FDA Uncovers More Types of Cancer Linked to Breast Implants
The Food and Drug Administration (FDA) is warning that breast implants are linked to certain cancers that can develop in the scar tissue that forms around the implants.
The FDA issued the warning in a safety communication, noting that these cancers are different from Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), a form of cancer linked to breast implants that the agency has previously warned about.
The cancers flagged by the FDA, which include squamous cell carcinoma (SCC) and different cancers of the immune system (lymphomas), are linked to all types of implants, whether they’re smooth or textured, or filled with saline or silicone. The cancers form in the scar tissue around the implant, which is known as the capsule.
This isn’t the first time breast implants have been linked to cancer: In 2019, the FDA asked for a recall of textured implants made by Allergan after they were linked to nearly 600 cases and 33 deaths. (The company complied.)
The newly-flagged cancers seem to be rare: The FDA says that a preliminary review of scientific literature turned up less than 20 cases of squamous cell carcinoma and less than 30 cases of lymphomas in the capsule around the breast implant. The FDA says it will “continue to gather and review all available data” about cancers in the capsule around breast implants.
If you have breast implants or are considering implants, it’s understandable to have concerns. Here’s what you need to know.
Why are breast implants linked to cancer?
It’s actually not known at this point. “The incidence, etiology, and risk factors for developing squamous cell carcinoma and non-BIA-ALCL lymphomas related to breast cancers remains unclear although some theories exist for its development,” says Sameer A. Patel, M.D., chief of Plastic and Reconstructive Surgery at Fox Chase Cancer Center.
One major theory is that the tissue around the implant and capsule can become inflamed, causing fluid to build up and damage the cells. That can cause cancer to develop in the fluid. If things progress, the cancer enters the capsule and can invade other tissues, including lymph nodes, from there.
Another theory is that the silicone or polyurethane material in the implant may cause a person’s immune system to overreact, leading to a toxic chain reaction that can eventually lead to cancer.
“This is not breast cancer—that’s an important distinction,” says Janie Grumley, M.D., breast surgical oncologist and Director of the Margie Petersen Breast Center at Providence Saint John’s Center and Associate Professor of Surgery at Saint John’s Cancer Institute in Santa Monica, Calif. “This is a reactive type of disease. The body recognizes something in it that’s not you and overreacts.”
Are breast implants safe to use?
Breast implants are fairly common: About 200,000 people in the U.S. got breast implants in 2020, according to data from the American Society of Plastic Surgeons (ASPS), which was a 33% decrease from the year before (likely due to the pandemic).
But they come with some risks. Breast implants have black-box labels from the FDA that warn they’ve been linked to a slew of serious health conditions, like autoimmune diseases, lymphoma, joint pain, and more.
The ASPS also warns that people may have issues with the following from breast implant surgery:
Anesthesia risks
Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL)
Bleeding
Changes in nipple or breast sensation
Fluid accumulation
Formation of tight scar tissue around the implant
Hematoma (a pool of clotted blood)
Implant leakage or rupture
Infection
Persistent pain
Poor scarring
Possible need for revision surgery
Wrinkling of the skin over the implant
Wrong or poor position of the implant
Overall, breast implants are thought to be relatively safe medical devices, keeping all of those risks in mind. “It is important to remember that the number of reported cases remains quite low,” Dr. Patel says. “However, patients considering breast implants should be informed of this finding.”
There are other issues you can develop from having breast implants, Dr. Grumley points out. “People can have pain associated with scar tissue and implant-related illnesses where they just feel off. Those things are much more common,” she says.
But, as for cancer linked to implants, “this is an emerging issue and our understanding is evolving,” says says Alexis Parcells, M.D., a board-certified plastic and reconstructive surgeon and founder of Parcells Plastic Surgery. She adds, “The FDA and ASPS take this matter very seriously.”
What to do if you have breast implants
The FDA stresses in the safety communication that officials think that these cancers are rare. However, they note that people with these cancers have reported having the following symptoms:
Swelling
Pain
Lumps
Skin changes
If you have implants, there’s no need to change your standard medical care or to schedule a follow-up with your doctor based on this, Dr. Parcells says. However, she recommends monitoring your breasts, making a point to feel them on the first of every month for changes. “If you notice a change, see your board-certified plastic surgeon and discuss your options,” she says. “It’s your body—you had the right to have them put in, and you have the right to have them removed.”
The FDA also recommends that you do the following:
Learn more about the risks and benefits of breast implants.
Be aware that cases of SCC and various lymphomas in the capsule around the breast implant have been reported.
Monitor your breast implants for as long as you have them. If you notice any abnormal changes in your breasts or implants, contact your surgeon or health care provider.
If you have breast implants and have a problem, the FDA encourages you to file a report through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
Worth noting: The FDA currently does not recommend that people have their implants removed due to this cancer risk. “With medicine, there is a side effect to everything we do,” Dr. Grunley says. “People need to understand that there is a cancer risk, but it’s a very, very low risk.”
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