FDA Flags Squamous Cell Carcinomas, More Lymphomas Tied to Breast Implants

The FDA issued a safety alert warning patients and providers of reports of squamous cell carcinoma (SCC) and various lymphomas located in the capsule or scar tissue around breast implants.

“After an initial extensive review, we currently believe that the risk of SCC and other lymphomas occurring in the tissue around breast implants is rare,” the FDA said. “However, in this case, and when safety risks with medical devices are identified, we wanted to provide clear and understandable information to the public as quickly as possible.”

The agency noted that these new lymphoma reports differ from those of breast implant-associated anaplastic large-cell lymphoma, which the FDA began issuing warnings about more than a decade ago.

In all, the FDA said that after a review of published literature it has become aware of less than 20 cases of SCC and fewer than 30 cases of various lymphomas in the capsule around the breast implant. And as of September 1, it has received 10 medical device reports (MDRs) about SCC and 12 about various lymphomas related to breast implants.

The agency said these reports of SCC and lymphomas involved both textured and smooth breast implants, as well as both saline and silicone breast implants, and that in some cases patients were diagnosed years after receiving breast implants, with signs and symptoms including swelling, pain, lumps, or skin changes.

“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 agency said. “For this reason, instances of SCC, lymphoma and any cancer located in the scar tissue around breast implants should be reported to the FDA.”

The FDA suggested patients should “promptly” talk to their surgeon or healthcare provider in case of abnormal changes in their breasts of implants, and encouraged patients to file a report through MedWatch, the FDA Safety Information and Adverse Event Reporting program, if they experience a problem.