Risk Of Breast Implant-associated Anaplastic Large Cell Lymphoma Research Articles

Breast Implant-Associated Anaplastic Large Cell Lymphoma Awareness: An Analysis of the Responses to an Institutional Campaign and Global Recall.

We performed an assessment of patient response rates and clinical outcomes to the global recall for textured breast implants and to our institution's letters informing them of their risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). A retrospective review of patients who had textured implants placed at our institution was completed. Outcome measures included patient response rates to either the global recall or our institution's letters, rate of textured implant removal, and type of subsequent revision surgery. A total of 1176 patients with textured implants were reviewed for this study. In total, 374 patients (31.8%) reached out to discuss their risk of BIA-ALCL, and 297 (25.3%) eventually presented to the clinic. One hundred twenty eight patients (34.2%) responded after the letter but before the US Food and Drug Administration (FDA) ban of macrotextured BIOCELL implants, 186 (49.7%) after the FDA ban, and 48 (12.8%) after the manufacturer's multichannel campaign. One hundred eighteen patients with textured implants (11.6%) proceeded with surgery. Most underwent exchange with smooth implants (76 patients [64.4%]) after textured implant removal. A significant portion of patients (31.8%) responded to our letters, the FDA ban, and the manufacturer's campaign. Despite the low incidence of BIA-ALCL and the ongoing recommendation for observation in the setting of no symptoms, 11.6% of our patients still elected to proceed with implant removal. Exchange to smooth implants was the most popular surgical option at 64.4%.

Risk of Breast Implant-Associated Anaplastic Large Cell Lymphoma in Patients with Textured Tissue Expanders.

The association between textured implants and breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is well established, but the risk of BIA-ALCL in patients with transient exposure to a textured tissue expander (TE) is not as well documented. The aim of this study was to assess the incidence and risk of BIA-ALCL in patients with temporary exposure to a textured TE with subsequent smooth implant placement. This single-institution retrospective cohort study included all female patients who underwent two-stage breast reconstruction with placement of a textured TE from 1995 to 2016 with subsequent exchange to a smooth permanent implant. Primary outcome of interest was development of BIA-ALCL. Patients with exposure to textured implants were excluded. Follow-up was determined by last documented visit. The authors calculated summary statistics for exposure time and follow-up intervals. Overall, 3310 patients had temporary exposure to a textured TE with exchange to a smooth implant, totaling 5201 textured TEs. Average textured TE exposure time was 6.7 months (median, 5.8 months). Average follow-up was 6.8 years (median, 6.3 years), ranging from 3.7 months to 18 years. No cases of BIA-ALCL were identified. As no cases of BIA-ALCL were identified, the risk of BIA-ALCL with short exposure to textured TEs is likely lower than the risk from exposure to permanent textured implants. Although longer follow-up is needed, these results can help counsel patients with previous exposure to textured TEs who are concerned about their risk of BIA-ALCL and can contribute to discussions on potential continued utility of textured TEs. Risk, IV.

Novel method of securing non-textured tabbed anatomical implants in breast reconstruction

Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) has rapidly become a significant concern for women with textured breast implants in the last twenty years since it was first reported. 1 Cordeiro P.G. Ghione P. Ni A. Hu Q. Ganesan N. Galasso N. et al. Risk of breast implant associated anaplastic large cell lymphoma (BIA-ALCL) in a cohort of 3546 women prospectively followed long term after reconstruction with textured breast implants. J Plast Reconstr Aesthet Surg. 2020; 73: 841-846 Abstract Full Text Full Text PDF PubMed Scopus (72) Google Scholar The incidence appears to depend on texturization but a recent prospective cohort study reports the overall risk of BIA-ALCL is 1/355 women or 0.311 cases per 1000 person-years. 1 Cordeiro P.G. Ghione P. Ni A. Hu Q. Ganesan N. Galasso N. et al. Risk of breast implant associated anaplastic large cell lymphoma (BIA-ALCL) in a cohort of 3546 women prospectively followed long term after reconstruction with textured breast implants. J Plast Reconstr Aesthet Surg. 2020; 73: 841-846 Abstract Full Text Full Text PDF PubMed Scopus (72) Google Scholar The highest overall risk reportes is associated with the use of macro-textured implants. 2 Collett D.J. Rakhorst H. Lennox P. Magnusson M. Cooter R. Deva A.K. Current Risk Estimate of Breast Implant-Associated Anaplastic Large Cell Lymphoma in Textured Breast Implants. Plast Reconstr Surg. 2019; 143: 30S-40S Crossref PubMed Scopus (122) Google Scholar This risk was felt to be significant enough that the US Food and Drug Administration (FDS) recalled Allergan Natrelle BIOCELL-textured breast implants in July 2019. 3 Administration UFaD . The FDA requests Allergan voluntarily recall Natrelle BIOCELL textured breast implants and tissue expanders from the market to protect patients. In: Administration UFaD, editor. FDA safety communication. US2019. Google Scholar This has triggered a shift away from the accepted paradigm of textured anatomical implants back to the traditional smooth round implant.

The Macrotextured Implant Recall: Breast Implant-Associated-Anaplastic Large Cell Lymphoma Risk Aversion in Cosmetic and Reconstructive Plastic Surgery Practices.

The recall of Allergan Biocell (Irvine, CA) devices due to the association between anaplastic large cell lymphoma (ALCL) and macrotextured breast implants means that plastic surgeons are faced with the challenge of caring for patients with these implants in situ. Cosmetic and reconstructive surgeons have been contacting affected patients to encourage them to follow up and discuss the most appropriate risk-reduction strategies. The aim of this study was to evaluate patient concerns about the risk of breast implant-associated ALCL (BIA-ALCL) and to compare management differences between cosmetic and reconstructive patients. A retrospective review was performed of 432 patients with macrotextured implants who presented to clinic after being contacted (121 reconstructive and 311 cosmetic). These records were analyzed for their presenting concerns, surgery wait times, and management plans. Statistical analysis was performed to compare the cohorts, and odds ratios (ORs) were computed to determine the association between patient concerns and their choice of management. After consultation, 59.5% of the reconstructive cohort and 49.5% of the cosmetic cohort scheduled implant removal or exchange. The reconstructive population had a higher rate of ALCL concern (62.7%); however, both cohorts had a significant OR, demonstrating an expressed fear of ALCL likely contributed to their subsequent clinical management (OR cosmetic, 1.66; OR reconstructive, 2.17). Although the risk of ALCL appears to be more concerning to the reconstructive population, both cohorts were equally motivated to have their implants removed. Informing patients about their ALCL risk is crucial to ensure a patient-supported risk reduction plan.

Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) in axillary lymph nodes – a case report and review of 29 other cases from world literature

Introduction. Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALC) is a new disease established by the WHO in 2016. BIA-ALCL is one of the most severe adverse effects of breast augmentation or breast reconstruction with the use of silicone implants. Material and methods. In our report we present a case of a 46-year-old patient diagnosed with BIA-ALCL in the General and Oncological Surgery Clinic of the Pomeranian Medical University in Szczecin. This is one of the first described cases of this disease in Poland. Especially interesting is the fact that the lymphoma developed two years after the removal of the implants and the pathology occurred in the axillary lymph nodes. In order to compare the published case of BIA-ALCL we reviewed 29 cases from literature. Results. We described the most clinically relevant factors. The age range of females analysed with diagnosed BIA-ALCL is between 27 to 87 years. The time from implant insertion to the appearance of the first symptoms varies. The use of textured implants seems to be one of the most important risk factors of novel lymphoma. Conclusions. The patients with breast implants should be informed about the risk of BIA-ALCL and related symptoms. The number of articles about BIA-ALCL is minimal, therefore knowledge about the disease remains limited. There is a need to broaden knowledge about the pathological process, clinical manifestations, risk factors and medical tests crucial to achieve an accurate diagnosis.

Risk of breast implant associated anaplastic large cell lymphoma (BIA-ALCL) in a cohort of 3546 women prospectively followed long term after reconstruction with textured breast implants

The risk of BIA-ALCL for patients with textured breast implants has been estimated between 1/2832 and 1/30,000 women. Existing studies estimating the numbers exposed and at risk, may have under reported cases, and/or lacked comprehensive follow-up. Our objective is to determine the risk of BIA-ALCL in a defined cohort of patients reconstructed with macro-textured breast implants and consistently followed long-term. A prospective cohort study was conducted in patients who underwent breast reconstruction by a single surgeon at Memorial Sloan Kettering Cancer Center (MSKCC) from December 1992 to December 2017. Major events related to implants were prospectively recorded. We identified cases of BIA-ALCL by cross-checking clinical, pathology and external records data. Patients were followed until lymphoma occurrence or last follow-up. The primary outcomes were incidence rate per person-years and cumulative incidence. From 1992 to 2017, 3546 patients underwent 6023 breast reconstructions, mainly after breast cancer removal, or contralateral prophylactic mastectomy, using macro-textured surface expanders and implants. All reconstructions were performed by a single surgeon (PGC). Median follow-up was 8.1 years (range, 3 months - 30.9 years). Ten women, 1/354, developed ALCL after a median exposure of 11.5 years (range, 7.4-15.8 years). Overall risk of BIA-ALCL in our cohort is 1/355 women or 0.311 cases per 1000 person-years (95% CI 0.118 to 0.503). This study, the first to evaluate the risk of macro-textured breast implants from a prospective database with long term follow-up, demonstrates that the incidence rate of BIA-ALCL may be higher than previously reported. These results can help inform implant choice for women undergoing breast reconstruction.

Incidence of Delayed Seromas and Related Risk of Bia-ALCL in a Cohort of 3521 Breast Cancer Women with Textured Implants Prospectively Followed Long Term

Incidence of Delayed Seromas and Related Risk of Bia-ALCL in a Cohort of 3521 Breast Cancer Women with Textured Implants Prospectively Followed Long Term

Public Perceptions on Breast Implant–associated Anaplastic Large Cell Lymphoma

BACKGROUND: Breast implant–associated anaplastic large cell lymphoma (BIA-ALCL) has entered the spotlight as high-profile media outlets, and the Food and Drug Administration has begun to relay the evolving science to the public. This study aimed to gauge the baseline knowledge and concern regarding BIA-ALCL among adult laywomen within the United States. Additionally, we sought to understand the influence of variables including previous exposure to breast implants for both cosmetic and reconstructive purposes and the source of information on these outcomes. METHODS: Amazon.com’s Mechanical Turk and Qualtrics were used to survey 500 American women about the risk of BIA-ALCL. Respondents self-reported demographics and any prior experience with breast implants. Eleven questions were asked regarding respondents’ concerns of BIA-ALCL and the source of their knowledge. Responses were reviewed for quality control before participants were paid for involvement. Responses were analyzed using descriptive statistics and chi-square tests. RESULTS: The average age in our cohort (n = 500) was 37.8 ± 11.7 years. The majority of respondents were white (71.4%) and had completed at least a 2-year college degree (69.4%). Of respondents, 12% had previously received breast implants, 73% knew at least one person with breast implants, and nearly 50% would consider receiving a breast implant. After providing information about the risk of BIA-ALCL, respondents showed a clear preference to smooth implants and 58.4% were still willing to receive a reconstructive implant and 45.8% a cosmetic implant. One-third reported that they would be less likely to receive implants. Most respondents with implants or those who knew someone with implants were still willing to receive an implant (P ≤ 0.001). Of respondents with breast implants, 66.7% reported some degree of concern regarding BIA-ALCL and 35.0% are strongly considering removing their implants. When presented with information on autologous reconstruction, 17.0% of all respondents preferred implants and 42.4% would consider both options. Fourteen percent had previously heard about BIA-ALCL, the majority from multiple sources—predominantly health professionals or media/healthcare blogs. The source of a respondent’s information regarding BIA-ALCL was not associated with their degree of concern or desire to remove the implant. Respondents who had previously heard of BIA-ALCL or who had implants were more likely to understand the association between implants and BIA-ALCL (P < 0.001). Of respondents, 89.8% believe that plastic surgeons should discuss BIA-ALCL with all patients considering prosthetic implants. CONCLUSIONS: Patients undergoing breast reconstruction using implants for both cosmetic and reconstructive purposes receive their information primarily from healthcare professionals or media/healthcare blogs; however, only a minority have heard of BIA-ALCL and understand the strength of the association between BIA-ALCL and implants. When provided with the most up-to-date information, patients understand the rarity of the complication and the majority are unchanged in their decision to receive breast implants. As plastic surgeons, we can promote awareness among prospective patients and reassure the anxieties of those who have previously received breast implants. Our findings suggest that professional healthcare blogs and media outlets may be the most effective way to spread knowledge to those who are not in direct contact with healthcare professionals.

Risk of breast implant-associated anaplastic large cell lymphoma in patients submitted to breast implantation: A systematic review.

Although breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is a rare disease, its incidence has been increasing. The aim of this study was to assess the risk of BIA-ALCL in women with breast implants. A systematic search was carried out in Pubmed, Scopus, ScienceDirect, LIVIVO, Cochrane Library, Google Scholar, and OpenGrey databases. The risk assessment of bias was based on the Newcastle-Ottawa Scale. The rarity of BIA-ALCL was a major limitation. Although we have found evidence of an increased risk of BIA-ALCL, further studies are needed to understand why some large samples did not present any case of the disease.

Risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) in a cohort of 3,546 women prospectively followed after receiving textured breast implants.

1565 Background: Breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL) is a rare subtype of T-cell lymphoma, developing in in the fluid or capsule surrounding breast implants, primarily or exclusively in those with textured surfaces. Several prior series have estimated the risk of BIA- ALCL at 1/6920 - 1/3800 women in retrospectively defined cohorts (from diagnosed cases within national or pathology databases), approximating the population at risk from sales records or other estimates (Sirinvasa 2017; Loch-Wilkinson 2017; de Boer 2018). Methods: A prospective cohort study was conducted in the population that underwent breast reconstruction by a single surgeon at Memorial Sloan Kettering Cancer Center (MSKCC) from April 1993 to December 2017. Patients had long-term follow-up, and events related to implants were prospectively recorded. We identified all cases of BIA-ALCL by cross-checking data from internal clinical records, pathology records, and outside reports. Incidence rate per person-years and cumulative incidence when accounting for competing risk were calculated. 134 women who received smooth-surface implants were excluded from the analysis, since these implants have not been associated with BIA-ALCL. Results: From 1993 to 2017, 3546 patients underwent 6023 breast reconstructions using textured surface implants. All reconstructions were performed by a single surgeon (PGC) on patients enrolled in this study. To identify BIA-ALCL occurrence, clinical and pathological data were assessed from a prospective database. Median follow-up was 7 years (range, 3 days - 24.7 years). Eight women developed ALCL after a median exposure of 11.2 years (range, 8.3-15.8 years). Overall risk of BIA-ALCL in this cohort was 0.294 cases per 1000 person-years (1/443 women). Conclusions: This study, evaluating the risk of women with textured breast implants from a prospective database with long-term follow-up, demonstrated that the incidence rate of BIA-ALCL may be higher than previously reported. These results can help inform implant choice for women undergoing breast reconstruction.

Perspective from the United Kingdom on Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)

Abstract Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is a rare disease known to be associated with textured breast implants. The most up-to-date incidence in the United Kingdom is 1:24,000 and 45 confirmed cases have been reported since the first UK case was reported in 2012 and there has been one confirmed death as a result of BIA-ALCL. How the regulatory framework in the United Kingdom works and shapes the information, which must be given by surgeons to patients contemplating breast augmentation, for any reason, is discussed. In addition, the approach to informing patients with breast implants in situ is discussed. It is surgeons’ duty to inform all prospective patients that there is a risk of BIA-ALCL. Not to do so in the United Kingdom would be likely to leave surgeons open to legal action by patients who develop the disease.

Abstract P1-08-13: A prospective evaluation of HLA expression in breast implant associated anaplastic large cell lymphoma to identify disease susceptibility

Abstract Background: Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is a rare T-cell lymphoma found to occur in association with breast implants. Proposed pathogenic factors for BIA-ALCL include immunologic reaction to textured implants, bacteria and biofilm, chronic inflammation, autoimmune disease, or genetic predisposition. While HLA alleles have been found to be associated with other forms of lymphoma, the frequency of HLA allele polymorphisms have not been described for BIA-ALCL. The aim of this study is to evaluate the frequency of HLA alleles in patients with BIA-ALCL. Methods: We prospectively evaluated HLA alleles in 13 patients with BIA-ALCL seen at a single institution from 2017 to 2018. HLA testing was carried out using probe based sequence specific testing and sequence based typing. The frequency of HLA-A, HLA-B, HLA-C, HLA-DRB1, and HLA-DQB1 were evaluated in the study population. Allele frequencies in the Caucasian European general population were obtained from the National Marrow Donor Program for normative controls. We estimated the relative risk of BIA-ALCL with 95% confidence intervals for each HLA allele using a t test. All statistics were performed using SPSS. Results: Thirteen patients with BIA-ALCL and HLA testing were identified with ages ranging from 37 – 76 years. We identified 10, 11, and 9 HLA A, B, and C alleles respectively. There were 8 DRB1 alleles and 5 DQB1 alleles in the BIA-ALCL patients. The following alleles occurred more than two times more frequently in patients with BIA-ALCL as compared with the general population: A*31, A*32, A*68, B*27, B*39, B*49, B*51, and C*15. Conversely, the A*01, A*24, and B*35 alleles occurred less frequently in patients with BIA-ALCL. The A*26 allele was found to occur significantly less often in BIA-ALCL patients (0.2992 vs. 0.07692, p&amp;lt;0.001) versus normative controls. Conclusions: Our results identify differences in the frequency of specific HLA alleles in patients who develop BIA-ALCL compared with the general population. These alleles may signify genetic susceptibility factors for germline genetic variation in HLA in Caucasian patients with BIA-ALCL. Further work is needed to elucidate if these alleles confer susceptibility or resistance and are predictive for the disease in women with textured surface breast implants. Citation Format: Tevis SE, Hunt KK, Miranda RN, Butler CE, Clemens MW. A prospective evaluation of HLA expression in breast implant associated anaplastic large cell lymphoma to identify disease susceptibility [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr P1-08-13.

EUSOMA position regarding breast implant associated anaplastic large cell lymphoma (BIA-ALCL) and the use of textured implants

During the last two decades the number of breast implants used in aesthetic, oncologic and risk reducing surgery has increased substantially mainly due to the improvement and confirmed safety of these devices. Since identification of the first case of anaplastic large cell lymphoma associated with a breast implant (BIA-ALCL) 20 years ago, there has been an increase in the number of reports of this very rare disease, demonstrating a clear association with breast implants. Whilst the majority of cases are localised and cured by implant removal and full capsulectomy, a small percentage require chemotherapy and the mortality rate is very low. The evidence linking BIA-ALCL to implant surface texturing, as the majority of cases were diagnosed in patients with textured implants, has raised concerns about the long term safety of these devices resulting in patient and regulatory authority concerns globally. We hereby present the current published knowledge about the link between BIA-ALCL and implant surface texture and a review of current regulatory and professional body advice across Europe, which may enable a better understanding of this rare disease, how to manage and ultimately prevent it. We conclude by giving EUSOMA recommendation, towards the unnecessary change in attitudes towards implant based surgery, according to the most recent available published evidence as long as patients are properly informed about the risk of BIA-ALCL.