FDA Warns About Breast Implant Squamous Cell Carcinoma

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 surrounding the implant, which is not the same as previous problems with breast implant-associated anaplistic large cell lymphoma (BIA-ALCL) that the agency has previously warned about.

On March 8, the United States Food and Drug Administration (FDA) issued a safety communication update, stating that the agency had identified at least 19 cases of squamous cell carcinoma (SCC) in breast implant capsules that were described in published literature, including a number of deaths that were likely linked to the condition.

The update comes on the heels of a breast squamous cell carcinoma warning issued in September 2022, which indicated the government was looking into the possible risk following the discovery of SCC and other lymphomas in breast tissue capsules around implants in post-marketing reports.

The second most frequent type of skin cancer is squamous cell carcinoma, which causes aberrant squamous cell development. It frequently manifests as red, scaly patches, sores, and thickened wart-like skin that bleeds, itches, cracks, and crusts. It is frequently treatable if discovered early, but it can be disfiguring and fatal if diagnosed and treated late. According to health experts, an estimated 1.8 million SCC cases are identified each year, and the incidence rate has more than quadrupled in the previous 30 years.

Lymphomas are a kind of cancer, often known as lymphatic cancer, that can take numerous forms but all assault the body's lymphatic system. The two most common varieties are Hodgkin's lymphoma and non-lymphoma, Hodgkin's although the types, manifestations, therapies, and prognoses, as well as rarity, can vary widely among its many diverse forms.

According to the FDA's most recent update, published literature, rather than postmarketing data, reveals at least 19 such incidents. It is unclear whether these occurrences are distinct from those listed in the postmarketing reports, while there is certainly overlap.

The FDA statement notes that there have been reports in the literature of fatalities caused by illness progression. While the FDA continues to think that SCC in the capsule around a breast implant is uncommon, the etiology, incidence, and risk factors remain unclear.

The organization warns healthcare practitioners and people seeking breast implants about the dangers of SCC and other lymphomas in the capsule around the implant. The FDA has asked healthcare professionals and patients who have breast implants to continue reporting incidences of malignancies associated with the implants to the agency.

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