Thirty-three women have died from breast implant-related lymphoma, otherwise known as BIA-ALCL.

By Faith Brar
Updated July 24, 2019
Photo: Shutterstock / Rawpixel

Earlier this month, the Food and Drug Administration (FDA) issued a statement confirming that there is a direct link between textured breast implants and a rare form of blood cancer known as anaplastic large cell lymphoma (ALCL). So far, at least 573 women across the globe have been diagnosed with breast implant-associated anaplastic large cell lymphoma (BIA-ALCL)–at least 33 have died as a result, according to the latest report from the FDA.

As a result, Allergan, the world's leading breast implant manufacturers, agreed to the FDA's request for a worldwide recall of the products.

"Allergan is taking this action as a precaution following notification of recently updated global safety information concerning the uncommon incidence of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) provided by the U.S. Food and Drug Administration (FDA)," Allergan announced in a press announcement obtained by CNN.

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 a significant enough risk of developing ALCL after getting breast implants. At the time, they'd only received 64 accounts of women developing the rare disease. Since that report, the scientific community has slowly learned 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 the FDA does not recommend the removal of textured breast implant products in women who don't have any symptoms of BIA-ALCL. Instead, the organization is encouraging women to monitor their symptoms and the area around breast implants for any changes. If you feel like something is off, then you should go talk to your doctor.

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 Shape exclusively about her struggles 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 because of the FDA's new findings. Plus, given that the likelihood of developing something as serious as BIA-ALCL is quite low–about 0.1 percent to be exact–the threat is an important component to consider, but might not be a deciding factor for some. (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.

Bottom line: This report raises some red flags. It's also opening an important dialogue with medical professionals to take women's symptoms more seriously.