FDA Issues Statement on New Cases of Rare Breast Implant-Related Cancers

The Food and Drug Administration (FDA) issued a statement informing the public about cancers — specifically squamous cell carcinoma and lymphomas — that may occur in the scar tissue around breast implants.

Of note, these cancers are not the same as the previously reported breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), according to the agency.

According to the Skin Cancer Foundation, squamous cell carcinoma is the second most common form of skin cancer.

The FDA reported being aware of fewer than 20 cases of squamous cell carcinoma and fewer than 30 cases of different lymphomas found in the scar tissue around implants, known as the capsule. As of Sept. 1, there have been a total of 22 medical device reports (which monitor and report on potential safety issues from medical devices) for breast implants: 10 related to squamous cell carcinoma, and 12 related to lymphomas.

The incidence rate and risk factors for breast implant-related cancers are currently unknown, according to the FDA.

“When breast implant information was provided, there have been literature reports of (squamous cell carcinoma) and various lymphomas in the capsule around the breast implants for both textured and smooth breast implants, and for both saline and silicone breast implants,” the FDA wrote in their report. “In some cases, people were diagnosed after years of having breast implants. Some of the reported signs and symptoms included swelling, pain, lumps or skin changes.”

Recommendations for Individuals With or Considering Breast Implants

The FDA recommended that people with breast implants, or those who are considering them should learn more about the potential risks.

Those who already have implants do not need to change their medical care, according to the agency, though they should monitor their implants and talk to their surgeons or health care team if they notice any changes. At this time, the FDA is not recommending the removal of implants for women without symptoms.

For women who experience issues or symptoms from their implants, the FDA urges them to file a report through MedWatch, which is the agency’s way of collecting data on side effects, which can potentially improve patient safety.

In the future, the FDA noted that it plans to complete a literature review of data and continue its partnership with the American Society of Plastic Surgeons to gather more information about cancers arising in the breast capsule. These findings will be communicated to the public.

“Right now, we do not have enough information to say whether breast implants cause these cancers or if some implants pose higher risks than others,” the FDA said in a statement. “For this reason, instances of (squamous cell carcinoma), lymphoma and any cancer located in the scar tissue around breast implants should be reported to the FDA.”

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