FDA Reports Rare Cancers in Scar Capsule Around Breast Implants
According to a recent report from the U.S. Food and Drug Administration (FDA), squamous cell carcinoma (SCC) and various lymphomas may develop in the capsule that forms around breast implants. The lymphomas are not the same as the breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) that prompted previous FDA announcements. The FDA learned about the newly associated cancer during a post-market review of breast implants.
It is very important to know that these cancers are extremely rare. Less than 20 cases of SCC and fewer than 30 cases of lymphoma were found in the capsule around a breast implant.
“After an initial extensive review, we currently believe that the risk [for squamous cell carcinoma] and other lymphomas occurring in the tissue around breast implants is rare,” said Binita Ashar, MD, director of the Office of Surgical and Infection Control Devices in the FDA’s Center for Devices and Radiological Health. “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 Type of Implant Probably Doesn’t Matter
The type of implant appears to be irrelevant – all types of implants (smooth, textured, saline, and silicone) have been linked to SCC and lymphomas in the scar capsule around the implants. In some cases, women were diagnosed years after the placement of their implants. Some signs and symptoms include swelling, pain, lumps, or skin changes.
If you are considering breast implants or currently have them, the FDA recommends the following:
- Ensure you are fully educated about the risks and benefits of breast implants.
- Be aware that cases of SCC and various lymphomas in the capsule around the breast implant have been reported, but they are rare.
- You should monitor your breasts and implants by regular self-exam and contact your plastic surgeon about any changes.
- File a report through MedWatch if you experience any problems.
What Doctors Should Know
If you are a healthcare professional caring for patients with breast implants, the FDA recommends you:
- Be aware that cases of SCC and lymphomas in the capsule around the breast implant have been reported.
- When examining breast implant specimens for diagnostic evaluation, characterize all findings and potential diagnoses.
- Report cases of SCC, lymphomas, and any other cancers in the capsule around the breast implant to the FDA.
The FDA said their consumer and healthcare recommendations don’t affect the previously provided suggestions on BIA-ALCL. They are continuously assessing the post-market safety of approved breast implants and will communicate any findings as soon as new information is available.
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