US agency warns of cancers in people with breast implants

The US regulatory agency, Food and Drug Administration (FDA) is warning the public about certain cancers — including squamous cell carcinoma and various lymphomas — that have been reported in scar tissue that forms around breast implants.

The FDA announced Thursday that while it believes that squamous cell carcinoma and various lymphomas in the capsule around breast implants may be rare, healthcare professionals and people who have or are considering implants in their Breasts should be aware of these cases — and report these or any other cancers found around the implant to the agency.

These various lymphomas are not the same lymphomas that were previously described as associated with breast implants, according to the FDA announcement.

The FDA said that after a preliminary review of the published literature, it is aware of fewer than 20 cases of squamous cell carcinoma and less than 30 cases of various lymphomas in the capsule around the breast implant.

Last week, the FDA received 10 medical device reports on breast implant-related squamous cell carcinoma and 12 medical device reports on various breast implant-related lymphomas, the announcement said.

People with breast implants don’t need to change their routine medical care, according to the FDA, but they should be aware that some of the reported signs and symptoms include swelling, pain, lumps, or skin changes.

The agency said it learned about these reports of squamous cell carcinoma and various lymphomas during an ongoing post-market review of the safety of breast implants in the United States.

“Reports submitted to the FDA are just one source the FDA uses to monitor the safety of medical devices, in addition to mandatory aftermarket studies, published literature, and real-world data from registries and claims databases,” said the report. announcement.

“The FDA will continue to gather and review all available data from these sources to assess the occurrence of cancer in the capsule around breast implants.”

The exact incidence rate and risk factors for these cancers remain unknown, and “this is an emerging issue and our understanding is evolving.”

A history of health problems and breast implants

A link between breast implants and systemic diseases, including autoimmune diseases, has been reported since the 1960s, according to an article published in the journal Plastic and Reconstructive Surgery in 2019.

In 2011, the FDA first identified a possible association between breast implants and the development of a rare cancer called breast implant-associated anaplastic large cell lymphoma, or BIA-ALCL.

In 2019, pharmaceutical company Allergan issued a worldwide recall of textured Biocell breast implants and tissue expanders that have been linked to rare cancer.

The move came after the FDA requested that the manufacturer voluntarily withdraw the products, and the FDA maintains a registry to which doctors must report cases of anaplastic large cell lymphoma in people with breast implants.

Since then, efforts have been made to better inform breast implant patients about possible health risks.

Last year, the FDA made several changes to breast implant regulations, including new labels with a boxed warning and a patient checklist that informs people that implants are not a medical device that will last a lifetime.

The agency said it has decided to restrict the sale of breast implants to healthcare professionals who provide patients with a standardized checklist that explains the risks.

The changes require physicians to educate patients about these potential health issues and give the patient the opportunity to sign the checklist to show that they have been properly informed about the risks to their health.

While most women have breast implants without serious complications, up to 20% of women who receive implants for augmentation need to have their implants removed within eight to 10 years due to complications, according to the FDA.

The older the implants, the more health risks they pose, and those risks may require additional surgery.

“Breast implants should not be lifelong devices. They have a lifespan, and that can range from seven to over 10 years, based on the implant and the patient,” Tommaso Addona, plastic surgeon and president of the Long Island Plastic Surgical Group in New York, told CNN in 2019, when the FDA held a meeting to review the safety of breast implants.

He added that he often discusses benefits and risks with his own patients.

“We discussed complications. These range from scarring around the implant, to sometimes pain and discomfort from the implant… even in the last seven years, probably a little longer, we’ve become more aware of a specific type of lymphoma that’s associated with breast implants,” he said.

“What the general public should appreciate is that, as doctors and clinicians, we always want what is best and safest for our patients. We are constantly not only educating ourselves, but also educating our patients.”