A Rare Lymphoma May Be Linked with Breast Implants
The FDA is working to better understand if there is a definitive association between a cancer of the immune system and the use of breast implants.
Many women have breast implants with no serious complications, but they are being urged to stay vigilant about changes in their bodies as cases of a rare cancer grow.
Doctors too are being encouraged by the Food and Drug Administration to learn about breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) so they can better diagnose and treat women who may be at risk.
“We need better information about the condition so we have accurate information about what interventions should be,” says Paul Cederna, M.D., chief of plastic surgery at Michigan Medicine, who has promoted the use of registries for maintaining breast implant surveillance, as well as informed consent discussions between patients and their doctors.
In March, an FDA advisory committee met to hear testimony about the safety of implants.
Benefits and risks
But the benefits and risks of breast implants have been on the forefront of plastic and reconstructive surgery discussions for years.
The link between breast implants and the disease was first reported in 1997. Since then, about 450 cases have been reported to the FDA, and nine people have died from it.
“This is not a breast cancer, but a rare and treatable T-cell lymphoma — a cancer of the cells of the immune system — that usually develops as a fluid swelling around breast implants,” says Cederna, a past president of the Plastic Surgery Foundation.
Experts say the cancer is considered treatable if found early enough, with surgery to remove the implants and any masses, and possibly chemotherapy or radiation if the disease has spread.
The American Society of Plastic Surgeons, or ASPS, worked closely with the FDA in creating a registry to track cases of BIA-ALCL in 2012. Last year, the organization created a National Breast Implant Registry.
While the FDA says it doesn’t have definitive evidence suggesting breast implants are associated with these conditions, the agency says it’s looking to gain a fuller understanding of this issue to communicate risk, minimize harm and help in the treatment of affected patients.
The ASPS recently released new data that revealed 313,735 breast augmentation procedures were done last year in the United States, both for post-cancer reconstruction and, as is much more frequently the case, breast enhancement reasons alone.
BIA-ALCL occurs most often in patients who have breast implants with textured surfaces.
Textured implants are designed to disrupt the organization of surrounding tissue to prevent hardening of the breast. For this reason, some patients and surgeons believe they get superior results.
They are used in hospitals and clinics worldwide; however, French authorities have taken them off the market. At Michigan Medicine, textured implants haven’t been used in more than a decade.
“Michigan Medicine has not put in a textured implant in well over 15 years, and I probably haven’t placed one since 2000, 2001,” says Cederna, who specializes in reconstructive surgery.
During his plastic surgery foundation leadership in 2016, textured implants were a topic issue, he says. The organization worked to raise awareness among physicians by hosting webinars and panel talks and creating fact sheets.
“We had editorials in medical journals,” he says. “We talked about it everywhere we could.”
In 2018, Michigan Medicine decided to directly inform patients under its care who had received a breast implant at the hospital or from another health care provider to monitor their breast implants and to call their physician if they noticed changes.
Those changes could include pain, swelling or any unusual symptoms in or around their breast implant. A couple of other hospitals have made similar moves.
“We need to be sure everyone is informed of the disease and symptoms and provide the best care possible,” Cederna says. “It’s the right thing to do.”
To learn more from the Plastic Surgery Registries Network: What Patients Should Know About BIA-ALCL.
Michigan Medicine patients with BIA-ALCL symptoms can call the Plastic Surgery Team at 734-998-6022 or toll-free at 877-863-6267 to set up a time to talk to a physician.