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An estimated 1.5 million breast augmentation surgeries are performed worldwide each year, typically for aesthetic or reconstructive purposes.1 In the United States, breast augmentation surgery ranked as the most commonly performed cosmetic procedure in 2019, with 299,715 surgeries reported.2 Because of the cancellation of elective surgeries during the early months of the COVID-19 pandemic, the number of breast augmentations performed in 2020 decreased to 193,073.3

Recent studies have implicated breast implants in the development of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). The first documented case was described in 1997; as of January 5, 2020, the US Food and Drug Administration (FDA) had received a total of 733 global and US medical device reports associated with BIA-ALCL, with 36 of those resulting in death.4,5 Of global cases in which a manufacturer was listed, 90.4% involved an Allergan implant, 7.3% involved Mentor implants, 1.5% involved Sientra implants, and 0.9% involved other manufacturers.6

In February 2019, the FDA issued a “Letter to Health Care Providers” to increase awareness of BIA-ALCL, its clinical presentation, and diagnostic recommendations in order to raise awareness of this potentially fatal condition. On July 24, 2019, the FDA asked Allergan to remove Natrelle BIOCELL textured breast implants and tissue expanders from the market.7

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Recent studies have shown variability in the occurrence rates of BIA-ALCL with the reported lifetime risk ranging from 1 in 355 to 1 in 86,029 persons depending on the population and type of textured implant studied.6,8 For implants with a textured outer shell, the risk in the US is estimated at 1 in 30,000 persons.6,8 In general, the number of reported cases has dramatically increased in the past decade as more cases are appropriately identified, although epidemiologic statistics may not be accurate due to underreporting.8,9 Among the medical device reports submitted to the FDA as of January 5, 2020, the median age of BIA-ALCL diagnosis is 52 years (range, 37-83 years); 36% of these cases occurred in the United States.5

BIA-ALCL has predominantly been reported in women, but there have been 3 cases reported in transgender male-to-female individuals who received breast implants.9 Some studies have shown that the majority of cases have occurred in Australia and New Zealand, while the lowest number of cases have occurred in Europe, Brazil, and China.  Ethnicity may also play a role in conferring risk as there have been very few cases reported in patients of Scandinavian, Asian, African, and Native American descent.8


BIA-ALCL has been classified as a rare, peripheral form of non-Hodgkin T-cell lymphoma. Although the formal etiology is unknown, the risk for developing BIA-ALCL is related to the characteristics of the external surface of the implant: cases reported to the FDA have mostly occurred in women whose implants have a textured outer shell vs a smooth outer shell.5

For those cases that have developed in conjunction with a smooth implant, the patient typically reported a history of previously removed textured implants. The inner fill material of the implant does not appear to confer an independent risk as BIA-ALCL has developed with both saline and silicone-filled implants.5

It is theorized that insertion of a breast implant may trigger a inflammatory response with chronic T-cell stimulation; subsequent cell differentiation then results in malignant cell formation.10 Friction generated by the natural movement of textured implants within their surrounding fibrous capsules may contribute to this chronic inflammation.11

Additionally, Staphylococcus species, Pseudomonas aeruginosa, and Ralstonia pickettii have been found on the surface of implants, demonstrating the potential for implants to chronically harbor bacteria that may cause further recruitment of lymphocytes, particularly CD4+ and CD30+ T cells.9,12,13 In‐vitro bacterial attachment studies show a linear relationship between surface area/roughness and bacterial attachment/growth, supporting the hypothesis that the uneven surfaces of textured implants are more conducive to bacterial growth.10,13 In an editorial, Santanelli di Pompeo et al have noted the possibility of genetic susceptibility, but chronic inflammation and infection remain the most widely accepted causes of BIA-ALCL.11

Clinical Presentation

BIA-ALCL typically develops approximately 8 to 13 years after the implant is inserted.7,14,15 The most common presentation is a unilateral malignant effusion containing liquefied lymphoma cells and high protein levels. In most cases, the lymphoma cells are contained within the fibrous capsule that forms around the implant (Figure), although approximately 5% of reported cases have shown bilateral effusion.16-18 The effusion frequently causes the affected breast to become edematous with or without associated pain. A solid tumor occurs in about 30% of cases, with or without effusion, and is palpable along the contour of the implant by the patient.16

Figure. Axial MRI T2-weighted image demonstrating a large fluid collection (red arrows) surrounding an intact right breast implant capsule (blue arrow). Reprinted from Letter H, et al. Cureus. 2016;8(3):e546.18

Skin induration or rashes overlying the effusion may occur but are not common. Other reported signs include axillary or infraclavicular lymphadenopathy, or contractures of the fibrous capsule surrounding the affected implant with associated distortion of the overlying breast shape.12,16 A minimal number of cases have been diagnosed incidentally during an unrelated breast surgery and were asymptomatic or presented with very small effusions.16