Injury guide

Breast implant lymphoma (BIA-ALCL)

Updated Oct 6, 202619 sources

BIA-ALCL is a cancer of the immune system that can form near breast implants. Here is how it is found, which records show it, and what the Allergan lawsuits claim.

What the public record says

These are cited sources. Their inclusion does not imply that they endorse People’s Justice or reviewed this page.

Judicial Panel on Multidistrict Litigation · Panel that grouped the federal BIOCELL cases (MDL No. 2921); court summary of what the lawsuits claim, not a finding

“factual questions arising from the allegation that Allergan’s BIOCELL textured breast implants and tissue expanders significantly increase the risk of developing BIA-ALCL, and that Allergan failed to warn the FDA, patients, and healthcare providers of this risk.”

JPML transfer order, Allergan BIOCELL MDL No. 2921 (Dec. 18, 2019) (opens in a new tab) · Dec 18, 2019 · Checked Oct 5, 2026

The evidence and its limits

U.S. Food and Drug Administration · 2025

Medical device reports of BIA-ALCL (data as of June 30, 2024)

Design:
Agency review
Participants:
1,380 U.S. and worldwide BIA-ALCL cases reported to FDA from 2011 to June 30, 2024.
Finding:
Of the reported cases, 73% involved textured implants. FDA says only 1 of the 40 cases listed as smooth had no known history of a textured implant. 86% named Allergan as the implant maker.
Main limitation
These are passive reports. FDA says they alone cannot show how often BIA-ALCL happens or what caused it, and many reports lack details.

Read the source: Medical device reports of BIA-ALCL (data as of June 30, 2024) (opens in a new tab) · Checked Oct 5, 2026

The short answer

What is BIA-ALCL?
BIA-ALCL is a cancer of the immune system that can form after breast implants. It is not breast cancer. It most often grows in the fluid or scar tissue around the implant, but it can spread. [1]
What are the signs of BIA-ALCL, and when should I see a doctor?
The main signs are swelling that does not go away, a lump, or pain near the implant. They often show up years after surgery. If you notice any of these, talk to your doctor about whether you need more tests. [1]
How do doctors diagnose BIA-ALCL?
Doctors start with an exam and imaging. If there is fluid or a lump, they take a sample of the fluid or tissue near the implant. A lab then checks the cells for a marker called CD30. [1]
Which records show BIA-ALCL?
The pathology report on the fluid or tissue gives the diagnosis. Scan reports show the fluid or lump. Your surgery records show which implants you had. [2]

What rules a case out

Not covered by this case

  • This page is not medical advice. Talk to your doctor about your own care.
  • It does not cover breast cancer, breast implant illness or other cancers found in the scar tissue around implants.

What is BIA-ALCL?

BIA-ALCL is a cancer of the immune system that can form after breast implants. It is not breast cancer. It most often grows in the fluid or scar tissue around the implant, but it can spread.

Its full name is breast implant-associated anaplastic large cell lymphoma. It is a type of non-Hodgkin lymphoma. The National Cancer Institute says the cancer cells in this kind of lymphoma carry a marker called CD30.

FDA says a person’s risk of getting it is low. But it is serious and can lead to death, especially if not treated promptly. In most patients, surgery to take out the implant and the scar tissue around it treats it.

Some VA and federal worker benefit lists name non-Hodgkin lymphoma or lymphoma. Each program has its own service or work exposure rules, apart from implants and apart from any lawsuit. The non-Hodgkin lymphoma guide explains them.

What are the signs of BIA-ALCL, and when should I see a doctor?

The main signs are swelling that does not go away, a lump, or pain near the implant. They often show up years after surgery. If you notice any of these, talk to your doctor about whether you need more tests.

On exam, a doctor often finds a pocket of fluid around the implant, called a seroma. Some reports also describe a lump under the skin or a thick, noticeable scar around the implant.

FDA does not advise taking out implants in people who have no symptoms. Talk with your surgeon before making any change.

How do doctors diagnose BIA-ALCL?

Doctors start with an exam and imaging. If there is fluid or a lump, they take a sample of the fluid or tissue near the implant. A lab then checks the cells for a marker called CD30.

FDA tells doctors to send fresh fluid and pieces of the scar capsule for lab tests. Those tests look for CD30 and for another marker, called ALK.

A firm diagnosis matters before surgery. A confirmed case usually means taking out the scar capsule along with the implant, which is a bigger operation.

Which records show BIA-ALCL?

The pathology report on the fluid or tissue gives the diagnosis. Scan reports show the fluid or lump. Your surgery records show which implants you had.

The pathology report is written by a pathologist, a doctor who studies cells under a microscope. NCI says this report gives the definitive diagnosis of a cancer.

To learn the maker and model of your implants, check the device card your surgeon may have given you. You can also ask the surgeon or the hospital for your operative notes.

You can ask for copies of these records and your scan images. A provider normally has up to 30 days to respond.

What does research say about Allergan breast implants and BIA-ALCL?

FDA says it “has identified an association” between breast implants and BIA-ALCL. It says the risk is higher for textured implants than for smooth ones. A link like this does not prove what caused one person’s cancer.

In July 2019, FDA asked Allergan to recall its BIOCELL textured implants and tissue expanders because of the risk of BIA-ALCL.

FDA said its analysis showed the risk with BIOCELL implants was about six times the risk with textured implants from other makers sold in the U.S.

FDA also counts reports it gets from device makers, hospitals and others. As of June 30, 2024, FDA had reports of 1,380 BIA-ALCL cases from the U.S. and other countries since 2011, and 86% named Allergan. FDA warns that these reports alone cannot show how often the cancer happens or what caused it.

The lawsuits claim BIOCELL implants caused BIA-ALCL or greatly raised its risk. In the federal court records we read, we found no ruling that the implants cause it. The court rulings we found were about which claims may go ahead and how to plan the first trials.

Who brings BIA-ALCL claims in the Allergan breast implant cases?

People who had Allergan BIOCELL textured implants or tissue expanders brought these federal cases. Some have BIA-ALCL. Others had their implants taken out or still have them. Whether you could bring a claim depends on your own records.

A July 2026 court order set pretrial dates for the first two test trials. For what has happened since, see the Allergan case page.

Can a family member get records for someone with BIA-ALCL?

Yes, if they have legal authority to act for the patient. Whether a spouse or other relative has that power depends on state law. A health care power of attorney is one common way to let someone make health care decisions and get related records.

If the patient is a minor, a parent can usually get the records, with a few exceptions. If the patient has died, the person put in charge of the estate can get the records that role needs. A provider may also share limited details with a relative who was involved in care or in paying for it, unless the patient had said not to. Rules differ by state.

If someone died, the wrongful death case page explains in general how those claims work.

Sources

  1. FDA: Questions and answers about BIA-ALCL
  2. NCI: Pathology reports
  3. FDA: What to know about breast implants
  4. JPML transfer order, Allergan BIOCELL MDL No. 2921 (Dec. 18, 2019)
  5. FDA: Risks and complications of breast implantsFDA: Risks and complications of breast implants · regulator
  6. NCI: Adult non-Hodgkin lymphoma treatment (PDQ, patient version)NCI: Adult non-Hodgkin lymphoma treatment (PDQ, patient version) · regulator
  7. VA: Camp Lejeune water contamination health issuesVA: Camp Lejeune water contamination health issues · regulator
  8. VA: The PACT Act and your VA benefitsVA: The PACT Act and your VA benefits · regulator
  9. VA: Agent Orange exposure and disability compensationVA: Agent Orange exposure and disability compensation · regulator
  10. DOL: EEOICPA Special Exposure Cohort specified cancersDOL: EEOICPA Special Exposure Cohort specified cancers · study
  11. FDA news release: Allergan textured implant recall request (July 24, 2019)FDA news release: Allergan textured implant recall request (July 24, 2019) · regulator
  12. HHS: Your right to access your health informationHHS: Your right to access your health information · regulator
  13. Allergan: BIOCELL recall announcement (posted by FDA, July 2019)Allergan: BIOCELL recall announcement (posted by FDA, July 2019) · regulator
  14. FDA: Medical device reports of BIA-ALCLFDA: Medical device reports of BIA-ALCL · regulator
  15. D.N.J.: Allergan BIOCELL MDL No. 2921 opinion (Mar. 19, 2021)D.N.J.: Allergan BIOCELL MDL No. 2921 opinion (Mar. 19, 2021) · court
  16. D.N.J.: Allergan BIOCELL MDL No. 2921 Case Management Order No. 42 (July 14, 2026)D.N.J.: Allergan BIOCELL MDL No. 2921 Case Management Order No. 42 (July 14, 2026) · court
  17. HHS: Personal representatives under HIPAAHHS: Personal representatives under HIPAA · regulator
  18. HHS: Health information of deceased individualsHHS: Health information of deceased individuals · regulator
  19. eCFR: 45 CFR 164.502(g), personal representativeseCFR: 45 CFR 164.502(g), personal representatives · regulator

Checked against 19 primary sources by People's Justice editors · Updated

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