FDA Reports Squamous Cell Carcinoma and Various Lymphomas in Capsule Around Breast Implants

September 12, 2022

On September 8, 2022, the U.S. Food and Drug Administration (FDA) reported (https://www.fda.gov/medical-devices/safety-communications/breast-implants-reports-squamous-cell-carcinoma-and-various-lymphomas-capsule-around-implants-fda?utm_medium=email&utm_source=govdelivery) that cancers, including squamous cell carcinoma (SCC) and various lymphomas, may develop in the capsule that forms around breast implants.

FDA Reports Squamous Cell Carcinoma and Various Lymphomas in Capsule Around Breast Implants

FDA said (https://www.fda.gov/medical-devices/safety-communications/breast-implants-reports-squamous-cell-carcinoma-and-various-lymphomas-capsule-around-implants-fda?utm_medium=email&utm_source=govdelivery) the lymphomas are not the same as the breast implant–associated anaplastic large cell lymphoma (BIA-ALCL) that triggered other FDA announcements (https://voice.ons.org/news-and-views/fda-recalls-textured-breast-implants-because-of-lymphoma-risk). FDA learned (https://www.fda.gov/medical-devices/safety-communications/breast-implants-reports-squamous-cell-carcinoma-and-various-lymphomas-capsule-around-implants-fda?utm_medium=email&utm_source=govdelivery) about the newly associated cancers during a postmarket review of breast implants and collaboration with external stakeholders.  

In its review of published literature, FDA identified (https://www.fda.gov/medical-devices/safety-communications/breast-implants-reports-squamous-cell-carcinoma-and-various-lymphomas-capsule-around-implants-fda?utm_medium=email&utm_source=govdelivery) fewer than 20 cases of SCC and fewer than 30 cases of lymphomas in the capsule around a breast implant. As of September 1, 2022, FDA said that it received 10 medical device reports (MDRs) about SCC and 12 MDRs about various lymphomas related to breast implants.

FDA said that SCC or various lymphomas in the capsule around a breast implant are likely rare, but healthcare providers and people who have or are considering breast implants should be aware of the concern. FDA also said (https://www.fda.gov/medical-devices/safety-communications/breast-implants-reports-squamous-cell-carcinoma-and-various-lymphomas-capsule-around-implants-fda?utm_medium=email&utm_source=govdelivery) that the incidence and risk factors for SCC and lymphomas around breast implants is unknown.

SCC and lymphomas in the capsule around the breast implants have been reported for both textured and smooth breast implants and both saline and silicone breast implants. In some cases, people were diagnosed years after their breast implantation. Signs and symptoms included swelling, pain, lumps, or skin changes. 

For those who are considering breast implants or currently have them, FDA recommended (https://www.fda.gov/medical-devices/safety-communications/breast-implants-reports-squamous-cell-carcinoma-and-various-lymphomas-capsule-around-implants-fda?utm_medium=email&utm_source=govdelivery) that consumers:

When caring for patients with breast implants, FDA recommended (https://www.fda.gov/medical-devices/safety-communications/breast-implants-reports-squamous-cell-carcinoma-and-various-lymphomas-capsule-around-implants-fda?utm_medium=email&utm_source=govdelivery) that healthcare providers:

For consumers with breast implants, FDA does not advise changing routine medical care or follow up. FDA also does not recommend removing breast implants if a patient has no symptoms.

FDA said (https://www.fda.gov/medical-devices/safety-communications/breast-implants-reports-squamous-cell-carcinoma-and-various-lymphomas-capsule-around-implants-fda?utm_medium=email&utm_source=govdelivery) the consumer and healthcare recommendations do not affect the previously provided recommendations (https://www.fda.gov/medical-devices/breast-implants/questions-and-answers-about-breast-implant-associated-anaplastic-large-cell-lymphoma-bia-alcl) on BIA-ALCL at this time. The agency also said (https://www.fda.gov/medical-devices/safety-communications/breast-implants-reports-squamous-cell-carcinoma-and-various-lymphomas-capsule-around-implants-fda?utm_medium=email&utm_source=govdelivery) that it is continually evaluating the postmarket safety of approved breast implants and will communicate any significant findings as new information and analyses become available.

Healthcare professionals should report any adverse reactions or quality problems (https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program/reporting-serious-problems-fda) they suspect are associated with breast implants to MedWatch, FDA’s Safety Information and Adverse Event Reporting Program.


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