Breast cancer: Is BIA-ALCL increasing in women in the US?

Breast cancer: Is BIA-ALCL increasing in women in the US?

Last Updated on August 15, 2022 by Joseph Gut – thasso

August 13, 2022 – Breast cancer: Is BIA-ALCL increasing in women in the US? Over the last couple of years, the recognition of an seemingly increased rate of incidence of Anaplastic Large-Cell Lymphoma (ALCL) in woman who received breast implants after breast cancer disease was of great concern to women concerned and the medical community as well. New estimates reported reported as of July 2022 in a research letter in JAMA Oncology reveals now that breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is diagnosed more often as time goes on.

This research letter presents some new research about current population-based estimates of the incidence of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) in the USA, and the findings are somewhat alarming. The research team behind the published study from the Columbia University, New York City, looked at the age-adjusted annual incidence rate of ALCL and found that it increased over time. Thus, 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,  at a rate of 19.6 per million persons per year in the period from 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 researchers noted. These trends are appear concerning, as the use of textured implants increased more than 5-fold from 2.3% to 13% of augmentation procedures between 2011 and 2015, when compared to a safety overview  communication from the FDA in 2011. One should note that overall 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. This observation might also be associated with the fact that there exists an increased recognition of the disease itself and an increasing incidence of all breast lymphomas in general.

As the actual situation is concerned, we should be aware of the fact that the data presented here are from a period from 2000 up to 2018. If the trend of increasing numbers of cases will continue up to today and beyond is less clear for two reasons. First, national databases tend to lag by several years in reporting actual data, i.e., it is likely too soon to determine if the incidence of BIA-ALCL cases is still increasing or actually has decreased as a result of the FDA-requested recall of Allergan’s BIOCELL textured breast implants in 2019. Secondly, Allergan effectively has recalled from the markets worldwide all his BIOCELL textured breast implant products (see a list here). Since up to then, most reported cases of BIA-ALCL seemingly were associated with Allergan’s BIOCELL implants, the drastic recall measure may have had a major impact on the incidence of cases in the patient population. On the other hand, the exact mechanisms behind the particularity of the texture of the BIOCELL products that could produce this very serious adverse effect of BIA-ALCL in some patients are not yet know. However, there are still textured breast implants on the market, and apparently, their use is ever increasing.  However, this happens under harshly strengthened “Safety Reqirements and Updates on Study Results for Breast Implants” by the FDA. Under these conditions, there is hope that actual BIA-ALCL cases are no more increasing, and the safety of patients is at a very high level, although we still need to await the actual pharmacovigilance.based and epidemiological data. By the way, the European Union has suggested via a fundamental overview by its “Scientific Committee on Health, Environmental and Emerging Risks (SCHEER)” the introduction of BIA-ALCL specific clinical registries in order to gain more precise data on frequencies and reasons of cases of BIA-ALCL emerging.

Since breast cancer is just such a life-changing and dominant clinical condition for women, thasso had already in the past a couple of posts on several facets of this disease, such as in 1, 2, 3, 4, and many others as well (just search for “breast cancer” on thasso).

Our empathy is with patients. So, see here this impressive sequence by a patient affected byBIA-ALCL:

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Ph.D.; Professor in Pharmacology and Toxicology. Senior expert in theragenomic and personalized medicine and individualized drug safety. Senior expert in pharmaco- and toxicogenetics. Senior expert in human safety of drugs, chemicals, environmental pollutants, and dietary ingredients.

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