Latest Update on Breast Implant-Associated Anaplastic Large Cell Lymphoma – BIA-ALCL
Breast implant devices are among the most tested type of prostheses in the history of medicine. The decades of studies have shown that serious complications are extremely rare.
One concerning complication that came into the spotlight in the early 2010s is Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). This rare immune breast cancer has been the most trending topic in plastic surgery research in the past few years.
We’re still learning more about BIA-ALCL as studies emerge. We know it’s related exclusively to textured implants. We know it arises 6-12 years after the surgery. Furthermore, we know that early capsule and implant removal is 100% curative. However, many questions remain unanswered:
- Should you remove your textured implants if you don’t have symptoms?
- If you do swap your implants should you switch to smooth implants?
- Should you get an en-bloc capsulectomy?
- Should you be worried about BIA-ALCL?
Keep reading to find out the latest 2021 BIA-ALCL updates, and learn more about the causes, risks, prevention, and trends in treatment.
What is BIA-ALCL?
Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) is a rare immune-cell cancer that develops in the breasts, and it’s been linked to textured breast implants.
This cancer arises from the immune cells in your breast (T-cell lymphoma). It usually presents as a seroma; a collection of fluid near your breast implant that can cause deformity or pain. Others might feel a tumour in the breast or armpit.
BIA-ALCL is 100% curable with surgery if you receive an early diagnosis.
History of BIA-ALCL
The first reported BIA-ALCL case was in 1997, and since then, there have been increasing reports of this condition from all around the world. As of 2011, the plastic surgery community has acknowledged the link between BIA-ALCL and the use of textured breast implants.
After a few years, researchers noticed that 85% of the cases of breast implant lymphoma happened with Allergan’s Biocell implants (a popular brand at the time). This has lead the company to issue a worldwide voluntary product recall in 2019. Meaning, every woman with an Allergan Biocell implant can get hers removed and receive free smooth replacement implants instead.
Until today, no cases of BIA-ALCL have ever been reported with smooth-surfaced implants.
BIA-ALCL Numbers and Facts
- So far, there have been 994 cases of BIA-ALCL worldwide
- There has been a total of 37 BIA-ALCL deaths worldwide
- There were no reports of any BIA-ALCL deaths in 2020
- The risk of getting BIA-ALCL with textured implants is between 1-in-2,500 and 1-in-25,000
- There are still no reported BIA-ALCL cases with smooth implants
- Around 85% of BIA-ALCL cases are with Allergan Biocell implants
- BIA-ALCL is 100% curable with surgery if diagnosed early
Updates on BIA-ALCL Symptoms
The symptoms of breast implant cancer have been known for some time, and emerging research does not seem to add anything new in this regard. So far, the most common symptoms of BIA-ALCL are:
- Fluid collection in the breast (late seroma) in 70-80% of cases
- Breast pain
- Palpable breast mass
- Breast deformity
- Palpable armpit nodules
- Breast swelling
- Breast rash
When should you see your plastic surgeon?
When you notice one or more of these symptoms, you should not delay visiting your plastic surgeon. There’s a very high chance that these symptoms are caused by a more benign process, like implant rupture or capsular contracture. However, a surgeon’s evaluation is crucial to rule out breast implant cancer early on.
Pathogenesis – New insights
Unfortunately, doctors are still not exactly sure how textured breast implants cause BIA-ALCL. The strongest theory suggests that BIA-ALCL is a result of chronic inflammation around the breast implant that causes immune cells to turn malignant. Genetics might also play a role in making you more susceptible.
This is probably the most accepted theory so far. A chronic inflammation that happens around the implant might be the cause of BIA-ALCL. The inflammation causes your immune cells to mutate and become cancerous.
The fact that BIA-ALCL is more associated with textured implants fits into this theory. Textured implants have a much larger surface area, and can hence be more easily and heavily colonized with bacteria. Here’s how doctors think breast implant cancer starts:
- During your boob job, some bacteria manage to come in contact with the implant
- These bacteria multiply and form a resistant biofilm on your implant
- Chronic inflammation will take place around your implant (can extend for years)
- Malignant changes in your immune cells and transformation to BIA-ALCL
Other theories suggest that silicone itself might contribute to inflammation (silicone auto-immunity). Some also suggest that viruses might also play a role. Nevertheless, these theories are still far from being confirmed.
Where do the bacteria come from?
Your skin and breast tissue are full of residing bacteria. If they come in contact with your implant, they might cause complications like infection, capsular contracture, breast implant illness (BII), and BIA-ALCL.
Some studies have identified no difference between bacteria in BIA-ALCL patients and non-cancer patients. This might lead to the conclusion that developing BIA-ALCL depends more on your own immune response and genetics, which determine how your body reacts with the colonizing bacteria.
In any case, bacteria are still thought to be the initiator of this inflammatory response. This is why sterility is critical in preventing BIA-ALCL. For this reason, many surgeons around the globe follow the 14-point plan for breast surgery.
What is the 14-point plan?
The 14-point plan is a work plan that ensures maximal sterility when performing a boob job to prevent any bacterial colonization of the implant.
The plan includes steps like using nipple shields, Keller funnels, changing gloves regularly, antibiotic and betadine wound irrigation, IV antibiotic administration, and others. The aim is to make the risk of bacterial colonization negligible.
- One study done in 2017 on 42,000 textured biocell implants showed that there were no cases of BIA-ALCL in any of them. According to the known statistics, the expected number of BIA-ALCL cases should have been at least 15. But there were zero cases in this study. This might suggest that technique and sterility do play an essential role in preventing BIA-ALCL.
Our Coco Ruby Plastic Surgeons strictly adhere to the 14-points plan. We believe that it’s necessary to reduce the risk of capsular contracture, implant infection, BIA-ALCL, and BII.
Updates For Asymptomatic Patients – Patients with NO Symptoms
There’s been a lot of debate in the plastic surgery community on how to deal with BIA-ALCL, especially if a patient has textured implants but no symptoms and no BIA-ALCL. If you have a textured breast implant you will be asking yourself:
- Should you remove your textured implants? Get a smooth replacement?
- Should I get a capsulectomy?
- Is en-bloc removal necessary? A lie?
Keep reading to find out!
Should I remove my textured implants?
It’s all matter of risk versus benefits. The risk of BIA-ALCL is generally low, and that of death due to BIA-ALCL is much lower. So, should you remove your textured implants? Should you get smooth implants instead? Even if you don’t have symptoms?
The decision to remove your textured breast implants for fear of BIA-ALCL should be taken after a thorough discussion with your plastic surgeon regarding the risks of surgery, cosmetic outcomes, and the actual risk of BIA-ALCL. If you have Allergan Biocell implants, the company will provide you with free replacements, so the financial aspect would not be an issue. A lot comes into determining the decision:
- How old are the implants?
- How old are you?
- Do you have other breast implant complications (capsular contracture or malposition)?
- Are you covered by warranty or insurance?
- What brand of implants do you have?
So far, no health authority (FDA, TGA, WHO, etc.) in the world recommends the removal of breast implants prophylactically in asymptomatic patients. Breast implants, even-textured ones, are still very safe prostheses. According to our current data, the low risk of BIA-ALCL does not seem to justify urging patients to remove their implants. However, those who do decide to get their implants removed should be offered explantation.
Should you have a capsulectomy?
Current research shows that the prophylactic removal of the capsule is not necessary if there’s no proven BIA-ALCL, especially since it carries a lot of avoidable risks like:
- Bad cosmetic outcomes
- Breast deformity and asymmetry
- More pain
- More bleeding risk (hematoma)
- Lung trauma
- Nerve injury
- Blood clots
- Surgery and anaesthetic risks
Your surgeon will perform a capsulectomy when there’s proven BIA-ALCL. Otherwise, most surgeons should keep the capsule, and maybe just take a biopsy to be completely safe.
Should I get “en-bloc” breast implant removal?
Thanks to false advertising and baseless social media claims, “en-bloc” is being thrown around frequently among patients. Some women now come requesting “en-bloc” removal of their breast implants, with photo proof, without knowing what this term really means, what risks it entails, and whether it’s really necessary or not.
A lot of plastic and surgeons have taken advantage of this social media trend, and market themselves as “en-bloc experts” or “top en-bloc removal surgeons”. And unfortunately, many patients fall victim to their claims and regret it when it’s too late.
“En-bloc” explantation means the removal of the breast implant along with the surrounding fibrous tissue capsule in one piece. It is unnecessary and does not change the outcome in preventing or treating BIA-ALCL. It’s just a marketing term. Your surgeon might attempt en-bloc removal when possible, but you should know that it’s unnecessary. Moreover, you should know that capsulectomy is not mandatory if you don’t actually have BIA-ALCL.
Updates in Diagnosis and Treatment
Breast implant lymphoma is, thankfully, highly treatable. When detected in the early stages, the cure rate can reach 100% with surgery. Here are the latest recommendations for treatment and diagnosis of BIA-ALCL in 2021:
- Patient education: This is a pillar of BIA-ALCL treatment. Every plastic surgeon should explain to their patients the risk of BIA-ALCL and teach them about symptoms that they should look out for.
- In-office breast ultrasound: Ecography is a simple and cheap imaging modality that your plastic surgeon can use to assess your breasts. It can help identify fluid collections and assess the quality of the implant.
- Surgery: Surgical removal (explantation) of the breast implants with total capsulectomy (removal of the capsule) are the mainstay of treatment for BIA-ALCL. It can completely cure breast implant cancer if done early on.
- En-bloc removal: You can attempt En-bloc removal however it’s hasn’t been proven to be necessary. Furthermore, it does not change the outcome of BIA-ALCL surgery.
- Implant replacement: After removal of the textured implants, you can opt to receive new smooth-surfaced implants so that you retain your perky full breasts.
- Pathology testing: All capsule samples should be sent to pathology (CD-30 testing) the fluid should be analyzed in cytology, this is usually not covered by insurance.
FDA Label Updates
The United States Food and Drugs Administration (FDA), one of the leading health authorities worldwide, did a hearing last year in regards to BIA-ALCL. In October 2020 the hearing was concluded with a final guidance document which recommended:
- Adding a black box warning label that includes BIA-ALCL
- Making a patient consent checklist that includes language on BIA-ALCL
- Further describing the materials and chemicals used in each breast implant brand, including heavy metals
- Providing all patients with a patient device card
Similar recommendations had already been issued by the TGA in Australia to make sure that the risks of BIA-ALCL are well known among physicians and patients alike.
How common is BIA-ALCL
Every breast augmentation patient wants to know: “How likely is BIA-ALCL?”
The thing is that BIA-ALCL is still very recent. The numbers vary greatly between countries and between individual studies. The advances in screening and diagnosis are leading to discovering more and more BIA-ALCL patients every year. In 2008, the risk was thought to be 1 in every 3 million women. Today, it’s becoming clear that it’s more common (but still generally low).
In general, the risk of developing BIA-ALCL ranges between 1 in 2,200 and 1 in 300,000 cases. Here in Australia, a total of 55 cases were identified by 2016. According to the TGA, the risk is 1 in 2,500 to 1 in 25,000 textured implant patients.
Keep in mind that most (85%) of the reported cases are exclusive with Allergan Biocell breast implants. So, if you have another brand of implants, you’re much less likely to develop BIA-ALCL. And so far, there haven’t been any BIA-ALCL cases with smooth implants.
Should you worry?
Despite the recent concerns, breast implants are still very safe devices and breast augmentation is still a beautiful life-changing surgery.
If you’re getting (or have) smooth implants, BIA-ALCL should not be a worrying concern for you. This is because it is believed that BIA-ALCL only has ties to textured implants.
Even if you are getting (or have) a textured implant, your risk of developing BIA-ALCL is still extremely low. Most cases (85%) of BIA-ALCL are related to (the now suspended) biocell implants. To put it into perspective, the risk of surgery and anaesthesia complications is actually multiple times higher than the risk of BIA-ALCL.
In the end, all you need to do is to be informed about the risks of your boob job. Follow up with your surgeon regularly to make sure everything is okay, and learn more about any updates. An ideal surgeon will be always next to you, helping you make the best medical decisions every step of the way.
Further Reading – Medical Sources:
- The Plastic Surgery Foundation PROFILE Project
- ASPS BIA-ALCL Physician Resources
- Nature Scientific Reports on Insights into the Microbiome of Breast Implants and Periprosthetic Tissue in Breast Implant-Associated Anaplastic Large Cell Lymphoma
- PubMed Article on Macrotextured Breast Implants with Defined Steps to Minimize Bacterial Contamination around the Device: Experience in 42,000 Implants
- PubMed Article on The role of bacterial biofilms in device-associated infection
- Australian Government Therapeutic Goods Administration on Breast implants and anaplastic large cell lymphoma
- Regulatory Affairs Professionals Society on Breast implant label guidance finalized by FDA
- U.S. Food & Drug on Questions and Answers about Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)
- U.S. Food & Drug on Medical Device Reports of Breast Implant-Associated Anaplastic Large Cell Lymphoma
- FDA Updates Analysis of FDA Updates Analysis of Medical Device Reports of Breast Implant Illness and Breast Implant-Associated Lymphoma
- U.S. Food & Drug on Breast Implant Associated-Anaplastic Large Cell Lymphoma (BIA-ALCL) – Letter to Health Care Providers