Modern breast implants are a staple of plastic surgery, finding uses in esthetic and reconstructive procedures. Their history began in the 1960s, with the first generation of smooth devices with thick silicone elastomer, thick silicone gel, and Dacron patches on the back. They presented hard consistency, high capsular contracture rates and the patches increased the risk of rupture. In the same decade, polyurethane coating of implants was implemented. A second generation was introduced in the 1970s with a thinner shell, less viscous gel filler and no patches, but increased silicone bleed-through and rupture rates. The third generation, in the early 1980s, featured implants with a thicker multilayered elastomer shell reinforced with silica to reduce rupture risk and prevent silicone bleed-through. A fourth generation from the late 1980s combined thick outer elastomer shells, more cohesive gel filler, and implemented for the first-time outer shell texturing. In the early 1990s, the fifth generation of devices pioneered an anatomical shape with highly cohesive form-stable gel filler and a rough outer shell surface. Surface texturing was hampered by the discovery of Breast Implant Associated-Anaplastic Large Cell Lymphoma and its link with textured devices. From the 2010s, we have the era of the sixth generation of implants, featuring innovations regarding the surface, with biomimetic surfaces, more resistant shells and variations in gel consistency. The road to innovation comprises setbacks such as the FDA moratorium in 1992, the PIP scandal, the Silimed CE mark temporary suspension and the FDA-requested voluntary recall of the Allergan BIOCELL implants.

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 3rd World Consensus Conference on BIA-ALCL.Objectives: The authors sought 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 with 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 employing the Delphi process, gathering 18 experts panelists and utilizing 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 employed to accept, reject, or revise each statement.Results: The literature search initially yielded 764 manuscripts, of which 405 were discarded. From the remaining 359, only 218 were included in the review and utilized to prepare 36 statements subdivided into 5 sections. After 1 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.Level of Evidence: 4:

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. We aimed at updating the BIA-ALCL epidemiology by using all available data through a systematic review of scientific literature. 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. United States, Netherlands, Italy, and Australia were the most reporting countries. Mean age at 1^st 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. 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.

Background: Breast implant–associated anaplastic large cell lymphoma (BIA-ALCL) epidemiologic studies focus on incidence and risk estimates. Objectives: The aim of this study was to perform a thorough literature review, and to provide an accurate estimate of BIA-ALCL prevalence in Europe. Methods: We searched PubMed, Web of Science, SCOPUS, and Google Scholar databases to identify publications reporting 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 by combining European demographic data with scientific reports. Results: Our research identified 507 articles: 106 were excluded for not being relevant to BIA-ALCL. From the remaining 401 articles, we selected 35 that discussed epidemiology and 12 reviews. The CDSD reported 420 cases in Europe, with an overall prevalence of 1:13,745 cases in the 28 member states of the European Union (EU-28). Countries where specific measures have been implemented to tackle BIA-ALCL account for 61% of the EU-28 population and actively reported 382 cases with an overall prevalence of 1:9121. Conclusion: Countries where specific measures have been implemented show a higher prevalence of BIA-ALCL compared with the European mean, suggesting that these countries have improved the detection of the condition and reduced underreporting, which affects the numerator value. Other nations should adopt projections based on these measures to avoid underestimating how widespread BIA-ALCL is. Level of Evidence: 4:

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

Breast implants are biomaterials eliciting a physiological and mandatory foreign body response. We designed an animal study to investigate the impact of different implant surfaces on the formation of the perirprosthetic capsule, the inflammatory response and the cellular composition. We implanted 1 scaled-down version of breast implants by different manufactures on 70 female Sprague Dawley rats. Animals were divided into five groups of 14 animals. Group A received a smooth implant (Ra≈0.5µm) according to the ISO 14607-2018 classification, Group B smooth implant (Ra≈3.2µm), Group C smooth implant (Ra≈5µm), Group D macrotextured implant (Ra≈62µm) and Group E macrotextured implant (Ra≈75µm). At 60 days, all animals received a magnetic resonance imaging (MRI) and 35 animals were sacrificed and their capsules sent for histology (capsule thickness, inflammatory infiltrate) and immunohistochemistry analysis (cellular characterization). The remaining animals repeated the MRI at 120 days and were sacrificed following the same protocol. MRI showed a thinner capsule in the smooth implants (Group A, B, C) at 60 days (p < 0.001) but not at 120 days (p = 0.039), confirmed with histology both at 60 days (p = 0.005) and 120 days (p < 0.001). Smooth implants (Group A, B, C) presented a mild inflammatory response at 60 days that was maintained at 120 days and a high M2-Macrophage concentration (anti-inflammatory). Our study confirms that smooth implants form a thinner capsule, inferior inflammatory infiltrate and a cellular composition that indicates a mild host inflammatory response. A new host inflammatory response classification is elaborated classifying breast implants into mild, moderate, and high.