An NCI-designated Comprehensive Cancer Center
By Samantha Bonar | November 30, 2018
Leslie Popplewell Leslie Popplewell, M.D.
A recent NBC News report highlighted the small but apparently growing risk of a rare kind of lymphoma in women who have received breast implants. The cancer, breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), has been documented in just over 400 women, according to the Food and Drug Administration (FDA). But that number has jumped from just 34 cases reported between 1997 and 2010 to 55 cases reported over the last year.
“It’s not very common, but it’s a real thing,” said Leslie Popplewell, M.D., associate clinical professor in the Department of Hematology & Hematopoietic Cell Transplantation at City of Hope, who published a study on nine BIA-ALCL cases at City of Hope in the Journal of Leukemia and Lymphoma in 2010. Still, she said she thinks the statistics "don't warrant panic. There are so many women with implants in the U.S., and it’s really not even all implants that are implicated in this, just certain types.” The cancer, a form of non-Hodgkin's lymphoma, is associated with the use of textured breast implants in particular, although cases have been linked to smooth implants as well.
The FDA first identified a possible association between breast implants and the development of ALCL in 2011. According to an August 2018 article in the journal Blood, 550,000 women in the U.S. receive implants each year for cosmetic and reconstructive purposes. It is estimated that the incidence of BIA-ALCL in the United States is 33 per 1 million people with textured breast implants, which equates to an estimated lifetime risk of 1 in 30,000. On average, the diagnosis is made seven to 10 years after implantation.
As of Sept. 30, 2017, the FDA had received a total of 414 medical device reports (MDRs) of BIA-ALCL, including the deaths of nine patients. However, the agency says it is difficult to determine the total number of cases or estimate risk from the MDRs “due to potential under-reporting of events, possible duplicate reporting, and lack of data about the exact number of breast implants.” Because of these limitations, the FDA says the risk could be as high as 1 in 3,817.
Another reason the incidence may be underreported is because of underdiagnosis or misdiagnosis, Popplewell said. A common symptom of BIA-ALCL is developing fluid around the breast implant, but that can also be a symptom of inflammation or infection. Often the fluid is drained and/or the implant is removed and the fluid is never tested for lymphoma. In most cases, BIA-ALCL is found in the fluid and scar tissue near the implant. “Complete surgical excision is usually curable,” for BIA-ALCL, Popplewell explained. “If you don’t test the effusion, you don’t know you have it. It could be that doctors weren’t even looking for it up until recently.”
Most of the time, ALCL doesn’t spread outside of the breast area, “but there are, of course, patients who present with advanced-stage disease,” Popplewell said. “This is why it’s important to test the fluid, to make sure the surgery you do is adequate.”
Textured implants, which have a rougher surface to help them stay in place, can irritate surrounding tissue, creating chronic inflammation that initiates an immune response, Popplewell said. That immune response involves lymphocytes, which can become malignant over time. “If you get chronic inflammation in an area long enough, there’s more opportunity for genetic mistakes in the cells to be made,” she explained, leading to ALCL.
Developing BIA-ALCL is entirely based on the implant and doesn’t have anything to do with the state of the health of the woman getting it, Popplewell said, meaning women with or without breast cancer are equally at risk. It also doesn’t seem to matter whether the implant is silicone- or saline-filled.
Even though the incidence of BIA-ALCL is low, “If you have other choices, I don’t know why you’d choose to use something that’s linked to this problem,” Popplewell said. “It doesn’t make sense to me that anyone would continue to use these [textured implants], knowing what could happen. You’re putting the patient at risk for a lymphoma that may or may not be curable.”
For women who already have textured implants, if they aren’t having any symptoms of pain or swelling, “I don’t think there’s a reason to remove them, but if they’re developing fluid around the implant, that needs to be checked out. Just removing the fluid isn’t therapeutic. It has to be tested, specifically looking for lymphoma cells. If you are having symptoms, they have to be evaluated properly,” Popplewell said.
For those considering implants, Popplewell asks, “If one could do the job just as well as the other, why would you choose one that would put you at risk in the future?”
The FDA plans to hold public hearings on the issue of the link between ALCL and textured implants, and to ask experts and the public what should be done about it, next year.

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