The FDA has a warning for women with breast implants: Doctors have seen a worrisome spike in cases of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) in women who’ve gotten implants, suggesting the two are correlated and urging caution in any woman—cis or trans—considering them.
BIA-ALCL is not breast cancer; rather, it’s a type of non-Hodgkin’s lymphoma that attacks the immune system. Its fatality rate is low. When caught early, it usually can be treated.
It is, however, a rarer form of lymphoma, a type that normally isn’t seen often. Indeed, when the suspected correlation of breast implants with BIA-ALCL was initially pointed out in 2011, the FDA didn’t even have enough data points to make the connection.
But BIA-ALCL is becoming increasingly concerning, with both diagnoses and deaths of women with BIA-ALCL on the rise, according to the FDA. In the U.S., nine people died since the organization has been tracking deaths in 1997. As of 2016, there were at least 56 confirmed cases of women with BIA-ALCL, with three deaths in Australia. Other developed countries are reporting similar patterns.
And while the risk remains low, it’s certainly not a calming statistic.
Some wonder if the rates might continue to climb as more and more women get implants. Tamar Reisman, a gender-affirming surgeon at Mount Sinai in New York City, said breast augmentation rates have blown up over the last 20 years for both trans and cis women.
According to the American Society of Plastic Surgeons, there were about 310,444 breast augmentations in 2016, more than triple the number in 1997, when there were about 100,000. Potentially, one in about 4,000 women could be at risk of getting BIA-ALCL. However, Reisman said, “It’s still a teeny tiny percentage of people who suffer from the complication of textured implants.”
Implants come in different roundnesses, shapes, and sizes, and can be filled with saline or silicone. But there are only two types of implants: textured and smooth, which refers to how the shell feels.
Both textured and smooth implants have their pros and cons. Many women prefer silicone implants over smooth implants because of their more “natural” feel compared to saline. “The shell is made of silicone,” explained Rachel Blubond-Langner is an associate professor of plastic surgery at New York University's Langone Health who's done plenty of breast implants for both cis women and transgender women seeking gender-affirming surgeries.
“There’s silicone pre-filled from the factory,” she said. “The implant feels like a smooth ziplock bag if it’s smooth, or it has texture if it’s textured.”
Blublond-Langner said breast implants are personalized for women with consideration of their anatomy and aesthetic desires.
“There is no such thing as implants for transgender women,” she told The Daily Beast. “The same implants used for cosmetic breast augmentation for cis women are used for trans women. And the same implants used for cosmetic breast augmentation are used for oncological reconstruction cosmetic breast augmentation and chest feminization.”
“The reason textured implants were historically used is that [breast] tissue grows and attaches to the implant better,” she said. The smooth implants are made of silicone, too.
Reisman said textured implants avoid the problem that silicone has with migrating, but “there’s the correlation of textured implants and this lymphoma, so that’s something for patients to consider.”
Blubond-Langner only uses smooth implants in her practice, avoiding textured implants and their connection to BIA-ALCL. Reisman said she recommends counseling patients so they understand the risks and benefits of the procedure, and said that while she doesn’t recommend against a specific implant, she “[recommends] avoiding textured implants.”
But the FDA noted that both textured and smooth implants could be the problem, though textured implants appeared to be a source much more than smooth. Per the FDA:
272 of the 414 reports included information on the surface information of the implant at the time of the report, including 242 with textured surfaces and 30 with smooth surfaces. 413 of the 414 reports included information on implant fill types. Of these, 234 reported implants filled with silicone gel and 179 reported implants filled with saline.
Riesman’s practice deals a lot with transgender women, and she said gender-affirming surgeries only started picking up with legal changes around 2014 and 2015, when it became illegal for insurance companies to deny coverage for gender-affirming surgeries if they were deemed medically necessary. That meant it became easier for patients to get breast implants covered, “and there does seem to be data that indicates that the percentage of [transgender] patients [seeking breast implants] have increased accordingly,” she said.
Trans women are not necessarily at higher risk for BIA-ALCL than cis women for contracting the disease. But as Tamar Reisman points out, there’s not enough data for us to understand what the effect is on trans women: The most recent National Transgender Discrimination Survey only came out in 2016, and there’s normally a five-year gap between surveys, so our understanding of transgender women and their desires to get gender-affirming surgeries that include breast implants are limited to a single data point after the insurance change.
Blubond-Langner agreed, citing data and guidelines from the University of California at San Francisco. “The long and short of it is the data that we have wasn’t broken down according to gender identity,” she said. “We assume all the cases that have been reported in the database was in cisgender females. We would have to assume that the risk is the same in a transgender female.” That’s because there’s no indication of there being a hormonal or chromosomal component that could be affected and therefore lead to an increased chance of BIA-ALCL.
This latest warning raises yet another point of concern about the safety of breast augmentation. Just last November, the FDA released a warning about injectable silicone, which is often delivered in shoddy operations for butt and breast enhancement operations. The FDA said the liquid, cheaper alternative to silicone (not the same as the rubbery cups that are the basis of plastic surgery but more similar to commercial sealants and jellies) could float to vital vessels, clog them, and cause a stroke, perhaps death.
“This is not something to dismiss in any way, shape, or form,” Blubond-Langner said. “All patients, cis or trans, should be aware of signs and symptoms.” But she also said patients should be realistic about the chance of getting BIA-ALCL, which she emphasized is rare: “There are 10 million women walking around with breast implants,” she pointed out. “It’s a risk, but the instances are low and it’s treatable when addressed.”