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

Cordeiro, Peter G.; Ghione, Paola; Ni, Andy; Hu, Qunying; Ganesan, Nivetha; Galasso, Natasha; Doğan, Ahmet; Horwitz, Steven M.

doi:10.1016/j.bjps.2019.11.064

Cited by 150 publications

(148 citation statements)

References 20 publications

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“…The release of sales data is critically important to calculate manufacturer-specific risks. Recently, Cordeiro et al 27 from Memorial Sloan Kettering Cancer Center presented their 20-year single-surgeon prospective cohort study of breast reconstruction in 3546 patients (6023 implants) and identified 10 BIA-ALCL patients. The overall risk of BIA-ALCL in this cohort was calculated by 0.294 cases per 1000 person-years or 1:443 women.…”

Section: Discussionmentioning

confidence: 99%

Breast Implant–associated Anaplastic Large Cell Lymphoma in Colombia: Report of a Multidisciplinary National Registry

Gomez¹,

Abad

Duque

et al. 2020

Plastic and Reconstructive Surgery - Global Open

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Background: An estimated 43,390 breast augmentation surgeries (86,780 implants) and 1486 breast implant reconstructions are performed annually in Colombia, representing the second-most breast surgery destination in South America, the fourth in the western hemisphere, and the fifth country worldwide. No previous reports have evaluated the incidence of breast implant–associated anaplastic large cell lymphoma (BIA-ALCL) epidemiology or outcomes in a Hispanic population. Published data on the incidence of this disease in Colombia are unknown; therefore, a National Joint Multidisciplinary Committee was developed between the Colombian scientific societies of Mastology, Plastic Surgery, Hemato-Oncology, and the Invima (The National Food and Drug Surveillance Institute) to track national cases of BIA-ALCL. Materials and Methods: We performed a retrospective review (survey-based study) of historical cases since 2011–2019, and a prospective collection of all patients with a confirmed World Health Organization diagnosis of BIA-ALCL identified in a newly established National Registry of BIA-ALCL. The trial was approved by Institutional Review Board (IRB). Results: Eighteen cases of BIA-ALCL were identified in Colombia between 2011 and 2019. Hundred percent developed as sequelae of textured implants. Six patients (33.3%) presented either a peri-implant capsule mass or axillary lymph node involvement. Seven (38.9%) required adjuvant chemotherapy most commonly with CHOP regimen. Different brands of implants were associated with our cases. One death (5.6%) was attributed to BIA-ALCL, and one (5.6%) case displayed with relapsed with bone marrow involvement requiring a bone marrow transplantation. Six cases (33.3%) were identified with advanced stage (IIB-IV). Disease-free survival of 92.3% was achieved at 30.8-month follow-up. Conclusions: Colombia has one of the highest volumes of breast surgery and use of textured surface breast implants in the world. This study is the initial report of an implant registry in South America. A high proportion of advanced disease may be a consequence of delayed presentation, lack of disease awareness, and timely access to tertiary cancer centers for diagnosis and treatment. Brands other than Allergan and Mentor were found to be associated with BIA-ALCL in our study.

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Section: Discussionmentioning

confidence: 99%

Breast Implant–associated Anaplastic Large Cell Lymphoma in Colombia: Report of a Multidisciplinary National Registry

Gomez¹,

Abad

Duque

et al. 2020

Plastic and Reconstructive Surgery - Global Open

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“…1 Possible relationship between vulnerability to BIA-ALCL and placement of a textured breast implant was recently suggested. Cordeiro et al 2 prospectively enrolled a cohort of 3,546 women receiving 6,023 textured implants between 1993 and 2017, all of whom were surgically treated at a median age of 48 (range, 18-89) years old by the same single surgeon and then followed up during a median period of 7 years (range, 3 days to 24.7 years). According to these authors, a total of 8 women developed BIA-ALCL after receiving textured implants during a median period of 11.2 (range, 8.3-15.8) years.…”

Section: Introductionmentioning

confidence: 99%

The Emerging Crisis of Stakeholders in Implant-based Augmentation Mammaplasty in Korea

Kim¹,

Paik

Nam

et al. 2020

J Korean Med Sci

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Background: Korea is no longer safe from the risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL); the first reported case was a Korean woman in her 40s who had a 7-year-history of receiving an implant-based augmentation mammaplasty using a textured implant. We conducted this study to discuss the emerging crisis of stakeholders in implant-based augmentation mammaplasty and to propose a multidisciplinary approach to early detection of its complications. Methods: We analyzed medical examination data that was collected from patients who visited us between August 12 and September 27, 2019. We evaluated a total of 114 women (n = 114) in the current study. They were evaluated for whether they were in healthy condition. Moreover, their baseline characteristics were also examined; these included age, gender, height (cm), weight (kg), duration since surgery (years), possession of a breast implant card, the site of surgical incision, side of symptoms and reasons for outpatient visit. Furthermore, the patients were also evaluated for their subjective awareness of the manufacturer, surface and shape of the breast implant. Potential complications include malrotation, folding, seroma, capsule thickening, upside-down rotation, rupture, capsule mass and breast mass. Results: A majority of the patients had a past history of receiving textured implants. The corresponding percentage was 78.95% (90/114) and 85.09% (97/114) based on their subjective awareness of a breast implant and sonographic findings, respectively. That is, it was slightly increased with the use of a breast ultrasound. Conclusion: Here, we propose the following approaches. First, patient data should be prospectively collected. By tracking outcomes and complications of an implant-based augmentation mammaplasty, both high-quality care and patient safety can be ensured. Second, stakeholders in implant-based augmentation mammaplasty should collaborate with customers and regulatory authorities. Third, surgeons should consider applying imaging modalities for early detection of postoperative complications.

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“…As of July 2019, a total of 573 cases have been identified within the United States [2,3], with 33 deaths reported. The calculated risk of BIA-ALCL incidence has been related to the patient's age (1 in 35,000 at 50 years and 1 in 7000 at 75 years) [4] and recent data indicate that the lifetime risk of BIA-ALCL among women with breast implants is estimated to be 1 in 355 women exposed [5]. The majority of patients manifest either seroma and/or in situ disease, both of which are associated with an excellent prognosis (89% overall survival rate at 5 years from the diagnosis) [6].…”

Section: Introductionmentioning

confidence: 99%

A Novel JAK1 Mutant Breast Implant-Associated Anaplastic Large Cell Lymphoma Patient-Derived Xenograft Fostering Pre-Clinical Discoveries

Fiore

Cappelli

Zumbo

et al. 2020

Cancers

Self Cite

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Breast implant-associated lymphoma (BIA-ALCL) has recently been recognized as an independent peripheral T-cell lymphoma (PTCL) entity. In this study, we generated the first BIA-ALCL patient-derived tumor xenograft (PDTX) model (IL89) and a matching continuous cell line (IL89_CL#3488) to discover potential vulnerabilities and druggable targets. We characterized IL89 and IL89_CL#3488, both phenotypically and genotypically, and demonstrated that they closely resemble the matching human primary lymphoma. The tumor content underwent significant enrichment along passages, as confirmed by the increased variant allele frequency (VAF) of mutations. Known aberrations (JAK1 and KMT2C) were identified, together with novel hits, including PDGFB, PDGFRA, and SETBP1. A deep sequencing approach allowed the detection of mutations below the Whole Exome Sequencing (WES) sensitivity threshold, including JAK1G1097D, in the primary sample. RNA sequencing confirmed the expression of a signature of differentially expressed genes in BIA-ALCL. Next, we tested IL89’s sensitivity to the JAK inhibitor ruxolitinib and observed a potent anti-tumor effect, both in vitro and in vivo. We also implemented a high-throughput drug screening approach to identify compounds associated with increased responses in the presence of ruxolitinib. In conclusion, these new IL89 BIA-ALCL models closely recapitulate the primary correspondent lymphoma and represent an informative platform for dissecting the molecular features of BIA-ALCL and performing pre-clinical drug discovery studies, fostering the development of new precision medicine approaches.

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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

Cited by 150 publications

References 20 publications

Breast Implant–associated Anaplastic Large Cell Lymphoma in Colombia: Report of a Multidisciplinary National Registry

Breast Implant–associated Anaplastic Large Cell Lymphoma in Colombia: Report of a Multidisciplinary National Registry

The Emerging Crisis of Stakeholders in Implant-based Augmentation Mammaplasty in Korea

A Novel JAK1 Mutant Breast Implant-Associated Anaplastic Large Cell Lymphoma Patient-Derived Xenograft Fostering Pre-Clinical Discoveries

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