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On Wednesday, the Food and Drug Administration (FDA) issued a statement confirming that there is a direct link between breast implants and a rare form of blood cancer known as anaplastic large cell lymphoma (ALCL). So far, at least 457 women in the U.S. have been diagnosed with breast implant-associated anaplastic large cell lymphoma (BIA-ALCL)—and nine have died as a result, according to the latest report from the FDA.
While this news might come as a shock to some, this isn't the first time the FDA has sounded the alarm on BIA-ALCL. Doctors have been reporting incidents of this particular cancer since 2010, and the FDA first connected the dots back in 2011, reporting that there was a small but significant enough risk of developing ALCL after getting breast implants. At the time, they'd only received 64 reports of women developing the rare disease. Since that report, the scientific community has slowly started to learn more about BIA-ALCL, with the most recent findings solidifying the link between breast implants and the development of this potentially fatal disease.
"We hope that this information prompts providers and patients to have important, informed conversations about breast implants and the risk of BIA-ALCL," they said in the statement. They also published a letter asking health care providers to continue reporting possible cases of BIA-ALCL to the agency.
Should Women with Breast Implants Be Concerned About Cancer?
For starters, it's important to note that while women with all types of implants are at a heightened risk of developing ALCL, the FDA found that textured implants, in particular, tend to pose the greatest risk. (Some women opt for textured implants as they tend to prevent slipping or movement over time. Smooth implants are more likely to move and might need to be readjusted at some point, but generally feel more natural.)
Overall, the risk for women with implants is quite low. Based on the current numbers received by the organization, BIA-ALCL may develop in 1 in every 3,817 to 1 in every 30,000 women with textured breast implants.
Still, "this is far greater than previously reported," Elisabeth Potter, M.D., a board-certified plastic surgeon and reconstruction expert, tells Shape. "If a woman has textured implants in place, she needs to understand the risk of developing BIA-ALCL." (Related: Getting Rid of My Breast Implants After a Double Mastectomy Finally Helped Me Reclaim My Body)
Right now, it's not entirely clear why textured implants are more susceptible to causing BIA-ALCL, but some doctors have their theories. "In my own experience, textured implants create a more adherent capsule around the breast implant that is different from the capsule around a smooth implant, in that the capsule around a textured implant adheres more strongly to the surrounding tissue," says Dr. Potter. "BIA-ALCL is a cancer of the immune system. So there may be an interaction between the immune system and this textured capsule that contributes to the disease."
How BIA-ALCL and Breast Implant Illness Are Related
You may have heard of breast implant illness (BII) before, at least in the last few months as it's gained traction among influencers who have spoken up about their mysterious symptoms and theories of how they relate to their implants. The term is used by women to describe a series of symptoms that stem from ruptured breast implants or an allergy to the product, among other things. This illness isn't currently recognized by medical professionals, but thousands of women have taken to the internet to share how their implants were causing unexplainable symptoms that all went away after they got their implants removed. (Sia Cooper told us all about her struggles here, in I Got My Breast Implants Removed and Feel Better Than I Have In Years.)
So while BIA-ALCL and BII are two very different things, it's possible that women who think they are having an allergic reaction to their implants could have something more serious like BIA-ALCL. "I think it is important to listen to women and to continue to gather data regarding any adverse event associated with implants," says Dr. Potter. "As we listen and understand, we will learn. This new report on BIA-ALCL is an example of that."
What This Means for the Future of Breast Implants
Every year, 400,000 women opt to get breast implants in the U.S. alone—and there's no way to tell whether that number will decrease despite the FDA's new findings. Plus, as we mentioned above, the likelihood of developing something as serious as BIA-ALCL is quite low—about 0.1 percent to be exact, so the threat isn't exactly substantial enough to suddenly change everyone's minds about breast implants. (Related: 6 Things I Learned from My Botched Boob Job)
"Breast implants have been studied extensively and the FDA still considers them safe to use in both cosmetic and reconstructive surgeries," Dr. Potter says. "The adverse event reporting system is in place to make sure that our knowledge of safety is evolving over time as we learn more from patient experience. Clearly, our understanding of the safety of breast implants is evolving and the statement from the FDA reflects that." (Related: This Influencer Opened Up About the Decision to Get Her Implants Removed and Breastfeed)
What we do need is more research. "We need to understand more about the disease in order to treat and prevent it," says Dr. Potter. "In order for this to happen, women have to speak up. If you have breast implants, you need to be an advocate for your own health."
What Women Considering Breast Implants Should Know
If you're considering getting implants, educating yourself about what exactly you're putting into your body is key, says Dr. Potter. "You need to know whether the implant is textured or smooth on the outside, what type of material is filling the implant (saline or silicone), the shape of the implant (round or teardrop), the name of the manufacturer, and the year the implant was placed," she explains. "Ideally, you will have a card from your surgeon with this information and the serial number of the implants." This will help you in the event that there's a recall on the implant or if you experience an adverse reaction.
It's also important to know that the breast implant industry itself is taking some steps in response to these claims to make women feel safer. "Some new implants now have warranties that cover the medical costs of the testing for BIA-ALCL," says Dr. Potter.
But on a broader level, it's important for women to know that implants aren't perfect and that there may be other options available to them. "In my own practice, I have seen a dramatic shift away from implant-based breast reconstruction toward reconstruction that doesn't use an implant at all. In the future, I hope to see cutting-edge surgery available to all women, including women who want to enhance their breasts for cosmetic reasons, without needing an implant at all," she says.
In the meantime, the complaints and concerns surrounding breast implants have pushed the FDA to hold a public meeting, slated for this year, to "ensure that patients and health care providers continue to have accurate, scientifically sound information about breast-implant safety and effectiveness."
Bottom line: While this report does raise some red flags it's also starting an important dialogue and encouraging medical professionals to take women's symptoms more seriously.