FDA Warns Breast Implants May Be Linked to Additional Cancers

The U.S. Food and Drug Administration is warning patients who have breast implants or are considering getting them of additional cancers linked to implants, according to an FDA Safety Communication issued Thursday.

The cancers—squamous cell carcinoma (SCC) and various lymphomas—are considered extremely rare, but the agency is still urging patients and healthcare providers to be aware of the newly-discovered potential risks associated with breast implants.

The cancers are also different from breast implant-associated anaplastic large cell lymphoma (BIA-ALCL)—another rare type of cancer linked to breast implants with textured surfaces. In 2019, the FDA requested Allergan—the manufacturer of a specific type of textured implant—to recall the specific implants associated with an increased risk of BIA-ALCL.

The cancers are also not specifically breast cancers—they are just linked to breast implants.

"Importantly, while these cancers are being associated with breast implants, they are not cancers of the breast tissue or designated as breast cancer," Colleen McCarthy, MD, a plastic and reconstructive surgeon at Memorial Sloan Kettering Cancer Center, told Health. "The FDA explicitly states that because of the small number of documented cases, it is not yet known if these unexpected cancers are in fact caused by breast implants or if there are specific types of implants that may pose a higher risk."

As of right now, the FDA and the American Society of Plastic Surgeons are not recommending that patients who have breast implants have them removed, but rather to keep a watchful eye on their bodies if they have breast implants and recognize signs of any potential issues.

Newly Identified Cancers Linked to Breast Implants

According to the FDA, the reports of SCC and various lymphomas (cancers of part of the immune system) linked to breast implants were in the scar tissue, or capsule, that forms around a breast implant once it's in the body.

The true incidence of SCC and lymphomas is unknown, although there have been reports in medical literature of both SCC and lymphomas linked to both textured and smooth, and saline and silicone breast implants.

The FDA is aware of less than 20 cases of SCC and less than 30 cases of various lymphomas linked to breast implants—which means the cancers are rare, but something to keep an eye on.

"These new cancers found around breast implants appear to be rare," said Dr. McCarthy, who is also the lead investigator of the PROFILE Registry, a collaborative effort between the FDA and the ASPS that aims to evaluate U.S. cases of BIA-ALCL.

Dr. McCarthy cites the huge amount of people who have—and who get—breast implants in the U.S. "An average of 400,000 women will have breast implants placed in the United States in a typical year," she said. "It is thus estimated that millions of women in the U.S. alone currently have breast implants."

Because these incidences appear to be rare—and because experts aren't yet sure of the relationship between the implants and the cancers—patients who have implants are being told to monitor their health and recognize any potential warning signs.

"Women should arm themselves with the knowledge of how to recognize signs of potential issues with their implants," said Dr. McCarthy. "If an implant changes in size or shape, and/or if a bump in the breast develops, it should be evaluated by a physician." Changes in the skin of the breast, or lumps or bumps in the armpit may be important warning signs too.

According to the FDA, some of the reported changes in patients with cancers linked to breast implants included swelling, pain, lumps, or skin changes.

It is important to note, however, that these signs and symptoms don't necessarily mean a cancer diagnosis is imminent. "These changes, for example, can also result from a leaking implant or trauma to the breast area," said Dr. McCarthy. "Ongoing monitoring is one of the best defenses we have against any implant-associated health concerns."

And if a person with breast implants is not experiencing any issues with them, the best course of action may be to leave them in. "The risk of removing the implants and the scar tissue around them outweighs the risk of 'watchful waiting' if the patient has no problems with their implants," Nigel Mercer, FRCS, a U.K.-based plastic surgeon. "Unfortunately there are no screening tests for the cancers associated with breast implants."

Other Issues Linked to Breast Implants

Previously, the FDA warned about BIA-ALCL, an uncommon type of T-cell lymphoma, or a cancer that forms in the immune system. It's still quite rare; as of April 2022, the FDA has received 1,130 U.S. and global reports of BIA-ALCL.

BIA-ALCL is not a type of breast cancer—instead, it's a type of non-Hodgkin's lymphoma. The cancer forms in the scar tissue and fluid around the breast implant, and has the potential to spread throughout the body, according to the FDA.

"BIA-ALCL" is associated with a specific type of implant with a rough or textured surface," said Dr. McCarthy, adding that breast implants with smooth surfaces have not been linked to BIA-ALCL.

The link between textured breast implants and BIA-ALCL led the FDA to request a worldwide recall of Allergan's BIOCELL textured breast implant products.

Last year, the FDA also added so-called "black box" warnings on breast implant packages, urging physicians to let patients known not only of the risks of BIA-ALCL, but also of other chronic conditions like autoimmune diseases, joint pain, muscle aches, and chronic fatigue—a constellation of symptoms that make up what's known as breast implant illness (BII).

BII is not recognized as a formal medical diagnosis. "However, any patient with symptoms must be dealt with sensitivity and compassion and not just dismissed," said Dr. Mercer, who added that it's only logical to assume that the immune response the body makes to anything inserted under the skin will become clinically significant in a proportion of patients.

The adverse outcomes linked to breast implants have prompted the FDA to recommend patients become aware of the risks before opting for surgery. A patient decision checklist provided by the FDA outlines possible complications of breast implants—including BIA-ALCL and BII—and reminds patients that breast implants are not intended to be lifetime devices. The agency also advises patients that the longer they have breast implants, the greater the likelihood of complications.

Overall, people with breast implants and those considering them should consider all of the potential risks and benefits so they can make an informed decision that feels right for them. "Women with breast implants should know when to seek medical attention," said Dr. McCarthy, "and be empowered to take ownership of their health."