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Sep 05, 2023

UPDATE: Reports of Squamous Cell Carcinoma (SCC) in the Capsule Around Breast Implants

Español Update: March 22, 2023 As of March 22, 2023, health care providers can submit case reports of SCC, various lymphomas, and any other cancers in the capsule around breast implants to the Patient

Español

Update: March 22, 2023

As of March 22, 2023, health care providers can submit case reports of SCC, various lymphomas, and any other cancers in the capsule around breast implants to the Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma (ALCL) Etiology and Epidemiology (PROFILE) Registry, a collaborative effort between the American Society of Plastic Surgeons (ASPS), the Plastic Surgery Foundation (PSF), and FDA. Health care providers can continue to submit case reports of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) to PROFILE as well.

The FDA reviews data from the PROFILE registry on an ongoing basis to gather all available information on cancers in the capsule around breast implants, and will keep the public informed on significant findings as new information becomes available.

The FDA continues to recommend that health care providers also report all cases of SCC, various lymphomas, BIA-ALCL and any other cancers in the capsule around the breast implant to the FDA.

Date Issued: March 8, 2023

The U.S. Food and Drug Administration (FDA) is providing an update on reports of squamous cell carcinoma (SCC) in the scar tissue (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 various lymphomas are not the same as the lymphomas described previously by the FDA as Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL).

This 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 progression of the disease. 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, 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 FDA continues to recommend the following:

Currently, these recommendations do not change or affect the recommendations previously provided by FDA on Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL).

The FDA continues to recommend the following:

Currently, these recommendations do not change or affect the recommendations previously provided by FDA on Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL).

Breast implants are medical devices implanted under the breast tissue or chest muscle to increase breast size (augmentation) or to replace breast tissue that has been removed (reconstruction) due to cancer or trauma, or that has failed to develop properly due to a severe breast abnormality. Breast implants are also used in revision surgeries, which seek to correct or improve the result of an original surgery.

There are two types of breast implants approved for sale in the United States: saline-filled and silicone gel-filled. Both types have a silicone outer shell. They vary in size, shell thickness, shell surface texture, and shape (contour).

Breast implants are not lifetime devices. The longer you have your implants, the more likely it will be for you to have them removed or replaced.

After 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 females or women, 1 was reported in a male or man, 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 of 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, or magnetic resonance imaging (MRI) 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.

* Case refers to SCC reported per breast

** Percentage in terms of the total 19 cases

*** Sex or Gender terms in the table are based on the information as provided in the literature.

# In the 4 cases of SCC with smooth implants at the time of diagnosis, 2 have a history of prior implants of unknown texture, 1 has a history of textured implant, and 1 has a history of one smooth implant and no known textured implant.

± The term "foam covered" in the table is based on the information as provided in the literature.

‡ The range in years is approximation only. In some cases, there was a range of years reported for when the first breast implant was placed.

∆ For some cases, more than one clinical presentation was reported.

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.

As of January 15, 2023, the FDA has received 24 medical device reports (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 under-reporting, 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.

MDRs submitted to the FDA are just one source the FDA uses to monitor the safety of medical devices, in addition to mandated postmarket studies, published literature, and real-world data from registries and databases.

The FDA continues to collect and evaluate all available information about SCC, lymphomas, and any other cancers in the capsule around the breast implant. We are collaborating with other regulatory authorities, clinical and scientific experts, professional societies, manufacturers, and breast implant registries, to increase awareness of SCC in the capsule around the breast implant. In addition, the FDA is working with breast implant manufacturers to help ensure that patients receive and understand information about this emerging issue. The FDA continues our collaborative efforts with the American Society of Plastic Surgeons (ASPS) and the Plastic Surgery Foundation (PSF) to better characterize these cancers in people with breast implants.

We will continue to communicate to the public on significant findings as new information and analyses become available.

If you think you had a problem with your device, the FDA encourages you to report the problem through the MedWatch Voluntary Reporting Form.

Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.

If you have questions, email the Division of Industry and Consumer Education (DICE) at [email protected] or call 800-638-2041 or 301-796-7100.

03/22/2023