Nine women have died of a rare type of lymphoma that Food and Drug Administration officials now say may be caused by breast implants.
This form of cancer, called breast implant-associated anaplastic large cell lymphoma (ALCL), has occurred more often in women with implants that are textured rather than smooth, the FDA said Tuesday.
As of Feb. 1, the FDA said it had received reports of 359 cases of the implant-related cancer, including the nine deaths. Of those reports, 231 contained information about the surface of the implants. Among this group, textured implants made up 203 of the cases and smooth implants accounted for 28. It’s unclear why.
“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 announcement said.
Imperfect medical record-keeping complicates the task of knowing the full scope of the problem, according to the FDA.
In 2016, surgeons performed 290,467 breast augmentations, according to the American Society of Plastic Surgeons.
Though not a type of breast cancer, the malignancy develops in scar tissue around the implant, The New York Times reported. It can take 10 years for the cancer to develop after an implant, NBC News reported. Symptoms often include pain, lumps and swelling.
Women with implants do not need immediate medical attention because of the link, the FDA said.
“Breast implant removal in patients without symptoms or other abnormality is not recommended,” the FDA said. “If you have breast implants, there is no need to change your routine medical care and follow-up.”
Several developments in medical research contributed to the FDA’s conclusion. The World Health Organization, for instance, last year issued a report about the increased chance of lymphoma developing in women who’d received breast implants. There was also an Australian government report on ALCL in women with implants. The 46 confirmed cases of ALCL there all occurred in women with textured implants.
The FDA first looked at the relationship between implants and ALCL in 2011 but held off from reaching concluding that a heightened risk existed. The relative low number of cases made it tough to investigate the risk, the FDA said.
In the new report, the FDA placed less emphasis on the material filling the implant than on the texture. Silicone implants made up 186 of the 359 cases and saline implants showed up in 126 cases.
“It is important to note that details on breast implant surface and fill type are limited,” the FDA said on its website. “Over time, we may gather more information about a report and thus the numbers listed above may change.”
Patients considering breast implants for aesthetic or reconstructive reasons should ask their doctors about the benefits and risks of textured and smooth implants, the FDA said.
Doctors should likewise inform their patients about the possible risk.