Breast Implant–Associated Anaplastic Large-Cell Lymphoma in Brazil

What Are We Missing?

Anne K. Groth, M.D., Ph.D.; Mark W. Clemens, M.D.; Ruth Graf, M.D., Ph.D.; Ana P. Sebastião, M.D., Ph.D.; Ana P. Azambuja, M.D.; Maria H. Louveira, M.D., Ph.D.; Linei A. B. D. Urban, M.D., M.Sc., Ph.D.; Bernardo N. Batista, M.D., Ph.D.

Disclosures

Plast Reconstr Surg. 2022;150(5):970e-978e. 

In This Article

Abstract and Introduction

Abstract

Background: Breast implant–associated anaplastic large-cell lymphoma (BIA-ALCL) has been diagnosed in more than 1000 patients in more than 30 countries, although only a few cases have been reported in Latin America and the Caribbean to date. As the second-largest global market for breast implants with a predominance of textured-surface implants, Brazil is a major global market for cosmetic augmentations, making it unlikely that cases of BIA-ALCL are actually scarce.

Methods: A local and voluntary registry of patients with BIA-ALCL was initiated in 2018. All patients diagnosed with BIA-ALCL were confirmed by the World Health Organization criteria. Implant characteristics, disease symptoms, treatment, and oncologic outcomes were assessed.

Results: Fourteen cases of BIA-ALCL in a Brazilian population were identified in the Paraná state. Disease-specific diagnostic tests were omitted before surgical intervention in 50 percent of patients. With additional cases from a literature review, the treatment and outcomes of 29 cases of BIA-ALCL in Brazil were assessed.

Conclusions: Compared with other populations, these initial observations suggest that awareness of the disease by the local breast surgery community remains low and that a number of cases may remain undiagnosed. Lack of preoperative diagnostic testing compromises disease treatment, oncologic outcomes, and both short- and long-term surveillance.

Introduction

Breast implant–associated anaplastic large-cell lymphoma (BIA-ALCL) is a recognized complication of textured implants.[1] First described in 1997,[2] centralized efforts from local stakeholders to collect and interpret data from the several hundred currently known cases have recently led to an increase in the available literature.[3] Although initial reports indicated a relatively low prevalence, these considered breast implants of all kinds. However, an exponentially higher risk of developing BIA-ALCL (one in 2832) has been shown to occur in patients with macrotextured (grade 3 and 4 surface) implants.[4] These findings led to sales of Allergan (Dublin, Ireland) Biocell implants being restricted in 38 countries, followed by a mandatory class I device recall in the United States and a subsequent worldwide voluntary recall in July of 2019. The Australian Therapeutic Goods Administration recently canceled the supply of all macrotextured and polyurethane implants to the Australian market. As awareness of BIA-ALCL cases continues to increase, the number of reported cases has risen. For instance, Cordeiro and colleagues[5] recently reported a risk of one in 355 in a prospective study of a cohort of patients with breast cancer who received reconstructions with Biocell textured implants in a single institution.

With a population of more than 200 million people and widespread enthusiasm for cosmetic surgery, Brazil leads the world in number of cosmetic surgical procedures and is the second-largest market for breast implants worldwide.[6] Furthermore, Brazil hosts one of the most complex global marketplaces, with at least a dozen manufacturers licensed to sell by the national regulatory agency, the Agência Nacional de Vigilância Sanitária. Furthermore, until recently, textured-surface implants were the only type of implants used in Brazil. Few cases of BIA-ALCL in the Brazilian population have been reported in the medical literature.[7–11] The purpose of this article is to present the first prospective registry of BIA-ALCL in the Brazilian population using a process developed by a local task force to increase awareness, diagnosis, and registration, and analyze outcomes of published national cases.

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