What Is BIA-ALCL?

Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is a rare type of cancer of the immune system that forms in the capsule of scar tissue around some some breast implants. Common symptoms of BIA-ALCL include swelling and pain near the implant.

Most people recover from BIA-ALCL if it’s diagnosed early and the implant and surrounding scar tissue are removed. But, in some cases, BIA-ALCL can spread throughout the body. 

As of August 2024, there have been 1,577 reported cases of BIA-ALCL and 63 deaths from BIA-ALCL worldwide.

Doctors and researchers are still learning about this rare disease.

BIA-ALCL is not a type of breast cancer. It’s also not the same as breast implant illness (BII), a range of symptoms that may be related to breast implants. 

BIA-ALCL seems to only develop in people who have or had implants with a textured surface (shell), as opposed to a smooth one. BIA-ALCL can develop in people who got textured implants as part of breast reconstruction surgery after mastectomy, cosmetic surgery, or as part of gender-affirming surgery.  

The risk is highest for people who have or had Biocell textured implants manufactured by Allergan. These implants, which were recalled in 2019, have a surface with bigger, deeper divots than other textured implants.  

Researchers aren’t sure why BIA-ALCL develops around textured breast implants. One theory is that the rough, sandpaper-like surface of textured implants might cause chronic inflammation, which leads to lymphoma in some people. Some experts say Allergan Biocell implants might be linked to more cases of BIA-ALCL because they are more deeply textured than other types of textured implants.

Genes also probably play a role in BIA-ALCL. Researchers have identified certain genetic mutations that seem to increase the risk of developing the illness — in particular, mutations in the JAK1 and STAT3 genes. People who have BRCA1, BRCA2, or TP53 mutations also appear to be at higher risk of developing BIA-ALCL and for having an earlier onset of the illness. 

The most common symptom of BIA-ALCL is swelling caused by a buildup of fluid in the area of a breast implant. Sometimes there might be a lump next to an implant’s surface or in the armpit. Other, less common symptoms of BIA-ALCL include enlarged lymph nodes, skin rash, fever, and weight loss.

BIA-ALCL symptoms tend to develop years after an implant is placed — on average, seven to 10 years — but they can develop sooner.

According to guidelines from the National Comprehensive Cancer Network (NCCN), if doctors suspect a BIA-ALCL diagnosis, they should order imaging with ultrasound or MRI. If they find either fluid around the implant or a mass near the implant, they'll do more tests.

If the imaging results show more than a small amount of fluid around an implant, then doctors should collect a sample of the fluid using fine needle aspiration (a thin needle inserted through the skin).

The fluid should be tested for:

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  certain abnormal cells that may suggest BIA-ALCL

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  CD30, a protein that is found in higher-than-normal amounts on lymphoma cells, particularly in BIA-ALCL

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  ALK, a protein that helps control cell growth. In BIA-ALCL, the lymphoma cells do not make the ALK protein, so the fluid would test negative for it.

If the imaging results show a mass near the implant, doctors should order a tissue biopsy to test the mass. 

Since BIA-ALCL is so rare and relatively new, some doctors may not have experience diagnosing and treating it. If you think you might have BIA-ALCL, talk to your doctors about the latest NCCN guidelines for diagnosing and treating the illness. Your doctors may refer you to a medical team with experience treating BIA-ALCL or might develop a treatment plan for you in collaboration with one. Depending on your location and insurance health care plan, you may want to go to a large cancer center with experience treating BIA-ALCL, such as the MD Anderson Cancer Center or Memorial Sloan Kettering Cancer Center. If not and your state allows it, you can also ask for a virtual consultation. 

The NCCN guidelines recommend that people diagnosed with BIA-ALCL:

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  Get a combined PET and CT scan (known as PET/CT scan) to see the extent of the illness.

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  Have surgery to remove the breast implant and the capsule of scar tissue surrounding it in one piece, plus a margin of surrounding tissue. This surgery is called an en bloc capsulectomy.

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  Have both implants removed, even if only one is affected by BIA-ALCL.

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  Have any masses (tumors) or any lymph nodes that are affected (or look like they might be) removed during the surgery.

Some people diagnosed with BIA-ALCL may also need to receive immunotherapy, chemotherapy, radiation therapy, stem cell transplant therapy, or any combination of these treatments.

For patients who receive appropriate and timely treatment, the prognosis is very good. Research has shown that 93% of people diagnosed with BIA-ALCL are still disease-free three years after treatment.

Some people who’ve been treated for BIA-ALCL decide to have breast reconstruction surgery with smooth implants, flaps (autologous reconstruction), or fat grafting. Doctors generally recommend that people who’ve been treated for BIA-ALCL wait about two years after having their implants removed and finishing other treatments for BIA-ALCL before having another reconstructive procedure. 

First introduced in the 1980s, breast implants with textured surfaces stick to surrounding tissue so they are less likely to slip out of place or rotate than implants with smooth surfaces. Textured implants can be round or teardrop-shaped and can be filled with silicone gel or saline. 

There are a number of different brands of textured implants. Textured implants have been used much more for breast reconstruction and cosmetic enlargement surgery in other countries than in the United States and Canada. In some countries, 80% of the implants sold to medical practices are textured. In 2018, by contrast, less than 10% of breast implants sold to medical practices in the United States were textured. Macro-textured breast implants, which have surfaces with bigger, deeper divots — including Allergan’s Biocell implants — represented less than 5% of the implant market.

In July 2019, Allergan announced a worldwide recall of its Biocell textured breast implants and tissue expanders. The FDA requested the recall after finding the risk of BIA-ALCL was six times higher with Allergan Biocell textured implants versus other textured implants sold in the United States. (The FDA published a full list of recalled products, including some products that were previously sold under the McGhan brand.)

The FDA and Allergan asked plastic surgeons to stop using Allergan Biocell implants and to return all unused Biocell implants to the manufacturer. The recall didn't apply to implants that are already in use, which means that people who have Biocell implants should not necessarily have them removed.

Textured implants and tissue expanders from other manufacturers (and from Allergan’s other line of textured implants, called BRST Microcell) are thought to carry a lower risk of BIA-ALCL and were not included in the recall. These other brands are still sold in many countries, including the United States.

If you’re considering replacing your breast implants or getting implants for the first time, talk with your plastic surgeon about the differences between textured and smooth implants and tissue expanders as well as potential risks and complications.

Your plastic surgeon should discuss with you the risk of developing BIA-ALCL and other rare cancers in the scar tissue capsule surrounding a breast implant as part of your informed consent before you have surgery. 

“This is an important conversation for patients to have with their physicians. An implant should be chosen through shared decision-making,” says Mark Clemens, MD, FACS, an associate professor of plastic surgery at the University of Texas MD Anderson Cancer Center in Houston who studies BIA-ALCL and other health conditions linked to breast implants.

If you have breast implants or tissue expanders but don’t have any symptoms of BIA-ALCL or any other complications, the FDA and other health authorities say you don’t need to have them removed. 

However, it’s important to monitor your implants for changes and to have periodic appointments with your breast surgeon or plastic surgeon to check your implants. Call your doctor if you develop any symptoms such as pain, lumps, swelling, or asymmetry at any point after breast implant surgery. 

If you have implants and want to find out which kind they are, check to see if your plastic surgeon gave you a patient device identification card with the implant’s manufacturer, style, and serial number, or ask your surgeon for this information. If not, you can contact the plastic surgeon who performed your surgery or the facility where your surgery took place to try to find this information.

It may be difficult to find out which implant you have. For example, if you had surgery more than seven years ago, the records may no longer be available, especially if the office or facility kept paper records. Sometimes it’s not possible to find out which type of implants you have until your plastic surgeon removes them during surgery.

Read Breastcancer.org’s Special Report: Breast Implant Illness and BIA-ALCL.

There are other very rare cancers that can develop in the scar tissue capsule surrounding a breast implant besides BIA-ALCL, including some other types of lymphomas and breast implant-associated squamous cell carcinoma (BIA-SCC). The potential symptoms for these may be similar to the symptoms of BIA-ALCL. Researchers are still trying to understand the risk factors for these cancers and whether there is a link to any particular type of breast implant or breast implant characteristic.

Squamous Cell Carcinoma in Breast Implant Scar Tissue

Oct 28, 2022

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