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FDA Updates Cancer Risks Linked to Breast Implants

In September 2022, the FDA warned the public about certain cancers in the capsules that form around breast implants. Recently, the agency released an updated advisory for individuals with breast implants. This safety communication provides new details on new reports and deaths linked to breast implants and updates for healthcare providers.  

Previous Safety Communication on Breast Implants and Cancer

By September 2022, the FDA had received several reports of Squamous Cell Carcinoma (SCC) and lymphomas forming the scar tissue surrounding breast implants. SCC is a form of skin cancer that develops in the cells in the middle and outer layers of the skin. While it is usually not life-threatening, this cancer is aggressive. When SCC spreads to other parts of the body, it can cause severe health complications. 

The cancers specified in this warning differ from previous FDA advisories on Allergan Biocell textured breast implants. These breast implants were associated with a rare form of non-Hodgkin’s lymphoma called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). 

FDA Update on Cancer Risks for Breast Implant Patients

As of March 8, the FDA is aware of 19 reports of SCC in breast implant patients. Also, the agency noted there have been three deaths linked to the progression of this disease. The FDA reviewed published abstracts and articles through January 2023. Through this literature, the FDA discovered 17 cases of SCC in women and 1 in a man, with no available information for 1 case. Those diagnosed with SCC, whose ages ranged from 40 to 81 years, reported experiencing: 

• Swelling
• Pain
• Lumps
• Skin discoloration 

The agency specified that SCC occurred approximately 7 to 42 years after initial implant placement. The cause of SCC in breast implant patients remains unknown, but the FDA has promised to continue evaluating data and updating the public on new information. 

Recommendations for Breast Implant Patients and Healthcare Providers

There have been no significant changes since the FDA’s last safety communication in September 2022. The FDA urges patients to monitor their breast implants and to talk to their healthcare provider if they notice any changes. Currently, the agency does not recommend removing implants if you show no symptoms. 

Individuals considering breast implants should understand the risks of cancer before getting them. Also, healthcare providers should advise patients with breast implants or those considering implants about SCC and lymphomas developing in scar tissue. The FDA has asked healthcare providers to develop treatment plans alongside experts in surgical oncology, plastic surgery, breast surgery, radiology, oncology, and pathology for affected breast implant patients.