Getting the Facts on Breast Implants and ALCL: What We Know So Far + Our Recommendations for Staying Safe

If you have breast implants or have been considering breast augmentation, chances are you’ve come across some scary headlines about breast implants and cancer over the last year or so. When the FDA announced there was an association between breast implants and anaplastic large cell lymphoma (ALCL), the press went wild—and women everywhere began wondering, “do breast implants cause cancer?”

While we first want to reiterate that breast augmentation is, by and large, still considered a safe procedure in the hands of an experienced cosmetic surgeon, it’s important for women considering the procedure to understand all of the risks and how often they occur so they can make an educated decision.

Unfortunately, wading through all the available information can be overwhelming, and it can be a challenge to separate opinion from facts. At the American Board of Cosmetic Surgery, our primary focus is keeping patients safe through education and access to highly trained cosmetic surgeons, so we wanted to take this opportunity to answer some of the most common questions we receive about BIA-ALCL diagnosis, treatment, and current trends.

What is breast implant associated anaplastic large cell lymphoma (BIA-ALCL)?

ALCL is a rare type of non-Hodgkin lymphoma that impacts the immune system. It develops when there is a build-up of abnormal T-cells in the lymph nodes, though it can spread to other parts of the body. BIA-ALCL is an even rarer form of ALCL that develops specifically in the capsule of scar tissue that surrounds breast implants rather than lymph nodes. BIA-ALCL is not a form of breast cancer.

Treatment of BIA-ALCL is most successful with early detection and involves removing the breast implant and surrounding scar tissue.

Should I be worried about ALCL if I have breast implants?

When you look at the statistics from the FDA, it’s clear that ALCL is incredibly rare. But numbers and percentages aren’t always enough to ease your mind—and the fact is that a number of women have developed ALCL because of their breast implants.

But, while there is a correlation between breast implants and ALCL, that does not mean all women with breast implants are at risk, or that all breast implants cause ALCL. Here are key facts to keep in mind:

• Millions of women in the United States have breast implants. Since 2010, there have been 660 reports of BIA-ALCL, including nine fatalities, in the United States.
• These statistics reflect reports of BIA-ALCL, which does not necessarily equate to 660 confirmed cases of BIA-ALCL. Because some patients have multiple reports and reports from physicians and patients are voluntary, the total number of cases is likely different and somewhat lower.
• In July 2019, the FDA updated the numbers after an in-depth analysis of the reports to determine unique cases. They estimate 457 unique cases of BIA-ALCL in the United States and 573 unique cases worldwide, with an estimated 33 global fatalities.
• The vast majority of reports of BIA-ALCL occur in patients who have textured breast implants or who have had textured implants at some point in the past. In fact, the FDA has shared a number of studies that suggest textured implants are a risk factor.
• The medical community is still studying BIA-ALCL, including how textured implants impact the risk, what we can do to limit the risk, and the best options for treatment. There are still many unanswered questions and changing theories.

Ultimately, there is a very small risk of developing ALCL if you have breast implants or have had them in the past, but the risk does exist.

So, what does cause BIA-ALCL?

While there is not yet a concrete answer to this question, there are a few theories that are being explored by independent clinical studies and the medical community at large.

The prevailing theory is that certain types of textured implants increase your risk of developing BIA-ALCL. Because an overwhelming majority of BIA-ALCL cases occurred in patients with textured implants, many studies suggest that something about the surface texture of these implants or individual texturing processes used by various manufacturers create a perfect environment for the development of ALCL in the breast capsule.

Another theory has to do with the presence of a strain of bacteria, Ralstonia pickettii. This bacteria is found in the layer of microorganisms around a breast implant, known as biofilm—and a single study theorized patients with a higher amount of R. pickettii were more likely to develop breast implant associated ALCL. It is important to note that this study examined only 26 BIA-ALCL tissue samples and found a statistically small predominance of the bacteria in these tissues.

As of July 24, 2019, implant manufacturer Allergan has voluntarily recalled all of their BIOCELL textured implants at the request of the FDA: Natrelle Saline-Filled breast implants, Natrelle Silicone-Filled breast implants, Natrelle Inspira Silicone-Filled breast implants, and Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled breast implants. This recall does not impact patients who already have these breast implants; rather, it ceases the future sale and implantation of BIOCELL textured breast implants.

These implants were most closely linked to confirmed cases of BIA-ALCL, so the FDA is taking steps to help further reduce the risk of developing this rare condition. If you currently have any of the above Allergan implants, the FDA does not recommend removal if you aren’t experiencing symptoms. Because BIA-ALCL is so rare, removal without symptoms can cause unnecessary trauma to your body.

Smooth Natrelle and Microcell breast implants have not been recalled. 

How do I know if I have BIA-ALCL?

Before we go into the symptoms specific to breast implant associated ALCL, it’s important to note that if anything feels “off” about your breast implants, you should schedule an appointment with your physician right away to rule out any potential problems.

The most common symptoms that present with BIA-ALCL are breast pain and swelling or excess fluid accumulating around the breast implant. While it is a rarer symptom, the development of a rash on your breast skin may also be an indicator. It’s important to note that some of these symptoms, such as fluid accumulation, pain, and rash, may occur for reasons other than ALCL, such as capsular contracture (a painful squeezing of the implant by surrounding scar tissue), low-grade infection or bacterial colonization of the breast implant, and seroma.

Because BIA-ALCL is highly treatable when caught early, it’s important to seek medical care as soon as you notice anything. Whether you suspect or are diagnosed with a more serious condition or not, detecting any breast implant related complication as quickly as possible can help you avoid unnecessary discomfort or exacerbating the problem in the future.

Should I have my textured implants removed?

Because the risk of BIA-ALCL remains very low, current FDA recommendations for patients state, “If you have breast implants, there is no need to change your routine medical care and follow-up.”

In other words, if you are not experiencing any problems with your textured implants, there is no need to have them removed unless you wish to. Remember, undergoing another surgery carries some risk as well. All the same, if you have any concerns about your existing breast implants, schedule an appointment with your primary care doctor or cosmetic surgeon.

Can I avoid developing BIA-ALCL?

Ultimately, the only way to fully avoid breast implant-related complications is to not get breast implants. Realistically, if you are unhappy with your breasts and have been wanting to make a change, that may not be a viable option for you.

Based on the current data, one of the best ways to reduce your risk of developing BIA-ALCL is to opt for smooth implants vs textured implants. You will still be able to get the look you want. Talk with your cosmetic surgeon about your concerns and, together, you can find a smooth implant and placement option to match your aesthetic goals.

Breast augmentation has helped millions of women feel happier and more confident—and it is still considered a safe option for breast enhancement in the hands of a qualified cosmetic surgeon.

How often should I have my breast implants checked?

Follow-up care is an important part of breast augmentation. Breast implants are not considered lifetime devices, and eventually you will probably want or need to replace them. This could be as much as 20+ years after you get them, but you should visit your cosmetic surgeon well before this point. We recommend scheduling a follow-up at least once every 10 years to ensure your implants are still in good shape and stay abreast of new information regarding breast implant safety and your options.

The FDA also recommends that patients with silicone-filled implants undergo routine MRI or ultrasound imaging three years after surgery and every two years thereafter. This is to screen for possible shell rupture, as silicone implant ruptures usually cannot be detected through a physical examination only.

Finally, any time you have a concern about your breast implants, contact your doctor or cosmetic surgeon, no matter long you have had your implants. It is far better to rule out any problems than to continue worrying.

How to find more information

We hope you feel better informed about the risks and facts surrounding BIA-ALCL after reading this. If you have concerns about your own breast implants, we encourage you to contact your doctor or find a cosmetic surgeon near you.