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Summary: The impact of clinical prediction models within Artificial Intelligence (AI) and machine learning (ML) is significant. With its ability to analyze vast amounts of data and identify complex patterns, machine learning has the potential to improve and implement evidence-based plastic, reconstructive, and hand surgery. Among others, it is capable of predicting the diagnosis, prognosis, and outcomes of individual patients. This modeling aids daily clinical decision making, most commonly at the moment, as decision-support.Therefore, the purpose of this paper is to provide a practice guideline to plastic surgeons implementing AI in clinical decision-making or setting up AI research to develop clinical prediction models using the 7-step approach and the ABCD validation steps of Steyerberg et al. Secondly, we describe two important protocols which are in the development stage for AI research: 1) the Transparent Reporting of a multivariable prediction model for Individual Prognosis or Diagnosis (TRIPOD) checklist, and 2) The PROBAST checklist to access potential biases., (Copyright © 2024 by the American Society of Plastic Surgeons.)

Background: Financial toxicity is a growing concern due to its considerable effects on medical adherence, quality of life, and mortality. The cost associated with breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is substantial from diagnosis to treatment, including adjuvant therapy and surgery. This study aims to assess the prevalence of financial toxicity in BIA-ALCL patients., Methods: We performed a cross-sectional, survey-based study on women with confirmed cases of BIA-ALCL from December 2019 to March 2023. The primary study outcomes were financial toxicity measured by Comprehensive Score for Financial Toxicity (COST) score and patient-reported financial burden measured by the responses to the Evaluation of the Financial Impact of BIA-ALCL survey. Lower COST scores signify higher financial toxicity. Responses were linked to patient data extracted from the medical records., Results: Thirty-two women treated for confirmed BIA-ALCL were included. Patients were all White and were diagnosed at a median age of 51 years (range, 41-65 years). The mean COST score was 27.9 ± 2.23. Lower COST scores were associated with receipt of radiotherapy ( P = 0.033), exceeding credit card limits ( P = 0.036), living paycheck to paycheck ( P = 0.00027), requiring financial support from friends and family ( P = 0.00044), and instability in household finances ( P = 0.034)., Conclusions: Financial toxicity is prevalent in BIA-ALCL patients and has a substantial impact on patient reported burden. Insurance denial is frequent for patients with a prior history of cosmetic augmentation. Risk assessments and cost discussions should occur throughout the care continuum to minimize financial burden., Competing Interests: Conflicts of interest and sources of funding: none declared., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Background: Postmastectomy radiotherapy (PMRT) is associated with altered cosmetic outcomes and higher complication rates in implant-based breast reconstruction (IBR). Conventional wisdom suggests that muscle coverage is somewhat protective against PMRT-related complications. In this study, the authors compared surgical outcomes in patients who underwent two-stage prepectoral versus subpectoral IBR in the setting of PMRT., Methods: The authors performed a retrospective cohort study of patients who underwent mastectomy and PMRT with two-stage IBR from 2016 to 2019. The primary outcome was breast-related complications, including device infection; the secondary outcome was device explantation., Results: The authors identified 179 reconstructions (101 prepectoral and 78 subpectoral) in 172 patients with a mean follow-up time of 39.7 ± 14.4 months. There were no differences between the prepectoral and subpectoral reconstructions in rates of breast-related complications (26.7% and 21.8%, respectively; P = 0.274), device infection (18.8% and 15.4%, respectively; P = 0.307), skin flap necrosis (5.0% and 1.3%, respectively; P = 0.232), or device explantation (20.8% and 14.1%, respectively; P = 0.117). In adjusted models, compared with prepectoral device placement, subpectoral device placement was not associated with a lower risk of breast-related complications [hazard ratio (HR), 0.75; 95% confidence interval (CI), 0.41 to 1.36], device infection (HR, 0.73; 95% CI, 0.35 to 1.49), or device explantation (HR, 0.58; 95% CI, 0.28 to 1.19)., Conclusions: Device placement plane was not predictive of complication rates in IBR in the setting of PMRT. Two-stage prepectoral IBR provides safe long-term outcomes with acceptable postoperative complication rates comparable to those with subpectoral IBR, even in the setting of PMRT., Clinical Question/level of Evidence: Therapeutic, III., (Copyright © 2023 by the American Society of Plastic Surgeons.)

Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is a distinct subtype of T-cell non-Hodgkin lymphoma that arises in the context of prolonged exposure to textured breast implants. The intent of this manuscript is to explore whether the bacterial presence in biofilms on these implants is a mere incidental finding or plays a pivotal role in the pathogenesis of BIA-ALCL. Our goal is to delineate the extent of bacterial involvement, offering insights into potential underlying mechanisms, and establishing future research priorities aimed at resolving the remaining uncertainties surrounding this complex association. A comprehensive systematic review of several databases was performed. The search strategy was designed and conducted by an experienced librarian using controlled vocabulary with keywords. The electronic search identified 442 publications. After evaluation, six studies from 2015 to 2021 were included, encompassing 201 female patients aged 23 to 75. The diagnosis span post-implantation ranged from 53 to 135.6 months. Studies consistently found bacteria near breast implants in both BIA-ALCL cases and controls, with varied microbial findings. Both BIA-ALCL cases and controls exhibited the presence of specific bacteria, including Pseudomonas aeruginosa , Klebsiella oxytoca , Staphylococcus aureus , and Ralstonia spp., without any statistically significant differences between groups. The use of antiseptic and antimicrobial agents during implant insertion did not demonstrate any impact on reducing or altering the risk of developing BIA-ALCL. Our systematic review reveals that the current evidence is inadequate to link bacterial etiology as a central factor in the development of BIA-ALCL. The limitations in the existing data prevent a complete dismissal of the role of biofilms in its pathogenesis. The observed gap in knowledge underscores the need for more focused and comprehensive research, which should be structured in a multi-faceted approach. Initially, this involves the utilization of sophisticated genomic and proteomic methods. Following this, it is crucial to delve into the study of immunological reactions specifically induced by biofilms. Finally, this research should incorporate extended observational studies, meticulously tracking the evolution of biofilm development and its correlation with the emergence of BIA-ALCL. In light of the inconclusive nature of current findings, further investigation is not only justified but urgently needed to clarify these unresolved issues., Competing Interests: All authors declared that there are no conflict of interest.

Background: Although textured implants represent fewer than 10% of implants used in the United States, the country reports the highest incidence of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL)., Objectives: The aim of this study was to perform a systematic literature review on US-based epidemiology to update knowledge on BIA-ALCL in the United States., Methods: Publications on US BIA-ALCL epidemiology were searched between September 2022 and March 2023 on MEDLINE (National Institutes of Health; Bethesda, MD), Embase (Elsevier, Amsterdam, the Netherlands), Web of Science (Clarivate, London, UK), and SCOPUS (Elsevier, Amsterdam, the Netherlands). The US numerator was obtained by averaging the FDA MAUDE database and the PSF PROFILE registry, while the denominator was estimated from chest X-rays, and included female transgender individuals. Prevalence and risk were assessed accordingly, but the incidence rate (IR) could not be updated due to the lack of available follow-up data., Results: Out of 987 identified manuscripts, 10 were included. The US prevalence of BIA-ALCL in the literature ranged from 1:300 to 1:500,000 and the IR from 4.5 per 10,000 to 31.1 per 100 million persons per year. A mean value of 453.5 BIA-ALCL cases was calculated. From a denominator of 4,264,618 individuals, which includes all breast implant surfaces, we calculated 414,521 individuals with textured implants, indicating a textured prevalence of 109.4 cases per 100,000 individuals and a risk of 1:913., Conclusions: BIA-ALCL IR, prevalence, and risk has increased when calculated exclusively for patients with textured devices. Although US macrotextured implants were recalled by the FDA, these findings may influence the surveillance of existing patients and the use of macrotextured implants in other parts of the world where they remain widespread., (© The Author(s) 2023. Published by Oxford University Press on behalf of The Aesthetic Society. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background: In January of 2011, the U.S. Food and Drug Administration released a safety communication regarding the potential association between breast implants and anaplastic large-cell lymphoma (ALCL). In 2012, the American Society of Plastic Surgeons, The Plastic Surgery Foundation, and the Food and Drug Administration signed a cooperative research and development agreement to develop the Patient Registry and Outcomes for Breast Implants and Anaplastic Large-Cell Lymphoma Etiology and Epidemiology (PROFILE) patient registry., Method: This is an updated report of registry findings. From August of 2012 to August of 2020, 330 unique, suspected, or confirmed cases of breast implant-associated (BIA) ALCL in the United States were reported to PROFILE, including 144 cases newly reported since the 2018 publication., Results: Median time from implantation of any device to BIA-ALCL diagnosis was 11 years (range, 2 to 44 years). At the time of presentation, 91% of cases had local symptoms and 9% had concurrent systemic symptoms. The most common local symptom was seroma, seen in 79% of patients. All patients had a history of a textured device; there were no patients who had a confirmed smooth-only device history. Approximately 11% of the reported cases were diagnosed with stage 1A disease (tumor-node-metastasis staging classification)., Conclusions: The PROFILE registry continues to be an essential tool in unifying the collection of granular-level data pertaining to BIA-ALCL. These data emphasize the critical importance of detailed tracking of BIA-ALCL cases, and will contribute significantly to our understanding of the relationship between breast implants and ALCL., (Copyright © 2023 by the American Society of Plastic Surgeons.)

Background: Abdominal wall reconstruction (AWR) is one of the most commonly performed procedures, yet large comparative studies comparing outcomes of AWR using bovine acellular dermal matrix (BADM) and porcine acellular dermal matrix (PADM) are lacking., Methods: In this retrospective cohort study of patients who underwent AWR from March of 2005 to June of 2019, the primary comparative outcome measure was hernia recurrence with BADM versus PADM. The secondary outcome was the incidence of surgical-site occurrence (SSO) and surgical-site infection. A propensity score matching approach was applied to compare the clinical outcomes between the two study groups., Results: The authors identified 725 patients who underwent AWR using BADM (50.5%) or PADM (49.5%). Their mean ± SD age was 59.8 ± 11.5 years, mean body mass index was 31.4 ± 6.7 kg/m 2 , and mean follow-up time was 42 ± 29 months. With propensity score matching, 219 matched pairs were identified. Hernia recurrence rates in BADM (11.4%) and PADM (13.7%) groups did not differ significantly ( P = 0.793). SSO (26.5% versus 29.2%; P = 0.518) and SSI (13.2% versus 11%; P = 0.456) rates did not differ significantly in the PADM and BADM groups, respectively. Conditional logistic regression model and marginal Cox proportional hazards regression model determined that type of acellular dermal matrix was not significantly associated with SSOs (adjusted OR, 1.11; 95% CI, 0.74 to 1.70; P = 0.589) or hernia recurrence (adjusted hazard ratio, 0.85; 95% CI, 0.50 to 1.42; P = 0.52)., Conclusions: Both BADMs and PADMs provide durable, long-term outcomes. The hernia recurrence and postoperative surgical complication rates were not significantly different between BADM and PADM., Clinical Question/level of Evidence: Therapeutic, III., (Copyright © 2023 by the American Society of Plastic Surgeons.)

Background: Opinion regarding the optimal plane for prosthetic device placement in breast reconstruction patients has evolved. The purpose of this study was to assess the differences in complication rates and patient satisfaction between patients who underwent prepectoral and subpectoral implant-based breast reconstruction (IBR)., Methods: The authors conducted a retrospective cohort study of patients who underwent two-stage IBR at their institution from 2018 to 2019. Surgical and patient-reported outcomes were compared between patients who received a prepectoral versus a subpectoral tissue expander., Results: A total of 694 reconstructions in 481 patients were identified (83% prepectoral, 17% subpectoral). The mean body mass index was higher in the prepectoral group (27 versus 25 kg/m 2 , P = 0.001), whereas postoperative radiotherapy was more common in the subpectoral group (26% versus 14%, P = 0.001). The overall complication rate was very similar, with 29.3% in the prepectoral and 28.9% in the subpectoral group ( P = 0.887). Rates of individual complications were also similar between the two groups. A multiple-frailty model showed that device location was not associated with overall complications, infection, major complications, or device explantation. Mean scores for Satisfaction with the Breast, Psychosocial Well-Being, and Sexual Well-Being were similar between the two groups. Median time to permanent implant exchange was significantly longer in the subpectoral group (200 versus 150 days, P < 0.001)., Conclusion: Prepectoral breast reconstruction results in similar surgical outcomes and patient satisfaction compared with subpectoral IBR., Clinical Question/level of Evidence: Therapeutic, III., (Copyright © 2023 by the American Society of Plastic Surgeons.)

Background: Skin-preserving, staged, microvascular, breast reconstruction often is preferred in patients requiring postmastectomy radiotherapy (PMRT) but may lead to complications. We compared the long-term surgical and patient-reported outcomes between skin-preserving and delayed microvascular breast reconstruction with and without PMRT., Methods: We conducted a retrospective, cohort study of consecutive patients who underwent mastectomy and microvascular breast reconstruction between January 2016 and April 2022. The primary outcome was any flap-related complication. The secondary outcomes were patient-reported outcomes and tissue-expander complications., Results: We identified 1002 reconstructions (672 delayed; 330 skin-preserving) in 812 patients. Mean follow-up was 24.2 ± 19.3 months. PMRT was required in 564 reconstructions (56.3%). In the non-PMRT group, skin-preserving reconstruction was independently associated with shorter hospital stay (β - 0.32, p = 0.045) and lower odds of 30-days readmission (odds ratio [OR] 0.44, p = 0.042), seroma (OR 0.42, p = 0.036), and hematoma (OR 0.24, p = 0.011) compared with delayed reconstruction. In the PMRT group, skin-preserving reconstruction was independently associated with shorter hospital stay (β - 1.15, p < 0.001) and operative time (β - 97.0, p < 0.001) and lower odds of 30-days readmission (OR 0.29, p = 0.005) and infection (OR 0.33, p = 0.023) compared with delayed reconstruction. Skin-preserving reconstruction had a 10.6% tissue expander loss rate and did not differ from delayed reconstruction in terms of patient-reported satisfaction with breast, psychosocial well-being, or sexual well-being., Conclusions: Skin-preserving, staged, microvascular, breast reconstruction is safe regardless of the need for PMRT, with an acceptable tissue expander loss rate, and is associated with improved flap outcomes and similar patient-reported quality of life to that of delayed reconstruction., (© 2023. Society of Surgical Oncology.)

Summary: This report provides a 5-year follow-up on the first reported simultaneous scalp, calvarium, kidney, and pancreas transplant. The previously published case report represented both the first composite calvarial-scalp transplant and combination of a vascularized composite allotransplantation with double organ transplantation. Over the ensuing 5 years, the patient underwent a single episode of acute scalp rejection successfully managed with intravenous Solu-Medrol, one resection of a basal cell carcinoma on the native scalp, hardware removal, and bony contouring. In addition, the patient developed seizures secondary to delayed, postirradiation cerebral necrosis requiring craniotomy and resection. His seizures were ultimately controlled. Currently, more than 5 years after his multiorgan transplant, the patient continues to have excellent allograft function and a very satisfactory aesthetic outcome, demonstrating that in certain cases, combined vascularized composite allotransplantation with solid organ transplantation can be performed safely without compromising the solid organ transplantation., (Copyright © 2022 by the American Society of Plastic Surgeons.)

As more information about the potential risks and complications related to breast implants has become available, the United States Food and Drug Administration (FDA) has responded by implementing changes to improve patient education, recalling certain devices and updating the recommendations for screening for silicone implant rupture. In addition to staying up-to-date with FDA actions and guidance, radiologists need to maintain awareness about the types of implants they may see, breast reconstruction techniques including the use of acellular dermal matrix, and the multimodality imaging of implants and their complications. Radiologists should also be familiar with some key differences between the updated FDA guidelines for implant screening and the imaging recommendations from the American College of Radiology Appropriateness Criteria. The addition of US as an acceptable screening exam for silicone implant rupture by the FDA is one of the most notable changes that has potentially significant implications., (© Society of Breast Imaging 2023. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Breast implant associated anaplastic large cell lymphoma (BIA-ALCL) is an uncommon and emerging malignancy caused by textured breast implants. The most common patient presentation is delayed seromas, other presentations include breast asymmetry, overlying skin rashes, palpable masses, lymphadenopathy, and capsular contracture. Confirmed diagnoses should receive lymphoma oncology consultation, multidisciplinary evaluation, and PET-CT or CT scan evaluation prior to surgical treatment. Disease confined to the capsule is curable in the majority of patients with complete surgical resection. BIA-ALCL is now recognized as one disease among a spectrum of inflammatory mediated malignancies which include implant-associated squamous cell carcinoma and B cell lymphoma., Competing Interests: Disclosure MD Anderson Cancer Center participates in FDA clinical trials for Abbvie Allergan, Mentor Corporation, and Establishment Labs. All authors report no financial conflicts of interest., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Background: Postmastectomy breast reconstruction in patients with a history of breast-conserving surgery (BCS) and radiotherapy is challenging, with a paucity of literature on the outcomes of different breast reconstructive techniques. The authors hypothesized that implant-based breast reconstruction (IBR) would be associated with higher complication rates compared to either IBR combined with latissimus dorsi (LD) or free flap breast reconstruction (FFBR)., Methods: The authors conducted a retrospective review of patients who underwent mastectomy with a history of BCS and radiotherapy between January of 2000 and March of 2016. Surgical and patient-reported outcomes (BREAST-Q) were compared between IBR versus IBR/LD versus FFBR., Results: The authors identified 9473 patients who underwent BCS and radiotherapy. Ninety-nine patients (105 reconstructions) met the authors' inclusion criteria, 29% ( n = 30) of whom underwent IBR, 26% ( n = 27) of whom underwent IBR/LD, and 46% ( n = 48) of whom underwent FFBR. The overall complication rate was not significantly different between the three groups (50% in IBR versus 41% in IBR/LD versus 44% in FFBR; P = 0.77), whereas reconstruction failures were significantly lower in the FFBR group (33% in IBR versus 19% in IBR/LD versus 0% in FFBR; P < 0.0001). The time between the receipt of radiotherapy and reconstruction was not a significant predictor of overall complications and reconstruction failure. No significant differences were identified between the three study cohorts in any of the three studied BREAST-Q domains., Conclusions: In patients with prior BCS and radiotherapy, FFBR was associated with lower probability of reconstruction failure compared to IBR but no significant difference in overall and major complication rates. The addition of LD flap to IBR did not translate into lower complication rates but may result in decreased reconstruction failures., Clinical Question/level of Evidence: Therapeutic, III., (Copyright © 2022 by the American Society of Plastic Surgeons.)

Background: Breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL) has been diagnosed in more than 1000 patients in more than 30 countries, although only a few cases have been reported in Latin America and the Caribbean to date. As the second-largest global market for breast implants with a predominance of textured-surface implants, Brazil is a major global market for cosmetic augmentations, making it unlikely that cases of BIA-ALCL are actually scarce., Methods: A local and voluntary registry of patients with BIA-ALCL was initiated in 2018. All patients diagnosed with BIA-ALCL were confirmed by the World Health Organization criteria. Implant characteristics, disease symptoms, treatment, and oncologic outcomes were assessed., Results: Fourteen cases of BIA-ALCL in a Brazilian population were identified in the Paraná state. Disease-specific diagnostic tests were omitted before surgical intervention in 50 percent of patients. With additional cases from a literature review, the treatment and outcomes of 29 cases of BIA-ALCL in Brazil were assessed., Conclusions: Compared with other populations, these initial observations suggest that awareness of the disease by the local breast surgery community remains low and that a number of cases may remain undiagnosed. Lack of preoperative diagnostic testing compromises disease treatment, oncologic outcomes, and both short- and long-term surveillance., (Copyright © 2022 by the American Society of Plastic Surgeons.)

Background: As more plastic surgery clinicians pursue advanced degrees and strive to become stronger physician-scientists, an objective understanding of how such degrees influence careers becomes important. We hypothesized that having a master's degree is associated with higher scholarly activity, research funding, academic progression, and leadership appointments., Methods: Accreditation Council for Graduate Medical Education-accredited integrated plastic surgery residency program Web sites were queried to create a data set of current academic plastic surgeons (APSs) and plastic surgery residents (PSRs). Scholarly metrics such as publications, citations, and H-indices were extracted from the Scopus database. National Institutes of Health and Plastic Surgery Foundation funding information was collected through their respective Web sites., Results: Our cohort comprised 799 APSs and 922 PSRs, of whom 8% and 7.4%, respectively, had at least one master's degree. Academic plastic surgeons with master's of public health degrees had a significantly higher median number of publications and citations than APSs without a master's of public health. There was no association between any master's degree and academic rank or being a department chairman or program director. Academic plastic surgeons with master of science degrees were more likely to receive National Institutes of Health grants. Among PSRs, master's of science graduates had a higher median number of publications. Other master's degrees did not significantly influence scholarly productivity or funding., Conclusions: Certain master's degrees had an impact on scholarly productivity, with no significant effect on academic rank or leadership positions. The value of master's degrees in programs focusing on healthcare management, leadership skills, and business acumen likely extends beyond the scope of this study., Competing Interests: Conflicts of interest and sources of funding: none declared., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

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., (© The Author(s) 2022. Published by Oxford University Press on behalf of The Aesthetic Society. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background: Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) has increasingly become a significant concern for patients. Focus thus far has been on understanding pathogenesis and establishing treatment pathways. There has been less attention on the assessment of long-term treatment outcomes. The purpose of this study was to perform a systematic review to assess published data on treatment outcomes for BIA-ALCL., Methods: Using PRISMA guidelines, a systematic search of the literature was carried out from January 1997 to January 2021 using the Web of Science (PubMed) and Ovid Medline. Included in the review were any studies on the management and follow-up of patients, including disease status at a minimum of 18 months following treatment., Results: A total of 39 articles matched the inclusion criteria. However, 94% of patients were managed with explantation and capsulectomy. Then, 39% of patients had adjuvant chemotherapy, 19% radiotherapy, 6% autologous stem cell transplant, and 4% immunotherapy. The mean follow-up was 19 months (range 3-36 months), and 69% of patients were reported to be alive at 18 months. The mainstay of treatment was surgical - en bloc capsulectomy with adjuvant treatment for advanced disease., Conclusions: Robust survival data based on high-level evidence are challenging to establish in BIA-ALCL. Early diagnosis and en bloc capsulectomy with negative margins, whilst considering the need for adjuvant treatment, particularly targeted immune therapy in advanced disease represents the consistent forms of treatment. National databases, prospective studies, and treatment of patients in tertiary centres are all recommended to improve the quality of the research available in the management of BIA-ALCL., (© 2022 The Authors.)

Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is an uncommon peripheral T cell lymphoma arising in response to textured-surface breast implants. Frequently, BIA-ALCL is indolent and typically presents with peri-implant swelling after breast reconstruction or cosmetic augmentation. However, patients can present with an invasive breast or chest wall mass, palpable lymphadenopathy, or metastatic disease. The current literature is limited regarding surgical recommendations for patients with a more aggressive presentation of BIA-ALCL. This report aims to review the various clinical manifestations of BIA-ALCL, including the more advanced and less frequently encountered presentations, with an emphasis on a multidisciplinary approach, with early involvement of a surgical oncologist., (© 2022. Society of Surgical Oncology.)

Background: The goal of this study was to assess whether adding a latissimus dorsi (LD) flap to a secondary implant-based reconstruction (IBR) improves outcomes following explantation of the primary device due to infection., Methods: We conducted a retrospective study of patients who underwent a second IBR with or without the addition of an LD flap during 2006-2019, following explantation due to infection. Surgical outcomes were collected and compared between reconstruction types., Results: A total of 6093 IBRs were identified during the study period. Of these, 109 underwent a second attempt at breast reconstruction with IBR alone (n = 86, 79%) or IBR/LD (n = 23, 21%) following explantation of an infected device. Rates of secondary device explantation due to a complication were similar between the two groups (26% in the IBR/LD group and 21% in the IBR group; P = 0.60). Among the patients who underwent prior radiotherapy, the IBR/LD group had lower rates of any complication (38% versus 56%; P = 0.43), infection (25% versus 44%; P = 0.39), and reconstruction failure (25% versus 44%; P = 0.39); however, differences were not statistically significant., Conclusion: Following a failed primary breast reconstruction due to infection, it may be appropriate to offer a secondary reconstruction. For patients with a history of radiotherapy, combining an LD flap with IBR may provide benefits over IBR alone. Although not statistically different, this outcome may have clinical significance, considering the magnitude of the effect, and may result in decreased complication rates and a higher chance of reconstructive success., (Copyright © 2022 The Authors. Published by Wolters Kluwer Health, Inc. on behalf of The American Society of Plastic Surgeons.)

Background: Infection is a dreaded complication of implant-based breast reconstruction. There is a paucity of literature on the outcomes of a secondary reconstruction after infected implant-based breast reconstruction explantation., Methods: The authors conducted a retrospective study of patients who underwent a second implant-based breast reconstruction following a failed infected device between January of 2006 and December of 2019. Surgical and patient-reported outcomes (BREAST-Q) were collected and analyzed., Results: A total of 6093 implant-based breast reconstructions were performed during the study period, 298 (5 percent) of which involved device removal because of infection. Eighty-three patients ultimately received 92 second-attempt breast implants. Thirty-six percent of cases developed at least one postoperative complication, with infection [23 breasts (25 percent)] being the most common. Compared with first-attempt implant-based breast reconstruction, we found significantly higher infection rates among second-attempt cases (9 percent and 21 percent, respectively; p = 0.0008). Patient-reported satisfaction with the breast and sexual well-being were lower after second-attempt than after first-attempt implant-based breast reconstruction ( p = 0.018 and p = 0.002, respectively) reported in the literature. Mean follow-up was 41 ± 35 months. If we exclude patients with prior radiation therapy and those who received device exchange, the success rate is 88 percent., Conclusions: It is reasonable to offer women second-attempt implant-based breast reconstruction after explantation because of infection. However, this patient population has a higher infection and explantation rate and lower patient-reported satisfaction than patients undergoing first-attempt implant-based breast reconstruction. Because of these increased surgical risks and elevated complication rates, patients must be given reasonable expectations during preoperative discussions and when providing informed consent for second-attempt implant-based breast reconstruction., Clinical Question/level of Evidence: Risk, III., (Copyright © 2022 by the American Society of Plastic Surgeons.)

Background: Implant-based breast reconstruction infections often require implant explantation. Whereas some plastic surgeons pursue autologous reconstruction following the first implant-based breast reconstruction failure caused by infection, others argue that a second attempt is acceptable., Methods: The authors conducted a retrospective study of patients who underwent a second reconstruction attempt with implant-based or free flap breast reconstruction following explantation because of infection between 2006 and 2019. Surgical and patient-reported outcomes were compared between the two groups., Results: A total of 6093 implant-based breast reconstructions were performed during the study period, of which 130 breasts met our inclusion criteria [implant-based, n = 86 (66 percent); free flap, n = 44 (34 percent)]. No significant differences in rates of overall (25 percent versus 36 percent; p = 0.2) or major (20 percent versus 21 percent; p = 0.95) complications were identified between the free flap and implant-based cohorts, respectively. Implant-based breast reconstruction patients were more likely to experience a second infection (27 percent versus 2 percent; p = 0.0007) and reconstruction failure (21 percent versus 5 percent; p = 0.019). Among irradiated patients, reconstruction failure was reported in 44 percent of the implant-based and 7 percent of the free flap cohorts (p = 0.02). Free flap patients reported significantly higher scores for Satisfaction with Breasts (73.7 ± 20.1 versus 48.5 ± 27.9; p = 0.0046)., Conclusions: Following implant-based breast reconstruction explantation because of infection, implant-based and free flap breast reconstruction had similar rates of overall and major complications; however, implant-based breast reconstruction had considerably higher rates of infection and reconstructive failures and lower patient-reported scores for Satisfaction with Breasts. Given the high rates of implant-based breast reconstruction failure in patients with prior radiotherapy and infection-based failure, plastic surgeons should strongly consider autologous reconstruction in this patient population., Clinical Question/level of Evidence: Therapeutic, III., (Copyright © 2022 by the American Society of Plastic Surgeons.)

Background: There are no U.S. Food and Drug Administration (FDA)-approved indications for robotic plastic surgery. This study was designed to demonstrate safety and efficacy of the robotic latissimus dorsi harvest for FDA approval., Methods: This prospective, single-arm study was conducted under an investigational device exemption through the FDA for obtaining 510(k) approval. The primary safety endpoint was adverse events attributable to harvest. Primary efficacy endpoints included muscle viability after harvest and conversion to open technique. Secondary endpoints included postoperative pain and upper extremity function., Results: Fifteen patients enrolled, with a mean age of 50 ± 10 years and a mean body mass index of 25 ± 4 kg/m2. There were no adverse events, all muscles were viable after harvest, and there were zero conversions to open procedures. Visual analogue scale scores for pain progressively decreased postoperatively and returned to baseline, indicating resolution of postoperative pain. Physical therapy assessment demonstrated recovery of function in all range-of-movement domains by 36 weeks. There was no difference in function of the operated extremity between baseline and 36 weeks' follow-up for Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire (p = 0.87); QuickDASH Work Module (p > 0.05); and QuickDASH Sports Module (p > 0.05)., Conclusions: The use of the da Vinci Robotic Surgical System is safe based on zero adverse events attributable to harvest and efficacious based on 100 percent muscle viability after harvest and zero conversions to open technique. There appears to be little to no long-term functional deficit or pain from muscle harvest. Given these results and their own prestudy guidelines, the robotic latissimus dorsi qualifies for 510(k) submission by Intuitive Surgical and approval by the U.S. FDA., Clinical Question/level of Evidence: Therapeutic, IV., (Copyright © 2022 by the American Society of Plastic Surgeons.)

Background: Robotic surgery is emerging as a viable tool in reconstructive surgery. Harvesting of the deep inferior epigastric perforator flap is typically performed through an anterior approach, which involves a long fascial incision. A robotic approach allows the deep inferior epigastric pedicle to be harvested from the posterior surface. This approach reduces the length of the fascial incision and should decrease the abdominal morbidity associated with large fascial dissections., Methods: A case series study of 21 patients who underwent a robotic deep inferior epigastric perforator or during a 12-month period for breast reconstruction was performed. Patient demographics, surgical characteristics, and complications were assessed., Results: Mean patient age was 54.6 ± 7.6 years, and mean body mass index was 30.4 ± 3.9 kg/m2. Mean fascial incision and pedicle length were 3.6 ± 1.6 cm and 13.3 ± 1 cm, respectively. None of the patients required conversion to open harvest. Mean length of hospital stay was 3.8 ± 0.9 days. Surgical site occurrences were identified in five patients (31.3 percent). One patient had delayed wound healing at the donor site. None of the patients developed hernia or bulge. The mean benefit (B = C - A), defined as length of fascial incision spared and measured as the difference between pedicle length and intramuscular course, was 9.83 ± 2.28 cm. The precision of computed tomography angiography in identifying the intraoperative fascial incision was 86 percent., Conclusion: The robotic deep inferior epigastric perforator flap is a safe and reliable technique that decreases the length of fascial incision and short-term complications associated with the open approach., Clinical Question/level of Evidence: Therapeutic, IV., (Copyright © 2022 by the American Society of Plastic Surgeons.)

Peripheral T-cell lymphomas (PTCLs) are a heterogeneous group of lymphoproliferative disorders arising from mature T cells, accounting for about 10% of non-Hodgkin lymphomas. PTCL-not otherwise specified is the most common subtype, followed by angioimmunoblastic T-cell lymphoma, anaplastic large cell lymphoma, anaplastic lymphoma kinase-positive, anaplastic large cell lymphoma, anaplastic lymphoma kinase-negative, and enteropathy-associated T-cell lymphoma. This discussion section focuses on the diagnosis and treatment of PTCLs as outlined in the NCCN Guidelines for T-Cell Lymphomas.

Abstract: We present a case report of a 48-year-old woman with a late-onset seroma of her left breast, 6 years after removal of her textured breast implants. At that time, she also had a late-onset seroma of her left breast, and capsulectomy was performed along with removal of the implants. The current late seroma presentation, which followed 6 years of uneventful healing, was treated with en bloc excision of the encapsulated seroma. Pathology results were concordant with locally invasive anaplastic large cell lymphoma (ALCL). Review of her previous seroma cytology from 6 years ago was performed given the current updated guideline standards on breast implant-associated ALCL (BIA-ALCL). Evidence of BIA-ALCL confirmed the patient had the diagnosis 6 years ago. The disease persisted and remained indolent for 6 years and manifested clinically as a late seroma of the left breast. This case report emphasizes the high degree of suspicion that is required in late seroma cases involving textured breast implants or a history of textured breast implants, along with the need for en bloc capsulectomy as a primary treatment for diagnosed BIA-ALCL to avoid incomplete capsulectomy and recurrence of the disease., Competing Interests: Conflicts of interest and sources of funding: Yoav Barnea participates in educational lectures for Mentor Corporation. Mark W. Clemens participates in clinical trials for Motiva US Safety Trial (Establishment Labs) and Mentor Corporation., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)

Objective: We sought to evaluate patients at a single academic institution in a prospective manner to report patient presentation, clinical course, treatment, and outcomes in breast implant ALCL patients., Background: Breast implant-associated anaplastic large cell lymphoma (breast implant ALCL) is an uncommon T cell lymphoma, which is associated with textured surface breast implants. The disease has received increasing attention over the last 20 years. Previous retrospective studies have begun to outline the clinical course of breast implant ALCL., Methods: We prospectively followed women with cytologically proven breast implant ALCL from 2014 to 2019. Demographic, clinical, treatment, and outcome data were collected and descriptive statistics were performed on variables of interest., Results: We identified 52 women with pathologically confirmed breast implant ALCL. Implants were placed for augmentation in 61.5% of women and reconstruction in 36.5% of women. All of the 41 patients with known implant information had implants with textured surface. The majority of patients presented with delayed seroma (69.2%) and without systemic symptoms (86.5%). Most patients with staging information presented with Stage IA disease. Patient outcomes were excellent with 2 disease recurrence (3.8%) and all patients ultimately achieved complete remission., Conclusions: Further evaluation of the prospective and growing database of patients with breast implant ALCL will further improve our understanding of the disease and its clinical course. Robust participation in the breast implant ALCL PROFILE registry will improve our knowledge of long-term outcomes after implant placement. Finally, increasing awareness for patients and providers will lead to earlier diagnosis and improved outcomes for patients., Competing Interests: The authors report no conflicts of interest., (Copyright © 2020 Wolters Kluwer Health, Inc. All rights reserved.)

Background: An increasing number of patients with cancer diagnoses and prior SARS-CoV-2 infection will require surgical treatment. The objective of this study was to determine whether a history of SARS-CoV-2 infection increases the risk of adverse postoperative events following surgery in patients with cancer., Methods: This was a propensity-matched cohort study from April 6, 2020 to October 31, 2020 at the UT MD Anderson Cancer Center. Cancer patients were identified who underwent elective surgery after recovering from SARS-CoV-2 infection and matched to controls based on patient, disease, and surgical factors. Primary study outcome was a composite of the following adverse postoperative events that occurred within 30 days of surgery: death, unplanned readmission, pneumonia, cardiac injury, or thromboembolic event., Results: A total of 5682 patients were included for study, and 114 (2.0%) had a prior SARS-CoV-2 infection. The average time from infection to surgery was 52 (range 20-202) days. Compared with matched controls, there was no difference in the rate of adverse postoperative outcome (14.3% vs. 13.4%, p = 1.0). Patients with a SARS-CoV-2-related inpatient admission before surgery had increased odds of postoperative complication (adjusted odds ratio [aOR] 7.4 [1.6-34.3], p = 0.01)., Conclusions: A minimal wait time of 20 days after recovering from minimally symptomatic SARS-CoV-2 infection appears to be safe for cancer patients undergoing low-risk elective surgery. Patients with SARS-CoV-2 infections requiring inpatient treatment were at increased risk for adverse events after surgery. Additional wait time may be required in those with more severe infections., (© 2021. Society of Surgical Oncology.)

Breast implant anaplastic large cell lymphoma (ALCL) is a T-cell neoplasm arising around textured breast implants that was recognized recently as a distinct entity by the World Health Organization. Rarely, other types of lymphoma have been reported in patients with breast implants, raising the possibility of a pathogenetic relationship between breast implants and other types of lymphoma. We report eight cases of Epstein-Barr virus (EBV)-positive large B-cell lymphoma associated with breast implants. One of these cases was invasive, and the other seven neoplasms were noninvasive and showed morphologic overlap with breast implant ALCL. All eight cases expressed B-cell markers, had a non-germinal center B-cell immunophenotype, and were EBV+ with a latency type III pattern of infection. We compared the noninvasive EBV+ large B-cell lymphoma cases with a cohort of breast implant ALCL cases matched for clinical and pathologic stage. The EBV+ large B-cell lymphoma cases more frequently showed a thicker capsule, and more often were associated with calcification and prominent lymphoid aggregates outside of the capsule. The EBV+ B-cell lymphoma cells were more often arranged within necrotic fibrinoid material in a layered pattern. We believe that this case series highlights many morphologic similarities between EBV+ large B-cell lymphoma and breast implant ALCL. The data presented suggest a pathogenetic role for breast implants (as well as EBV) in the pathogenesis of EBV+ large B-cell lymphoma. We also provide some histologic findings useful for distinguishing EBV+ large B-cell lymphoma from breast implant ALCL in this clinical setting., (© 2021. The Author(s), under exclusive licence to United States & Canadian Academy of Pathology.)

Breast implant-associated anaplastic large cell lymphoma (ALCL) is a distinctive type of T-cell lymphoma that arises around textured-surface breast implants. In a subset of patients, this disease can involve surrounding tissues, spread to regional lymph nodes, and rarely metastasize to distant sites. The aim of this study was to assess sequential pathologic specimens from patients with breast implant-associated ALCL to better understand the natural history of early-stage disease. To achieve this goal, we searched our files for patients who had breast implant-associated ALCL and who had undergone earlier surgical intervention with assessment of biopsy or cytologic specimens. We then focused on the patient subset in whom a definitive diagnosis was not established, and patients did not receive current standard-of-care therapy at that time. We identified a study group of ten patients with breast implant-associated ALCL in whom pathologic specimens were collected 0.5 to 4 years before a definitive diagnosis was established. A comparison of these serial biopsy specimens showed persistent disease without change in pathologic stage in three patients, progression in five patients, and persistence versus progression in two patients. Eventually, six patients underwent implant removal with complete capsulectomy and four underwent partial capsulectomy. Seven patients also received chemotherapy because of invasive disease, three of whom also received radiation therapy, two brentuximab vedotin after chemotherapy failure, and one allogeneic stem cell transplant. Eight patients achieved complete remission and two had partial remission after definitive therapy. At time of last follow-up, six patients were alive without disease, one had evidence of disease, one died of disease, and two patients died of unrelated cancers. In summary, this analysis of sequential specimens from patients with breast implant-associated ALCL suggests these neoplasms persist or progress over time if not treated with standard-of-care therapy., (© 2021. The Author(s), under exclusive licence to United States & Canadian Academy of Pathology.)

Background: Granzyme B (GrB) is a serine protease secreted, along with pore-forming perforin, by cytotoxic lymphocytes to mediate apoptosis in target cells. GrB has been detected in tumor cells associated with systemic and breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) but its potential use for detection of early BIA-ALCL has not been fully investigated., Objectives: Prompted by the increased incidence of BIA-ALCL, the aim of this study was to assess GrB as a new biomarker to detect early disease in malignant seromas and to better understand the nature of the neoplastic cell., Methods: A Human XL Cytokine Discovery Magnetic Luminex 45-plex Fixed Panel Performance Assay was used to compare cytokine levels in cell culture supernatants of BIA-ALCL and other T-cell lymphomas, as well as malignant and benign seromas surrounding breast implants. Immunohistochemistry was employed to localize GrB to cells in seromas and capsular infiltrates., Results: Differences in GrB concentrations between malignant and benign seromas were significant (P < 0.001). GrB was found in and around apoptotic tumor cells, suggesting that the protease may be involved in tumor cell death., Conclusions: GrB is a useful marker for early detection of malignant seromas and to identify tumor cells in seromas and capsular infiltrates. Because there is an overlap between the lowest concentrations of soluble GrB in malignant seromas and the highest concentrations of GrB in benign seromas, it is recommended that GrB be used only as part of a panel of biomarkers for the screening and early detection of BIA-ALCL., (© 2020 The Aesthetic Society. Reprints and permission: journals.permissions@oup.com.)

Background: With the increased use of acellular dermal matrix (ADM) in breast reconstruction, the number of available materials has increased. There is a relative paucity of high-quality outcomes data for use of different ADMs., Objectives: The goal of this study was to compare the outcomes between a human (HADM) and a bovine ADM (BADM) in implant-based breast reconstruction., Methods: A prospective, single-blinded, randomized controlled trial was conducted to evaluate differences in outcomes between HADM and BADM for patients undergoing immediate tissue expander breast reconstruction. Patients with prior radiation to the index breast were excluded. Patient and surgical characteristics were collected and analyzed., Results: From April 2011 to June 2016, a total of 90 patients were randomized to a mesh group, with 68 patients (HADM, 36 patients/55 breasts; BADM, 32 patients/48 breasts) included in the final analysis. Baseline characteristics were similar between the 2 groups. No significant differences in overall complication rates were identified between HADM (n = 14, 25%) and BADM (n = 13, 27%) (P = 0.85). Similar trends were identified for major complications and complications requiring reoperation. Tissue expander loss was identified in 7% of HADM patients (n = 4) and 17% of BADM patients (n = 8) (P = 0.14)., Conclusions: Similar complication and implant loss rates were found among patients undergoing immediate tissue expander breast reconstruction with HADM or BADM. Regardless of what material is used, careful patient selection and counseling, and cost consideration, help to improve outcomes and sustainability in immediate breast reconstruction., (© 2021 The Aesthetic Society. Reprints and permission: journals.permissions@oup.com.)

Silicone is widely used in chronic implants and is generally perceived to be safe. However, textured breast implants have been associated with immune-related complications, including malignancies. Here, by examining for up to one year the foreign body response and capsular fibrosis triggered by miniaturized or full-scale clinically approved breast implants with different surface topography (average roughness, 0-90 μm) placed in the mammary fat pads of mice or rabbits, respectively, we show that surface topography mediates immune responses to the implants. We also show that the surface surrounding human breast implants collected during revision surgeries also differentially alters the individual's immune responses to the implant. Moreover, miniaturized implants with an average roughness of 4 μm can largely suppress the foreign body response and fibrosis (but not in T-cell-deficient mice), and that tissue surrounding these implants displayed higher levels of immunosuppressive FOXP3 + regulatory T cells. Our findings suggest that, amongst the topographies investigated, implants with an average roughness of 4 μm provoke the least amount of inflammation and foreign body response., (© 2021. The Author(s), under exclusive licence to Springer Nature Limited.)

The Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) was requested by the European Commission (EC) to provide a scientific opinion on the safety of breast implants in relation to anaplastic large cell lymphoma (ALCL). There are several types of textured breast implants; surface textures of breast implants are not all manufactured in the same way, and breast implants with diverse surface textures may also present different benefits. The magnitude of the risk per type of textured implant is difficult to establish due to the low incidence of the breast implants associated anaplastic large cell lymphoma (BIA-ALCL). Therefore, risk assessments per implant type are needed. Overall SCHEER considers that there is a moderate weight of evidence for a causal relationship between textured breast implants and BIA-ALCL, particularly in relation to implants with an intermediate to high surface roughness.The pathogenic mechanisms are not fully elucidated; current hypotheses include genetic drivers, chronic inflammation resulting either from bacterial contamination, shell shedding of particulates, or shell surface characteristics leading to friction, or by implant associated reactive compounds. Reporting of new BIA-ALCL cases by the national clinical registries is critically important to obtain a better estimate of the risk of BIA-ALCL for patients with a breast implant., (Copyright © 2021. Published by Elsevier Inc.)

Background: Autologous tissue is the criterion standard in breast reconstruction, but traditionally has been used as a secondary option after implant-based options because of reduced reimbursement relative to effort and required additional technical skill. We intended to evaluate the overall frequency and trends of autologous breast reconstruction (ABR), the trends of ABR in teaching versus nonteaching hospitals and the trends of ABR in different hospital regions in the United States., Methods: Using the Nationwide Inpatient Sample database, we examined the clinical data of patients who underwent immediate or delayed ABR from 2009 to 2016 in the United States., Results: A total of 146,185 patients underwent ABR during this period. The overall rate of ABR increased 112%, from 26.6% to 56.5%. The majority of ABR were delayed reconstructions (62.3%), which increased gradually from 54.9% to 80% during the study period. The overall frequency of flaps included the deep inferior epigastric perforator (32.1%), latissimus dorsi myocutaneous (28.4%), free transvers rectus abdominus myocutaneous (15.9%), pedicled transvers rectus abdominus myocutaneous flap (14.5%), gluteal artery perforator (0.6%), superficial inferior epigastric artery (0.6%), and unspecified-ABR (7.2%). Most ABRs were performed in teaching hospitals (78.6%) versus nonteaching hospitals (21.4%). The teaching hospitals' ABR rate increased from 70.5% to 88.7%. The greatest proportion of ABRs were performed in the south (39.6%) followed by northeast (23.0%), midwest (18.9%), and west (18.5%)., Conclusions: The deep inferior epigastric perforator flap has become the predominant ABR method in the United States. In addition to more delayed reconstructions being performed in recent years, ABR rates are increasing overall and shifting from pedicled flaps to free flaps., Competing Interests: Conflicts of interest and sources of funding: none declared., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)

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., (© 2020 The Aesthetic Society. Reprints and permission: journals.permissions@oup.com.)

Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is a recently characterized T-cell malignancy that has raised significant patient safety concerns and led to worldwide impact on the implants used and clinical management of patients undergoing reconstructive or cosmetic breast surgery. Molecular signatures distinguishing BIA-ALCL from other ALCLs have not been fully elucidated and classification of BIA-ALCL as a WHO entity remains provisional. We performed RNA sequencing and gene set enrichment analysis comparing BIA-ALCLs to non-BIA-ALCLs and identified dramatic upregulation of hypoxia signaling genes including the hypoxia-associated biomarker CA9 (carbonic anyhydrase-9). Immunohistochemistry validated CA9 expression in all BIA-ALCLs, with only minimal expression in non-BIA-ALCLs. Growth induction in BIA-ALCL-derived cell lines cultured under hypoxic conditions was proportional to up-regulation of CA9 expression, and RNA sequencing demonstrated induction of the same gene signature observed in BIA-ALCL tissue samples compared to non-BIA-ALCLs. CA9 silencing blocked hypoxia-induced BIA-ALCL cell growth and cell cycle-associated gene expression, whereas CA9 overexpression in BIA-ALCL cells promoted growth in a xenograft mouse model. Furthermore, CA9 was secreted into BIA-ALCL cell line supernatants and was markedly elevated in human BIA-ALCL seroma samples. Finally, serum CA9 concentrations in mice bearing BIA-ALCL xenografts were significantly elevated compared to control serum. Together, these findings characterize BIA-ALCL as a hypoxia-associated neoplasm, likely attributable to the unique microenvironment in which it arises. These data support classification of BIA-ALCL as a distinct entity and uncover opportunities for investigating hypoxia-related proteins such as CA9 as novel biomarkers and therapeutic targets in this disease.

Summary: Proper management of symptomatic textured implant patients is critical to identify and treat associated oncologic disease. Textured surface breast implants were first introduced more than 50 years ago in an effort to decrease high rates of capsular contracture and implant malposition observed with first-generation smooth surface breast implants. Textured implants were dominant over smooth devices in the United States in the late 1990s, but they fell out of favor for newer-generation smooth implants, while texture remained the dominant selling implants worldwide until recently. A class I device recall by the US Food and Drug Administration in 2019 precipitated a removal of the highest selling implant worldwide, Allergan Biocell, due to a disproportionately increased risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). Operative strategies, such as bacterial control at the time of textured implant insertion, have not been credibly shown to affect or prevent the future development of BIA-ALCL. BIA-ALCL patients require complete surgical excision of their disease, whereas textured implant patients who are otherwise asymptomatic do not require surgical removal. For suspicious cases, diagnostic testing with CD30 immunohistochemistry should be performed before any surgical intervention. Capsules are evaluated with 12 strategic regional biopsies in a standardized approach. If surgeons are revising or exchanging textured implants, they may reasonably consider a total capsulectomy, though this is not advocated by the Food and Drug Administration or national societies, and has not been shown to mitigate future risk of BIA-ALCL. The purpose of this article is to review data on and outcomes for textured surface implants, disease-associated risk, and the management strategy for revisionary surgery and device surveillance., Competing Interests: Disclosure:The authors have no associations or financial disclosures to report that create a conflict of interest with the information presented in this article. M.D. Anderson Cancer Center participates in clinical trials for Motiva US Safety Trial (Establishment Labs) and Mentor Corporation., (Copyright © 2021 by the American Society of Plastic Surgeons.)

Background: High treatment costs associated with breast cancer are a substantial burden to patients and society. Despite mounting awareness, patient perspectives about the value of cost discussions in breast reconstruction and risk factors for financial distress are unknown., Methods: The authors performed a single-institution, cross-sectional survey of all women who underwent breast reconstruction following mastectomy or lumpectomy for breast cancer or risk reduction. Questions were derived from previously published survey items, and the authors leveraged regression analysis to identify patient-level risk factors for major financial distress., Results: A total of 647 of 2293 patients returned the survey questionnaires (28.2 percent response rate). From the 647 respondents, 399 (62 percent) underwent breast reconstruction, and of these, 140 (35 percent) reported that total treatment expenses were higher than expected. One hundred twenty-nine breast reconstruction patients (32 percent) paid over $5000 in out-of-pocket costs. Two hundred eighty-four (71 percent) felt that surgeons should explain the estimated out-of-pocket costs when choosing a type of breast reconstruction and 205 (51 percent) believed that a financial consultation should be scheduled with every new cancer diagnosis. However, only 52 patients (13 percent) reported having had cost discussions with the treatment team. The incidence of major financial distress was n = 70 (18 percent), and following regression analysis, higher credit score and annual income were associated with a 66 percent and 69 percent risk reduction, respectively., Conclusions: Recipients of breast reconstruction demonstrate unanticipated and unplanned financial strain related to out-of-pocket expenses and believe that cost-consciousness should impact treatment decisions. Lower income and credit score are associated with financial distress. Cost discussions may optimize decision-making in preference sensitive conditions., Competing Interests: Disclosure:The authors report no financial conflicts of interest., (Copyright © 2021 by the American Society of Plastic Surgeons.)

Summary: Breast implant removal and replacement has been a common secondary breast procedure in the long-term maintenance of breast augmentation, but more recently growing concerns about silicone-related systemic illness, breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), and changing perceptions of aesthetic beauty have seen breast implant removal without replacement become increasingly requested by patients. Explantation can be challenging, especially when performed with a total capsulectomy. Currently, there is no evidence regarding whether a partial or total capsulectomy has any effect on BIA-ALCL risk mitigation in patients that have textured implants without disease. Total capsulectomy with incomplete resection of a mass can contribute to hyperprogression of BIA-ALCL and death. There have also been cases of BIA-ALCL diagnosed years after removal of the textured device and "total capsulectomy." Therefore, the common practice of simple prophylactic capsulectomy in a textured implant to mitigate future disease has not been established and at the current time should be discouraged. In addition, aesthetic outcomes can be quite variable, and patients should have appropriate preoperative counseling regarding the indications and contraindications for explantation, associated risks, financial implications, and postoperative appearance. The authors review salient aspects related to the planning and management of breast implant removal., (Copyright © 2021 by the American Society of Plastic Surgeons.)

Objective: This evidence-based systematic review synthesizes and critically appraises current clinical recommendations and advances in the diagnosis and treatment of BIA-ALCL. This review also aims to broaden physician awareness across diverse specialties, particularly among general practitioners, breast surgeons, surgical oncologists, and other clinicians who may encounter patients with breast implants in their practice., Background: BIA-ALCL is an emerging and treatable immune cell cancer definitively linked to textured-surface breast implants. Although the National Comprehensive Cancer Network (NCCN) consensus guidelines and other clinical recommendations have been established, the evidence supporting these guidelines has not been systematically studied. The purpose of this evidence-based systematic review is to synthesize and critically appraise current clinical guidelines and recommendations while highlighting advances in diagnosis and treatment and raising awareness for this emerging disease., Methods: This evidence-based systematic review evaluated primary research studies focusing on the diagnosis and treatment of BIA-ALCL that were published in PubMed, Google Scholar, and other scientific databases through March 2020., Results and Conclusions: The clinical knowledge of BIA-ALCL has evolved rapidly over the last several years with major advances in diagnosis and treatment, including en bloc resection as the standard of care. Despite a limited number of high-quality clinical studies comprised mainly of Level III and Level V evidence, current evidence aligns with established NCCN consensus guidelines. When diagnosed and treated in accordance with NCCN guidelines, BIA-ALCL carries an excellent prognosis., Competing Interests: The authors report no conflicts of interest., (Copyright © 2020 Wolters Kluwer Health, Inc. All rights reserved.)

Summary: Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is an emerging and highly treatable cancer of the immune system that can form around textured-surface breast implants. Although the underlying cause has yet to be elucidated, an emerging theme-linking pathogenesis to a chronic inflammatory state-continues to dominate the current literature. Specifically, the combination of increasing mutation burden and chronic inflammation leads to aberrant T-cell clonal expansion. However, the impetus remains largely unknown. Proposed mechanisms include a lipopolysaccharide endotoxin response, oncogenic transformation related to viral infection, associated trauma to the breast pocket, particulate matter digestion by capsular macrophages, chronic allergic inflammation, and genetic susceptibility. The Janus kinase-signal transducer and activator of transcription 3 (JAK-STAT3) pathway is a major signaling pathway that regulates a variety of intracellular growth and survival processes. Constitutive activation of JAK-STAT3 has been implicated in several malignancies, including lymphomas, and has recently been identified as a potential key mediator in BIA-ALCL. The purpose of this article is to review the cellular and molecular mechanisms of BIA-ALCL with a focus on the role of oncogenic JAK-STAT3 signaling in BIA-ALCL tumorigenesis and progression. Selected experimental work from the authors' group on aberrant JAK-STAT3 signaling in BIA-ALCL is also included. The authors discuss how an inflammatory microenvironment may facilitate malignant transformation through the JAK-STAT3 pathway-highlighting its potential mechanistic role. The authors' hope is that further investigation of this signaling pathway will reveal avenues for using JAK-STAT3 signaling as a prognostic indicator and novel therapeutic target in the case of advanced disease., Competing Interests: Disclosure:The authors have no associations or financial disclosures to report that create a conflict of interest with the information presented in this article. Dr. Clemens is a clinical investigator for Motiva U.S. Safety Trial (Establishment Labs) and is a former Allergan consultant (2012 to 2015)., (Copyright © 2020 by the American Society of Plastic Surgeons.)

Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is an emerging cancer of the immune system that is exclusively associated with textured-surface breast implants. This clinical review provides an update on the diagnosis and management of BIA-ALCL with an emphasis on major advances. The epidemiology and pathophysiology of the disease are also reviewed, focusing on current paradigm shifts and highlighting current controversies related to disease classification and risk mitigation. Finally, the authors conclude by discussing medicolegal and ethical issues surrounding BIA-ALCL while establishing a future basic science and clinical research agenda that is central to improving patient safety., Competing Interests: Disclosure The authors have no associations or financial disclosures to report that create a conflict of interest with the information presented in this article., (Copyright © 2020 Elsevier Inc. All rights reserved.)

The United States Food and Drug Administration (FDA) recently recognized the necessity for improved patient education and public awareness of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). BIA-ALCL is an uncommon T-cell lymphoma that can arise years after placement of a textured breast implant or tissue expander. Patients and providers would greatly benefit from a broader awareness of BIA-ALCL and how it presents with both common and rare symptoms. Disease awareness can be improved with specific steps moving forward. This includes improved counseling about annual recommendations from the FDA, standard of care guidelines, current estimates of disease prevalence, and manufacturer-specific risk for developing the malignancy. Informed consent for implant-based breast surgery should include a discussion of BIA-ALCL, symptoms, inherent risks and alternatives. Consideration should be given for reasonable efforts to retroactively contact patients with textured implants to inform them of recent regulatory actions as well as the risk of developing the disease and the signs and symptoms to watch for. Where risk can be reduced, all steps should be taken to ensure patient safety. In keeping with our commitment to patient safety, the strategies moving forward for implant-based breast surgery should be marked by patient awareness, physician vigilance, and defined by evidence-based diagnosis and treatment., Competing Interests: Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at http://dx.doi.org/10.21037/gs.2020.03.06). The authors have no conflicts of interest to declare., (2021 Gland Surgery. All rights reserved.)

Recent epidemiological studies have attempted to accurately determine the risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). However, comparisons of previously published works are difficult due to widespread variations in reporting. We systematically review the epidemiology in order to better define the current risk of BIA-ALCL. Herein, we report the global epidemiology with an emphasis on the U.S. breast implant population while simultaneously assessing the oncologic safety of smooth-surface devices. In the current manuscript, a systematic review of PubMed and other scientific databases, as well as the grey literature, was conducted for epidemiologic studies on BIA-ALCL. Using analytical and descriptive epidemiology, we estimated the cumulative incidence and incidence rate of BIA-ALCL using a standardized approach. Cumulative incidence was reported at implant and patient-specific levels. The patient-specific cumulative risk within the U.S. market ranges from 1.79 per 1,000 (1:559) to 2.82 per 1,000 (1:355) patients with a textured implant. The implant-specific risk of Allergan textured devices ranges from 1:602-871 to 1:8,500, while the risk of commercially available Mentor Siltex implants is 1:50,000. No epidemiological study or regulatory agency reported a case of BIA-ALCL occurring exclusively with a smooth device. As such, with the removal of Allergan textured breast devices, this study demonstrates substantial gaps in the epidemiological knowledge of BIA-ALCL, including the current risk of commercially available textured breast implants in the U.S. market. Although the risk of BIA-ALCL is low, surgeons should exercise extreme caution when considering the use of a textured breast device for cosmetic or reconstructive purposes., Competing Interests: Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at http://dx.doi.org/10.21037/abs-20-96). The series “Novel Innovations and Advancements in Breast Reconstruction” was commissioned by the editorial office without any funding or sponsorship. The authors have no other conflicts of interest to declare.