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1.
Ann Plast Surg ; 92(1): 34-40, 2024 Jan 01.
Article in English | MEDLINE | ID: mdl-37994417

ABSTRACT

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.


Subject(s)
Breast Implantation , Breast Implants , Breast Neoplasms , Lymphoma, Large-Cell, Anaplastic , Humans , Female , Adult , Middle Aged , Aged , Breast Implants/adverse effects , Financial Stress , Lymphoma, Large-Cell, Anaplastic/epidemiology , Lymphoma, Large-Cell, Anaplastic/etiology , Lymphoma, Large-Cell, Anaplastic/therapy , Cross-Sectional Studies , Quality of Life , Breast Implantation/adverse effects , Breast Neoplasms/etiology , Breast Neoplasms/surgery
2.
Aesthet Surg J ; 44(7): 757-768, 2024 Jun 14.
Article in English | MEDLINE | ID: mdl-38307034

ABSTRACT

Squamous cell carcinoma may arise primarily from the breast parenchyma (PSCCB) or from the periprosthetic capsule in patients with breast implants (breast implant-associated squamous cell carcinoma [BIA-SCC]). A systematic literature review was performed to identify all PSCCB and BIA-SCC cases, and to estimate prevalence, incidence rate (IR), and risk. Studies up to November 2023 were searched on PubMed, Web of Science, Google Scholar, and Cochrane Library for predefined keywords. The numerator for PSCCB and BIA-SCC was the number of cases obtained from the literature; the denominator for PSCCB was the female population aged from 18 to 99, and the denominator for BIA-SCC was the population with breast implants. Overall, 219 papers were included, featuring 2250 PSCCB and 30 BIA-SCC cases. PSCCB prevalence was 2.0 per 100,000 (95% CI, 0.2:100,000 to 7.2:100,000) individuals, with a lifetime risk of 1:49,509 (95% CI, 0.2:10,000 to 5.6:10,000); and BIA-SCC prevalence was 0.61 per 100,000 (95% CI, 0.2:100,000 to 1.3:100,000), with a lifetime risk of 1:164,884 (95% CI, 0.2:100,000 to 5.6:100,000). The prevalence of BIA-SCC is 3.33 times lower than that of PSCCB, while the prevalence of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is 3.84 times higher than that of primary breast ALCL. When comparing the BIA-SCC prevalence of 1:164,910 individuals with breast implants regardless of texture to the BIA-ALCL prevalence of 1:914 patients with textured implants, the BIA-SCC risk is 180 times lower than the BIA-ALCL risk. BIA-SCC occurs less frequently than PSCCB and considerably less than BIA-ALCL. The association between textured implants and BIA-SCC cases is relevant for patient education regarding uncommon and rare risks associated with breast implants, and ongoing vigilance, research, and strengthened reporting systems remain imperative.


Subject(s)
Breast Implantation , Breast Implants , Breast Neoplasms , Carcinoma, Squamous Cell , Humans , Breast Implants/adverse effects , Female , Breast Neoplasms/epidemiology , Breast Neoplasms/etiology , Carcinoma, Squamous Cell/epidemiology , Carcinoma, Squamous Cell/etiology , Prevalence , Incidence , Breast Implantation/adverse effects , Breast Implantation/instrumentation , Risk Factors , Middle Aged , Adult , Aged , Aged, 80 and over , Young Adult , Adolescent
3.
Ann Surg Oncol ; 30(9): 5711-5722, 2023 Sep.
Article in English | MEDLINE | ID: mdl-37285093

ABSTRACT

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 (ß - 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 (ß - 1.15, p < 0.001) and operative time (ß - 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.


Subject(s)
Breast Neoplasms , Mammaplasty , Humans , Female , Mastectomy/adverse effects , Breast Neoplasms/surgery , Breast Neoplasms/complications , Cohort Studies , Retrospective Studies , Quality of Life , Postoperative Complications/etiology , Mammaplasty/adverse effects , Radiotherapy, Adjuvant/adverse effects , Patient Reported Outcome Measures , Treatment Outcome
4.
Aesthetic Plast Surg ; 47(3): 914-926, 2023 06.
Article in English | MEDLINE | ID: mdl-36376583

ABSTRACT

BACKGROUND: Because of poor knowledge of risks and benefits, prophylactic explantation of high BIA-ALCL risk breast implant (BI) is not indicated. Several surgical risks have been associated with BI surgery, with mortality being the most frightening. Primary aim of this study is to assess mortality rate in patients undergoing breast implant surgery for aesthetic or reconstructive indication. MATERIALS AND METHODS: In this retrospective observational cohort study, Breast Implant Surgery Mortality rate (BISM) was calculated as the perioperative mortality rate among 99,690 patients who underwent BI surgery for oncologic and non-oncologic indications. Mean age at first implant placement (A1P), implant lifespan (IL), and women's life expectancy (WLE) were obtained from a literature review and population database. RESULTS: BISM rate was 0, and mean A1P was 34 years for breast augmentation, and 50 years for breast reconstruction. Regardless of indication, overall mean A1P can be presumed to be 39 years, while mean BIL was estimated as 9 years and WLE as 85 years. CONCLUSION: This study first showed that the BISM risk is 0. This information, and the knowledge that BI patients will undergo one or more revisional procedures if not explantation during their lifetime, may help surgeons in the decision-making process of a pre-emptive substitution or explant in patients at high risk of BIA-ALCL. Our recommendation is that patients with existing macrotextured implants do have a relative indication for explantation and total capsulectomy. The final decision should be shared between patient and surgeon following an evaluation of benefits, surgical risks and comorbidities. LEVEL OF EVIDENCE IV: This journal requires that authors assign a level of evidence to each article. 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 .


Subject(s)
Breast Implantation , Breast Implants , Breast Neoplasms , Lymphoma, Large-Cell, Anaplastic , Mammaplasty , Humans , Female , Breast Implants/adverse effects , Retrospective Studies , Treatment Outcome , Breast Implantation/adverse effects , Breast Implantation/methods , Mammaplasty/adverse effects , Mammaplasty/methods , Lymphoma, Large-Cell, Anaplastic/etiology , Breast Neoplasms/etiology , Observational Studies as Topic
5.
Int J Mol Sci ; 25(1)2023 Dec 26.
Article in English | MEDLINE | ID: mdl-38203524

ABSTRACT

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.


Subject(s)
Breast Implants , Lymphoma, Large-Cell, Anaplastic , Humans , Female , Breast Implants/adverse effects , Lymphoma, Large-Cell, Anaplastic/etiology , Proteomics , Breast , Bacteria
6.
J Reconstr Microsurg ; 39(5): 327-333, 2023 Jun.
Article in English | MEDLINE | ID: mdl-35988578

ABSTRACT

BACKGROUND: Following implant-based breast reconstruction (IBR) infection and explantation, autologous reconstruction is a common option for patients who desire further reconstruction. However, few data exist about the outcomes of secondary autologous reconstruction (i.e., free flap breast reconstruction) in this population. We hypothesized that autologous reconstruction following infected device explantation is safe and has comparable surgical outcomes to delayed-immediate reconstruction. METHODS: We conducted a retrospective analysis of patients who underwent IBR explantation due to infection from 2006 through 2019, followed by secondary autologous reconstruction. The control cohort comprised patients who underwent planned primary delayed-immediate reconstruction (tissue expander followed by autologous flap) in 2018. RESULTS: We identified 38 secondary autologous reconstructions after failed primary IBR and 52 primary delayed-immediate reconstructions. Between secondary autologous and delayed-immediate reconstructions, there were no significant differences in overall complications (29 and 37%, respectively, p = 0.45), any breast-related complications (18 and 21%, respectively, p = 0.75), or any major breast-related complications (13 and10%, respectively, p = 0.74). Two flap losses were identified in the secondary autologous reconstruction group while no flap losses were reported in the delayed-immediate reconstruction group (p = 0.18). CONCLUSION: Autologous reconstruction is a reasonable and safe option for patients who require explantation of an infected prosthetic device. Failure of primary IBR did not confer significantly higher risk of complications after secondary autologous flap reconstruction compared with primary delayed-immediate reconstruction. This information can help plastic surgeons with shared decision-making and counseling for patients who desire reconstruction after infected device removal.


Subject(s)
Breast Implants , Breast Neoplasms , Free Tissue Flaps , Mammaplasty , Humans , Female , Breast Implants/adverse effects , Device Removal/adverse effects , Retrospective Studies , Free Tissue Flaps/surgery , Mammaplasty/adverse effects , Postoperative Complications/surgery , Postoperative Complications/etiology , Breast Neoplasms/surgery , Breast Neoplasms/complications
7.
Aesthet Surg J ; 44(1): NP32-NP40, 2023 Dec 14.
Article in English | MEDLINE | ID: mdl-37616552

ABSTRACT

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.


Subject(s)
Breast Implantation , Breast Implants , Breast Neoplasms , Lymphoma, Large-Cell, Anaplastic , Humans , Female , United States/epidemiology , Breast Implants/adverse effects , Lymphoma, Large-Cell, Anaplastic/epidemiology , Lymphoma, Large-Cell, Anaplastic/etiology , Lymphoma, Large-Cell, Anaplastic/pathology , Breast Implantation/adverse effects , Incidence , Netherlands , Breast Neoplasms/etiology
8.
Ann Surg ; 275(1): e245-e249, 2022 01 01.
Article in English | MEDLINE | ID: mdl-32568749

ABSTRACT

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.


Subject(s)
Breast Implants/adverse effects , Breast Neoplasms/etiology , Mammaplasty/adverse effects , Postoperative Complications/etiology , Adult , Aged , Biopsy , Breast Neoplasms/diagnosis , Female , Follow-Up Studies , Humans , Lymphoma, Large-Cell, Anaplastic/diagnosis , Middle Aged , Postoperative Complications/diagnosis , Prospective Studies , Time Factors
9.
Ann Surg Oncol ; 29(9): 5722-5729, 2022 Sep.
Article in English | MEDLINE | ID: mdl-35597841

ABSTRACT

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.


Subject(s)
Breast Implantation , Breast Implants , Breast Neoplasms , Lymphoma, Large-Cell, Anaplastic , Mammaplasty , Neoplasms, Second Primary , Breast Implants/adverse effects , Breast Neoplasms/etiology , Breast Neoplasms/surgery , Female , Humans , Lymphoma, Large-Cell, Anaplastic/etiology , Lymphoma, Large-Cell, Anaplastic/therapy , Neoplasms, Second Primary/surgery
10.
J Natl Compr Canc Netw ; 20(3): 285-308, 2022 03.
Article in English | MEDLINE | ID: mdl-35276674

ABSTRACT

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.


Subject(s)
Immunoblastic Lymphadenopathy , Lymphoma, T-Cell, Peripheral , Lymphoma, T-Cell , Humans , Immunoblastic Lymphadenopathy/diagnosis , Immunoblastic Lymphadenopathy/pathology , Immunoblastic Lymphadenopathy/therapy , Lymphoma, T-Cell/diagnosis , Lymphoma, T-Cell/therapy , Lymphoma, T-Cell, Peripheral/diagnosis , Lymphoma, T-Cell, Peripheral/therapy
11.
Ann Plast Surg ; 88(2): 157-161, 2022 02 01.
Article in English | MEDLINE | ID: mdl-34270472

ABSTRACT

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.


Subject(s)
Breast Implantation , Breast Implants , Lymphoma, Large-Cell, Anaplastic , Breast Implantation/adverse effects , Breast Implants/adverse effects , Device Removal , Female , Humans , Lymphoma, Large-Cell, Anaplastic/diagnosis , Lymphoma, Large-Cell, Anaplastic/etiology , Middle Aged , Seroma/diagnosis , Seroma/etiology , Seroma/surgery
12.
Ann Plast Surg ; 89(5): 478-486, 2022 11 01.
Article in English | MEDLINE | ID: mdl-36279571

ABSTRACT

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.


Subject(s)
Surgeons , Surgery, Plastic , United States , Humans , National Institutes of Health (U.S.) , Efficiency , Bibliometrics
13.
Aesthet Surg J ; 42(11): 1262-1278, 2022 10 13.
Article in English | MEDLINE | ID: mdl-35639805

ABSTRACT

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.


Subject(s)
Breast Implantation , Breast Implants , Breast Neoplasms , Lymphoma, Large-Cell, Anaplastic , Breast Implantation/adverse effects , Breast Implantation/methods , Breast Implants/adverse effects , Breast Neoplasms/etiology , Female , Humans , Lymphoma, Large-Cell, Anaplastic/diagnosis , Lymphoma, Large-Cell, Anaplastic/epidemiology , Lymphoma, Large-Cell, Anaplastic/etiology , Neoplasm Recurrence, Local , Risk Factors
14.
Ann Surg ; 273(3): 449-458, 2021 03 01.
Article in English | MEDLINE | ID: mdl-33234792

ABSTRACT

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.


Subject(s)
Breast Implants/adverse effects , Lymphoma, Large-Cell, Anaplastic/etiology , Breast Implantation/adverse effects , Breast Neoplasms/surgery , Evidence-Based Medicine , Female , Humans , Lymphoma, Large-Cell, Anaplastic/diagnosis , Lymphoma, Large-Cell, Anaplastic/therapy
15.
Mod Pathol ; 34(12): 2148-2153, 2021 12.
Article in English | MEDLINE | ID: mdl-34155351

ABSTRACT

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.


Subject(s)
Breast Implantation/adverse effects , Breast Implants/adverse effects , Lymphoma, Large-Cell, Anaplastic/pathology , Biopsy , Breast Implantation/instrumentation , Breast Implantation/mortality , Disease Progression , Female , Humans , Lymphoma, Large-Cell, Anaplastic/etiology , Lymphoma, Large-Cell, Anaplastic/mortality , Lymphoma, Large-Cell, Anaplastic/therapy , Middle Aged , Predictive Value of Tests , Prosthesis Design , Remission Induction , Retrospective Studies , Risk Factors , Surface Properties , Time Factors , Treatment Outcome
16.
Mod Pathol ; 34(12): 2154-2167, 2021 12.
Article in English | MEDLINE | ID: mdl-34226673

ABSTRACT

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.


Subject(s)
Breast Implantation/adverse effects , Breast Implants/adverse effects , Epstein-Barr Virus Infections/virology , Lymphoma, Large B-Cell, Diffuse/pathology , Lymphoma, Large-Cell, Anaplastic/pathology , Adult , Aged , Biomarkers, Tumor/analysis , Breast Implantation/instrumentation , Diagnosis, Differential , Epstein-Barr Virus Infections/diagnosis , Female , Humans , Lymphoma, Large B-Cell, Diffuse/immunology , Lymphoma, Large B-Cell, Diffuse/virology , Lymphoma, Large-Cell, Anaplastic/etiology , Lymphoma, Large-Cell, Anaplastic/immunology , Middle Aged , Neoplasm Staging , Predictive Value of Tests , Prosthesis Design , Risk Factors , Surface Properties
17.
Ann Surg Oncol ; 28(13): 8046-8053, 2021 Dec.
Article in English | MEDLINE | ID: mdl-34176060

ABSTRACT

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.


Subject(s)
COVID-19 , Neoplasms , Cohort Studies , Elective Surgical Procedures , Humans , Neoplasms/surgery , SARS-CoV-2 , Treatment Outcome
18.
Haematologica ; 106(6): 1714-1724, 2021 06 01.
Article in English | MEDLINE | ID: mdl-32414854

ABSTRACT

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.


Subject(s)
Breast Implants , Breast Neoplasms , Lymphoma, Large-Cell, Anaplastic , Animals , Breast Implants/adverse effects , Female , Humans , Hypoxia/genetics , Immunohistochemistry , Lymphoma, Large-Cell, Anaplastic/genetics , Mice , Tumor Microenvironment
19.
Regul Toxicol Pharmacol ; 125: 104982, 2021 Oct.
Article in English | MEDLINE | ID: mdl-34214611

ABSTRACT

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.


Subject(s)
Breast Implants/statistics & numerical data , Lymphoma, Large-Cell, Anaplastic/epidemiology , Causality , Humans , Risk Assessment , Risk Factors , Time Factors
20.
Ann Plast Surg ; 87(3): 242-247, 2021 09 01.
Article in English | MEDLINE | ID: mdl-33443887

ABSTRACT

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.


Subject(s)
Breast Neoplasms , Free Tissue Flaps , Mammaplasty , Myocutaneous Flap , Perforator Flap , Female , Humans , Inpatients , Retrospective Studies , United States
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