FDA Warns About Breast Implant Squamous Cell Carcinoma and Lymphoma Risks, Which May Result in Death

Federal regulators have issued an updated warning about the risk of squamous cell carcinoma from breast implants, as well as various lymphomas that may form in the capsule around the implant, which are not the same as prior problems involving breast implant-associated anaplistic large cell lymphoma (BIA-ALCL) the agency has previously warned about.

The U.S. Food and Drug Administration (FDA) issued a safety communication update on March 8, indicating the agency has identified at least 19 cases for squamous cell carcinoma (SCC) in breast implant capsules which were described in published literature, including a number of deaths likely linked to the condition.

The update follows a breast squamous cell carcinoma warning first released in September 2022, which confirmed the agency was investigating the potential risk following the identification of SCC and other lymphomas occurring in breast tissue capsules around implants in postmarketing reports.

Squamous cell carcinoma is the second most common form of skin cancer, which causes abnormal squamous cell growth. It often appears as red, scaly patches, sores, and thickened wart-like skin which can bleed, itch, crack and crust over. It can often be easily treated if caught early, but can be disfiguring and deadly if diagnosis and treatment are delayed. An estimated 1.8 million SCC cases are diagnosed each year, and the incidence rate has doubled over the last 30 years, health experts warn.

Lymphomas are an entire class of cancer, also known as lymphatic cancer, which comes in many forms, but all of which attack the body’s lymphatic system. The main types are Hodgkin’s lymphoma and non-Hodgkin’s lymphoma, but the types, expressions, treatments, and prognoses and rarity can vary greatly among its many different forms.

In this latest update, the FDA indicates published literature, as opposed to postmarketing reports, indicate there are at least 19 of such instances. It is unclear whether these are different from the incidents mentioned in the postmarketing reports, although there is likely overlap.

“There have been reports in the literature of deaths from progression of the disease,” the FDA update adds. “While the FDA continues to believe that occurrences of SCC in the capsule around the breast implant may be rare, the cause, incidence and risk factors remain unknown.”

The agency urges health care providers and those considering breast implants to be aware of the risks of SCC and various lymphomas in the capsule around the breast implant. The FDA asks health care providers and those with breast implants to continue reporting cases of any cancers involving the implants to be reported to the agency.

Breast Implant ALCL Lawsuits

In this new warning, the FDA emphasizes that these cancer cases are different from incidents of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), which have resulted in prior warnings by the agency and a number of breast implant lawsuits against certain manufacturers of products with textured designs known to increase the risk of this unique cancer.

ALCL is a serious type of non-Hodgkin lymphoma linked to breast implants, which is often aggressive and may spread quickly if not diagnosed promptly. Researchers found that women with breast implants were 40 times more likely to develop the cancer, compared to women without implants, and there is growing evidence that certain designs carry a particularly high risk.

After a growing number of breast implant ALCL cases were identified several years ago, the FDA began requiring manufacturers to provide black box warnings designed to alert patients about the risk, and a number of manufacturers have faced breast implant cancer lawsuits brought by women who allege they may have avoided a diagnosis if proper warnings had been provided to users and the medical community about the ALCL risk.

Allergan issued a breast implant recall for its textured Biocell implants in 2019, after the FDA warned that the design was linked to nearly all cases of BIA-ALCL. Since then, doctors have determined removing the implants is the best means of treating BIA-ALCL in most cases, but the manufacturer continues to refuse to pay for women to have the recalled breast implants removed.

In October 2021, the FDA required breast implant manufacturers to add a prominent “boxed” warning designed to alert patients to the risk of breast implant ALCL.

Since the recall, there has been hundreds of breast implant ALCL lawsuits, each raising similar allegations that Allergan sold unreasonably dangerous and defective textured implants, without warning women about the potential risks.