FDA Tracking Squamous Cell Carcinoma Cases Linked to Breast Implants On New Registry

Amid growing concerns about the potential link between breast implants and squamous cell carcinoma (SCC), federal health officials have announced a registry to track reports of the skin cancer among breast implant recipients, and provided a series of recommendations for healthcare providers and patients.

The U.S. Food and Drug Administration (FDA) released an updated safety communication regarding breast implant cancer risks on March 23, informing the public about reports involving women who developed squamous cell carcinoma (SCC) tumors in the scar tissue surrounding the implants.

The update follows a breast implant squamous cell carcinoma warning first released in September 2022, which confirmed the agency was investigating the potential link after identifying cases of the skin cancer and other lymphomas in postmarketing reports.

Breast Implant Cancer Risks

Concerns about the risk of cancer from certain types of breast implants first emerged several years ago, after the FDA issued an Allergan Biocell implants recall in 2019, which warned the textured surface design of the Biocell implant was linked to nearly all known cases of breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL).

Since that recall, more than 1,000 Allergan breast implant ALCL lawsuits have been filed each raising similar allegations that Allergan sold unreasonably dangerous and defective textured implants, without warning women about the potential risks.

However, over the past six months concerns have emerged about a new cancer risk from breast implants, after reports were identified involving women diagnosed with squamous cell carcinoma (SCC), which is a form of skin cancer that develops in the middle and outer layers of the skin.

FDA Breast Implant Squamous Cell Carcinoma (SCC) Warning

In the latest safety communication, FDA officials indicate published literature has identified at least 19 cases of individuals who received breast implants developing squamous cell carcinoma, including a number of deaths likely linked to the condition.

Of the reported cases, 17 involved women, while one was reported in a male and no information was provided on another. The age at the time of diagnosis ranged from 40 years to 81 years and the majority of the patients presented symptoms of:

• Swelling around the implant
• Pain in the breast
• Lumps on the breast
• Skin discoloration

Reports of symptoms leading to the SCC diagnosis ranged from seven to 42 years after implantation, and the cancer was found in the capsule (scar tissue) behind the breast implant. The FDA stated three fatal cases of SCC breast cancer have been reported in medical literature.

Squamous cell carcinoma is the second most common form of skin cancer, which causes abnormal squamous cell growth. It often appears as red, scaly patches, sores, and thickened wart-like skin which can bleed, itch, crack and crust over. It can often be effectively treated if caught early, but can be disfiguring and deadly if diagnosis and treatment are delayed.

An estimated 1.8 million SCC cases are diagnosed each year, and the incidence rate has doubled over the last 30 years, health experts warn.

Breast Implant Cancer Monitoring & Recommendations

Given the growing number of breast implant squamous cell carcinoma cases, the FDA has released a series of recommendations to both healthcare providers and patients. Healthcare professionals are being instructed to;

• 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.
• Report all cases of SCC, lymphomas, and any other cancers in the capsule around the breast implant to the FDA.

For individuals who have already received breast implants, the FDA is instructing individuals to keep their routine medical care and follow-up schedule, and to report any changes in the breast implant promptly to your surgeon.

The FDA stated that as of March 22, health care providers may now submit case reports of SCC, various lymphomas and any other cancers found 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)