The U.S. Food and Drug Administration (FDA) has warned people about the risks of additional cancers in people who receive breast implants.
He 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 described in previous FDA submissions.
Lymphomas are a cancer of the immune system and SCC is a type of skin cancer.
“The FDA learned of these reports through our ongoing post-sales review of breast implants and our continued collaboration with external stakeholders,” the federal agency said.
The FDA said these cases are rare, adding that it is now aware of fewer than 20 cases of SCC and fewer 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 increase breast size or to replace tissue lost due to cancer or trauma.
Devices in the United States are filled with saline or filled with silicone gel, and both types have a silicone outer shell.
The FDA noted that it received 10 reports on SCC related to breast implants and 12 on various lymphomas related to breast implants.
The agency said its teams will continue to collect and review available data from sources to assess the occurrence of tumors in the scar tissue (capsule) around breast implants.
Although the appearance of such carcinoma or lymphomas in the capsule region may be rare, according to the federal agency, 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,” he noted, adding that some of the reported signs and symptoms include swelling, pain, lumps or skin changes.
“This is an emerging problem and our understanding is evolving. For this reason, the FDA asks healthcare professionals and people with breast implants to report cases of SCC, lymphoma or any other cancer around the breast implant to the FDA, “noted the agency responsible for protecting and promoting public health in the United States .
The agency has urged those who have received implants to monitor them “as long as” they have them and to speak promptly with their healthcare professionals or surgeons if they notice any abnormal changes in the breasts or implants.
If people have problems with their breast implants, the FDA has urged them to file a report through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
The agency called on healthcare professionals to characterize all findings and potential diagnoses when examining breast implant samples 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 better identify and understand the risks associated with medical devices, ”the FDA said in a statement.