FDA issues safety alert over reports of cancer in scar tissue around breast implants


The Food and Drug Administration (FDA) issued a warning for doctors and patients on Thursday after it received reports of people with breast implants being diagnosed with multiple types of cancer. 

Binita Ashar, the director of the Office of Surgical and Infection Control Devices in the agency’s Center for Devices and Radiological Health, said in a release that the FDA received reports of squamous cell carcinoma and various lymphomas in the capsule or scar tissue near the implants. 

Ashar said the FDA reviewed the reports and determined that such occurrences are rare, but the agency wanted to provide “clear and understandable information” to the public as soon as possible. 

Some of those who reported having cancer had symptoms of swelling, pain, lumps or skin changes, Ashar said. 

She said these reports are separate from breast implant-associated anaplastic large cell lymphoma, which the FDA started warning about more than 10 years ago. 

Ashar said the agency does not have enough information to conclude if the implants cause certain cancers or if some implants pose a higher risk than others. Any instances of squamous cell carcinoma, lymphoma or any cancer near the scar tissue around breast implants should be reported to the FDA as a result. 

“Our collective understanding has advanced significantly because of the efforts to study, communicate and act when needed,” she said. “As the agency moves further into adopting modernized approaches to our regulatory responsibilities to promote faster science-based decision-making, accurate data is crucial.” 

Ashar said the FDA will conduct a literature review and continue its partnership with the American Society of Plastic Surgeons to identify ways to collect more detailed information about these cases.



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