U.S. Epidemiology of Breast Implant-Associated Anaplastic Large Cell Lymphoma.
01 May 2017-Plastic and Reconstructive Surgery (Lippincott Williams and Wilkins)-Vol. 139, Iss: 5, pp 1042-1050
TL;DR: Although women with a textured breast implant have a low risk of developing breast implant–associated ALCL, the current U.S. incidence is significantly higher than that of primary ALCL of the breast in the general population.
Abstract: Background:Breast implant–associated anaplastic large cell lymphoma (ALCL) is a distinctive type of T-cell lymphoma that arises around breast implants. Although rare, all cases with adequate history have involved a textured breast implant. The objective of this study was to determine the U.S. incide
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TL;DR: The results emphasize the need for increased awareness among the public, medical professionals, and regulatory bodies, promotion of alternative cosmetic procedures, and alertness to signs and symptoms of breast-ALCL in women with implants.
Abstract: Importance Breast implants are among the most commonly used medical devices. Since 2008, the number of women with breast implants diagnosed with anaplastic large-cell lymphoma in the breast (breast-ALCL) has increased, and several reports have suggested an association between breast implants and risk of breast-ALCL. However, relative and absolute risks of breast-ALCL in women with implants are still unknown, precluding evidence-based counseling about implants. Objective To determine relative and absolute risks of breast-ALCL in women with breast implants. Design, Setting, and Participants Through the population-based nationwide Dutch pathology registry we identified all patients diagnosed with primary non-Hodgkin lymphoma in the breast between 1990 and 2016 and retrieved clinical data, including breast implant status, from the treating physicians. We estimated the odds ratio (OR) of ALCL associated with breast implants in a case-control design, comparing implant prevalence between women with breast-ALCL and women with other types of breast lymphoma. Cumulative risk of breast-ALCL was derived from the age-specific prevalence of breast implants in Dutch women, estimated from an examination of 3000 chest x-rays and time trends from implant sales. Main Outcomes and Measures Relative and absolute risks of breast-ALCL in women with breast implants. Results Among 43 patients with breast-ALCL (median age, 59 years), 32 had ipsilateral breast implants, compared with 1 among 146 women with other primary breast lymphomas (OR, 421.8; 95% CI, 52.6-3385.2). Implants among breast-ALCL cases were more often macrotextured (23 macrotextured of 28 total implants of known type, 82%) than expected (49 193 sold macrotextured implants of total sold 109 449 between 2010 and 2015, 45%) based on sales data (P Conclusions and Relevance Breast implants are associated with increased risk of breast-ALCL, but the absolute risk remains small. Our results emphasize the need for increased awareness among the public, medical professionals, and regulatory bodies, promotion of alternative cosmetic procedures, and alertness to signs and symptoms of breast-ALCL in women with implants.
229 citations
TL;DR: Recommendations focus on parameters for achieving reliable diagnosis and disease management and emphasize the critical role for complete surgical ablation in BIA-ALCL with lymph node involvement.
215 citations
TL;DR: Assessment of how BIA-ALCL develops, its risk factors, diagnosis, and subsequent treatment and to disseminate information about this entity to the medical field is conducted.
Abstract: Importance Breast implant–associated anaplastic large cell lymphoma (BIA-ALCL), a rare peripheral T-cell lymphoma, is increasing in incidence. However, many practitioners who treat patients with breast cancer are not aware of this disease. Objectives To assess how BIA-ALCL develops, its risk factors, diagnosis, and subsequent treatment and to disseminate information about this entity to the medical field. Evidence Review A literature review was performed in an academic medical setting. All review articles, case reports, original research articles, and any other articles relevant to BIA-ALCL were included. Data on BIA-ALCL, such as pathophysiology, patient demographics, presentation, diagnosis, treatment, and outcomes, were extracted. Particular focus was paid to age, time to onset, implant type, initial symptoms, treatment, and survival. The search was conducted in January 2017 for studies published in any year. Findings After duplicates were excluded, 304 relevant articles were assessed, and 115 were included from the first documented case in August 1997 through January 2017. Thirty review articles, 44 case reports or series, 15 original research articles, and 26 “other” articles (eg, techniques, special topics, letters) were reviewed. A total of 93 cases have been reported in the literature, and with the addition of 2 unreported cases from the Penn State Health Milton S. Hershey Medical Center, 95 patients were included in this systematic review. Almost all documented BIA-ALCL cases have been associated with a textured device. The underlying mechanism is thought to be due to chronic inflammation from indolent infections, leading to malignant transformation of T cells that are anaplastic lymphoma kinase (ALK) negative and CD30 positive. The mean time to presentation is approximately 10 years after implant placement, with 55 of 83 (66%) patients initially seen with an isolated late-onset seroma and 7 of 83 (8%) with an isolated new breast mass. Ultrasonography with fluid aspiration can be used for diagnosis. Treatment must include removal of the implant and surrounding capsule. More advanced disease may require chemotherapy, radiotherapy, and lymph node dissection. Conclusions and Relevance Breast implant–associated anaplastic large cell lymphoma is a rare cancer in patients with breast implants but is increasing in incidence. It is important for all physicians involved in the care of patients with breast implants to be aware of this entity and be able to recognize initial symptoms.
177 citations
Cites background from "U.S. Epidemiology of Breast Implant..."
...7 years.(2,3)A prospective study(4) onNatrelle (Allergan) 410 breast implant risk factor analysis found that 4 patients of 17 656 who received breast implants developed BIA-ALCL, suggesting that the incidencemay actually be closer to 1 caseper 4000....
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TL;DR: The essential recommendations and optimal therapeutic strategies of the NCCN guidelines critical to the plastic surgery community are summarized, and international adoption of these BIA-ALCL treatment standards by oncology and surgery disciplines are encouraged.
169 citations
TL;DR: Although many barriers stand in the way of calculating accurate estimates of the incidence and risk of developing BIA-ALCL, steady progress, international registries, and collegiality between research teams are for the first time allowing early estimates.
Abstract: Background:With breast implant–associated anaplastic large cell lymphoma (BIA-ALCL) now accepted as a unique (iatrogenic) subtype of ALCL directly associated with textured breast implants, we are now at a point where a sound epidemiologic profile and risk estimate are required. The aim of this artic
166 citations
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Additional excerpts
...6 Reason for implant Cosmetic 49 (49) Mastectomy 44 (44) Unknown 7 (7) Texturing of implant Textured 51 (51) Smooth 0 (0) Unknown 49 (49) Manufacture type Salt-loss 43 (43) Negative-imprint stamp 5 (5) Both 3 (3) Unknown 49 (49) Incidence years Before 2000 7 (7) 2000–2013 70 (70) After 2013 23 (23)...
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University of Jordan1, Peter MacCallum Cancer Centre2, VU University Amsterdam3, Oakland University4, Columbia University5, Tufts University6, Emory University7, Harvard University8, University of Texas MD Anderson Cancer Center9, University of Houston10, Brown University11, Netherlands Cancer Institute12, American University of Beirut13
TL;DR: Most patients with breast implant-associated ALCL who had disease confined within the fibrous capsule achieved complete remission, justifying cytotoxic chemotherapy in addition to removal of implants.
Abstract: Purpose Breast implant‐associated anaplastic large-cell lymphoma (ALCL) is a recently described clinicopathologic entity that usually presents as an effusion-associated fibrous capsule surrounding an implant. Less frequently, it presents as a mass. The natural history of this disease and long-term outcomes are unknown.
351 citations
TL;DR: Preliminary findings suggest an association between silicone breast prostheses and ALCL, although the absolute risk is exceedingly low due to the rare occurrence of ALCL of the breast (11 cases in The Netherlands in 17 years).
Abstract: Context Recently, we identified 2 patients with anaplastic large T-cell lymphoma (ALCL) negative for tyrosine kinase anaplastic lymphoma kinase (ALK-negative) in the fibrous capsule of silicone breast prostheses, placed for cosmetic reasons. Similar cases have been reported in the literature. Although an increased risk of ALCL in patients with breast prostheses has been speculated, no studies have been conducted so far. Objective To determine whether ALCL risk is associated with breast prostheses. Design A search for all patients with lymphoma in the breast diagnosed in the Netherlands between 1990 and 2006 was performed through the population-based nationwide pathology database. Subsequently, we performed an individually matched case-control study. Conditional logistic regression analysis was performed to estimate the relative risk of ALCL associated with breast prostheses. Setting and Patients Eleven patients with breast ALCL were identified in the registry. For each case patient with ALCL in the breast, we selected 1 to 5 controls with other lymphomas in the breast, matched on age and year of diagnosis. For all cases and controls (n = 35), pathological and clinical information was obtained with special emphasis on the presence of a breast prosthesis. Main Outcome Measure Association between breast implants and ALCL of the breast. Results The 11 patients with ALCL of the breast were diagnosed between 1994 and 2006 at a median age of 40 years (range, 24-68 years). In 5 of these patients, bilateral silicone breast prostheses had been placed 1 to 23 years before diagnosis. All received prostheses for cosmetic reasons. Lymphoma classes of 35 eligible control patients were 12 diffuse large B-cell lymphomas, including 1 T-cell rich B-cell lymphoma; 5 Burkitt lymphomas; 10 mucosa-associated lymphoid tissue–type lymphoma; 3 follicular lymphomas; 3 peripheral T-cell lymphomas; and 2 indolent B-cell lymphomas, unclassified. One of 35 control patients had a breast implant placed before diagnosis of lymphoma. The odds ratio for ALCL associated with breast prostheses was 18.2 (95% confidence interval, 2.1-156.8). Conclusions These preliminary findings suggest an association between silicone breast prostheses and ALCL, although the absolute risk is exceedingly low due to the rare occurrence of ALCL of the breast (11 cases in the Netherlands in 17 years). These findings require confirmation in other studies.
340 citations
TL;DR: Surgical management with complete surgical excision is essential to achieve optimal event-free survival (EFS) and OS in patients with BI-ALCL.
Abstract: PurposeBreast implant–associated anaplastic large-cell lymphoma (BI-ALCL) is a rare type of T-cell lymphoma that arises around breast implants. The optimal management of this disease has not been established. The goal of this study is to evaluate the efficacy of different therapies used in patients with BI-ALCL to determine an optimal treatment approach.Patients and MethodsIn this study, we applied strict criteria to pathologic findings, assessed therapies used, and conducted a clinical follow-up of 87 patients with BI-ALCL, including 50 previously reported in the literature and 37 unreported. A Prentice, Williams, and Peterson model was used to assess the rate of events for each therapeutic intervention.ResultsThe median and mean follow-up times were 45 and 30 months, respectively (range, 3 to 217 months). The median overall survival (OS) time after diagnosis of BI-ALCL was 13 years, and the OS rate was 93% and 89% at 3 and 5 years, respectively. Patients with lymphoma confined by the fibrous capsule sur...
334 citations
Additional excerpts
...6 Reason for implant Cosmetic 49 (49) Mastectomy 44 (44) Unknown 7 (7) Texturing of implant Textured 51 (51) Smooth 0 (0) Unknown 49 (49) Manufacture type Salt-loss 43 (43) Negative-imprint stamp 5 (5) Both 3 (3) Unknown 49 (49) Incidence years Before 2000 7 (7) 2000–2013 70 (70) After 2013 23 (23)...
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