ALCL Increasing Rapidly in US Women as Breast Implants Rise

The incidence rate of anaplastic large-cell lymphoma (ALCL) of the breast is increasing rapidly among women in the United States, which is consistent with what has been observed in the Netherlands, Australia, and New Zealand, a large cohort study shows.

Given the “strong association” between textured implants and breast ALCL, the authors suggest that the rising incidence of breast ALCL may be associated with the increased use of textured implants in the US.

They add, however, that the rising incidence of breast ALCL may also reflect an increased recognition of the disease itself, and an increasing incidence of all breast lymphomas.

The findings were published as a research letter today in JAMA Oncology.

The team, led by Connor Kinslow, MD, Columbia University, New York City, looked at the age-adjusted annual incidence rate of ALCL and found that it increased over time.

The incidence was 3.2 per 100 million persons per year from 2000-2005, then increased to 4.4 per 100 million persons per year from 2006-2011, and then tripled to an incidence of 14.5 per 100 million persons per year from 2012-2018.

“Similar rates and trends were observed when including cases of T-cell lymphoma not otherwise specified,” the authors note, at a rate of 19.6 per million persons per year in [the period] 2012 to 2018.

These current incidence estimates are much higher than the previous estimate of 3 per 100 million persons per year quoted by the Food and Drug Administration (FDA), which had been based on data from the Surveillance, Epidemiology and End Results (SEER) data base from 2001-2007, the authors note.

“These trends are concerning, as the use of textured implants increased more than 5-fold from 2.3% to 13% of augmentation procedures between 2011 and 2015, despite a safety communication from the FDA in 2011,” they comment.

An estimated 3%–5% of women in the US have breast implants, they note.

In 2020, the FDA mandated a black box warning on the labeling of all saline and silicone gel-filled implants highlighting the association with breast ALCL, and again strengthened safety warnings and patient decision checklists last October.  

In 2019, Allergan recalled all BioCell textured breast implant products from the United States and around the world because of the risk for breast implant-associated ALCL. According to the FDA, the risk of breast ALCL associated with Allergan’s BioCell textured implants was approximately six times the risk of breast ALCL with textured implants from other manufacturers in the US.

Kinslow and colleagues suggest that their study provides “updated risk estimates [that] should increase the accuracy of epidemiological studies and support continued surveillance of breast ALCL by government and regulatory agencies.”

Kinslow reports no relevant financial relationships. Several other co-authors have disclosed relationships with industry outside the submitted work. The full list can be found with the original article.

JAMA Oncology. Published online July 21, 2022. Research Letter

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