The short answer
This page explains BIA-ALCL, the lymphoma linked to breast implants, the textured-implant recall, and the changes worth reporting. It is general education, not individual medical advice.
BIA-ALCL is a cancer of the immune system, not a breast cancer, and it grows in the scar tissue and fluid around an implant.
The risk is higher with textured-surface implants, and certain Allergan textured implants were recalled in July 2019.
The FDA does not recommend removing implants in people who have no symptoms.
Persistent swelling, pain, or a new lump near an implant, even years after surgery, deserves a prompt call to a doctor.
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The full explanation.
BIA-ALCL stands for breast implant-associated anaplastic large cell lymphoma. The FDA describes it as a type of non-Hodgkin lymphoma, a cancer of the immune system. It is not breast cancer. It usually grows in the scar tissue and fluid that form around a breast implant, and it is rare.
If you have implants, whether after cancer surgery or cosmetic surgery, the practical questions are the same. What is the risk, what should you watch for, and what does the FDA actually advise? This page walks through each one.
What is BIA-ALCL?
When an implant is placed, the body builds a layer of scar tissue around it, called a capsule. BIA-ALCL typically develops in that capsule and in the fluid near the implant. In most cases it stays there, but the FDA notes it can spread through the body.
Because it is a lymphoma, it behaves differently from breast cancer and is treated differently. When BIA-ALCL is confirmed, the FDA states that treatment includes removing the implant along with the surrounding scar capsule. Some people need additional treatment, which their cancer team plans.
Why were textured implants recalled?
Implant shells come in two main surfaces, smooth and textured. The FDA determined that the risk of BIA-ALCL is higher with textured-surface implants than with smooth-surface implants.
On July 24, 2019, the FDA asked Allergan to voluntarily recall certain Natrelle BIOCELL textured breast implants and tissue expanders. Allergan did so, and providers were told to stop implanting the listed products. The FDA has also said certain textured tissue expanders should not be used.
Here is the part people often miss. The recall stopped new use of those devices. It did not advise people who already had them, and felt well, to have surgery. The FDA is explicit that it does not recommend routine removal of these or other breast implants in patients who have no symptoms.
How rare is it?
The FDA tracks reports through its medical device reporting system. As of June 30, 2024, it had received 1,380 unique medical device reports of BIA-ALCL, including 64 reports of death. The agency notes the data has limits, since some reports lack the detail needed to rule out duplicates.
Those totals cover many years of reporting across many millions of implants worldwide. The condition is rare. It is tracked closely precisely because implants are so common.
What symptoms should you watch for?
The FDA lists these as the main symptoms of BIA-ALCL:
- Persistent swelling in the area of the breast implant, often from fluid building up around it (a seroma)
- A mass or lump near the implant
- Pain in the area of the implant
Timing matters. The FDA notes these changes may occur well after the surgical incision has healed, often years after the implant was placed. So a new change near an old implant still counts. Swelling near an implant has many possible causes, and most are not cancer, but a persistent change is worth a prompt call so it can be examined and, if needed, the fluid tested.
What the FDA advises people with implants
For people with implants and no symptoms, the FDA's advice is steady monitoring, not surgery:
- Do not seek routine implant removal just because of BIA-ALCL risk.
- Know what type of implant you have. Your surgical records or surgeon's office can tell you the brand and whether it is textured or smooth.
- Monitor the area around your implants and tell a doctor about changes.
Two more FDA points give useful context. First, breast implants are not considered lifetime devices, and the longer people have them, the greater the chance of complications of any kind. Second, for silicone gel implants, MRI is the most effective way to detect a silent rupture, and ultrasound is an acceptable alternative for people without symptoms. Ask your care team what checking schedule fits your implants.
Other risks the FDA tracks
BIA-ALCL is not the only condition under watch. The FDA reports that the scientific literature and device reports include cases of squamous cell carcinoma and other lymphomas in the scar tissue around implants, plus rare mesenchymal tumors. It also tracks systemic symptoms some patients report, such as fatigue, joint pain, and "brain fog," which are poorly understood. In some reported cases, removing the implants was followed by improvement. These issues are less well defined than BIA-ALCL, and research continues.
None of this changes the core message. Most people with implants never develop BIA-ALCL. Knowing your implant type and reporting persistent changes are the two actions that matter.
Sources
- Questions and Answers about Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) — U.S. Food and Drug Administration
- Risks and Complications of Breast Implants — U.S. Food and Drug Administration
- Medical Device Reports of Breast Implant-Associated Anaplastic Large Cell Lymphoma — U.S. Food and Drug Administration
Words to know
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Common questions
Is BIA-ALCL a type of breast cancer?
No. The FDA describes BIA-ALCL as a type of non-Hodgkin lymphoma, which is a cancer of the immune system. It usually develops in the scar tissue and fluid that form around a breast implant, not in the breast tissue itself. In some cases it can spread beyond that area.
Should breast implants be removed to prevent BIA-ALCL?
The FDA does not recommend routine removal of breast implants, including recalled textured ones, in people who have no symptoms. Its advice is to know your implant type, watch for changes around the implant, and talk with a doctor if changes appear. Any decision about removal is individual and belongs with your care team.
How common is BIA-ALCL?
As of June 30, 2024, the FDA had received 1,380 unique medical device reports of BIA-ALCL worldwide, including 64 reports of death. These reports come from many years and many millions of implants, and the FDA notes the counts have limits. The condition is rare, but real.
Which implants were recalled?
In July 2019, at the FDA's request, Allergan recalled certain Natrelle BIOCELL textured breast implants and tissue expanders. The FDA asked health care providers to stop implanting the listed products. The recall did not tell people with these implants to have them removed if they had no symptoms.
What symptoms should someone with implants watch for?
The FDA lists persistent swelling, a mass, or pain in the area of the breast implant as the main symptoms of BIA-ALCL. A fluid collection around the implant, called a seroma, is also common. These changes may appear years after the surgery has healed, so new changes always count, whatever the implant's age.
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Sources last checked: 2026-08-21 what this meansLast updated: 2026-08-21Next planned review: 2027-08-21
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How this page was created
Cancer Explained does not originate medical claims. Every page restates guidance already published by the National Cancer Institute, the CDC, the USPSTF and the FDA, in plain language, with the source cited so you can check the original yourself. AI does the translating and organizing; automated checks test claims, citations, clarity and safety before anything publishes. We do not employ clinicians and do not intend to — our work is translation and navigation, not clinical judgment. Nothing here is personal medical advice, and no page can account for your particular situation.
Editorial status: Source checked — This page was written with AI assistance and checked line by line against the sources listed on it. That confirms the sources support what the page says. It is not a medical review, and it does not confirm the page is complete or right for your situation.
Human medical review: not completed. Pages here are not signed off by a clinician before they publish. That is not an oversight we are quietly working around: we restate published guidance and cite it, so the authority belongs to the source rather than to us, and every page names where its claims come from — you can verify us instead of trusting us. Where a volunteer clinician has reviewed a page, their name and credentials appear on it; where no name appears, no clinician has checked it. We are glad to have reviewers and are recruiting them, and we do not hold pages back waiting for one. Use this site to understand your situation and to ask better questions of the people treating you.
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