Textured implants are associated with a rare form of cancer.
The recent recall of textured breast implants has people with them wondering what to do: Leave them, or get them removed immediately?
Allergan voluntarily recalled its Biocell textured breast implants last week after the
The implants have been linked to a rare cancer known as breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).
Biocell textured breast implants make up less than 5 percent of implants in the United States.
BIA-ALCL isn’t breast cancer; it’s a type of non-Hodgkin’s lymphoma. It’s mostly found in the scar tissue and fluid near the implant, but it can spread from the surgery site.
While the risk of developing BIA-ALCL is considered low, it can lead to death, especially if not discovered and treated early.
There have been 573 cases and 33 deaths from the cancer across the globe, reports the
Of the 33 deaths, the implant type was known in 13 cases, and 12 of the people had Allergan implants.
Most people with BIA-ALCL can successfully be treated with surgery to remove the implant and surrounding scar tissue. Some people may require radiation, chemotherapy, or both, notes the
Cases typically occur years after implants are inserted. Symptoms of BIA-ALCL include persistent swelling or pain near the breast implant. People should monitor the area for any changes.
Assessing people for BIA-ALCL typically involves a physical exam, imaging, and an assessment of the fluid or tissue around the breast implant.
People who have BIA-ALCL should have their implant and scar tissue removed. The surgery is a more involved procedure than regular implant removal.
Dr. Joshua Brody, director of the lymphoma immunotherapy program at The Tisch Cancer Institute at Mount Sinai, says some types of implants induce inflammation that can increase the chance of developing cancer, and also help “hide” developing cancers from the immune system.
“Many cases of implant-associated lymphoma have developed mutations and expression of immune-suppressive proteins, which prevent anti-tumor immune cells from clearing the cancer, and these chances likely begin with the inflammation induced by some implants,” Brody said.
Dr. Lara Devgan, a plastic surgeon in New York City, says the textured material may be at the root of the problem.
“The hypothesis underlying this voluntary recall is that texturing of certain breast implants may result in an inflammatory reaction that is linked to a rare but present risk of ALCL,” Devgan told Healthline.
She points out that smooth breast implants aren’t associated with that risk and are considered to be safe and effective devices.
Despite the dangers, the FDA doesn’t advise all women without symptoms to have their implants removed. People should talk to their healthcare providers about any questions.
All people with breast implants — regardless of surface texture or brand — should familiarize themselves with the symptoms of BIA-ALCL and continue with their regular screening mammograms per their doctor’s recommendation.
They should monitor for changes in the look or feel around their breast implants as well as discuss any concerns they may have with their healthcare provider.
People who experience symptoms, such as swelling, masses, pain, firmness, or changes in the size or shape of the breast, should be promptly evaluated.
If there’s concern related to the potential diagnosis of BIA-ALCL, a workup is recommended before removing the breast implant. That can include imaging, fluid aspiration, or biopsy, an FDA spokesperson told Healthline.
If you have questions about the Allergan recall, email the Division of Industry and Consumer Education (DICE) at dice@fda.hhs.gov, or call 800-638-2041 or 301-796-7100.
There are risks that come with having any implant inserted.
People may be more prone to having capsular contracture, which is scar tissue that forms around the device and puts pressure on it.
They can also experience changes in nipple and breast sensation, pain, and implant rupture.
Other complications can include hematoma, skin thinning and shrinking, asymmetry, lymphedema, and implant wrinkling, among
“Generally speaking, the most common risks of breast augmentation are bleeding, infection, scarring, and capsular contracture,” Devgan said. “Textured implants are associated with a small but present risk of ALCL, and this is why they are not recommended going forward.”
Devgan says the recall brings up another gripe she has with the industry as a whole: The industry of medical aesthetics and plastic surgery is “far too lax.”
She’d like for board-certified plastic surgeons to be the only doctors performing breast implant procedures.
“Right now in the U.S., any doctor — a gynecologist, an ear specialist, and even a pediatrician — is legally allowed to place breast implants, even though he or she may not be well informed in the nuances of proper protocols, informed consent discussions, and data collection,” Devgan said.
“This is the first thing I would change. Even extremely smart and well-informed patients don’t realize that there is a difference between a plastic surgeon and a cosmetic surgeon, and they may not be hearing about all of the real risks and considerations if they… see a nonspecialist,” Devgan said.