Anterior Surface of Human Silicone Breast Implants.

Soft implantable devices are crucial to optimizing form and function for many patients. However, periprosthetic capsule fibrosis is one of the major challenges limiting the use of implants. Currently, little is understood about how spatial and temporal factors influence capsule physiology and how the local capsule environment affects the implant structure. In this work, we analyzed breast implant capsule specimens with staining, immunohistochemistry, and real-time polymerase chain reaction to investigate spatiotemporal differences in inflammation and fibrosis. We demonstrated that in comparison to the anterior capsule against the convex surface of breast implants, the posterior capsule against the flat surface of the breast implant displays several features of a dysregulated foreign body reaction including increased capsule thickness, abnormal extracellular remodeling, and infiltration of macrophages. Furthermore, the expression of pro-inflammatory cytokines increased in the posterior capsule across the lifespan of the device, but not in the anterior capsule. We also analyzed the surface oxidation of breast explant samples with XPS analysis. No significant differences in surface oxidation were identified either spatially or temporally. Collectively, our results support spatiotemporal heterogeneity in inflammation and fibrosis within the breast implant capsule. These findings presented here provide a more detailed picture of the complexity of the foreign body reaction surrounding implants destined for human use and could lead to key research avenues and clinical applications to treat periprosthetic fibrosis and improve device longevity.

Impact of post-operative infection on revision procedures in breast reconstruction: A marketscan database analysis.

BACKGROUND: Esthetic complications, such as capsular contracture and soft-tissue contour defects, hinder the desired outcomes of breast reconstruction. As subclinical infection is a prevailing theory behind capsular contracture, we investigated the effects of post-operative infections on these issues and revision procedures. METHODS: We conducted a retrospective database study (2007-2021) on breast reconstruction patients from the MarketScan® Databases. Esthetic complications were defined by their associated revision procedures and queried via CPT codes. Severe capsular contracture (Grade 3-4) was defined as requiring capsulotomy or capsulectomy with implant removal or replacement. Moderate and severe soft-tissue defects were determined by the need for fat grafting or breast revision, respectively. Generalized linear models were used, adjusting for comorbidities and surgical factors (p < 0.05). RESULTS: We analyzed the data on 62,510 eligible patients. Post-operative infections increased the odds of capsulotomy (OR 1.59, p < 0.001) and capsulectomy (OR 2.30, p < 0.001). They also raised the odds of breast revision for severe soft-tissue defects (OR 1.21, p < 0.001). There was no significant association between infections and fat grafting for moderate defects. Patients who had post-operative infections were also more likely to experience another infection after fat grafting (OR 3.39, p = 0.0018). In two-stage reconstruction, infection after tissue expander placement was associated with greater odds of infection after implant placement. CONCLUSION: Post-operative infections increase the likelihood of developing severe soft-tissue defects and capsular contracture requiring surgical revision. Our data reinforce the role of infections in the pathophysiology of capsular contracture. Additionally, infections elevate the risk of subsequent infections after fat grafting for moderate defects, further increasing patient morbidity.

Multimodality Imaging of Postmastectomy Breast Reconstruction Techniques, Complications, and Tumor Recurrence.

For women undergoing mastectomy, breast reconstruction can be performed by using implants or autologous tissue flaps. Mastectomy options include skin- and nipple-sparing techniques. Implant-based reconstruction can be performed with saline or silicone implants. Various autologous pedicled or free tissue flap reconstruction methods based on different tissue donor sites are available. The aesthetic outcomes of implant- and flap-based reconstructions can be improved with oncoplastic surgery, including autologous fat graft placement and nipple-areolar complex reconstruction. The authors provide an update on recent advances in implant reconstruction techniques and contemporary expanded options for autologous tissue flap reconstruction as it relates to imaging modalities. As breast cancer screening is not routinely performed in this clinical setting, tumor recurrence after mastectomy and reconstruction is often detected by palpation at physical examination. Most local recurrences occur within the skin and subcutaneous tissue. Diagnostic breast imaging continues to have a critical role in confirmation of disease recurrence. Knowledge of the spectrum of benign and abnormal imaging appearances in the reconstructed breast is important for postoperative evaluation of patients, including recognition of early and late postsurgical complications and breast cancer recurrence. The authors provide an overview of multimodality imaging of the postmastectomy reconstructed breast, as well as an update on screening guidelines and recommendations for this unique patient population. ©RSNA, 2024 Test Your Knowledge questions for this article are available in the supplemental material.

Surface Topography, Microbial Adhesion, and Immune Responses in Silicone Mammary Implant-Associated Capsular Fibrosis.

Breast cancer is the most common cancer in women globally, often necessitating mastectomy and subsequent breast reconstruction. Silicone mammary implants (SMIs) play a pivotal role in breast reconstruction, yet their interaction with the host immune system and microbiome remains poorly understood. This study investigates the impact of SMI surface topography on host antimicrobial responses, wound proteome dynamics, and microbial colonization. Biological samples were collected from ten human patients undergoing breast reconstruction with SMIs. Mass spectrometry profiles were analyzed for acute and chronic wound proteomes, revealing a nuanced interplay between topography and antimicrobial response proteins. 16S rRNA sequencing assessed microbiome dynamics, unveiling topography-specific variations in microbial composition. Surface topography alterations influenced wound proteome composition. Microbiome analysis revealed heightened diversity around rougher SMIs, emphasizing topography-dependent microbial invasion. In vitro experiments confirmed staphylococcal adhesion, growth, and biofilm formation on SMI surfaces, with increased texture correlating positively with bacterial colonization. This comprehensive investigation highlights the intricate interplay between SMI topography, wound proteome dynamics, and microbial transmission. The findings contribute to understanding host-microbe interactions on SMI surfaces, essential for optimizing clinical applications and minimizing complications in breast reconstruction.

Flow Cytometry Analysis in Breast Implant-Associated Anaplastic Large Cell Lymphoma: Three Case Reports.

Breast Implant-Associated-Anaplastic Large Cell Lymphoma (BIA-ALCL) is a rare T-cell non-Hodgkin lymphoma associated with breast prosthetic implants and represents a diagnostic challenge. The National Comprehensive Cancer Network (NCCN) guidelines, updated in 2024, recommend for diagnosis an integrated work-up that should include cell morphology, CD30 immunohistochemistry (IHC), and flow cytometry (FCM). CD30 IHC, although the test of choice for BIA-ALCL diagnosis, is not pathognomonic, and this supports the recommendation to apply a multidisciplinary approach. A close collaboration between pathologists and laboratory professionals allowed the diagnosis of three BIA-ALCLs, presented as case reports, within a series of 35 patients subjected to periprosthetic effusions aspiration from 2018 to 2023. In one case, rare neoplastic cells were identified by FCM, and this result was essential in leading the anatomopathological picture as indicative of this neoplasm. In fact, the distinction between a lymphomatous infiltrate from reactive cells may be very complex in the cytopathology and IHC setting when neoplastic cells are rare. On the other hand, one limitation of FCM analysis is the need for fresh samples. In this study, we provide evidence that a dedicated fixative allows the maintenance of an unaltered CD30 expression on the cell surface for up to 72 h.

Photon-counting CT of degenerative changes and rupture of silicone breast implants: a pilot study.

BACKGROUND: Accurate assessment of breast implants is important for appropriate clinical management. We evaluated silicone properties and diagnostic accuracy for characterizing silicone implants and detecting degenerative changes including rupture in photon-counting computed tomography (PCCT). METHODS: Over 16 months, we prospectively included patients with silicone implants and available breast magnetic resonance imaging (MRI) who received thoracic PCCT performed in prone position. Consensus reading of all available imaging studies including MRI served as reference standard. Two readers evaluated all implants in PCCT reconstructions for degenerative changes. In a subgroup of implants, mean density of silicone, adjacent muscle, and fat were measured on PCCT reconstructions. Contrast-to-noise ratios (CNRs) were calculated for implant-to-muscle and implant-to-fat. RESULTS: Among 21 subjects, aged 60 ± 13.1 years (mean ± standard deviation) with 29 implants PCCT showed the following: high accuracy for linguine sign, intraimplant fluid (all > 0.99), peri-implant silicone (0.95), keyhole sign (0.90), and folds of the membrane (0.81); high specificity for linguine sign, intraimplant fluid, keyhole sign, folds of the membrane (all > 0.99), and peri-implant silicone (0.98); and high sensitivity for linguine sign and intraimplant fluid (all > 0.99). In a subgroup of 12 implants, the highest CNR for implant-to-muscle was observed on virtual unenhanced reconstructions (20.9) and iodine maps (22.9), for implant-to-fat on iodine maps (27.7) and monoenergetic reconstructions (31.8). CONCLUSIONS: Our findings demonstrate that silicone breast implants exhibit distinct contrast properties at PCCT, which may provide incremental information for detection of degenerative changes and rupture of implants. RELEVANCE STATEMENT: Thoracic photon-counting computed tomography is a promising modality for the diagnostic assessment of silicone breast implants. KEY POINTS: • Thoracic photon-counting computed tomography demonstrates unique contrast properties of silicone breast implants. • Iodine map reconstructions reveal strong contrast-to-noise ratios for implant-to-muscle and implant-to-fat. • Thoracic photon-counting computed tomography shows high diagnostic accuracy in detecting implant degeneration and rupture. TRIAL REGISTRATION: German Clinical Trials Register number DRKS00028997, date of registration 2022-08-08, retrospectively registered.

In hospital outcomes of autologous and implant-based breast reconstruction in patients with chronic obstructive pulmonary disease.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) is a common comorbid condition that can be associated with postoperative mortality and morbidity. However, the outcome profile of patients with COPD after breast reconstruction has yet to be established. Therefore, this study aimed to assess the postoperative outcomes in patients with COPD who underwent autologous (ABR) and implant-based breast reconstruction (IBR). METHODS: National Inpatient Sample was used to identify patients who underwent ABR or IBR from Q4 2015 to 2020. Multivariable logistic regressions were used to compare inhospital outcomes between COPD and non-COPD patients while adjusting for demographics, primary payer status, hospital characteristics, and comorbidities. RESULTS: There were 1288 (9.92%) COPD and 11,696 non-COPD patients who underwent ABR. Meanwhile, 1742 (9.70%) COPD and 16,221 non-COPD patients underwent IBR. In both ABR and IBR, patients with COPD had higher rates of seroma (ABR, aOR = 1.863, 95% CI = 1.022-3.397, and p = 0.04; IBR, aOR = 1.524, 95% CI = 1.014-2.291, and p = 0.04), infection (ABR, aOR = 1.863, 95% CI = 1.022-3.397, and p = 0.04; IBR, aOR = 1.956, 95% CI = 1.205-3.176, and p = 0.01), and prolonged LOS (p < 0.01). Specifically, patients with COPD in ABR had higher risks of respiratory complications (aOR = 1.991, 95% CI = 1.291-3.071, and p < 0.01) and incurred higher total hospital charges (p < 0.01). Meanwhile, patients with COPD undergoing IBR had elevated risks of renal complications (aOR = 3.421, 95% CI = 2.108-5.55, and p < 0.01), deep wound complications (aOR = 3.191, 95% CI = 1.423-7.153, and p < 0.01), and a higher rate of transfers out (aOR = 1.815, 95% CI = 1.081-3.05, and p = 0.02). CONCLUSION: COPD is an independent risk factor associated with distinct adverse outcomes in ABR and IBR. These findings can be valuable for preoperative risk stratification, determining surgical candidacy, and planning postoperative management in patients with COPD.

Risk factors for severe complications and salvage management in direct-to-implant immediate breast reconstruction: A retrospective study.

Controversies regarding the risk factors affecting direct-to-implant (DTI) immediate breast reconstruction still exist. This study aimed to evaluate the risk factors for severe complications in DTI breast reconstruction and explore potential salvage management strategies. We conducted a retrospective review of 238 patients (240 breasts) who underwent DTI immediate breast reconstruction between 2011 and 2020. Multivariate logistic regression analyses were used to identify the risk factors predicting severe complications. Seventeen (7.08%) reconstructed breasts experienced severe complications, of which only 5 were successfully salvaged through surgical revision, while the others failed and resulted in implant removal. Multivariate analyses demonstrated that mesh use [odds ratio (OR) = 4.054, 95% confidence interval: 1.376-11.945, P = .011] and post-mastectomy radiotherapy (odds ratio = 4.383, 95% confidence interval 1.142-16.819, P = .031) were independent predictors of severe complications. Mesh use and post-mastectomy radiotherapy for breast reconstruction increase the risk of severe complications. Despite positive surgical treatment, the successful salvage rate was poor.

The Spectrum of Non-neoplastic Changes Associated With Breast Implants: Histopathology, Imaging, and Clinical Significance.

Breast implant-associated anaplastic large cell lymphoma has been recognized as a distinct entity in the World Health Organization classification of hematolymphoid neoplasms. These neoplasms are causally related to textured implants that were used worldwide until recently. Consequently, there is an increased demand for processing periprosthetic capsules, adding new challenges for surgeons, clinicians, and pathologists. In the literature, the focus has been on breast implant-associated anaplastic large cell lymphoma; however, benign complications related to the placement of breast implants occur in up to 20% to 30% of patients. Imaging studies are helpful in assessing patients with breast implants for evidence of implant rupture, changes in tissues surrounding the implants, or regional lymphadenopathy related to breast implants, but pathologic examination is often required. In this review, we couple our experience with a review of the literature to describe a range of benign lesions associated with breast implants that can be associated with different clinical presentations or pathogenesis and that may require different diagnostic approaches. We illustrate the spectrum of the most common of these benign disorders, highlighting their clinical, imaging, gross, and microscopic features. Finally, we propose a systematic approach for the diagnosis and handling of breast implant specimens in general.