If you have breast implants or have been considering breast augmentation, it’s likely you’ve come across articles warning about a specific type of cancer that impacts those with breast implants. It’s called Breast Implant-Associated Anaplastic Large Cell Lymphoma or BIA-ALCL for short. While being aware of medical developments that may impact you is crucial, this news has inspired fear disproportionate to the number of cases.
Unfortunately, wading through all of the information and studies available can be a little overwhelming. This leaves many women unsure—particularly when fact and opinion coexist so frequently online. To help you understand BIA-ALCL, I’ve answered some of the most common questions I receive at my practice.
What is BIA-ALCL?
BIA-ALCL is not breast cancer. Rather, it is a form of lymphoma. It helps to first understand the nature of anaplastic large cell lymphoma (ALCL).
ALCL is a very rare type of non-Hodgkin’s lymphoma – a cancer of the immune system that develops when lymph nodes have a build-up of abnormal T-cells. This is a type of white blood cell that scans for infections and cellular abnormalities in the body as part of the immune system.
Breast implant-associated ALCL (BIA-ALCL) is an even more uncommon form of ALCL. This develops specifically within the scar tissue capsule surrounding breast implants, not the lymph nodes.
How many people have BIA-ALCL?
Since 2010, there have been a total of 660 reports of BIA-ALCL, including 9 fatalities. Because the FDA relies on voluntary medical device reports from physicians and patients, it has been difficult to settle on an actual number of confirmed cases of BIA-ALCL. It is known that some of the same incidences have been reported multiple times.
In their annual statistics report, the American Society of Plastic Surgeons disclosed that in 2018, their member surgeons performed a total of 313,735 breast augmentations. That is just one year and one reporting body. Since 2010, millions of breast augmentations have been performed all over the world. Thus the risk of developing BIA-ALCL is likely considerably less than .01% (one-tenth of one percent).
These statistics reflect the fact that BIA-ALCL is very rare. But it is critical for women to be aware of the issue in case they experience symptoms, such as breast swelling, that could be indicative of BIA-ALCL. With early identification, it can be successfully treated with removal of the breast implants and surrounding capsule.
Physicians must educate women with breast implants as well as those who are considering breast augmentation so they can understand fully understand risks and symptoms.
What causes BIA-ALCL?
Frustratingly, we do not yet have a definitive answer to this question. Though we do know enough to make strong hypotheses and caution our patients accordingly.
Researchers are exploring a number of theories to determine what causes BIA-ALCL and working to lower the risk of contracting the disease. The predominant theory is that certain textured breast implants increase your BIA-ALCL risk. Based on the fact that the overwhelming majority of cases of BIA-ALCL have occurred in patients who have, at one point in their lives, had textured implants.
Textured Breast Implants
Textured breast implants are designed with a rough, uneven, silicone gel surface. This rough surface helps them stick to the capsule of scar tissue that develops, improving stability within the breast cavity. And reduces the risk of them moving around or becoming malpositioned.
Studies point to implants with a high-surface-area texture, which, for yet unknown reasons, can create an environment that supports the development of abnormal T-cells in the breast capsule. Some specific texturizing processes further increase the risk of developing BIA-ALCL. And make certain styles and brands of textured implants riskier than others.
Are textured breast implants banned?
As of April 2019, the FDA has chosen not to blanket ban all textured breast implants because current data does not show that these devices meet the banning standards outlined by the Federal Food, Drug, and Cosmetic Act. Even though textured implants are still on the market, some plastic surgeons are opting not to place them until more is known, while others have chosen instead to stop placing the specific brands most associated with BIA-ALCL.
While the FDA has not removed all textured implants on the market, they are taking steps to protect patients. On July 24, 2019, breast implant manufacturer Allergan voluntarily recalled all of their BIOCELL textured implants at the request of the FDA, including:
- Natrelle Saline-Filled breast implants
- Natrelle Silicone-Filled breast implants
- Natrelle Inspira Silicone-Filled breast implants
- Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled breast implants.
Review of incident reports of BIA-ALCL has indicated a much higher rate among patients who have or have had implants manufactured with the BIOCELL texturing process. Therefore, the move to take these implants off the market may be another step toward further minimizing incidences of BIA-ALCL.
If you currently have any of the aforementioned breast implants, the FDA does not recommend removal if you aren’t experiencing any symptoms, given the rarity of the disease. If you have concerns, please contact your primary care provider or plastic surgeon.
Other brands of textured implants are still available to patients
It’s important to understand the role textured implants play and why certain surgeons still offer them. The purpose of a textured surface is to help the implants stay in position within the breast cavity. Often recommended to women with very little natural breast tissue and mastectomy patients, shaped implants are textured as any degree of malpositioning would be easily seen.
Additionally, highly active women may also prefer textured implants (regardless of the specific implant shape) because they are much less likely to be pushed out of the ideal position by muscular movement. For these patients, the small risk of developing BIA-ALCL may be worth getting the benefits of having textured implants.
How do I know if I have BIA-ALCL?
Routine care for women with breast implants
Before I go into the specifics of diagnosing BIA-ALCL, I want to emphasize the importance of routine check-ups of your breast implants. Remember, breast implants are not meant to be lifetime devices. And as your implants age, your risk of developing certain complications increase, whatever type or style of implant you have.
If you notice anything new or strange with your breast implants, it’s time to schedule an appointment with your plastic surgeon. Even if you haven’t noticed any changes, I recommend booking a check-up around the 10-year-mark so you can make sure all is well.
BIA-ALCL can be tricky to diagnose since certain symptoms overlap with other diseases or cancers of the breast. For this reason, I caution patients to avoid self-diagnosing.
Common symptoms of BIA-ALCL include:
- Enlarged breasts
- Chest pain
- Breast asymmetry
- Lump in the breast or armpit
- Skin rash on the breast
- Hardening of the breast
- A large collection of fluid (at least a year after surgery, typically after 8-10 years)
When you visit your plastic surgeon with any of these symptoms, he or she will begin with a physical examination of the breast. And a thorough discussion of your medical history, current health, lifestyle, and history of breast surgery.
If your surgeon believes your symptoms may indicate BIA-ALCL, they will use one or more of the following diagnostic tests to confirm the diagnosis and determine if your lymph nodes have been impacted:
- Needle biopsy
- Drainage of fluid inside capsule/collection of seroma fluid
- PET-CT or CAT scans
Once pathological testing and diagnostic evaluation have been performed, you will be notified if you have markers for BIA-ALCL. And, if necessary, an individualized treatment plan will be developed. During this time, you will likely be working with a team that includes your plastic surgeon, a surgical oncologist, lymphoma oncologist, and/or a hematopathologist.
How do you treat BIA-ALCL?
When caught early, BIA-ALCL is highly treatable—and while those 9 documented deaths are heartbreaking, the risk of it being fatal is very low.
Per the treatment guidelines set forth by the National Comprehensive Cancer Network (updated in 2019) and recommendations from the FDA, both the breast implant and the entire implant capsule should be removed from the body. In some cases, chemotherapy and radiation may be required.
Do I need an en bloc capsulectomy?
“En bloc” means the scar capsule around the implant will be left intact with the breast implant inside and removed as one piece. While the en bloc capsulectomy method requires a longer scar and increases certain risks, I feel it is best for BIA-ALCL patients if the capsule can be removed in this way. This is because cancer cells are present.
That said, the FDA does not distinguish what type of capsulectomy should be used when treating BIA-ALCL. Some patients’ anatomy may make safe en bloc removal difficult or impossible (in which case a total capsulectomy would be used). Because every patient’s anatomy and circumstances are different, implant and capsule removal details are ultimately up to you and your surgeon.
Should I not get breast implants? Should I have my textured implants removed?
Ultimately, this is your decision. While breast augmentation has helped millions of women enjoy a better quality of life and feel more confident with their bodies, it is not a medically necessary procedure. Which means it’s up to you to weigh the risk versus reward.
Speak with your surgeon about your concerns, learn about all of your options, and take some time to think. If you’ve come across this information while researching breast augmentation, remember there is no need to rush to a decision.
For women who currently have textured breast implants, the FDA states that there is no need to adjust your routine medical care and follow-up if you do not present with any symptoms. And, in fact, they do not recommend prophylactic breast implant removal if you are asymptomatic. That being said, this is your body. If you feel unsure or have found that worrying about BIA-ALCL is impacting your life, talk to your plastic surgeon about your options.
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How to find more information
I hope you feel more informed about BIA-ALCL after reading this article. However, if you would like to learn more about BIA-ALCL, I encourage you to review the FDA website, which links to a number of studies on the subject.
If you have concerns about your breast implants or suspect something may not be right, please contact your plastic surgeon immediately or locate a board-certified plastic surgeon with BIA-ALCL experience in your area.
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This story was initially published on 6/30/19. It is being republished today (7/24/19) because of breaking news about Allergan’s worldwide recall of certain textured implants.