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:

• Learn more about the risks and benefits of breast implants (https://www.fda.gov/medical-devices/implants-and-prosthetics/breast-implants).
• Be aware that cases of SCC and various lymphomas in the capsule around the breast implant have been reported.
• Monitor their breasts and implants and contact healthcare provider about any changes.
• File a report through MedWatch (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home) if they experience any problems.

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:

• Provide routine care and support to patients with breast implants.
• Be aware that cases of SCC and lymphomas in the capsule around the breast implant have been reported.
• Characterize all findings and potential diagnoses when examining breast implant specimens.
• Report cases of SCC, lymphomas, and any other cancers in the capsule around the breast implant to FDA.

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.

On March 8, 2023, FDA reported (https://www.fda.gov/medical-devices/safety-communications/update-reports-squamous-cell-carcinoma-scc-capsule-around-breast-implants-fda-safety-communication?utm_medium=email&utm_source=govdelivery) that it identified 19 additional cases of SCC in the capsule around the breast implant in its latest review of literature and MDRs in January. Three deaths were reported in the literature from progression of the disease.

Of the 19 literature cases, 17 were in females, one in a male, and one case had no information available. Patients’ ages at time of diagnosis ranged from 40–81 years, and time since their breast implant placement ranged from 7–42 years.

SCC was often located behind the implant without being present in the breast tissue. The most commonly reported symptoms were swelling or pain in the breast, lumps, and skin discoloration.

FDA also updated recommendations for healthcare providers caring for patients with breast implants in March 2023. In additional to its previous recommendations, FDA advised that healthcare providers:

• Educate patients about SCC and various lymphomas in the capsule around the breast implant.  
• Develop an interprofessional treatment plan for patients diagnosed with SCC or various lymphomas in the capsule around the breast implant.
• Report (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=professional.reporting1) all cases of SCC, lymphomas, and any other cancers in the capsule around the implant to FDA.

The updated SCC recommendations currently do not change or affect FDA’s recommendations for BIA-ALCL.

Although FDA reiterated that occurrences of SCC in the capsule around breast implants may be rare, it does not currently have sufficient evidence to identify the cause, incidence, and risk factors. 
 
Healthcare providers and people who have or are considering breast implants should be aware that cases of SCC and various lymphomas in the capsule around the breast implant have been reported to FDA and in the literature.

FDA reminded healthcare providers and people with breast implants to report cases of SCC, lymphomas, or any other cancers around breast implants. In addition, FDA said it will 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. 

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.