FDA Issues New Safety Warning on Rare Cancers Linked to Breast Implants

Silicone breast implants in a file photo. Miguel Medina/AFP via Getty Images

The U.S. Food and Drug Administration (FDA) has issued a new warning about rare cases of certain cancers, including squamous cell carcinoma (SCC) and various lymphomas, linked to breast implants.

In a safety communication notice posted on Sept. 8, the FDA said it had received reports of cancers found in the scar tissue, or capsule, that forms around breast implants.

SCC is the second most common form of skin cancer, according to the Mayo Clinic, and occurs in the skin’s squamous cells, which construct the middle and outer layer of the skin. Lymphomas refer to cancer of the lymphatic system.

These cancers are different from those described in previous warnings from the FDA about Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), which was first identified in 2011, the FDA said.

BIA-ALCL is not breast cancer but a rare type of non-Hodgkin’s lymphoma, or cancer of the immune system. Although rare, it can develop in the scar tissue capsule and fluid surrounding a breast implant and in some cases can spread to the rest of the body, according to Breastcancer.org.

According to the FDA, the risk of BIA-ALCL is higher for textured surface implants than it is for smooth surface implants.

The FDA said it had learned about the latest cancers linked to breast implants through an extensive review of published literature on breast implants as well as its “ongoing collaboration with external stakeholders. ”

The agency said it is aware of fewer than 20 cases of squamous cell carcinoma and fewer than 30 cases of various lymphomas in the capsule around the breast implant.

“As of September 1, 2022, the FDA has received 10 medical device reports (MDRs) about SCC related to breast implants and 12 MDRs about various lymphomas related to breast implants,” the agency said. “The FDA recognizes the limitations of MDR data, including that reports do not necessarily represent unique cases.”

Benefits and Risks of Breast Implants

Reports of the cancers have been linked to both textured and smooth breast implants, and both saline and silicone breast implants, the agency said.

The FDA noted that reports submitted to the agency are just one of the sources it uses to monitor the safety of medical devices, along with “mandated postmarket studies, published literature, and real-world data from registries and claims databases.”

The agency said it would continue to collect and review data from all of these sources to assess the occurrence rate of such cancers in the scar tissue surrounding the breast implants.

Although the FDA believes that occurrences of squamous cell carcinoma and various lymphomas in the capsule around the breast implant may be rare, the agency urged health care providers to be aware that cases have been reported to the FDA.

It also urged people who have or are considering breast implants to be aware of the risks and benefits of them, including the cases of SCC and various lymphomas in the capsule around the breast implant.

Individuals who have breast implants are being asked to monitor them and look out for any abnormal changes in the implants or their breasts, and to speak to their surgeon or health care provider as soon as possible if they do notice any changes.

Signs and symptoms found in the individuals included swelling, pain, lumps, or skin changes, the agency said.

Those who do not notice any symptoms or changes in their breast implants do not need to have their implants removed following the latest safety communication, the FDA said.

However, the agency noted that in some cases, individuals were diagnosed with the cancers years after having the breast implants fitted.

According to the University of Utah Health, 300,000 breast implant surgeries are performed each year in the United States.