Nine deaths from a rare form of cancer have been linked to breast implants, the Food and Drug Administration announced Tuesday.
Red flags were raised in 2011 regarding the safety of breast implants and their possible link to a type of lymphoma, but the FDA has now updated information on the risk to women with both silicone and saline breast implants.
As of February 1, 2017, the FDA had received a total of 359 reports related to breast implant-associated anaplastic large cell lymphoma — a rare cancer of the immune system — including nine deaths, the agency said in a statement. ALCL is not a form of breast cancer, but it grows in the breast in implant patients.
The exact number of cases is unclear due to limitations in worldwide reporting and a lack of global implant sales data, according to the FDA statement. But the current data suggests the rare form of cancer occurs more frequently with textured-surface breast implants versus those with smooth surfaces.
Of the 359 reports, 231 included information on the implant surface; 203 were textured implants and 28 were smooth implants.
Women diagnosed with the implant-linked cancer have reported pain, lumps, swelling or breast asymmetry.
Last year, 290,467 breast augmentations were performed in the U.S. — 109,000 of which were for reconstruction after breast cancer — according to the American Society of Plastic Surgeons.
Dr. Maggie DiNome, a breast cancer surgeon and associate clinical professor of surgery at UCLA Medical Center, told CBS News that she received many calls after news of the FDA report broke this week. She said women with implants should know that it’s a very rare form of cancer.
“They have only documented 300 or so cases of this. We’re talking about 300 out of 10 million women worldwide with implants, so it’s very, very rare and it’s very curable if you were to get it,” said DiNome, noting that the implant would be taken out in most cases.
DiNome also said that the symptoms of implant-linked ALCL, such as one breast being more swollen than the other, can be due to other issues with an implant not related to cancer, including infection or trauma.
In cases not linked to breast implants, ALCL normally shows up on a blood test for the illness, said DiNome, typically ordered if a patient is experiencing enlarged lymph nodes, fatigue and other symptoms that prompt a physician to test for the condition.
“Be aware, but I don’t think it should cause alarm. Just like with breast cancer, if you find a mass in your breast, go get it checked out,” DiNome said. She doesn’t recommend having the implant removed as a precaution.
DiNome’s colleague, Dr. Deanna Attai, a breast cancer surgeon and assistant clinical professor of surgery at UCLA, anticipates discussing the issue with implant patients now more often.
“I think it stresses that implants, especially when performed for cosmetic purposes, should still be thoughtfully considered just like any other medical procedure, and there are associated risks,” said Attai, who encourages a prompt evaluation if a woman does experience breast changes.
The FDA said it will continue to collect information about the disease in women with breast implants and the agency encouraged health care providers to monitor implant patients regularly. They did not recommend implant removal in patients without symptoms or other abnormalities.
“If you already have breast implants, there is no need to change your routine medical care and follow-up,” the FDA statement said. It recommended that women who are considering implants weigh the risks and benefits with their health care providers.
Dr. Debra Johnson, a plastic surgeon in private practice in Sacramento, California, and president of the American Society of Plastic Surgeons, told CBS News that plastic surgeons have been aware of the link between ALCL and breast implants since the first case was described in 1996. The next cases were described in 2008 and 2011, she said.
“We hired RAND Corporation and did a very extensive evaluation from a plastic surgery, epidemiology, manufacturing and FDA standpoint — everybody that was a stakeholder,” said Johnson.
The society developed a registry for doctors to submit cases to learn more about the disease.
“We have been like a dog on a bone trying to figure it out. We have a worldwide group of all international plastic surgery societies and we meet regularly, sharing information and discussing this issue,” said Johnson.
Three issues appear to be linked to the condition, she said.
“Patients who’ve had these implants have all had textured implants at the time of discovery or at some point in the past. There also appears to be a bacterial, low-grade infection present. And there also appears to be some sort of genetic component. There are places where there are pockets of high numbers of cases, like Australia, and then other other places like Japan where they use exclusively textured implants and there are no cases. But we’re having a difficult time getting our hands around it,” said Johnson.
Doctors and patients can go to The Plastic Surgery Foundation’s website to report cases of anaplastic large cell lymphoma thought to be linked to breast implants. The organization created the registry to track cases and better understand the role of the breast implants in the disease and further identify possible risks.