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Case guide

BIOCELL recall: check the model first

The 2019 recall covered some textured implants and tissue expanders. Check the card from your surgery.

See If You Qualify

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Updated Oct 4, 202613 sources

This may apply to you if

  • Bring the implant brand, model and operation dates, if known.
  • Bring records of a BIA-ALCL diagnosis or other health concerns for an individual check.
  • Explain prior implant removal or replacement without assuming it decides your legal 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.

U.S. Food and Drug Administration · Federal medical-device safety agency

Finding: FDA requested the BIOCELL recall because of BIA-ALCL risk. It did not recommend routine removal in patients without symptoms because of surgical risks.

FDA recall request, July 24, 2019 (opens in a new tab) · Jul 24, 2019 · Checked Oct 3, 2026

Leda Dunn Wettre · United States District Court for the District of New Jersey · United States Magistrate Judge

Finding: The July 14, 2026 order set pretrial deadlines for the Henson and Rabin cases. It did not set an individual award.

Case Management Order 42 (opens in a new tab) · Jul 14, 2026 · Checked Oct 3, 2026

The evidence and its limits

U.S. Food and Drug Administration · 2019

FDA BIOCELL recall safety review

Design:
Agency review
Participants:
Review of safety reports, registry data and literature; not one enrolled patient trial.
Finding:
FDA requested recall of certain Allergan BIOCELL textured devices because of BIA-ALCL risk.
Main limitation
The recall does not decide an individual claim or mean all patients should have implants removed.

Read the source: FDA BIOCELL recall safety review (opens in a new tab) · Checked Oct 3, 2026

The short answer

What did the 2019 recall cover?
It covered some textured implants and tissue expanders. FDA acted because of cancer risk. Check the exact model. [1]
Did the recall cover every Allergan device?
No. Smooth implants are outside this notice. Check the model as well as the brand. [5]
Where can I find my implant model?
Check your device card or surgery notes. Ask the surgeon or facility if these are missing. Do not guess from the implant’s appearance. [2]
Does the notice tell me to have surgery now?
FDA does not recommend routine removal for people without symptoms. Talk to your surgeon about your situation. A symptom or change needs its own assessment. [1]

What rules a case out

Not covered by this case

  • A recalled model alone does not establish a legal claim.
  • Symptoms need a clinical assessment; no award or personal filing date is promised.

The process

What happens next

  1. 01

    You answer a few questions

    About two minutes. Nothing is sent until you agree on the last step and press submit.

  2. 02

    A lawyer looks at it

    A lawyer at the firm reads your answers and checks them against the current case criteria.

  3. 03

    The firm decides and gets in touch

    If the firm takes your case, you get the terms in writing to read before you sign. You can always say no.

The 2019 recall covered some textured implants and tissue expanders. Check the card from your surgery. Ask your doctor what it means for your care.

What did the 2019 recall cover?

It covered some textured implants and tissue expanders. FDA acted because of cancer risk. Check the exact model.

FDA’s July 24, 2019 release lists several Natrelle product lines. The company announcement lists model styles. Keep the full model name and any style number beside the implant date.

Did the recall cover every Allergan device?

No. Smooth implants are outside this notice. Check the model as well as the brand.

The announcement is Allergan’s notice posted by FDA, not a finding that every product caused injury. Match your device to the actual list. Ask the surgeon to clarify incomplete or unfamiliar model details.

Where can I find my implant model?

Check your device card or surgery notes. Ask the surgeon or facility if these are missing. Do not guess from the implant’s appearance.

FDA specifically recommends keeping the manufacturer and model. If you had replacements, obtain each procedure’s records. The device in place today may differ from an earlier implant.

Does the notice tell me to have surgery now?

FDA does not recommend routine removal for people without symptoms. Talk to your surgeon about your situation. A symptom or change needs its own assessment.

A recall removes unused products from the market; it is different from an individual care decision. Surgery itself has risks. Do not use a legal claim checklist to choose whether or how to have an operation.

Does a recalled implant guarantee a claim?

The notice does not decide that question. A lawyer needs your device and health records. Personal law and time limits also matter.

Give the lawyer the actual model and the harm you want reviewed. Do not turn a recall date into your filing deadline. Current claim terms need a separate check.

What should I do with an old recall letter?

Keep it with your device records. Note when you received it and any later care. Ask about missing information before filling gaps from memory.

The letter may help explain what you were told; it is not itself a diagnosis. Keep any reply from your surgeon too. Ask which parts matter to your care and which matter to a legal review.

Find out where you stand.

The review is free and private. Asking for it doesn’t commit you to anything.

Register your interest

Sources

  1. FDA recall request, July 24, 2019FDA recall request, July 24, 2019 · regulator
  2. FDA BIA-ALCL questions and answersFDA BIA-ALCL questions and answers · regulator
  3. FDA SCC safety communicationFDA SCC safety communication · regulator
  4. FDA BIA-ALCL medical device reportsFDA BIA-ALCL medical device reports · regulator
  5. Allergan recall announcement posted by FDAAllergan recall announcement posted by FDA · regulator
  6. District of New Jersey Allergan MDL homeDistrict of New Jersey Allergan MDL home · court
  7. Case Management Order 42Case Management Order 42 · court
  8. Case Management Order 43Case Management Order 43 · court
  9. FDA breast implant risks and complicationsFDA breast implant risks and complications · regulator
  10. FDA what to know about breast implantsFDA what to know about breast implants · regulator
  11. ABA Model Rule 1.5: FeesABA Model Rule 1.5: Fees
  12. HHS your medical recordsHHS your medical records · regulator
  13. SDNY how long do I have to file?SDNY how long do I have to file? · court

Checked against 13 primary sources by People's Justice editors · Updated

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