1,720,987 research outputs found
Correction of Darwin’s Tubercle with Plasma Exeresis
No full textDarwin’s tubercle (DT) is a congenital outer ear deformity characterized by a posterior thickening of the auricular helix. It is particularly common in certain ethnic groups, with reports ranging between 10% and 58% of the specific populations. Despite being common, this vestigial trait is poorly known. It carries no clinical significance, except in the cases where it might be hypertrophic, potentially causing psychological distress and significant social impairment. DT has been traditionally treated with surgical resections where part of the helical cartilage is removed. More recently, cartilage reshaping has been envisioned without cutting, suturing, or scars, using laser irradiation. Surgical resection, laser ablation and plasma exeresis are different tools in the surgeon’s armamentarium which may all be used successfully. Nevertheless, the first may cause noticeable scarring while the second may cause relevant laser-related complications. We present a noninvasive aesthetic medicine procedure based on plasma exeresis, which combines the benefits of a noninvasive procedure with the advantage of not requiring lasers for the correction of this cartilage defect. We present the case of a 28-year-old woman with right-sided hypertrophic DT, who requested a correction of the outer ear deformity. Two sessions were required, pain intensity during treatment was low, no complications were reported, and the patient was satisfied with the result at 6 months from the last session. Although plasma exeresis has been described in the past for several other non-invasive procedures of the skin, this is the first report of its kind for the correction of minor cartilage reshaping
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
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
Oncologic Outcome of 1000 Postmastectomy Breast Reconstructions with Fat Transfer. A Single-Center, Matched Case-Control Study
No full textBackground: Autologous fat transfer has an important role in breast reconstructive surgery. Nevertheless, some concerns remain with regard to its oncologic safety. The authors present a single-center, case-matching study analyzing the impact of autologous fat transfer in the cumulative incidence of local recurrences.Methods: From a prospectively maintained database, the authors identified 902 patients who underwent 1025 breast reconstructions from 2005 to 2017. Data regarding demographics, tumor characteristics, surgery details, and follow-up were collected. Exclusion criteria were patients with distant metastases at diagnosis, recurrent tumor, or incomplete data regarding primary tumor; and patients who underwent prophylactic mastectomies and breast-conserving operations. Statistical analysis was conducted to evaluate the impact of the variables on the incidence of local recurrence. A value of p < 0.05 was considered statistically significant.Results: After 1:n case-matching, we selected 919 breasts, of which 425 patients (46.2 percent) received at least one autologous fat transfer session versus 494 control cases (53.8 percent). Local recurrences had an overall rate of 6.8 percent, and we found local recurrences in 14 autologous fat transfer cases (3.0 percent) and 54 controls (9.6 percent). Statistical analysis showed that autologous fat transfer did not increase the risk of local recurrences (hazard ratio, 0.337; CI, 0.173 to 0.658; p = 0.00007). Multivariate analysis identified invasive ductal carcinoma subtype and lymph node metastases to have an increased risk of local recurrences (hazard ratio >1). Conversely, positive hormonal receptor status was associated with a reduced risk of events (hazard ratio <1).Conclusions: Autologous fat transfer was not associated with a higher probability of locoregional recurrence in patients undergoing breast reconstruction; therefore, it can be safely used for total breast reconstruction or aesthetic refinements
The ongoing hunt for a BIA-ALCL smooth case
No full textThe authors draw attention to patients exposed to textured tissue expanders as a possible source of BIA-ALCL.
There is a risk that immunologic disease boosted by immunosuppressant therapy could have potentiated pathogenesis and therefore this combination may need to be
considered as an indication for explantation or avoidance
of textured implants in similar types of patients in the future
Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL): review of epidemiology and prevalence assessment in Europe
No full textBackground: Breast Implant Associated-Anaplastic Large Cell Lymphoma (BIA-ALCL) epidemiological studies focus on incidence and risk estimates.
Objectives: The aim of this manuscript is to perform a thorough review of scientific literature, and provide an accurate estimate of BIA-ALCL prevalence in Europe.
Methods: For the review, we searched PubMed, Web of Science, SCOPUS, and Google Scholar databases to identify publications regarding BIA-ALCL epidemiology. Research was conducted between November 2019 and August 2020. European prevalence was assessed as the ratio between pathology-confirmed cases and breast implant-bearing individuals. The Committee on Device Safety and Development (CDSD) collected data from National Plastic Surgery Societies, Health Authorities, and Disease-Specific Registries to calculate the numerator. The denominator was estimated combining European demographic data with scientific reports.
Results: Our research identified 507 manuscripts: 106 were excluded for not being relevant to BIA-ALCL. From the remaining 401 manuscripts, we selected 35 that discussed epidemiology and 12 reviews. CDSD reported 420 cases in Europe, with an overall prevalence of 1:13,745 cases in the European Union counting 28 members (EU-28). Countries, where specific measures have been implemented to tackle BIA-ALCL, account for 61% of EU-28 population and actively reported 382 cases with an overall prevalence of 1:9,121.
Conclusion: Countries where specific measures have been implemented show a higher prevalence of BIA-ALCL compared to mean European value, suggesting that they improve the detection of the condition and reduce underreporting that affects the numerator value. Other nations should adopt projections based on those measures to avoid underestimating how widespread BIA-ALCL is
BIA-ALCL Epidemiology in an Aesthetic Breast Surgery Cohort of 1,501 Patients
No full textBackgroundEpidemiologic studies on breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) currently estimate the risk between 1:300 and 1:30,000, assessed mainly in large breast reconstruction populations.ObjectivesThe aim of the study was to assess BIA-ALCL epidemiology in a cohort of patients who have received textured implants for cosmetic indications.MethodsIn a prospective cohort observational study, 1501 patients who received a cosmetic breast augmentation between 2006 and 2016 were monitored, recording any implant-related complications, including BIA-ALCL. Cross-checking of clinical, pathology, and external records data identified cases. Prevalence, implant-specific prevalence (I-SP), incidence rate (IR), event-free time (EFT), and the Kaplan-Meier survival estimate were calculated.ResultsAll but 2 patients received macrotextured or microtextured devices bilaterally. Mean follow-up was 3.2 years (1 months to 16.4 years). Five BIA-ALCL cases were investigated. Prevalence was 1:300 patients; I-SP was 6.9 cases/1000 individuals/Allergan BIOCELL devices and 1.3 cases/1000 individuals/Mentor Siltex devices; and IR was 1.07 cases/1000 females/year. Mean (SD) EFT was 9.2 years.ConclusionsWhen using a denominator based on a cohort of cosmetic patients, BIA-ALCL occurrence is higher than previously reported, particularly with macrotextured devices. Given the similar IRs in reconstructive and cosmetic cohorts, their even distribution could be consequent to underreporting due to poorer follow-up and lower awareness in the latter group. The genetic predisposition in the oncologic cohort reasonably affects the early onset more than the IR. The importance of accurate follow-up is confirmed. Stratification risks analysis can guide surgeons during patient counseling regarding the decision for prophylactic explantation
Assessment of risk factors for rupture in breast reconstruction patients with macrotextured breast implants
Full text linkBackground: Breast implants (BI) are widely used in plastic surgery, though they are not lifetime devices. Average life before rupture is reportedto be around 10-15 years. No consensus exists regarding which factors are involved.Objectives: Following FDA recommendations, this study aims at identifying potential risk factors by evaluating their effect on BI rupture cases.Methods: In this observational study, 763 BI patients were operated between 2003 and 2019, with a mean implant indwelling of 12.2 years. Patients that returned for follow-up were administered a questionnaire regarding postoperative lifestyle and habits. Implant rupture rate was 15.1%, while BI lifespan was 10.1 years. We obtained complete data from 191 breast implant patients (288 implants). Twenty-three potential risk factors were evaluated and divided in four categories: patient-related, surgery-related, postoperative complications/symptoms, and postoperative care/lifestyle habits. Odds Ratio (OR) for each factor was calculated. Linear regression analysis was calculated for those with a significant OR.Results: We report 120 patients (195 implants) with intact and 71 (93 implants) with ruptured devices. BIs were macrotextured in 95.1% of cases (86.8% Allergan BIOCELL). OR was significant for underwire bra use (OR: 2.708), car seat belts (OR: 3.066), mammographic imaging (OR: 2.196), weightlifting (OR: 0.407) and carry-on heavy purses and backpacks (OR: 0.347).Conclusion: Wearing underwire bras, seat belts and undergoing mammography increases the risk of rupture. Weightlifting and carry heavy bags do not increase that risk. Implant rupture is directly linked with time of indwelling. Postoperative recommendations in BI patients should consider findings from our study, though larger multicenter studies should be encouraged
Immediate prepectoral breast reconstruction using an ADM with smooth round implants. A prospective observational cohort study
No full textPrepectoral breast reconstruction using acellular dermal matrices (ADMs) is well established and used in candidates for nipple/skin-sparing mastectomies; it is based on many different matrices and a great variability in breast implant selection. We describe our experience and clinical outcomes using Braxon & REG; ADMs and smooth round breast implants. Females aged 18-80 years who underwent mastectomies with immediate prepectoral reconstruction between April 2019 and April 2021 were prospectively included. Complications were classified as mastectomy-related (hematoma, necrosis) or reconstruction-related (seroma, infection, red breast syndrome). Binary logistic regression analysis was performed to assess correlation between complication rate and selected variables, which were analyzed per breast with Kruskal-Wallis H test. Fifty-eight patients (102 breasts) received 45 bilateral and 12 unilateral procedures. Drains collected 485.9 cc [range: 100-1260] and were removed 15.7 days [range: 6-29] postoperatively. We report 41 complications (40.2%): 33 mastectomy-related, 8 reconstruction-related. Reoperation occurred in 14 patients: 7 wound debridement and revisions under local anesthesia; and 7 explantation. Implant loss rate was 6.8%. Mastectomy and reconstruction complications were not correlated with any variable. In conclusion, we found prepectoral reconstruction with Braxon & REG; ADMs and smooth round implants to be associated with acceptable complication rates that are not influenced by any patient- or surgery-related factors. Drainage volume is comparable to other breast implant reconstructive techniques, but drains are left in place for longer.& COPY; 2023 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved
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