Dive Brief:

• Cases of squamous cell carcinoma may be linked to breast implants, the Food and Drug Administration said on Wednesday, noting that it had identified 19 cases of the cancer in the scar tissue around the implants in published studies.
• The report is an update to a previous warning by the FDA in September about squamous cell carcinoma and various lymphomas forming around breast implants. This is separate from breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), which has been a known issue for a decade. 
• While the FDA believes that occurrences of squamous cell carcinoma around the breast implant may be rare, “the cause, incidence and risk factors remain unknown,” the agency wrote.  

Dive Insight:

Of the 19 cancer cases, three deaths were reported, the FDA noted. The majority of the cases involved reports of swelling and breast pain, lumps and discoloration. People were diagnosed with squamous cell carcinoma seven to 42 years after the initial implant placement, which was for breast reconstruction or augmentation. 

As of Jan. 15, the agency had received a total of 24 medical device reports about squamous cell carcinoma related to breast implants. These don’t necessarily represent the incidence of the cancer, because of potential duplicate reports or underreporting, the FDA said.

There were 137,808 breast reconstruction and 193,073 breast augmentation surgeries in 2020, according to the American Society of Plastic Surgeons. 

Patients should notify their surgeon or doctor if they notice any changes with their breast implants, but if they don’t have any symptoms, the FDA doesn't recommend removing them. 

Squamous cell carcinoma is just one type of cancer linked to breast implants. In 2019, Allergan recalled its Biocell textured breast implants because they had been linked to breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). Mentor, Ideal Implant, and Sientra also have restrictions on selling breast implants. 

In 2021, the FDA put a black box warning on breast implants, and limited the sale of the devices to healthcare providers and facilities that review a decision checklist with each patient. As of April 2022, the agency had received medical device reports of 1,130 cases of BIA-ALCL, including 59 deaths. 

The FDA said it will continue to collect information about squamous cell carcinoma, lymphomas, and other cancers in the scar tissue around breast implants, and asked doctors and patients to report related cases.