Breast implants may be linked to more cancers than previously thought, FDA warns

‘This is an emerging issue and our understanding is evolving,’ FDA says

The US Food and Drug Administration (FDA) has warned people about the risks of additional types of cancers in people receiving breast implants.

It cited reports of cancers, including squamous cell carcinoma (SCC) and various lymphomas, in the scar tissue that forms around breast implants, adding that these were not the same malignancies as described in previous FDA communications.

Lymphomas are a cancer of the immune system and SCC is a type of skin cancer.

“The FDA learned about these reports through our continual postmarket review of breast implants and our ongoing collaboration with external stakeholders,” the federal agency said.

FDA said these cases are rare, adding that it is now aware of less than 20 cases of SCC and less than 30 cases of various lymphomas in the capsule around the breast implant.

These implants are medical devices placed under the breast tissue or chest muscle to augment breast size, or to replace tissue that is lost due to cancer or trauma.

The devices in the US are either saline-filled or silicone gel-filled and both types have a silicone outer shell.

FDA noted that it received 10 reports about SCC related to breast implants, and 12 about various lymphomas related to breast implants.

The agency said its teams would continue to gather and review available data from sources to evaluate the occurrence of cancers in the scar tissue (capsule) around breast implants.

While the occurance of such carcinoma or lymphomas in the capsule region may be rare, according to the federal agency, it said people should be aware that cases have been reported to the FDA and in the literature.

“Currently, the incidence rate and risk factors for SCC and various lymphomas in the capsule around the breast implants are unknown,” it noted, adding that some of the reported signs and symptoms include swelling, pain, lumps or skin changes.

“This is an emerging issue and our understanding is evolving. For this reason, the FDA is asking health care providers and people with breast implants to report cases of SCC, lymphomas, or any other cancers around the breast implant to the FDA,” the agency responsible for protecting and promoting public health in the US noted.

The agency called on those who have received implants to monitor them for “as long as” they have them, and to promptly talk to their health care providers or surgeons if they notice any abnormal changes in their breasts or implants.

If people experience problems with their breast implants, FDA urged them to file a report through MedWatch, the FDA Safety Information and Adverse Event Reporting program.

The agency called on health care providers to characterise all findings and potential diagnoses while examining breast implant specimens for diagnosis.

“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,” the FDA said in a statement.