Data quality assessment of the Dutch Breast Implant Registry by automated data verification using medical billing data.

BACKGROUND: The Dutch Breast Implant Registry (DBIR) provides real-time population-based data to monitor and improve the quality and safety of breast implants and to trace patients in the event of an (inter)national recall. To serve these main goals, the capture rate and percentage of implants that are actually registered should be known and data should be complete. This study aimed to describe an automated verification process for capture rates and data completeness using medical billing data as the external source. METHODS: DBIR-data on reconstructive permanent breast implants and tissue expanders (TEs) from 2019 were compared to medical billing data. At the hospital level, the capture rate of DBIR and accuracy of the selected data points were assessed. RESULTS: In total, 2389 implants (1420 patients) were included from 12 participating hospitals (11% of all healthcare institutions registering in DBIR). DBIR had capture rates of 99% to 114% for inserted permanent implants and TEs and 49% for explanted permanent implants and TEs. Among the 9015 data points analyzed in DBIR, 8861 (98%) matched the medical billing data. Mastopexy had the highest matching percentage (100%) and capsulectomy the lowest (86%). CONCLUSION: This study showed varying capture rates in DBIR depending on the intervention group, indicating that registration of DBIR-data and medical billing codes could be further optimized. Data accuracy was high as only 2% of data points did not correspond to medical billing data. For future data verification, other external data sources could be explored, including sources that enable verification of cosmetic implants.

Immediate prepectoral versus submuscular breast reconstruction in nipple-sparing mastectomy: a retrospective cohort analysis.

Objective: To evaluate early complications in prepectoral breast reconstruction. Methods: A retrospective cohort study including 180 consecutive cases of nipple-sparing mastectomy, comparing immediate breast reconstruction with subpectoral to prepectoral mammary implants in 2012-2022. Clinical and demographic characteristics and complications in the first three months following surgery were compared between the two techniques. Results: The prepectoral technique was used in 22 cases (12.2%) and the subpectoral in 158 (87.8%). Median age was higher in the prepectoral group (47 versus 43.8 years; p=0.038), as was body mass index (25.1 versus 23.8; p=0.002) and implant volume (447.5 versus 409 cc; p=0.001). The prepectoral technique was more associated with an inframammary fold (IMF) incision (19 cases, 86.4% versus 85, 53.8%) than with periareolar incisions (3 cases, 13.6% versus 73, 46.2%); (p=0.004). All cases in the prepectoral group underwent direct-to-implant reconstruction compared to 54 cases (34.2%) in the subpectoral group. Thirty-eight complications were recorded: 36 (22.8%) in the subpectoral group and 2 (9.1%) in the prepectoral group (p=0.24). Necrosis of the nipple-areola complex/skin flap occurred in 27 patients (17.1%) in the subpectoral group (prepectoral group: no cases; p=0.04). The groups were comparable regarding dehiscence, seroma, infection, and hematoma. Reconstruction failed in one case per group (p=0.230). In the multivariate analysis, IMF incision was associated with the prepectoral group (aOR: 34.72; 95%CI: 2.84-424.63). Conclusion: The incidence of early complications was comparable between the two techniques and compatible with previous reports. The clinical and demographic characteristics differed between the techniques. Randomized clinical trials are required.

Clinical Evaluation of Microbial Communities and Associated Biofilms with Breast Augmentation Failure.

The incidence of breast implant illness (BII) and BII-related explant procedures has not decreased with current surgical and treatment techniques. It is speculated the main underlying cause of BII complications is the result of chronic, sub-clinical infections residing on and around the implant. The infection, and subsequent biofilm, produce antagonistic compounds that drive chronic inflammation and immune responses. In this study, the microbial communities in over 600 consecutive samples of infected explant capsules and tissues were identified via next-generation sequencing to identify any commonality between samples. The majority of the bacteria identified were Gram-positive, with Cutibacterium acnes and Staphylococcus epidermidis being the dominant organisms. No correlation between sample richness and implant filling was found. However, there was a significant correlation between sample richness and patient age. Due to the complex nature, breast augmentation failures may be better addressed from a holistic approach than one of limited scope.

Trends and Early Complications in Direct-to-Implant Breast Reconstruction: An Updated Analysis of the ACS-NSQIP Database.

Background: Rates of direct-to-implant (DTI) breast reconstruction, in which breast implants are placed at the time of mastectomy, have been consistently rising. Advances in surgical adjuncts and technology, such as acellular dermal matrices (ADM), have made DTI reconstruction safer and more reliable. However, few studies have characterized early (30-day) postoperative complications following DTI. The aim of this study was to obtain a current understanding of early postoperative outcomes following DTI breast reconstruction. Methods: Using data from the American College of Surgeons-National Surgical Quality Improvement Program, we analyzed complications for female patients who underwent DTI reconstruction from 2017 to 2019, as well as trends in DTI reconstruction from data on mastectomy and DTI reconstruction from 2010 to 2019. We grouped complications into major surgical (including return to the operating room) or medical complications. Statistical analysis was performed using Fischer's exact test for categorical variables, Student's t-test for continuous variables, and logistic regression. Results: DTI breast reconstruction rates have increased since 2010. Among our 2017-2019 cohort of 4204 patients, the early major surgical complication rate was approximately 10% (422 patients) and the major medical complication rate was 0.83% (35 patients). Regression modeling identified body mass index, smoking status, hypertension, bleeding disorders, and intraoperative blood transfusion as having a relationship with surgical complications (P < .001). Conclusions: Despite increased use of ADM and indocyanine green angiography, compared to prior studies, early postoperative complications have remained stable. Further studies are needed to assess long-term complications and patient-reported outcomes in DTI breast reconstruction.

Historique: Le taux de reconstructions mammaires immédiates, c'est-à-dire que les implants mammaires sont installés au moment de la mastectomie, augmentent régulièrement. Grâce aux progrès des adjuvants chirurgicaux et de la technologie, tels que les matrices dermiques acellulaires (MDA), la reconstruction mammaire immédiate est désormais plus sécuritaire et plus fiable. Cependant, peu d'études ont caractérisé les complications précoces suivant une telle intervention (dans les 30 jours). La présente étude visait à comprendre les résultats postopératoires précoces actuels après une reconstruction mammaire immédiate. Méthodologie: À l'aide des données de l'American College of Surgeons-National Surgical Quality Improvement Program, les chercheurs ont analysé les complications qu'ont subies les femmes après une reconstruction mammaire immédiate entre 2017 et 2019, de même que les tendances de ce type de reconstruction à partir des données sur la mastectomie et la reconstruction mammaire immédiate entre 2010 et 2019. Ils ont divisé les complications entre les complications chirurgicales majeures (y compris le retour en salle opératoire) et les complications médicales. Ils ont effectué les analyses statistiques à l'aide de la méthode exacte de Fischer pour les variables nominales, du test de Student pour les variables continues et de la régression logistique. Résultats: Le taux de reconstructions mammaires directes a augmenté depuis 2010. Dans la cohorte de 4 204 patients de 2017 à 2019, le taux de complications chirurgicales majeures précoces s'élevait à environ 10% (422 patients) et le taux de complications médicales majeures, à 0,83% (35 patients). Selon la modélisation de régression, l'indice de masse corporelle, le tabagisme, l'hypertension, les troubles hémorragiques et la transfusion sanguine intraopératoire sont liés aux complications chirurgicales (P < 0001). Conclusions: Malgré le recours accru aux MDA et l'angiographie au vert d'indocyanine, par rapport aux études antérieures, les complications postopératoires précoces sont demeurées stables. D'autres études devront être réalisées pour évaluer les complications à long terme et les résultats cliniques déclarés par les patientes après une reconstruction mammaire immédiate.

A Prospective Observational Clinical Cohort of Women with Suspected Breast Implant Illness.

Background: This study aims to describe a prospective clinical cohort of patients with silicone breast implants and suspected Breast Implant Illness (BII). Methods: Women were included in a specialized silicone outpatient clinic at Amsterdam UMC, the Netherlands. Baseline characteristics were collected including medical history, implant details, and symptoms. Experienced physicians categorized BII suspicion as high, moderate, or low, based on symptoms and after exclusion of other probable causes. Additionally, participants completed questionnaires assessing symptoms and daily life impact at baseline, 6 months, 1, 2, and 5 years. For this initial analysis, the results from the first three years of inclusions were collected. Results: Data from 353 women were collected from December 2020-December 2023. At baseline, the most reported symptoms were fatigue, arthralgia, myalgia, and morning stiffness, accompanied by local symptoms in 83.3% of patients. At the clinic, 112 women were categorized as having high suspicion of BII, 147 women as moderate, and 94 women as low. At follow-up, 182 women (51.6%) opted for explantation. Following explantation, women with a high or moderate suspicion of BII experienced more significant symptom improvement, accompanied by a decrease in anxiety and a greater sense of control over their illness, compared to women with a low suspicion of BII. Conclusions: Our study highlights a distinct interplay of systemic and local symptoms among women with suspicion of BII. Women with a high or moderate BII suspicion benefit significantly more from explantation than women with low suspicion. Experienced physicians are pivotal in effectively assessing and guiding this patient group, highlighting the need for tailored clinical approaches.

Bibliometric analysis of quality of life in implant-based breast reconstruction.

Background: Implant-based breast reconstruction (IBR), following mastectomy, significantly impacts patients' quality of life (QoL), necessitating accurate measurement through psychometrically robust patient-reported outcome measure (PROM) tools. This bibliometric analysis aims to discern trends, identify gaps, and evaluate the use of such tools in the IBR literature. Methods: The 100 most cited publications regarding QoL in implant-based reconstruction were identified on Web of Science, across all available journal years (from 1977 to 2024) on 10 March 2024. Study details, including the citation count, main content focus, outcome measures, and usage of psychological questionnaires, were extracted and tabulated from each publication. The Oxford Centre for Evidence-Based Medicine (OCEBM) levels of evidence (LOE) of each study were assessed. Results: The 100 most cited publications on QoL in implant-based reconstruction were identified, encompassing 64,192 patients and 28,114 reconstructed breasts. Citations per publication ranged from 62 to 457 (mean, 124.95 ± 73.05), with the highest-cited study being authored by Al-Ghazal (n = 457). The vast majority of publications were LOE II (n = 52), representative of prospective cohort studies, systematic reviews of non-randomised studies, and systematic review and meta-analysis. The number of publications for LOE V, IV, III, and I was 0, 7, 41, and 0, respectively. The main content focus was "quality of life" in 83 publications, with significant utilisation of the BREAST-Q questionnaire. A total of 80 publications used validated questionnaires with psychometric development. Conclusions: This analysis demonstrates that the research methodologies within IBR mostly consist of moderate-quality publications; however, notably, there was a lack of LOE I studies, underscoring a gap in high-quality research within the field. Moreover, only 62/100 used validated PROM tools. Future IBR research studies should be focussed on most robust methodologies, incorporating validated PROM tools, to optimise shared-decision making and informed consent.

Is capsulectomy necessary for symptom improvement in patients undergoing implant removal for systemic symptoms?

A case of symptom improvement after implant removal without capsulectomy is presented with a review of the literature.

Secondary Breast Augmentation: The Six Winning Moves.

BACKGROUND: Breast augmentation in 2019 was the first among the top five cosmetic surgical procedures performed worldwide, according to the International Society of Aesthetic Plastic Surgery. It is not only the most commonly performed cosmetic surgery, but also the aesthetic procedure with the highest reoperation rate. METHODS: A retrospective observational study of 306 female patients who underwent secondary breast surgery, with a follow-up of at least 1 year after surgery, from 2010 to 2020 is presented. For patients'selection, we decided to include all patients who performed a secondary breast surgery for aesthetic reasons; only patients with history of previous radiotherapy were excluded. RESULTS: Patients were divided into different groups according to the performed procedure (the six winning moves) and associated postoperative outcomes are shown. CONCLUSIONS: The aim of this paper, based on authors' own experience, is to present a personalized approach to secondary breast reshaping, describing the six "winning" moves to apply, which, differently combined among each other, intend to address each specific cause of reintervention with a dedicated surgical procedure. LEVEL OF EVIDENCE IV: 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 .

The Low-Abundance Plasma Proteome Reveals Differentially Abundant Proteins Associated with Breast Implant Capsular Contracture: A Pilot Study.

Capsular contracture (CC) is one of the most common postoperative complications associated with breast implant-associated infections. The mechanisms that lead to CC remain poorly understood. Plasma is an ideal biospecimen for early proteomics biomarker discovery. However, as high-abundance proteins mask signals from low-abundance proteins, identifying novel or specific proteins as biomarkers for a particular disease has been hampered. Here, we employed depletion of high-abundance plasma proteins followed by Tandem Mass Tag (TMT)-based quantitative proteomics to compare 10 healthy control patients against 10 breast implant CC patients. A total of 450 proteins were identified from these samples. Among them, 16 proteins were significantly differentially expressed in which 5 proteins were upregulated and 11 downregulated in breast implant CC patients compared to healthy controls. Gene Ontology enrichment analysis revealed that proteins related to cell, cellular processes and catalytic activity were highest in the cellular component, biological process, and molecular function categories, respectively. Further, pathway analysis revealed that inflammatory responses, focal adhesion, platelet activation, and complement and coagulation cascades were enriched pathways. The differentially abundant proteins from TMT-based quantitative proteomics have the potential to provide important information for future mechanistic studies and in the development of breast implant CC biomarkers.

A case report of BIA-ALCL: Diagnostic, treatment, and mammary reconstruction.

INTRODUCTION AND IMPORTANCE: BIA-ALCL is a non-Hodgkin lymphoma occurring primarily in women with textured breast implants, typically presenting as late seroma. Diagnosis involves ultrasound-guided fine-needle aspiration or core needle biopsy, followed by cytologic and immunohistochemical evaluation. Positive results show CD30 cell expression and lack ALK expression. Treatment includes removing breast implants and the periprosthetic capsule. If the lymphoma has spread, en bloc capsulectomy, immunotherapy, and chemotherapy are required. Reconstruction can be done with smooth implants or autologous tissue. PRESENTATION OF CASE: We present here the case of a woman with a 12-year history of microtextured breast implants, without any cancer family background, who presented with peri-implant effusion in the left breast, which tested positive for BIA-ALCL at stage IA. The patient underwent breast implant removal with total capsulectomy and posterior successful autologous tissue reconstruction, demonstrating that outcomes can be satisfactory when properly treated. CLINICAL DISCUSSION: Paying attention to signs in women with breast implants, beyond imaging tests, can aid in the early diagnosis of BIA-ALCL and ensure a not aggressive treatment. This approach allows the reconstruction with autologous tissue without the need of further implants. CONCLUSION: BIA-ALCL is a rare disease, further studies about this lymphoma can help with early diagnosis and potential prevention.

Breast Implant Removal-Only: The Role of Targeted Compression.

BACKGROUND: The number of women seeking explantation of their breast implants has increased in recent years. Anxiety due to potential health problems has been one of the major catalysts. Mastopexy with or without autoaugmentation and fat grafting are the main techniques used in breast implant removal surgery. OBJECTIVES: To analyse the aesthetic and satisfactory outcomes after simple breast implant removal assisted by targeted compression. METHODS: Twenty-eight patients were included in the series. Targeted compression of the breast after implant removal was performed during the 1st month. A satisfaction survey using a Likert scale was used before and after the final visit. The patients were followed up for 1 year. RESULTS: The mean age of the patients was 41 years old, and the mean time between implantation and removal was 10 years. Subjective reasons for removal (46.4% of the patients) were more frequent in women with less time since implantation (5 years) versus 15 years for implant-related problems. A total of 57.14% of the women were satisfied with the aesthetic result, and 42.86% were very satisfied. Only 17.8% of the total would consider an aesthetic refinement. CONCLUSIONS: Simple breast implant removal yields good aesthetic outcomes, and patients are satisfied with the results. Good management of compression of the breast and close follow-up to treat any collection in the pocket provides good adhesion and allows for effective management of the process of deflation and setting of the breast mound. LEVEL OF EVIDENCE IV: 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.

Ultrasound versus MRI for evaluation of silicone leakage from silicone breast implants.

Background: Implant ruptures and gel bleed are not uncommon among women with silicone breast implants. While magnetic resonance imaging (MRI) is traditionally considered the gold standard diagnostic modality, recent studies suggest ultrasound might be an acceptable alternative. This study compares the efficacy of ultrasound and MRI in assessing implant integrity. Methods: Women with silicone breast implants underwent a breast and axillary ultrasound and MRI on the same day. All tests were assessed by experienced radiologists. The accuracy, sensitivity, and specificity of ultrasound and MRI for implant rupture detection and silicone depositions in axillary lymph nodes were evaluated. Findings: A total of 104 women participated in the study. The accuracy, sensitivity, and specificity of ultrasound for detecting implant ruptures compared to MRI were 96 %, 95 %, and 96 %, respectively. MRI demonstrated significantly lower sensitivity (44 %) for detecting silicone depositions in axillary lymph nodes compared to ultrasound. A significant association was observed between the presence of enlarged axillary lymph nodes and/or axillary pain and the detection of silicone depositions in axillary lymph nodes on ultrasound (χ2 (1, N = 104) = 5·1, p = 0·024). Six women exhibited silicone depositions in axillary lymph nodes despite having intact first-pair implants, indicative of gel bleed. Interpretation: Ultrasound is nearly as effective as MRI for detecting breast implant ruptures and is superior for detecting silicone depositions in axillary lymph nodes. We therefore recommend initiating radiological examination in women with breast implants with a breast and axillary ultrasound, proceeding to MRI only if the ultrasound is inconclusive. The prevalence of gel bleed is understudied and its potential adverse health effects might be underestimated. Further research is needed to explore its potential association with development of systemic symptoms.

Comparing outcomes of prepectoral, partial muscle-splitting subpectoral, and dual-plane subpectoral direct-to-implant reconstruction: implant upward migration and the pectoralis muscle.

Background: Although dual-plane subpectoral breast reconstruction has been widely implemented in implant-based breast reconstruction, animation deformities remain an issue. Recent advances in skin flap circulation detection have increased the use of prepectoral reconstruction. A partial muscle-splitting subpectoral plane was introduced to decrease the visibility of the implant edge. However, there is yet to be a direct comparison of these methods for optimal results, including changes in implant position after reconstruction. This study aims to compare the incidence of complications such as rippling, animation deformity, implant upward migration between the dual-plane, the partial muscle splitting subpectoral and the prepectoral reconstruction group. In addition, multivariate analysis was conducted to identify the risk factors of complications. Methods: We retrospectively investigated 349 patients who underwent unilateral direct-to-implant breast reconstruction from January 2017 to October 2020. Implants were inserted into the dual-plane subpectoral (P2) or partial muscle-splitting subpectoral (P1, the muscle slightly covering the upper edge of the implant) or the prepectoral pocket (P0). Postoperative outcomes and at least 2 years of follow-up complications were compared. Results: There was no significant difference in rippling (P=0.62) or visible implant edges on the upper pole (P=0.62) among the three groups. In contrast, the P0 group had a lower incidence of seroma (P=0.008), animation deformity (P<0.001), breast pain (P=0.002), and upward implant migration (P0: 1.09%, P1: 4.68%, P2: 38.37%, P<0.001). According to the multivariate analysis, P2 resulted in a greater risk of seroma (odds ratio: 4.223, P=0.002) and implant upward migration (odds ratio: 74.292, P<0.001) than did P0. Conclusions: P0 and P1 showed better postoperative outcomes than P2. Additionally, P0 had less implant migration than P1. Even though P1 minimally dissects the muscle, the location of the implant may change. Considering that muscle contraction can deteriorate symmetry and aesthetic results, the P0 method may be the most favorable.

Unveiling the Potential of Drain Tip Cultures: Impact on Surgical Site Infections in Implant-Based Breast Reconstruction.

PURPOSE: Surgical site infections (SSIs) remain a concern after implant-based breast reconstruction, despite preventive measures. These infections can have serious consequences. This study evaluated the correlation between drain tip culture results and SSIs in this patient population. METHODS: We analyzed data from patients who underwent implant-based breast reconstruction between July 2021 and May 2023. Drain tip cultures were collected, and any SSIs occurring within one month of surgery were documented. We then compared clinical data with the culture results. RESULTS: A total of 263 drain tip cultures were included. Notably, none of the 61 patients who underwent tissue expander removal and implant insertion had positive cultures. However, among the 202 patients who received tissue expanders or direct-to-implant procedures, 11 (5.45%) had positive cultures, with a total of 12 SSIs identified. Importantly, five of the 11 culture-positive wounds developed SSIs. Multivariate analysis revealed a significant two-way association between infection and positive drain tip cultures. For Staphylococcus aureus specifically, drain tip cultures showed excellent predictive value: sensitivity (33.33%), specificity (100%), positive predictive value (100%), and negative predictive value (95.96%). CONCLUSION: Drain tip cultures from immediate implant-based breast reconstructions significantly correlated with SSIs. Close monitoring is crucial, especially when S. aureus is identified in the culture.

Long-Term Biodegradation of Polyacrylamide Gel Residues in Mammary Glands: Physico-Chemical Analysis, Chromatographic Detection, and Implications for Chronic Inflammation.

In the past, polyacrylamide hydrogel was a popular choice for breast augmentation filler, and many women underwent mammoplasty with this gel. However, due to frequent complications, the use of polyacrylamide hydrogel in mammoplasty has been banned. Despite this ban, patients experiencing complications still seek medical treatment. The aim of this study was to investigate the fate of the polymer over a defined implantation period. Biopsies of breast implants were obtained from patients with 23 and 27 years of post-mammoplasty. These biopsies were meticulously purified from biological impurities and subjected to analysis using IR spectrometry, liquid chromatography-mass spectrometry, gas chromatography, and differential scanning calorimetry. The findings revealed the presence of polyacrylamide hydrogel residues, along with degradation products, within the infected material. Notably, the low-molecular-weight degradation products revealed via gas chromatography are aggressive and toxic substances capable of inducing chronic inflammation. This study sheds light on the long-term consequences of polyacrylamide hydrogel implantation, highlighting the persistence of harmful degradation products and their role in exacerbating patient complications.

A Decalogue on Enhanced Recovery After Breast Augmentation Surgery (ERABAS).

BACKGROUND: Medical and technical advances have changed the state of postoperative surgical patient care, allowing for better and faster recovery. Since its publication, predictable 24-hour recovery in breast augmentation surgery has been controversial and has generated discussion. In this study, we present a novel, easy, and reproducible protocol for Enhanced Recovery After Breast Augmentation Surgery (ERABAS), along with a summary of the ten points to follow. METHODS: We conducted a retrospective study of all primary breast augmentation surgeries performed between 2010 and 2020 by a private activity. All surgeries were performed by the same surgeon according to the same protocol, and all implants were obtained from the same company. Data were evaluated using two binary logistic regression models, taking as variables responses to recovery time and postoperative pain and as predictor or explanatory variables to the factors age, smoking, size, and location of the implant. RESULTS: In total, 2906 patients were included in this study. Of these, 2770 patients (95%) immediately returned to normal life within the first 24 h, 129 achieved normal life in four days, and only seven needed a week to recover. In these seven patients, the main acute complications were hemorrhage and acute hematoma. The implants were always round; textured implants were used in 88.8% of patients, while smooth implants were used in 11.2%. A subfascial pocket was used in 934 patients, and a dual-plane pocket was performed for 1972 patients. The only factor that showed a significant effect on recovery time was the location of the implant (p < 0.05), with the dual-plane pocket being the intervention associated with a later recovery, specifically a probability of recovery after 24 hour, 2.86 times greater than subfascial. CONCLUSIONS: The ERABAS protocol allowed rapid return to daily activities with low complication rates. Further prospective comparative multicenter studies are required to confirm these results. LEVEL OF EVIDENCE III: 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.

Evaluating silicone breast implant rupture with photon-counting CT and volumetric silicone maps.

We present a case of an 81-year-old woman who presented to the emergency department with bleeding from a right breast wound. The patient had prior imaging suggestive of bilateral silicone implant rupture and a history of low tolerance for MRI scans. Ultrasound imaging in the emergency setting showed findings in the right breast suggestive of a fistula with free silicone and hematoma. A subsequent photon-counting CT scan with custom silicone-specific segmentation allowed differentiation of silicone from hematoma, provided anatomic assessment and location of the fistula, and revealed bilateral silicone-induced lymphadenopathy.

Achados incomuns em ressonância magnética de pacientes com implantes mamários / Unusual findings on MRI of patients with breast implants

Introdução: O implante de prótese mamárias é uma das cirurgias mais realizadas no mundo. Ao longo do tempo, diversos materiais foram utilizados com objetivo de reconstituir o volume mamário. Apesar das melhorias técnicas, cirúrgicas e da segurança dos implantes atuais, os pacientes são confrontados com potenciais complicações "não usuais": rupturas intracapsulares e extracapsulares, hematomas tardios e deformidade de contorno, silicone intralinfonodal ou herniação da cápsula fibrosa. A ressonância magnética (RMN) é a modalidade de imagem mais útil para investigação dessas complicações. Método: Trata-se de uma série de casos em que foram levantadas alterações ditas "não usuais", pela baixa frequência ou ausência na citação da literatura, após cirurgias de inclusão de prótese de silicone. Os dados foram coletados da experiência pessoal da clínica privada de um dos autores, na cidade de Brasília-DF, entre abril de 2015 e março de 2023. Resultados: Foram um total de 211 pacientes avaliados, e foram encontradas alterações menos frequentes nas RMN de 12 pacientes (5,68%), das quais: 5 com volumosa quantidade de líquido pericapsular, 3 com granuloma capsular, 1 seroma tardio com conteúdo hemorrágico,1 rotura intra e extracapsular, 1 nódulo junto à cápsula fibrosa do implante, 2 linfonodopatia axilar ipsilateral, 1 silicone intralinfonodal, 1 edema do músculo peitoral, 2 tumor desmoide e 1 herniação da cápsula fibrosa. Conclusão: Estima-se que existam 50 milhões de mulheres com próteses de mama no mundo. Com base nesse dado, o número de complicações ditas "não usuais" passa a ser um desafio diagnóstico para o cirurgião plástico e o radiologista.

Introduction: Breast prosthesis implantation is one of the most performed surgeries in the world. Over time, different materials were used to reconstitute breast volume. Despite technical and surgical improvements and the safety of current implants, patients are faced with potential "unusual" complications: intracapsular and extracapsular ruptures, late hematomas and contour deformity, intra-nodal silicone, or herniation of the fibrous capsule. Magnetic resonance imaging (MRI) is the most useful imaging modality for investigating these complications. Method: This is a series of cases in which so-called "unusual" changes were reported, due to their low frequency or lack of mention in the literature, after surgeries to include a silicone prosthesis. The data were collected from the personal experience of one of the authors in his private clinic, in the city of Brasília-DF, between April 2015 and March 2023. Results: A total of 211 patients were evaluated, and less frequent changes were found in the MRI of 12 patients (5.68%), of which: 5 with a large amount of pericapsular fluid, 3 with capsular granuloma, 1 late seroma with hemorrhagic content, 1 intra and extracapsular rupture, 1 nodule close to the implant's fibrous capsule, 2 axillary lymph node disease ipsilateral, 1 intra-nodal silicone, 1 pectoral muscle edema, 2 desmoid tumor and 1 herniation of the fibrous capsule. Conclusion: It is estimated that there are 50 million women with breast implants in the world. Based on this data, the number of so-called "unusual" complications becomes a diagnostic challenge for the plastic surgeon and radiologist.

A Histological Assessment Tool for Breast Implant Capsules Validated in 480 Patients with and Without Capsular Contracture.

BACKGROUND: Understanding the impact of breast implants on the histological response in the surrounding fibrous capsule is important; however, consensus is lacking on how to analyze implant capsules histologically. We aimed to develop a standardized histological assessment tool to be used in research potentially improving diagnostic accuracy and treatment strategies for capsular contracture. METHODS: Biopsies of breast implant capsules from 480 patients who had undergone breast augmentation or reconstruction were collected and stained with hematoxylin and eosin. Initially, biopsies from 100 patients were analyzed to select histological parameters demonstrating the highest relevance and reproducibility. Then, biopsies from the remaining 380 patients were used to determine intra- and interobserver agreements of two blinded observers and agreement with a pathologist. Finally, we tested the association between the parameters and capsular contracture. RESULTS: The histological assessment tool included ten parameters assessing the inflammatory, fibrotic, and foreign-body reaction to breast implants, each graded on two-, three-, or four-point scales. Intra- and interobserver agreements were almost perfect (0.83 and 0.80), and agreement with the pathologist was substantial (0.67). Four parameters were significantly correlated with capsular contracture, namely chronic inflammation with lymphocyte infiltration (p < 0.01), thickness of the collagen layer (p < 0.0001), fiber organization (p < 0.01), and calcification (p < 0.001). CONCLUSIONS: This is the first validated histological assessment tool for breast implant capsules. The validated tool not only advances our understanding of capsular contracture but also sets a new standard for histological evaluation in breast implant research and clinical diagnostics. NO LEVEL ASSIGNED: This journal requires that authors assign a level of evidence to each submission to which Evidence-Based Medicine rankings are applicable. This excludes Review Articles, Book Reviews, and manuscripts that concern Basic Science, Animal Studies, Cadaver Studies, and Experimental Studies. 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 .