1,721,021 research outputs found
From Breast Implant to Rough Implant Associated–Anaplastic Large Cell Lymphoma (RIA-ALCL)
No full textThe FDA (Silver Spring, MD, USA) announcement in 2011 heralded the starting point of global alertness regarding the possible connection of breast implants with a rare form of a non-Hodgkin lymphoma: anaplastic large cell lymphoma (ALCL). Sporadic case reports, preliminary case review studies, and manuscripts proposing diagnostic, staging and treatment protocols, or etiopathogenesis theories filled the scientific lit- erature. In 2016, this new pathology was added as a distinct entity in the update to the World Health Organization (Geneva, Switzerland) classification of lymphoid neoplasms and now in- cludes over 420 cases in Europe1 and 1148 cases worldwide according to BIA-ALCL Global Network and EURAPS Scientific Committee on Device Safety and Development. The interest of scientific research towards this pathology increased year by year and was further boosted by a recent increase in media at- tention; therefore, various names or abbreviations have been given to it. The first attempt to give it a name was made by Story et al. in 2013, who referred to it as implant-associated ALCL, or iALCL.2 This was replaced the same year by Thompson et al. with the most widely accepted way of referring to it: breast im- plant–associated ALCL (BIA-ALCL).3
During the last 10 years, since the first FDA announce- ment, BIA-ALCL has been at the forefront of numerous dis- cussions in conferences around the world and hearings by regulatory authorities such as the FDA, the French National Security Agency of Medicines and Health Products (Issy-les- Moulineaux, France), the Therapeutic Goods Administration (Woden, Australia), and so on. In the past decade, as aware- ness increased toward implants and their connection with ALCL, numerous case reports were presented in which ALCL arose in sites other than the breast. This includes the gluteal
region from textured gluteal implants, pacemakers, orthopedic implants for tibial and shoulder repair, dental implants, chest ports, and even bariatric surgery devices.4 Some patients have developed a misplaced fear of all breast implants, but to date no BIA-ALCL case has been published or officially regis- tered with a clear history of only smooth implants; therefore it can be considered as a pathology connected to textured im- plant surfaces only. Additionally, the Scientific Committee on Health, Environmental and Emerging Risks (Brussels, Belgium) recently expressed their final opinion on the safety of breast implants in relation to ALCL and concluded the existence of a causal relationship between textured breast implants and BIA-ALCL, indicating the texturization as the risk factor.5 We believe the current definition of “breast implant associated” is misleading because it suggests a direct connection to breast or breast implant, whereas the same ALCL can occur, although occasionally, in regions other than the breast and with im- plantable medical devices different from breast implants, all connected to each other by the rough surface of devices. We therefore believe that a more specific term such as Rough Implant Associated-Anaplastic Large Cell Lymphoma (RIA- ALCL) is needed to better define this pathology
Comment on the Invited Discussion on "Assessment of Risk Factors for Rupture in Breast Reconstruction Patients with Macrotextured Breast Implants"
No full textWe here present a few comments on the invited discussion of Dr. van Heijningen on the paper "Assessment of Risk Factors for Rupture in Breast Reconstruction Patients with Macrotextured Breast Implants ". Dr. van Heijningen made some reservations regarding paper conclusions due to the high dropout rate, the adopted exclusion criteria and the location and mechanism of implant rupture. First of all, a high dropout rate is not unbeknown to researchers in surveys-based studies and may be expected when recalling in 6 months a population observed during last 20 years. In our study data are missing at random not affecting the risk of bias, while the population accurately depicts the people we care, mainly but not only reconstructive. Patients who did not respond to the questionnaire could not participate to the survey, while those who did not hold recent imaging were excluded because of the risk of false negative due to possible silent rupture, accounting to 10% in some reports. MRI imaging often shows that implants fold back on their selves when capsular contracture reduces implant pocket. As the use of the underwire bra prevents implant inferior displacement, repeated muscular contraction may worsen implant folds and the chronic wear-and-tear mechanism may be responsible for the rupture. Finally, folding is presumably easier to occur at the upper quadrants where anatomical implant shell is thinnest and gel concentration reduced than the opposite, therefore is not surprising that the higher percentage of ruptures is located in the upper implant quadrants
BIA-ALCL epidemiological findings from a retrospective study of 248 cases extracted from relevant case reports and series: a systematic review
No full textBackground: The epidemiologic picture of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is unclear, with no high-level evidence, because only case reports and series are available.Objectives: The aim of this study was to update knowledge on BIA-ALCL epidemiology by utilizing all available data through a systematic review of scientific literature. Methods: A search on PubMed, Scopus, and Web of Science was conducted between October 2021 and April 2022. Out of the 2799 available records, 114 pertinent articles were selected, featuring 248 BIA-ALCL cases which were retrospectively analyzed by means of descriptive statistics, incidence rate (IR), Kaplan-Meier survival curves, and Pearson correlation coefficients.Results: The United States, the Netherlands, Italy, and Australia were the countries reporting the most cases. The mean age at first implantation was 42 years, and the mean age at diagnosis was 53 years. Aesthetic indications were the reason for 52% of cases, and reconstruction for 48%; macrotextured surface was linked to 73.8% of cases, and seroma to 83%. Total follow-up was 492 months, and mean event-free time (EFT) to BIA-ALCL development was 129 months. The IR was 96 new cases/1,000 women per year after first implantation, and was directly correlated to the number of replacements. EFT was directly correlated to the number of replacements, implant rupture, and capsule contracture, and was inversely associated with patients' age at first implantation and to BRACA1/2 and TP53 mutations.Conclusions: Macrotextured implant use in older patients and in patients with BRCA1/2 and TP53 mutations should be reconsidered, because this is associated with earlier disease onset. Implant replacement of asymptomatic, risk-stratified patients can be indicated due to its protective role against BIA-ALCL, reducing IR and risk, while increasing the EFT
Thromboembolism Risk Factor Assessment
No full textThis application is based on the official Thromboembolism Risk assessment protocol adopted by the Sant'Andrea Hospital of Rome, after a multidisciplinary consensus for the prevention of DVT/PE in surgical patients. The protocoll represent a modification of the original Caprini Risk assessment model
Thromboembolism risk (ipad edition)
No full textThis application is based on the official Thromboembolism Risk assessment protocol adopted by the Sant'Andrea Hospital of Rome after a multidisciplinary consensus for the prevention of DVT/PE in surgical patients. The protocol represents a modification of the original Caprini Risk assessment model
EURAPS
No full textApplication Apple for iPhone, iPad and iPod (IOS devices) for the European Association of Plastic Surgeon
Breast Reconstruction in Elderly Patients: Risk Factors, Clinical Outcomes, and Aesthetic Results
No full textBackground Correlation among age, clinical, and aesthetic outcomes in implant-based and autologous breast reconstructions was investigated. Methods Between 2004 and 2014, a retrospective study was performed on patients who underwent reconstruction following mastectomy. Patients were divided in group A (< 50 years), group B (≥ 50-59 years), group C (≥ 60-69 years), and group D (≥ 70 years). Demographics, comorbidities, American Society of Anesthesiologists (ASA) class, and length of stay were assessed using chi-square and Kruskal-Wallis H analysis considering p ≤ 0.05 as significant. Pre- and postoperative photographs were taken to grade aesthetic results by patients and blinded plastic surgery team. Results A total of 993 patients underwent 1,251 breast reconstructions, of which 356 (28.5%) were implant-based, 402 (32.1%) pedicled-flap, 445 (35.6%) free-flap, and 48 (3.8%) fat-graft reconstructions. There were 316 (25.2%) complications, of which 124 (34.8%) in implant-based, 74 (18.4%) in pedicled-flap, 111 (24.9%) in free-flap, and 2 (4.2%) in fat-graft reconstructions. Mean length of stay was 5.4 days without significant difference between age groups (p = 0.357). The incidence of overall complications was not significantly related to age, ASA class, smoking history, and previous radiotherapy. Body mass index was a significant predictor (p = 0.001), but odds ratio (OR: 1.2) demonstrated only a minimal increase in risk. Implant-based reconstruction was associated with a higher risk for complications compared with the other ones (OR: 2.5, p = 0.001). Patient and surgeon aesthetic surveys demonstrated an overall positive opinion in all age groups for each reconstructive option. Conclusion Advanced age should not be considered a risk factor for breast reconstruction, while implant-based technique was associated with a higher risk for complications compared with autologous that may provide older women with greater benefits
EURAPS editorial: BIA-ALCL, a brief overview
No full textThe history of breast implants includes important technological breakthroughs, but also safety controversies such as
the 1992 FDA moratorium against silicone, the 2010 PIP
implant scandal, and the 2015 Silimed ban.1–3 Nevertheless,
the popularity of breast augmentation continues to grow,
and millions of patients receive breast implants each yea
BreastV
No full textThe Breast-V is a software based on an algorithm, result of a scientific study from the Department of Plastic, Reconstructive and Aesthetic Surgery, Faculty of Medicine and Psycology, "Sapienza" University of Rome. It is useful for breast volume assessment with only three anthropometric measurements (Sternal Notch-to-Nipple distance, Inframammary Fold-to-Nipple distance, and Inframammary Fold-to-Fold Projection distance
Sentinel Node Tool
No full textLa biopsia del Linfonodo Sentinella rappresenta ormai il gold standard per la stadiazione ascellare delle pazienti affette da tumore al seno.
Il protocollo attuale, nonostante le recenti “suggestioni” provenienti dagli Stati Uniti, prevede ancora la Linfoadenectomia Ascellare Completa in caso di Linfonodo Sentinella metastatico, ma solo nel 35-50% di questi casi si rinvengono metastasi addizionali.
Per identificare il rischio individuale di metastasi ai residui Linfonodi Ascellari, sono stati descritti in letteratura molti metodi statistici a partire dal primo risalente al 2003 e sviluppato dal Breast Service del Memorial Sloan-Kettering Cancer Center (MSKCC).
L’obiettivo di questi metodi è il calcolo della probabilità di presenza di metastasi ai residui Linfonodi Ascellari nelle pazienti con Linfonodo Sentinella positivo alla biopsia. In prospettiva, l’obiettivo finale è quello evitare Linfoadenectomie Ascellari Complete non necessarie in pazienti con Linfonodo Sentinella positivo, ma a basso rischio di metastasi nei rimanenti linfonodi.
Dopo aver validato i principali metodi statistici descritti in letteratura, è stato sviluppato un metodo originale sulla casistica dell’Azienda Sant’Andrea e di altre Istituzioni. Le variabili prese in considerazione sono state: le dimensioni del tumore primitivo, il suo istotipo ed il grading, le dimensioni della metastasi del Linfonodo Sentinella e il rapporto tra numero di Linfonodi Sentinella positivi e numero di Linfonodi Sentinella totali
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