Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)

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

Breast implant-associated anaplastic large cell lymphoma is also called BIA-ALCL. It’s a rare form of lymphoma that occurs in some people who’ve had breast implants. It’s a type of immune system cancer and isn’t breast cancer.

This type of lymphoma occurs in the fluid and scar tissue (fibrous capsule) around the implant. In more advanced cases, it may spread to lymph nodes near your breast and in other parts of your body. It can also enter your chest wall underneath your breast.

BIA-ALCL generally grows slowly. Usually, healthcare providers treat it surgically by removing the breast implant and surrounding capsule. In rare cases, it can be fatal.

How common is BIA-ALCL?

The Food and Drug Administration (FDA) tracks global cases of BIA-ALCL. As of January 5, 2020, there were 733 known cases and 36 deaths ever reported. This translates to a very small risk for the millions of people who’ve received breast implants.

What types of implants are associated with BIA-ALCL?

BIA-ALCL affects a very small number of people who’ve received textured (rough) breast implants. In the past, the rough texture of these implants was chosen to help breast implants stay in place.

Smooth breast implants aren’t as commonly associated with BIA-ALCL. However, research is still underway to confirm this.

The type of material inside of a breast implant (silicone vs. saline) doesn’t appear to play a role in this disease. Implants are usually made of silicone or saline. Both smooth and textured implants can be made from either material. BIA-ALCL has occurred in people with silicone and saline implants.

Have textured implants been recalled?

The FDA also reports that approximately 85% of BIA-ALCL cases have been in people who received BIOCELL® textured implants from Allergan. Because of this, Allergan has discontinued providing these implants and asked surgeons and hospitals to return any remaining stocks.

BIOCELL textured tissue expanders were also included in the “recall.” Tissue expanders are balloon-like devices healthcare providers implant after a mastectomy. They inflate slowly over time and help stretch your breast skin and tissue before you receive a permanent breast implant. It isn’t clear if tissue expanders increase the risk of BIA-ALCL.

What should I do if I have recalled implants?

If you have BIOCELL breast implants from Allergan, the FDA doesn’t recommend removing them. They advise you to:

• Be aware of the symptoms of BIA-ALCL and monitor your breasts for any changes.
• Talk to your healthcare provider if you develop symptoms of BIA-ALCL.
• Keep a record of your implants, including the device manufacturer, model name and device identifier (such as a serial or lot number). If you don’t have this information, talk to your surgeon or the facility where you had your surgery.

Alternatively, you can always elect to have your breast implants removed or exchanged.

What are the symptoms of BIA-ALCL?

The most common symptoms include changes in the size or shape of your breasts. Usually, one breast will appear larger than the other or look different in shape.

Symptoms can appear as early as one year after you receive the implant or many years later. On average, symptoms start eight years after implant surgery.

The symptoms of BIA-ALCL include:

• Enlargement or swelling of your breast.
• Hardening of your breast.
• Lumps in your breast or armpit.
• Pain in your breast or armpit.
• Redness or skin rash on or around your breast (rarely).

If you experience symptoms that concern you, remember that noncancerous issues are a much more likely cause. These may include:

• Capsular contracture.
• Implant rupture.
• Infection.
• Recent trauma.

What causes BIA-ALCL?

Healthcare providers aren’t sure why people with textured breast implants sometimes develop BIA-ALCL. One possible cause is a chronic infection around the implant that stimulates your immune system. Over time, this can lead to cancer of your immune cells.

Scientists think there may also be a genetic component to BIA-ALCL. This means that some people may be more susceptible to this type of cancer.

How is BIA-ALCL diagnosed?

Your healthcare provider will review your medical history and ask you about your symptoms. They’ll also perform a physical examination.

If your provider suspects you might have BIA-ALCL, they may schedule diagnostic tests. These may include:

• Medical imaging tests: An ultrasound is usually the first test providers order to look for fluid accumulation or lumps in your breast. Ultrasound can also show swelling in lymph nodes. If the ultrasound results aren’t clear, your healthcare provider may recommend an MRI, which provides more detail of your breast and lymph nodes.
• Biopsy: If imaging tests show there’s a mass or excess fluid, your provider will perform a needle biopsy. This test involves either a fine needle or a larger, hollow-core needle, depending on the type of tissue being collected. During the procedure, your provider draws up a small amount of fluid or tissue from your breast. They send the sample to a lab for testing. Perforation of the implant is a risk of this procedure.
• Laboratory testing: The fluid or tissue obtained from the biopsy carries important information for diagnosis. Testing will include a microscopic examination to look for cancer cells and biomarker testing. Biomarkers are molecules associated with diseases. They help healthcare providers diagnose BIA-ALCL and rule out other types of cancers and conditions.

How is BIA-ALCL treated?

If your healthcare provider makes a diagnosis of BIA-ALCL, they’ll refer you to a cancer specialist (oncologist). You’ll see your oncologist for further evaluation and treatment planning. Part of this evaluation may include a PET scan to find out if the cancer has spread.

The main treatment is breast implant removal. Your plastic surgeon can remove the implant, the surrounding fibrous capsule and any masses.

Surgery may be the only treatment you need. This is more likely if you have an early stage of the disease and the surgeon is able to remove the entire capsule.

The risk of the cancer returning is higher with incomplete removal of the capsule. If this happens, or if the cancer has spread, you may need other types of treatment. When planning your treatment, your healthcare provider will consider your:

• Overall health.
• Previous exposure to chemotherapy and/or radiation.
• Treatment goals.

Your treatment may include:

• Radiation therapy: This treatment uses a beam of energy to destroy cancer cells. Usually, you receive radiation therapy several days per week for several weeks.
• Chemotherapy: This involves a variety of drugs to treat cancer. The standard treatment is anthracycline-based chemotherapy. But BIA-ALCL care is evolving. Researchers have found that adding a newer drug called brentuximab vedotin to standard chemotherapy improves outcomes.

What type of follow-up should I expect after surgery?

If you don’t receive radiation therapy or chemotherapy, you may be asked to see your provider on a routine basis — perhaps every three to six months for a couple of years. Your visits may include PET/CT scans every six to 12 months to check for signs of recurrence.

Follow-up care after radiation therapy or chemotherapy will depend on your progress. Your healthcare provider will monitor you closely to provide appropriate follow-up care.

How can I reduce my risk?

You can’t prevent this disease, but early detection can improve your outcome. Monthly breast self-exams and annual checkups can help you identify lumps or other issues before they spread. Let your healthcare provider know if you notice any swelling, lumps, breast pain or changes in breast appearance.

While routine mammograms are important in detecting breast cancer, they won’t detect this type of lymphoma.

If you’re planning cosmetic or reconstructive breast surgery, let your surgeon know if you have any safety concerns. Your surgeon will help you make an informed decision about what type of surgery or implants are right for you. You may also want to review guidance from the FDA before getting breast implants.

What is the outlook for BIA-ALCL?

The prognosis for BIA-ALCL is better with:

• Early detection.
• Complete surgical removal of the capsule.
• Consistent follow-up care.

For the majority of people with BIA-ALCL, the cancer remains confined to the fibrous capsule. This leads to a better outlook. In 3% to 5% of patients, the cancer spreads beyond the capsule.

One study of 87 people who were diagnosed with BIA-ALCL found that 91% were alive five years after treatment.

When should I see my healthcare provider?

If you have breast implants, talk to your healthcare provider right away if you notice any changes in your breasts.

A note from Cleveland Clinic

Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is a very rare condition that occurs in people who have textured breast implants. Most cases of BIA-ALCL have been associated with BIOCELL implants made by Allergan. If you have breast implants, make sure you know what type yours are. You can contact your surgeon or surgical facility to find out.

Although the FDA recalled BIOCELL implants, they don’t recommend removing them. If you have these implants or another brand of textured implants, monitor your breasts for swelling or lumps through monthly self-exams. Schedule an appointment with your healthcare provider right away if you notice any changes in your breasts. Early detection and complete surgical removal of the implant and surrounding capsule can cure this condition. It can also prevent the need for additional treatment, such as radiation therapy and chemotherapy.