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.

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.

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.

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.

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.

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.

The case for a national breast implant registry in Canada.

SummaryThe House of Commons Standing Committee on Health proposed in 2022 to start a national registry for breast implants. Why, and what requirements are needed, will be outlined. Breast implant products are not always in compliance with international norms and standards, and several scandals have occurred because of industry fraud. To trace which patients have defective breast implants, a good registry is an absolute must. Furthermore, some diseases, such as lymphomas, autoimmune diseases, and so-called breast implant illness, are believed to be associated with breast implants. An accurate estimation of how often these diseases occur in patients with breast implants is lacking. A registry in which not only surgical data but also patient-reported outcome measurements are recorded will result in a better understanding of patient outcomes and device performance. The registry should not be a voluntary ("opt-in") registry but a mandatory ("opt-out") registry, in which only the patient (and not the surgeon) has the choice whether to participate.

Selective Capsulotomies and Partial Capsulectomy in Implant-Based Breast Reconstruction Revision Surgery.

Background: Breast cancer with about 2.3 million diagnoses and 685,000 deaths globally is the most frequent malignancy in the female population. Continuous research has led to oncological and reconstructive advances in the management of breast cancer, thus improving outcomes and decreasing patient morbidity. Nowadays, the submuscular expander and prosthesis (E/P) implant-based breast reconstruction (IBR) accounts for 73% of all reconstructions. Despite its widely accepted efficacy, the technique is not free from complications and up to 28% of cases require revision surgery for mechanical complications such as capsular contracture, implant displacement/rotation, and implant rupture. With this study, the authors report their experience in the management of E/P IBR revision surgery through the technique of Selective Capsulotomies (SCs) and Partial Capsulectomy (PC). Methods: A retrospective study was conducted on patients who had previously undergone E/P IBR and presented for revision reconstruction between January 2013 and May 2023 at the Department of Plastic Surgery of the University of Siena, Italy. Reasons for revision included capsular contracture, implant displacement/rotation, and implant rupture. Revision reconstructions involved SC and PC with implant replacement. Fat grafting was also considered. The complication rate was evaluated by analysis of patients' medical records. Patients' satisfaction with the treatment was assessed through a specific questionnaire. Results: 32 patients underwent revision surgeries. No early complication occurred. Recurrence rate was assessed at 19% with average follow-up of 59 months (range: 13-114 months). The average time between revision surgery and recurrence was 3 years (range: 1-6 years). 23 patients answered the questionnaire and were overall satisfied with the treatments (8.29/10). Conclusions: SC possibly associated to PC is a valuable option for E/P IBR revision surgery with minimal complications, reduced surgical trauma, short operating time, and relatively low recurrence risk. In addition, treated patients are overall satisfied with the results over time.

From Case Reports to Molecular Insight: Examining the Outcomes and Underlying Mechanisms of Squamous Cell Carcinoma in Breast Implant Patients-A Systematic Review.

There is extensive coverage in the existing literature on implant-associated lymphomas like anaplastic large-cell lymphoma, but breast implant-associated squamous cell carcinoma (BIA-SCC) has received limited scholarly attention since its first case in 1992. Thus, this study aims to conduct a qualitative synthesis focused on the underexplored association between breast implants and BIA-SCC. A systematic review was conducted utilizing the PubMed, Web of Science, and Cochrane databases to identify all currently reported cases of BIA-SCC. Additionally, a literature review was performed to identify potential biochemical mechanisms that could lead to BIA-SCC. Studies were vetted for quality using the NIH quality assessment tool. From an initial pool of 246 papers, 11 met the quality criteria for inclusion, examining a total of 14 patients aged between 40 and 81 years. BIA-SCC was found in a diverse range of implants, including those with smooth and textured surfaces, as well as those filled with saline and silicone. The condition notably manifested a proclivity for aggressive clinical progression, as evidenced by a mortality rate approximating 21.4% within a post-diagnostic interval of six months. Our literature review reveals that chronic inflammation, driven by various external factors such as pathogens and implants, can initiate carcinogenesis through epigenetic modifications and immune system alterations. This includes effects from exosomes and macrophage polarization, showcasing potential pathways for the pathogenesis of BIA-SCC. The study highlights the pressing need for further investigation into BIA-SCC, a subject hitherto inadequately addressed in the academic sphere. This necessitates the urgency for early screening and intervention to improve postoperative outcomes. While the review is confined by its reliance on case reports and series, it serves as a valuable reference for future research endeavors.

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.

Development and Validation of a Diagnostic Histopathological Scoring System for Capsular Contracture Based on 720 Breast Implant Capsules.

BACKGROUND: Capsular contracture is traditionally evaluated with the Baker classification, but this has notable limitations regarding reproducibility and objectivity. OBJECTIVES: The aim of this study was to develop and validate procedure-specific histopathological scoring systems to assess capsular contracture severity. METHODS: Biopsies of breast implant capsules were used to develop histopathological scoring systems for patients following breast augmentation and breast reconstruction. Ten histological parameters were evaluated by multivariable logistic regression to identify those most associated with capsular contracture. Significant parameters (P < .05) were selected for the scoring systems and assigned weighted scores (1-10). Validation was assessed from the area under the curve (AUC) and the mean absolute error (MAE). RESULTS: A total of 720 biopsies from 542 patients were included. Four parameters were selected for the augmentation scoring system, namely, collagen layer thickness, fiber organization, inflammatory infiltration, and calcification, providing a combined maximum score of 26. The AUC and MAE for the augmentation scoring system were 81% and 0.8%, which is considered strong. Three parameters were selected for the reconstruction scoring system, namely, fiber organization, collagen layer cellularity, and inflammatory infiltration, providing a combined maximum score of 19. The AUC and MAE of the reconstruction scoring system were 72% and 7.1%, which is considered good. CONCLUSIONS: The new histopathological scoring systems provide an objective, reproducible, and accurate assessment of capsular contracture severity. We propose these novel scoring systems as a valuable tool for confirming capsular contracture diagnosis in the clinical setting, for research, and for implant manufacturers and insurance providers in need of a confirmed capsular contracture diagnosis.

Outcomes After Implant-Based Breast Reconstruction Following the National Institution of a Ban on Bacitracin Irrigation.

BACKGROUND: The use of irrigation with bacitracin-containing solution is common among surgeons, as it was widely thought to have antibacterial properties and prevent postoperative infection. Current literature, however, suggests that antibiotic-containing irrigation confers little added benefit. On January 31, 2020, the Food and Drug Administration instituted a ban on bacitracin-containing irrigation for operative use. This study aimed to determine whether bacitracin has a beneficial effect on postoperative infection rates by analyzing infection rates before and after the Food and Drug Administration ban on bacitracin irrigation. METHODS: A single-institution retrospective chart review was conducted. Eligible patients underwent implant-based breast reconstruction after mastectomy from October 1, 2016, to July 31, 2022. Procedure date, reconstruction type, patient comorbidities, use of bacitracin irrigation, postoperative infection, and secondary outcomes were collected. Univariate and multivariable logistic regression analyses were performed. RESULTS: A total of 188 female patients were included in the study. Bacitracin use did not protect against infection in univariate or multivariable analysis. Age greater than 50 years was associated with an increased risk of postoperative infection ( P = 0.0366). The presence of comorbidities, smoker status, neoadjuvant therapy treatment before surgery, implant placement, and laterality were all not significantly associated with postoperative infection development. CONCLUSIONS: The results of this study demonstrate a lack of association between bacitracin use and postoperative infection. Additional research into the optimal antibiotic for perioperative irrigation is needed, as bacitracin is not encouraged for use.

Impact of mastectomy flap necrosis on prepectoral reconstructive outcomes.

INTRODUCTION: As reconstructive surgeons have increasingly transitioned to the prepectoral plane for prosthetic breast reconstruction, the implications of mastectomy skin flap necrosis have become more concerning. Our goal was to evaluate the effect of skin flap necrosis on reconstructive outcomes in patients undergoing immediate prepectoral breast reconstruction. METHODS: A retrospective review was conducted of patients undergoing immediate two-stage prepectoral reconstruction at a single center with at least 3 months follow-up. Postoperative complications, reconstructive outcome, and time to final implant were compared between patients with and without mastectomy skin necrosis. RESULTS: A total of 301 patients underwent 509 prepectoral breast reconstructions. Forty-four patients (14.6%) experienced postoperative mastectomy skin flap necrosis. Demographic and reconstructive characteristics were similar between the necrosis and no necrosis cohorts. Patients with skin necrosis were more likely to undergo reoperation after tissue expander (64% vs 19%, p < 0.01) and undergo expander replacement (13.6% vs 3.5%, p = 0.02). However, rates of reconstructive failure (6.8% vs 6.2%), major infection (9.1% vs 9.0%), and minor infection (13.6% vs 17.5%) after expander placement were statistically similar. Patients with skin necrosis trended toward longer time before final implant placement, although the difference was not statistically significant (6.5 vs 5.0 months, p = 0.08). There was no difference in complication rates between the necrosis and no necrosis cohort after final implant placement. There was a higher rate of revision surgery after implant placement in the necrosis cohort (12.5% vs 4.1%, p = 0.047). CONCLUSIONS: Mastectomy skin flap necrosis is a concerning postoperative event, particularly in patients with prepectoral prostheses. We observed that patients with skin necrosis experience higher reoperation rates in the expander period, yet have similar infection rates and achieve similar final reconstructive outcomes compared to patients without necrosis.

Biofilm-derived oxylipin 10-HOME mediated immune response in women with breast implants.

Breast implant illness (BII) is a poorly understood disease in which patients develop symptoms typical of autoimmune conditions following breast implantation. There is no known underlying cause, and patients often resort to breast implant removal and capsulectomy to alleviate symptoms. In this issue of the JCI, Khan and colleagues examined 86 breast explants from patients that reported BII symptoms and 55 control explants. The BII group showed a disproportionally high degree of biofilm, which was associated with oxylipin (10-HOME) on the implant surfaces. Injections of 10-HOME in the mammary fat pad of a murine model recapitulated BII symptoms and increased Th1 cell populations. Notably, macrophages in the periprosthetic tissue from BII patients were more likely to exhibit a proinflammatory phenotype, and naive T cells exposed to 10-HOME caused naive macrophages to differentiate to a proinflammatory phenotype. This work provides a pathophysiologic mechanism for a currently understudied and poorly characterized disease.