US FDA issues cancer warning linked to breast implants

On Sept 8, 2022, the US Food and Drug Administration (FDA) issued a safety communication to highlight reports of squamous cell carcinoma and various lymphomas in the scar tissue, or capsule, that surrounds breast implants. The lymphomas are distinct from breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), which is also found in the capsule. The FDA confirmed that it had received ten reports of squamous cell carcinoma, and 12 reports of the different types of lymphoma, linked to breast implants. A literature review done by the agency turned up a total of fewer than 50 cases of squamous cell carcinoma and of the various lymphomas in the scar tissue around the implant.
The safety communication added that the risk factors for the squamous cell carcinoma and various lymphomas associated with implantation have yet to be established. There have been cases both among individuals with textured breast implants and in those with smooth implants, as well as among individuals with implants filled with saline or with implants filled with silicone gel. A 2018 literature review identified five patients with squamous cell carcinoma of the breast implant capsule. The average time between the breast augmentation and the diagnosis of cancer was 23 years.

Nigel Mercer (UK Medicines and Healthcare products Regulatory Agency, London, UK) pointed out that it has been long established that chronic inflammation can cause squamous cell carcinoma. “Marjolin ulcers happen around long-standing areas of inflammation and leg ulcers; it is not surprising to hear of something similar happening around a breast implant”, Mercer said in a statement to The Lancet Oncology. He added that, although BIA-ALCL is the only lymphoma that WHO defines as a malignancy associated with breast implants, one would expect other lymphomas to occasionally result from an implant.

“With BIA-ALCL, a textured implant is considered causative for the disease. We are not aware of any cases involving purely smooth implants”, commented Mark Clemens (University of Texas MD Anderson Cancer Center, Houston, TX, USA). Identifying the exact mechanism behind cancers associated with breast implants is an extremely difficult task. “BIA-ALCL appears to be linked with the allergic pathway going astray, but beyond that we do not know what causes it. We do not have a good human model to study these implants—you cannot test them for the length of time a human being lives for”, explained Mercer.

BIA-ALCL is a T-cell lymphoma. The new FDA communication focuses on B-cell lymphomas associated with breast implants. “In all of the documented cases of B-cell lymphomas, we have seen the presence of the Epstein-Barr virus, so it would seem that there is a viral mediator contributing to the pathogenesis”, Clemens told The Lancet Oncology.

According to the FDA, as of April 1, 2022, 1130 cases of BIA-ALCL, including 59 deaths, have been recorded worldwide. These numbers are almost certainly underestimated, however, given the gaps in global data, especially when it comes to statistics on breast implants. Among individuals in the UK with breast implants, the prevalence of BIA-ALCL is estimated to be 1 in 15 000. The country has not registered a single case of squamous cell carcinoma arising from the capsule.

Calculating the worldwide prevalence of either squamous cell carcinoma or the various lymphomas associated with breast implants from the handful of reported cases would yield a tiny figure. Estimates on the number of women worldwide to have received breast implants range from 5 million to 35 million. In the USA alone, approximately 400 000 women have breast augmentation surgery every year, either for cosmetic reasons or after a mastectomy.

There are no screening tests for squamous cell carcinoma and the various lymphomas of the capsule; for instance, they do not show up on a mammogram. The FDA is not recommending that individuals without symptoms of disease have their implants removed in light of the reported cancers, or that their routine care and follow-up is altered. “Taking out a breast implant is a major undertaking”, agreed Mercer. He noted that if the scar tissue is left behind, the risk of BIA-ALCL remains. But removing the capsule is a complex task, especially if it is firmly attached to the ribs. The primary purpose of the FDA communication was to alert patients and caregivers to the existence of the cancers, rather than to recommend any particular course of action. “It is very important that women who either have implants, or are considering them, have this information, but they should also be aware that these cancers are incredibly rare”, Clemens added.

Woman selecting breast implant
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