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What Is BIA-ALCL?

BIA-ALCL is a rare lymphoma that can form around implants, mainly textured ones, often years later as breast swelling. Early surgery is usually curative.

By Vireon Medical Editorial TeamFirst published Evidence checked through

Short answer

BIA-ALCL (breast implant-associated anaplastic large cell lymphoma) is a rare cancer of the immune system that can develop in the scar tissue and fluid around a breast implant. It is a type of non-Hodgkin lymphoma, not breast cancer. It is linked mainly to textured implants and usually appears years after surgery, most often as sudden swelling of one breast. When found early and treated by removing the implant and the whole surrounding capsule, most people are cured.

Key points

  • It is a lymphoma (a cancer of white blood cells), not a cancer of breast tissue.
  • Almost all confirmed cases involve textured implants; cases with only smooth implants are very rare.
  • Symptoms typically start on average 7 to 10 years after the first implant.
  • The commonest sign is a build-up of fluid that makes the breast swell over a few weeks.
  • UK and US regulators do not advise removing implants in people who have no symptoms.

What BIA-ALCL is

Anaplastic large cell lymphoma (ALCL) is an uncommon type of non-Hodgkin lymphoma. In 2016 the World Health Organisation recognised the breast implant-associated form as a distinct variant, defined partly by laboratory markers: the cells are CD30 positive and ALK negative (two proteins that pathologists test for).1 The US Food and Drug Administration (FDA) describes it as a T-cell lymphoma (a cancer of one type of white blood cell) that can develop after breast implants.2

The disease grows in the capsule, the layer of scar tissue the body forms around any implant, or in fluid next to it.2

How common is it?

It is rare, but the exact risk is hard to pin down. The Medicines and Healthcare products Regulatory Agency (MHRA, the UK device regulator) had received 114 confirmed reports where surgery took place in the UK, plus 6 where surgery was abroad, by the end of 2024. It estimates a reporting rate of 1 per 12,187 breast implants and tissue expanders sold, and stresses that this is a reporting rate rather than a true incidence.1

The FDA counted 1,380 unique cases and 64 deaths reported worldwide up to 30 June 2024.3 The American Society of Plastic Surgeons (ASPS) notes that published incidence estimates range widely, from about 1 in 2,207 to 1 in 86,000 depending on the device.5 Because sales figures, reporting habits and follow-up differ between countries, the true figure has Uncertain incidence.

Does the implant surface matter?

Yes. Implants have smooth, textured (roughened) or polyurethane-coated surfaces, and the FDA states that the risk is higher with textured implants than with smooth ones.2

Data setTexturedSmoothNot known or other
UK primary cases (MHRA)62 of 6401 polyurethane-coated
Worldwide reports (FDA, to June 2024)1,010 (73%)40 (3%)330 (24%) not stated
Implant surface in reported BIA-ALCL cases. Sources: MHRA1 and FDA.3

Even the small number of smooth-implant cases is less clear than it looks. Of the 40 reports the FDA lists, only one had a known history of a single smooth implant and no known textured implant; most of the rest had a past textured implant or an unknown implant history.3 Global reports also link cases more often to macrotextured (more heavily roughened) surfaces than to microtextured ones.1

Symptoms and timing

The MHRA reports that symptoms appear on average 7 to 10 years after the first implant.1 ASPS gives a range from under a year to 27 years, with a mean of about 9.75 years.5

The commonest sign is a late seroma (fluid collecting around the implant). This typically causes a fairly quick increase in breast size, usually without pain, over a few weeks, sometimes in both breasts. Less often, a lump forms in the capsule.1 The FDA also lists persistent swelling, pain near the implant and, in some reports, capsular contracture (tightening of the scar capsule).2 ASPS notes that some people have a skin rash, fever, night sweats or enlarged lymph nodes.5

Swelling in the first weeks after surgery is expected and is not what this refers to. The concern is new swelling well after recovery, which the MHRA defines as more than a year after implantation.1

How it is diagnosed and treated

Diagnosis usually starts with an ultrasound scan and fine-needle aspiration (drawing off fluid with a thin needle under ultrasound guidance). The fluid is examined for CD30-positive lymphoma cells, and a PET-CT scan (an imaging test that shows active disease around the body) is used for staging once the diagnosis is confirmed.5 The FDA advises clinicians to send fresh fluid and capsule tissue for testing, including CD30 and ALK markers.2 ASPS notes that mammograms are not useful for assessing this lymphoma.5

Treatment centres on surgery: removal of the implant together with the whole surrounding capsule, which is more extensive than removing the implant alone.2 ASPS recommends removing both implants and both capsules, and notes that incomplete removal of the capsule is linked to recurrence and lower survival.5 Consensus guidelines from the US National Comprehensive Cancer Network (NCCN) place complete surgical removal at the centre of treatment, with chemotherapy and other treatments reserved for advanced disease, such as when lymph nodes are involved.6

Outlook is generally good when the disease is confined to the capsule. The MHRA reports significantly higher survival in this early stage and an overall five-year survival of 89%.1

Other cancers reported in the capsule

Separately from BIA-ALCL, the FDA has received reports of squamous cell carcinoma (a type of skin-cell cancer) and various other lymphomas in the scar tissue around breast implants, and added this to its risk information in December 2023.4 These reports are fewer and less well understood, and the FDA page gives no rate, so the evidence on how often they occur is Insufficient.

When to seek medical advice

If you develop swelling, a fluid build-up or a lump in a breast with an implant more than a year after surgery, the MHRA advises contacting the surgeon who placed the implant; your GP can also refer you to an NHS breast clinic.1 Persistent swelling, a mass or pain near the implant should be assessed rather than watched.2

Common questions

Should I have textured implants removed if I feel well?

Regulators do not advise it: the MHRA says there is no need to remove textured implants without implant-related symptoms, and the FDA does not recommend routine removal in people without symptoms.12 The MHRA adds that removal surgery is complex and carries more risk than the original operation.1

Is BIA-ALCL a form of breast cancer?

No, it is a lymphoma that grows around the implant, not a cancer of breast tissue.2 Routine breast screening is not designed to detect it.5

Can it happen with smooth implants?

Very rarely, and most reported smooth-implant cases had a past textured implant or an unknown history.3

How can I find out what implants I have?

Ask the surgeon or hospital for the implant record, which should list the manufacturer and model. In the UK, professional guidance asks surgeons to record implant details in the Breast and Cosmetic Implant Registry and to report problems to the MHRA Yellow Card scheme.7

Bottom line

BIA-ALCL is a rare lymphoma linked mainly to textured implants, usually appearing years after surgery as new swelling of the breast. Removing implants without symptoms is not advised, but late swelling or a lump deserves prompt assessment, because early disease is usually curable with complete surgery.

Sources

  1. Medicines and Healthcare products Regulatory Agency. Breast implant associated anaplastic large cell lymphoma (BIA-ALCL). GOV.UK; updated 2025. https://www.gov.uk/guidance/breast-implants-and-anaplastic-large-cell-lymphoma-alcl. Accessed 5 November 2026.
  2. US Food and Drug Administration. Questions and answers about breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). FDA; 2019. https://www.fda.gov/medical-devices/breast-implants/questions-and-answers-about-breast-implant-associated-anaplastic-large-cell-lymphoma-bia-alcl. Accessed 5 November 2026.
  3. US Food and Drug Administration. Medical device reports of breast implant-associated anaplastic large cell lymphoma. FDA; 2025. https://www.fda.gov/medical-devices/breast-implants/medical-device-reports-breast-implant-associated-anaplastic-large-cell-lymphoma. Accessed 5 November 2026.
  4. US Food and Drug Administration. Risks and complications of breast implants. FDA; 2023. https://www.fda.gov/medical-devices/breast-implants/risks-and-complications-breast-implants. Accessed 5 November 2026.
  5. American Society of Plastic Surgeons. BIA-ALCL summary and quick facts. ASPS; 2020. https://www.plasticsurgery.org/for-medical-professionals/health-policy/bia-alcl-physician-resources/summary-and-quick-facts. Accessed 5 November 2026.
  6. Clemens MW, Jacobsen ED, Horwitz SM. 2019 NCCN consensus guidelines on the diagnosis and treatment of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). Aesthetic Surgery Journal; 2019;39(Suppl 1):S3–S13. doi:10.1093/asj/sjy331. https://doi.org/10.1093/asj/sjy331
  7. British Association of Plastic, Reconstructive and Aesthetic Surgeons. Guidance update on breast implant associated anaplastic large cell lymphoma (BIA-ALCL). BAPRAS; 2021. https://bapras.org.uk/media-government/news-and-views/view/guidance-update-on-breast-implant-associated-anaplastic-large-cell-lymphoma-(bia-alcl). Accessed 5 November 2026.

Article history

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