Breast Implant-Associated Anaplastic Large Cell Lymphoma in Australia: A Longitudinal Study of Implant and Other Related Risk Factors

2019 ◽  
Vol 40 (8) ◽  
pp. 838-846 ◽  
Author(s):  
Anna Loch-Wilkinson ◽  
Kenneth J Beath ◽  
Mark R Magnusson ◽  
Rodney Cooter ◽  
Karen Shaw ◽  
...  

Abstract Background Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is an emerging cancer that has been linked to the use of textured devices. The recent increase in number and frequency of cases has led to worldwide regulatory action. Objectives The authors aimed to longitudinally study BIA-ALCL in Australia since the index case was first reported in 2007. Methods Confirmed historical cases were collected and then prospectively analyzed from October 2015 to May 2019. Clinical and implant exposure data were determined and compared with company sales data for 4 devices to generate implant-specific risk. Results A total 104 cases of BIA-ALCL were diagnosed in Australia with exposure to 149 unique breast implants. The mean age of patients was 48.2 years (range, 22.4-78.5 years). They had an average time from implantation to diagnosis of 6.8 years. A total 51.7% of implants utilized in this cohort were Allergan Biocell devices. The indication for implant usage was for primary cosmetic augmentation in 70%, post-breast cancer reconstruction in 23%, and following weight loss/pregnancy in 7%. The majority of women presented with early (stage 1) disease (87.5%). The risk for developing BIA-ALCL ranged from 1 in 1947 sales (95% confidence interval = 1199-3406) for Silimed Polyurethane devices to 1 in 36,730 (95% confidence interval = 12,568-178,107) for Siltex imprinted textured devices. Conclusions Implants with higher surface area/texture seem to be more associated with BIA-ALCL in Australia. Recent regulatory action to suspend, cancel, or recall some of these higher risk devices is supported by these findings. Level of Evidence: 2

2019 ◽  
Vol 33 (04) ◽  
pp. 270-278 ◽  
Author(s):  
Mark W. Clemens ◽  
Ryan C. DeCoster ◽  
Berry Fairchild ◽  
Alexander A. Bessonov ◽  
Fabio Santanelli di Pompeo

AbstractBreast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is an emerging and indolent, but potentially fatal cancer of the immune system that can develop around textured-surface breast implants. The World Health Organization first recognized BIA-ALCL as a unique clinical entity in 2016. To date, over 600 confirmed cases have been reported worldwide. BIA-ALCL most commonly presents with disease confined to the capsule, as a seroma or a mass adjacent to the implant. While BIA-ALCL has a fairly indolent clinical course, with an excellent prognosis in early stage disease, disseminated cancer and death have also been reported. In this review, the authors focus on the early diagnosis and treatment, including reconstructing the breast following BIA-ALCL, and also discuss recently updated National Comprehensive Cancer Network guidelines. They also review the current epidemiology and risk factors associated with BIA-ALCL. Finally, they discuss important medicolegal considerations and the bioethics surrounding the continued use of textured-surface breast implants.


Materials ◽  
2018 ◽  
Vol 11 (12) ◽  
pp. 2393 ◽  
Author(s):  
Maria Mempin ◽  
Honghua Hu ◽  
Durdana Chowdhury ◽  
Anand Deva ◽  
Karen Vickery

Breast implantation either for cosmetic or reconstructive e purposes is one of the most common procedures performed in plastic surgery. Biofilm infection is hypothesised to be involved in the development of both capsular contracture and anaplastic large cell lymphoma (ALCL). Capsular contracture is one of the principal reasons for breast revision surgery and is characterised by the tightening and hardening of the capsule surrounding the implant, and ALCL is an indolent lymphoma found only in women with textured implants. We describe the types of breast implants available with regard to their surface characteristics of surface area and roughness and how this might contribute to capsular contracture and/or biofilm formation. The pathogenesis of capsular contracture is thought to be due to biofilm formation on the implant, which results in on-going inflammation. We describe the current research into breast implant associated ALCL and how implant properties may affect its pathogenesis, with ALCL only occurring in women with textured implants.


2021 ◽  
Vol 4 (1) ◽  
pp. 28-34
Author(s):  
Kumkum Vadehra ◽  
Jennifer Cai ◽  
Rashmi Rekha Bhuyan ◽  
Ping Ji ◽  
Rose Venegas ◽  
...  

Breast implant-associated anaplastic large cell lymphoma (ALCL) is a recently recognized type of T-cell lymphoma that can develop following breast implants, with morphologic and immunophenotypic features indistinguishable from those of ALK-negative ALCL. Here we report a case of a 58-year-old woman with a history of subglandular silicone implants placed for bilateral breast augmentation 25 years ago, who presented with bilateral breast pain and was found to have bilateral Baker Grade III capsular contracture, and heterogenous fluid collection centered near the left third costochondral articulation, a suspicious left chest wall lesion, and left axillary lymphadenopathy on imaging. A left axillary lymph node core biopsy and an aspiration of the fluid were performed, and no malignant cells were identified. The patient underwent bilateral removal of breast implants and total capsulectomies. Microscopic examination of the capsule surrounding the left breast implant revealed large pleomorphic tumor cells in a fibrinous exudate. By immunohistochemistry, the tumor cells were found to be positive for CD3 (subset), CD4, CD7, CD30 (strong and uniform), and CD43, and negative for CD2, CD5, CD8, and ALK1, supporting the diagnosis of breast implant-associated ALCL. No lymphoma cells were identified in the right breast capsule, confirmed by CD30 stain. Breast implant-associated ALCL is a very rare disease that can develop many years after breast implant placement. Proper evaluation with breast imaging and pathologic workup is essential to confirm the diagnosis in suspected cases. Our case highlights that adequate sampling is important in the investigation of patients with suspected breast implant-associated ALCL.


Author(s):  
Fabio Santanelli di Pompeo ◽  
Michail Sorotos ◽  
Mark W Clemens ◽  
Guido Firmani ◽  
E Athanasopoulos ◽  
...  

Abstract Background Breast implant–associated anaplastic large cell lymphoma (BIA-ALCL) epidemiologic studies focus on incidence and risk estimates. Objectives The aim of this study was to perform a thorough literature review, and to provide an accurate estimate of BIA-ALCL prevalence in Europe. Methods We searched PubMed, Web of Science, SCOPUS, and Google Scholar databases to identify publications reporting BIA-ALCL epidemiology. Research was conducted between November 2019 and August 2020. European prevalence was assessed as the ratio between pathology-confirmed cases and breast implant–bearing individuals. The Committee on Device Safety and Development (CDSD) collected data from national plastic surgery societies, health authorities, and disease-specific registries to calculate the numerator. The denominator was estimated by combining European demographic data with scientific reports. Results Our research identified 507 articles: 106 were excluded for not being relevant to BIA-ALCL. From the remaining 401 articles, we selected 35 that discussed epidemiology and 12 reviews. The CDSD reported 420 cases in Europe, with an overall prevalence of 1:13,745 cases in the 28 member states of the European Union (EU-28). Countries where specific measures have been implemented to tackle BIA-ALCL account for 61% of the EU-28 population and actively reported 382 cases with an overall prevalence of 1:9121. Conclusion Countries where specific measures have been implemented show a higher prevalence of BIA-ALCL compared with the European mean, suggesting that these countries have improved the detection of the condition and reduced underreporting, which affects the numerator value. Other nations should adopt projections based on these measures to avoid underestimating how widespread BIA-ALCL is. Level of Evidence: 4


2021 ◽  
Vol 34 (13) ◽  
Author(s):  
Adriana Cunha ◽  
Ricardo Horta ◽  
Diogo Barreiro

Introduction: Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is a rare T-cell neoplasm that is predominantly associated with the use of textured implants. Recently, several countries have tried to clarify their epidemiological profile of BIA-ALCL. This study aims to estimate the number of cases of BIA-ALCL in Portugal and to describe the pattern of use of breast implants at a national level.Material and Methods: This is a cross-sectional study including 57 healthcare institutions - 29 public hospitals and 28 private institutions. Each department of Plastic, Reconstructive and Aesthetic Surgery was asked to provide information concerning the main manufacturer(s) and respective device texture of the breast implants used, and to report the number of registered cases of BIA-ALCL.Results: In our study sample, the response rate was 58%. In our sample, most hospitals reported using textured breast implants from Mentor (45.45%), Allergan (42.42%) and Polytech (39.39%). Only one private institution referred using smooth-coated implants from Mentor and Motiva. Despite several hospitals reporting late-onset seromas, there was only one confirmed case of BIA-ALCL after proper investigation with immunohistochemistry and histological procedures.Discussion: BIA-ALCL may represent a shift for surgeons regarding selection of implant type. Smooth-coated implants or autologous tissue represent adequate alternatives that could surpass the risks associated with textured devices.Conclusion: In the future, the creation of a national patient registry and proper recognition of BIA-ALCL by plastic surgeons could be useful tools to clarify the impact of the disease nationally and to mitigate potential risk factors.


2021 ◽  
Vol 108 (Supplement_7) ◽  
Author(s):  
Parisa Moori ◽  
Fran Ibison ◽  
Deepa Jacob ◽  
Julie Iddon

Abstract Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is a rare, non-Hodgkin lymphoma which arises within the capsules of breast implants. These particular tumours have expression of CD30 and are negative for Anaplastic Lymphoma Kinase (ALK). Here, we report a case of BIA-ALCL in a 48-year-old woman post breast reconstruction. This case report is aimed at raising awareness and education on the significance of considering the development of BIA-ALCL in cases where cytology is negative and helping better understand this disease process.


Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 3689-3689
Author(s):  
Maja Ølholm Vase ◽  
Søren Friis ◽  
Andrea Bautz ◽  
Henrik Toft Sørensen ◽  
Francesco d'Amore

Abstract Abstract 3689 Introduction: An increased risk of alk-negative T- cell anaplastic large cell lymphoma (T-ALCL) in women with silicone breast implants has recently been suggested. Several small series and case-reports have been published, but, so far, only one analytical epidemiological population-based study has specifically addressed this hypothesis (de Jong et al, JAMA, 2008). Methods: We identified a nationwide cohort of Danish women, who underwent breast implant surgery for any reason (cosmetic or reconstruction) at public hospitals or in private clinics. Data including civil registry number and date of surgery were obtained from the Danish National Hospital Register (1977–2009) and from The Danish Registry for Plastic Surgery of the Breast (1999–2009) and eight private clinics of plastic surgery (1973–1995). The civil registry number, assigned to all Danish citizens by the Central Population Registry (CPR), encodes gender and date of birth, and secures valid linkage to population-based registries in Denmark. Identification of lymphoma cases was performed by combined linkages to the Danish Cancer Registry and the Danish Lymphoma Group (LYFO). This combined strategy was applied in order to maximize catchment of incident lymphoma cases (capture-recapture analysis). Results: We identified a cohort of 18,356 women, who underwent breast implant surgery between 1973–2009. The vast majority of breast implants were silicone gel-filled implants. Among study-subjects, 11,380 underwent surgery for strictly cosmetic reasons, while 6,976 received breast implants as part of a breast reconstruction secondary to breast cancer. The number of non-Hodgkin lymphoma (NHL) and T-ALCL cases expected in the general female population of Denmark was 350/year and 10/year in the study period. The total person-years for the study-cohort (162699,5 years)were multiplied by the estimated incidence rates for T-ALCL in the breast (3/100.000.000 person-years)to ascertain the expected number (0,005) of ALCL in the breast among cohort members. The total number of NHL cases observed was 60. There were no cases of ALCL in the study-cohort and none had an implant-near localization. Conclusion: This is a comprehensive epidemiologic study addressing the specific issue of the possible association between T-ALCL and breast implants. Our large nationwide cohort study does not support a major association between T-ALCL lymphomas and breast implants either implanted for cosmetic reasons in otherwise healthy recipients or for reconstructive purposes in women previously treated for breast cancer. Due to the rarity of this condition, additional population-based analyses are needed to further evaluate potential biological procedure-related or implant-specific associations. An extended analysis of pooled data from different Nordic countries is ongoing. Disclosures: No relevant conflicts of interest to declare.


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