Is BIA-ALCL a Common Risk of Exposure to Allergan Biocell® Implants?
Breast Implant Associated Lymphoma (BIA-ALCL) is a type of non-Hodgkin's lymphoma, a cancer of the immune system. Accumulating evidence suggests that BIA-ALCL may be a common—not rare—risk from exposure to Allergan Biocell® breast implants. (1)
The Data
In 2023, a plastic surgery journal stated that the highest risk estimate for women exposed to Allergan Biocell® breast implants “has been updated since publication by Dr. Cordeiro to 1 in 100.” (2)
Dr. Cordeiro’s research involved breast cancer reconstruction patients. However, data in cosmetic augmentation patients presented at the American Association of Plastic Surgeon’s meeting in May 2023 shows similarly high risks. Specifically, the data presented there showed that “[i]mplant-specific IR was 8.6 cases/1000 individuals with Allergan Biocell® devices.” (3)
The ASPS website also highlights the evidence of a 1 in 100 lifetime risk of BIA-ALCL for Biocell® devices. (4)
BIA-ALCL is associated with many different brands of textured implants, not just Allergan Biocell®, and some of these textured implants are still on the market. (5)
Why it Matters
The FDA identifies 59 reported deaths from BIA- ALCL. (5)
The symptoms of BIA-ALCL overlap with other common and benign breast and implant-related conditions, making a high level of knowledge and a high index of suspicion critical to best outcomes. Prompt recognition and proper treatment greatly increases the odds of a cure.
If you have had changes in your breast, be sure to contact your doctors and plastic surgeon. Listed below are a list of resources that might be helpful included where to find patient support.
Resources & Support
FDA: Questions & Answers about BIA-ALCL
Support Group: ALCL in Women with Breast Implants
BIA-ALCL.com
Maria A Mitry, MD and others, Rare Cancer on the Rise: An Educational Review of Breast Implant-associated Anaplastic Large Cell Lymphoma, Journal of Breast Imaging, Volume 2, Issue 4, July/August 2020, Pages 398–407,
https://doi.org/10.1093/jbi/wbaa041
Jaffe ES, Ashar BS, Clemens MW, Feldman AL, Gaulard P, Miranda RN, Sohani AR, Stenzel T, Yoon SW. Best Practices Guideline for the Pathologic Diagnosis of Breast Implant-Associated Anaplastic Large-Cell Lymphoma. J Clin Oncol. 2020 Apr 1;38(10):1102-1111. doi: 10.1200/JCO.19.02778. Epub 2020 Feb 11. PMID: 32045544; PMCID: PMC7106983. https://pubmed.ncbi.nlm.nih.gov/32045544/
Breast Surgery Workshop & 4th World Consensus Conference on BIA-ALCL
At around minute 6:17:58 of the recording of his presentation at the 8th International Breast Surgery Workshop & 4th World Consensus Conference on BIA-ALCL, Dr. Clemens receives and answers an audience question about the many different ways BIA ALCL can present in patients.
References
(1) Defining “Common Epidemiology” as “an event with a frequency between 1 in 100 and 1 in 10.” https://www.eu2p.org/help/glossary
(2) Fracol ME, Rodriguez MM, Clemens MW. A Spectrum of Disease: Breast Implant-Associated Anaplastic Large Cell Lymphoma, Atypicals, and Other Implant Associations. Clin Plast Surg. 2023 Apr;50(2):249-257. doi: 10.1016/j.cps.2022.12.001. PMID: 36813403.
(3) Breast Implant-associated Anaplastic Large Cell Lymphoma (bia-alcl) Prevalence In A Cohort Of 1,508 Patients From A Private Cosmetic Practice Fabio Santanelli di Pompeo, MD, PhD1, Jerzy Kolasinski, MD2, Michail Sorotos, MD, PhD1. 1Sapienza University, Rome, Italy, 2Klinik Kolasinski, Poznań, Italy. Breast Implant-associated Anaplastic Large Cell Lymphoma (bia-alcl) Prevalence In A Cohort Of 1,508 Patients From A Private Cosmetic Practice (aaps1921.org)
(4) ASPS statement on Breast Implant Associated-Squamous Cell Carcinoma (BIA-SCC)
https://www.plasticsurgery.org/for-medical-professionals/publications/psn-extra/news/asps-statement-on-breast-implant-associated-squamous-cell-carcinoma
(5) See Table 5 of Lynch EB, DeCoster RC, Vyas KS, Rinker BD, Yang M, Vasconez HC, Clemens MW. Current risk of breast implant-associated anaplastic large cell lymphoma: a systematic review of epidemiological studies. Ann Breast Surg. 2021;5:30. doi: 10.21037/abs-20-96. Epub 2021 Sep 30. PMID: 35415602; PMCID: PMC9000366.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9000366/
(6) FDA Medical Device Reports of Breast Implant-Associated Anaplastic Large Cell Lymphoma