FDA issues safety communication about cancers in scar tissue around breast implants
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The FDA is aware of 19 cases of squamous cell carcinoma in scar tissue that forms around breast implants, the agency announced today in a safety communication.
“There have been reports in the literature of deaths from progression of the disease,” the safety communication stated. “[Although] the FDA continues to believe that occurrences of [squamous cell carcinoma] in the capsule around the breast implant may be rare, the cause, incidence and risk factors remain unknown.”
The FDA in September issued a safety alert informing the public about reports of cancers — including squamous cell carcinomas and certain lymphomas — being found in scar tissue surrounding breast implants.
The lymphomas cited in last fall’s safety alert differ from breast implant-associated anaplastic large-cell lymphoma, which the agency identified as a potential risk in 2011.
The FDA issued its updated safety communication today to share findings of its review of literature and medical device reports.
“Health care providers and people who have or are considering breast implants should be aware that cases of [squamous cell carcinoma] and various lymphomas in the capsule around the breast implant have been reported to the FDA and in the literature,” the safety communication stated. “The FDA continues to ask health care providers and people with breast implants to report cases of [squamous cell carcinoma], lymphomas or any other cancers around breast implants to the FDA. In addition, we continue to collaborate with other regulatory authorities, scientific experts, breast implant manufacturers and registries to gather all available information on cancers in the capsule around breast implants.”
The agency recommended people who have or are considering breast implants learn about the potential risks and benefits. Those who have breast implants should monitor them and report any changes to their surgeon or health care provider.
“If you do not have symptoms, the FDA does not recommend the removal of breast implants solely due to concern related to the risk of developing [squamous cell carcinoma] or various lymphomas,” the agency stated in its 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.”
The agency urged health care providers to continue to provide routine care and support to patients with breast implants, and be aware that cases of squamous cell carcinoma and various lymphomas — aside from breast implant-associated anaplastic large B-cell lymphoma — have been reported.
Providers are urged to characterize all findings of diagnostic evaluations, and include information about squamous cell carcinoma and various lymphomas in discussions with people who have or are considering breast implants. If a patient is diagnosed with squamous cell carcinoma or various lymphomas in the capsule around a breast implant, providers are urged to work with a multidisciplinary team — including surgical oncology, breast surgery, plastic surgery, oncology, radiology and pathology — to develop a personalized treatment plan.
Providers also are urged to report all cases to the FDA.
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