On March 8, the U.S. Food and Drug Administration (FDA) provided an update on reports of squamous cell carcinoma (SCC) in the scar tissue, or capsule, that forms around breast implants. Previously, on September 8, 2022, the FDA released a safety communication informing the public of reports of cancers, including SCC and various lymphomas, in the capsule that forms around breast implants. The new update includes information from the FDA’s review of literature and medical device reports (MDRs).
The FDA is aware of 19 cases of SCC in the capsule around the breast implant from published literature; there have been reports in the literature of deaths from disease progression. While the FDA continues to believe that occurrences of SCC in the capsule around the breast implant may be rare, the cause, incidence, and risk factors remain unknown.
Health-care 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 the FDA and in the literature. The FDA continues to ask health-care providers and people with breast implants to report cases of SCC, lymphomas, or any other cancers around breast implants to the FDA. In addition, the FDA continues 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. Lastly, the FDA is continuing its collaborative efforts with the American Society of Plastic Surgeons and the Plastic Surgery Foundation to better characterize these cancers in people with breast implants.
The various lymphomas are not the same as the lymphomas described previously by the FDA as breast implant–associated anaplastic large cell lymphoma (BIA-ALCL).
Results from FDA Review of Published Literature
After a review of published literature including abstracts and full articles through January 2023, the FDA is aware of 19 cases of SCC in the capsule around breast implants. Of the 19 literature cases, 17 were reported in female patients, 1 was reported in a male patient, and there was no available information for 1 case. Patients’ ages at time of diagnosis ranged from 40 years to 81 years. The majority of cases involved swelling and/or pain in the breast as symptoms; other reported symptoms included lumps and skin discoloration. Breast implants, when reason for implant was available, had been placed for breast reconstruction and augmentation.
In general, the diagnosis was established by pathology examination of the capsule tissue. Imaging studies were often used in the diagnostic workup, such as computed tomography (CT) of the chest, magnetic resonance imaging of the breast, or CT in combination with positron-emission tomography (PET) as a PET-CT. The diagnosis of SCC in the capsule around the breast implant occurred approximately 7 to 42 years (when data was available) after initial implant placement. SCC was located in the capsule around the breast implant often in the posterior aspect (behind the implant) without being present in the breast tissue. Three reports of death due to the disease were reported in the literature.
In summary, there have been reports in the literature of SCC in the capsule around the breast implant for both textured and smooth breast implants, and for both saline and silicone breast implants, when implant information was available. In most cases, people were diagnosed years after initial implant placement.
Results from FDA Review of MDRs
As of January 15, 2023, the FDA has received 24 MDRs about SCC related to breast implants. The FDA recognizes the limitations of MDR data, including duplicate reporting of cases within the MDRs and between the MDRs and the literature; therefore, MDRs do not necessarily represent unique cases. In addition, the incidence of SCC in the capsule around breast implants cannot be determined from this reporting system alone due to potential underreporting, duplicate reporting of events, and the lack of information about the total number of patients who have breast implants. Based on review of the MDRs, the information described about SCC related to breast implants is similar to information from the literature for patient age, implant type, reason for implant, time to diagnoses, and clinical presentation.
Recommendations for People Who Have or Are Considering Breast Implants
The FDA continues to recommend the following:
- If you are considering breast implants, or if you already have them, learn more about the risks and benefits of breast implants.
- If you have breast implants, you do not need to change your routine medical care or follow-up.
- Be aware that cases of SCC and various lymphomas (other than BIA-ALCL) in the capsule around the breast implant have been reported.
- Monitor your breast implants for as long as you have them. If you notice any changes in your breasts or implants, promptly talk to your 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 SCC or various lymphomas.
- 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.
Currently, these recommendations do not change or affect the recommendations previously provided by FDA on BIA-ALCL.
Recommendations for Health-Care Providers
The FDA continues to recommend the following:
- Continue to provide routine care and support to your patients with breast implants.
- Be aware that cases of SCC and various lymphomas (other than BIA-ALCL) in the capsule around the breast implant have been reported.
- When examining breast implant specimens (for example, seroma, capsule, devices) for diagnostic evaluation, characterize all findings and potential diagnoses.
Updated Recommendations for Health-Care Providers
- Include information about SCC and various lymphomas in the capsule around the breast implant in your discussions with people who have or are considering breast implants.
- For patients who have been diagnosed with SCC or various lymphomas in the capsule around the breast implant, develop an individualized treatment plan in coordination with a multidisciplinary team of experts, including surgical oncology, plastic surgery, breast surgery, radiology, oncology, and pathology.
- Report all cases of SCC, lymphomas, and any other cancers in the capsule around the breast implant to the FDA. Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. Please include the following information in the report, if known:
- Clinical presentation and breast implant history
- Imaging studies performed
- Pathology of the capsule tissue
- Treatment therapy
- Outcomes
Currently, these recommendations do not change or affect the recommendations previously provided by FDA on BIA-ALCL.
