Background Laboratory and clinical research on breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is rapidly evolving. Changes in standard of care and insights into best practice were recently presented at the 3 rd World Consensus Conference on BIA-ALCL. Objectives The aim of this manuscript is to provide practice recommendations from a consensus of experts, supplemented with a literature review regarding epidemiology, etiology, pathogenesis, diagnosis, treatment, socio-psychological aspects and international authority guidance. Methods A literature search of all manuscripts between 1997 and August 2021 for the above areas of BIA-ALCL was conducted using the PubMed database. Manuscripts in different languages, on non-human subjects, and/or discussing conditions separate from BIA-ALCL were excluded. The study was conducted using the Delphi process gathering 18 expert panelists, and employing email-based questionnaires to record the level of agreement with each statement, by applying a 5-point Likert Scale. Median response, interquartile range and comments were used to accept, reject or revise each statement. Results The literature search initially yielded 764 manuscripts out of which 405 were discarded. From the remaining 359, only 218 were included in the review and used to prepare 36 statements subdivided into 5 sections. After one round, panelists agreed on all criteria. Conclusions BIA-ALCL is uncommon and still largely underreported. Mandatory implant registries and actions by regulatory authorities are needed to better understand disease epidemiology and address initial lymphomagenesis and progression. Deviation from current diagnosis and treatment protocols can lead to disease recurrence, and research on breast implant risk factors provide insight to etiology.

Background 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.

Background The epidemiologic picture of Breast Implant Associated-Anaplastic Large Cell Lymphoma (BIA-ALCL) is unclear, with no high-level evidence, as only case reports and series are available. Objectives We aimed at updating the BIA-ALCL epidemiology by using 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 2,799 available records, we selected 114 pertinent articles, featuring 248 BIA-ALCL cases which were retrospectively analyzed by means of descriptive statistics, incidence rate (IR), Kaplan-Meier survival curves and Pearson correlation coefficient. Results United States, Netherlands, Italy, and Australia were the most reporting countries. Mean age at 1st implantation was 42y, and 53y at diagnosis. Aesthetic indication was 52% and reconstructive 48%, macrotextured surface was linked to 73.8% of cases and seroma to 83%. Total follow-up was 492 months, mean Event Free Time (EFT) to BIA-ALCL development was 129 months. IR was 96 new cases/1.000 women per year after first implantation, and directly correlated to number of replacements. EFT was directly correlated to number of replacements, implant rupture and capsule contracture, while inversely associated to patients’ age at first implantation and to BRACA1/2 and TP53 mutations. Conclusions Macrotextured implants use in older patients and in BRCA1/2 and TP53 mutated should be reconsidered, being associated to earlier disease onset. Implant replacement of asymptomatic, risk-stratified patients, can be indicated due to its protective role against BIA-ALCL, reducing IR rate and risk, while increasing the EFT.

No abstract

Background Nipple-areola complex reconstruction (NAR) most commonly represents the finishing touch to breast reconstruction (BR). Nipple presence is particularly relevant to the patient’s psyche, beyond any shadow of doubt. Many reconstructive options have been described in time. Surgery is easy, but final result is often disappointing on the long run. Methods The goal of this manuscript is to analyze and classify knowledge concerning NAR techniques and the factors that influence success, and then to elaborate a practical evidence-based algorithm. Out of the 3136 available articles as of August 8th, 2020, we selected 172 manuscripts that met inclusion criteria, which we subdivided into 5 main topics of discussion, being the various NAR techniques; patient factors (including patient selection, timing and ideal position); dressings; potential complications and finally, outcomes/patient satisfaction. Results We found 92 articles describing NAR techniques, 41 addressing patient factors (out of which 17 discussed patient selection, 14 described ideal NAC location, 10 described appropriate timing), 10 comparing dressings, 7 studying NAR complications, and 22 addressing outcomes and patient satisfaction. We elaborated a comprehensive decision-making algorithm to help narrow down the choice among NAR techniques, and choose the correct strategy according to the various scenarios, and particularly the BR technique and skin envelope. Conclusions No single NAR technique provides definitive results, which is why we believe there is no “end-all be-all solution”. NAR must be approached as a case-by-case situation. Furthermore, despite NAR being such a widely discussed topic in scientific literature, we still found a lack of clinical trials to allow for more thorough recommendations to be elaborated. Level of Evidence III 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