Breast implants can cause a rare form of cancer that may have killed at least nine people, the Food and Drug Administration said Tuesday.
The cancer is called anaplastic large cell lymphoma (ALCL) and the FDA is checking into more than 350 reports linking it with both silicone and saline breast implants.
“All of the information to date suggests that women with breast implants have a very low but increased risk of developing ALCL compared to women who do not have breast implants,” the FDA said in a statement.
Breast augmentation is the second most popular cosmetic procedure among women, after liposuction. More than 300,000 procedures were performed in 2015. So the cancer would be very rare even with 300 cases over 10 years or longer.
And the FDA says it is easily treated if caught early enough.
“Most cases of breast implant-associated ALCL are treated by removal of the implant and the capsule surrounding the implant and some cases have been treated by chemotherapy and radiation,” it said.
Suspicions have been growing that implants might cause ALCL, which is a type of non-Hodgkin’s lymphoma.The FDA first started looking into the possibility in 2011.
“At that time, the FDA knew of so few cases of this disease that it was not possible to determine what factors increased the risk,” the agency said.
But now there’s more information, including hundreds of complaints and a World Health Organization report pointing to breast implants as a possible cause.
“As of February 1, 2017, the FDA has received a total of 359 medical device reports of breast-implant-associated ALCL, including nine deaths,” it said.
“Breast implants approved in the U.S. can be filled with either saline or with silicone gel. They come in different sizes and shapes and have either smooth or textured surfaces (shells),” it says.
The FDA added, “There are 231 reports that included information on the implant surface. Of these, 203 were reported to be textured implants and 28 reported to be smooth implants.”
The cancer can take about 10 years to develop on average after the implant first goes in and usually stays in the area right around the implant, WHO researchers reported last year in the journal Blood. But it can break out and spread.
It’s usually diagnosed after a patient reports pain and swelling.
The FDA recommends that patients do some research before getting breast implants.
“Although it is rare, breast-implant-associated ALCL appears to develop more frequently in women with textured implants than in women with smooth-surfaced implants. Before getting breast implants, make sure to talk to your health care provider about the benefits and risks of textured-surface vs. smooth-surfaced implants.”
The FDA has a breast implants website with more details.
“If you have breast implants, there is no need to change your routine medical care and follow-up,” the agency added, noting that ALCL is rare.
“Follow your doctor’s instructions on how to monitor your breast implants. If you notice any changes, contact your health care provider promptly to schedule an appointment. Get routine mammography screening and ask for a technologist specifically trained in performing mammograms on patients with breast implants,” the FDA advised.
People with silicone gel implants should get magnetic resonance imaging (MRI) scans to look for leaks.
The American Society of Plastic Surgeons and the Plastic Surgery Foundation are making a list of implant patients who develop ALCL. “The research will also focus on identifying potential risk factors and criteria detection and management of this disease,” the groups say on a website devoted to the matter.
In 2011, the FDA reported that one in five women who had silicone breast implants for cosmetic purposes — and half of those who got implants after a mastectomy — needed surgery to remove the implants within a decade.