WASHINGTON, D.C. — The FDA is issuing a safety alert after getting reports of cancers in the scar tissue that forms around breast implants.

On Thursday, the FDA started informing the public about reports of cancers, including squamous cell carcinoma and various lymphomas, in the scar tissue that forms around breast implants. The reports come as the FDA continues review of breast implants.

These reports are different from the previously reported Breast Implant-Associated Anaplastic Large Cell Lymphoma. The FDA started communications about this potential risk more than a decade ago.

So far, the FDA is aware of fewer than 20 cases of squamous cell carcinoma and fewer than 30 cases of various lymphomas. In some cases, people were diagnosed after years of having breast implants. Some of the reported signs and symptoms included swelling, pain, lumps or skin changes. 

While the FDA believes these cases are rare, it is still a risk to be aware of.

“Right now, we do not have enough information to say whether breast implants cause these cancers or if some implants pose higher risk than others,” the FDA said.

Currently, the FDA says the incidence rate and risk factors for SCC and various lymphomas in the capsule around the breast implants are unknown. That is why the FDA is encouraging people to report any instances of squamous cell carcinoma and various lymphomas.

“We know that breast implants are not lifetime devices and that the longer a patient has breast implants, the more likely they will need to be removed or replaced,” the FDA said. “We also understand that information regarding breast implant risks can be overwhelming for a patient. For this reason, we encourage review of our website with attention to patient labeling, which has easy-to-understand information in the patient brochure.”

Recommendations for People who Have or Are Considering Breast Implants

  • If you are considering breast implants or if you have them, learn more about the risks and benefits of breast implants.
  • If you have breast implants, you do not need to change your routine medical care or follow-up.
  • Be aware that cases of SCC and various lymphomas in the capsule around the breast implant have been reported.
  • Monitor your breast implants for as long as you have them. If you notice any abnormal changes in your breasts or implants, promptly talk to your surgeon or health care provider.
  • If you do not have symptoms, the FDA does not recommend the removal of breast implants because of this safety communication.
  • If you have breast implants and experience a problem, the FDA encourages you to file a report through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Your report, along with information from other sources, can provide information that helps improve patient safety.

Currently, these recommendations do not change or affect the recommendations previously provided by the FDA on BIA-ALCL.

Recommendations for Health Care Providers

  • Continue to provide routine care and support to your patients with breast implants.
  • Be aware that cases of SCC and various lymphomas in the capsule around the breast implant have been reported.
  • When examining breast implant specimens (for example, seroma, capsule, devices) for diagnostic evaluation, characterize all findings and potential diagnoses. 
  • Report cases of SCC, lymphomas, and any other cancers in the capsule around the breast implant to the FDA. Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.

Currently, these recommendations do not change or affect the recommendations previously provided by FDA on BIA-ALCL.