Case guide

Implant removal: care first, then claim questions

Thinking about implant removal? Ask your surgeon about the reason, risks and options.

See If You Qualify

Free · No obligation · About 2 minutes

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

Does a recall mean I must have an implant removed?
FDA does not recommend routine removal without symptoms. Your surgeon can discuss your own situation. Do not choose surgery to match a claim checklist. [1]
Why can the diagnosis change the operation?
A confirmed BIA-ALCL diagnosis can change the surgery plan. Removing the implant alone may not be the recommended approach. Ask the specialist what the tests show. [2]
What does removal of the capsule mean?
The capsule is scar tissue around an implant. A surgeon may remove some, all or none of it in different situations. Ask which approach fits your medical need. [9]
Will insurance pay for the operation?
Ask your insurer about the planned surgery. Some plans may not pay for removal or replacement. Payment for the first surgery does not settle that question. [9]

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.

Thinking about implant removal? Ask your surgeon about the reason, risks and options. This page cannot choose your surgery or promise payment.

Does a recall mean I must have an implant removed?

FDA does not recommend routine removal without symptoms. Your surgeon can discuss your own situation. Do not choose surgery to match a claim checklist.

The recall addressed unused devices in the market. A person’s operation needs a separate benefits-and-risks discussion. Tell the clinician about any change near the implant and prior surgery.

Why can the diagnosis change the operation?

A confirmed BIA-ALCL diagnosis can change the surgery plan. Removing the implant alone may not be the recommended approach. Ask the specialist what the tests show.

FDA describes removal of the implant and surrounding scar capsule for confirmed lymphoma. This is different from choosing a removal method when that diagnosis is absent. Do not assume every operation must remove the same amount of tissue.

What does removal of the capsule mean?

The capsule is scar tissue around an implant. A surgeon may remove some, all or none of it in different situations. Ask which approach fits your medical need.

FDA describes implant removal and different capsule-removal options. More extensive surgery has its own risks. Ask for an explanation of the proposed method, its aim and alternatives before agreeing.

Will insurance pay for the operation?

Ask your insurer about the planned surgery. Some plans may not pay for removal or replacement. Payment for the first surgery does not settle that question.

Ask the surgeon’s office which records the insurer needs. Keep a written benefit or denial notice. This page does not quote surgery prices or decide an appeal against a health plan.

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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