Allergan Biocell Breast Implant Lawsuit
This MDL consolidates lawsuits against Allergan over textured breast implants linked to BIA-ALCL, a rare cancer of the immune system. The FDA requested a worldwide recall in July 2019 after finding these implants carried six times the cancer risk of other textured implants.
Key Takeaways
- Allergan BIOCELL implants linked to BIA-ALCL, a rare cancer—not breast cancer, but a T-cell lymphoma
- FDA issued Class I recall (most serious) in July 2019 affecting 4+ million devices worldwide
- Allergan implants account for 86% of all BIA-ALCL cases reported to the FDA
- BIA-ALCL is often curable when caught early—most patients treated successfully with surgery alone
- FDA does NOT recommend removal of implants for women without symptoms
Key Facts (May 2026)
| Pending Lawsuits | 1,488 cases in federal MDL |
| Total BIA-ALCL Cases (FDA) | 1,380 confirmed worldwide |
| Deaths Reported | 64 worldwide (per FDA as of June 2024) |
| Recall Classification | Class I (Most Serious) |
| Recall Date | July 24, 2019 |
| Devices Recalled | 4,026,287 implants and tissue expanders |
| Median Time to Diagnosis | 8 years after implant placement |
| Current Owner | AbbVie Inc. (acquired Allergan May 2020) |
| Presiding Judge | Hon. Brian R. Martinotti (D.N.J.) |
| Can You Still File? | Yes, lawsuits are being filed |
Steady Case Growth in 2025
Lawsuits continue to be filed as more women learn about the connection between Allergan BIOCELL implants and BIA-ALCL. Case count has grown 18% since January 2025.
Source: JPML MDL Statistics Reports, January 2025-May 2026
1 What Is This Lawsuit?
The Allergan Biocell MDL consolidates lawsuits from women who received Allergan's textured breast implants and subsequently developed BIA-ALCL (Breast Implant-Associated Anaplastic Large Cell Lymphoma), a rare cancer of the immune system, or suffered other serious complications.
The Core Allegation
Plaintiffs allege Allergan knew or should have known about the elevated cancer risk associated with its BIOCELL texturing process but failed to adequately warn patients and doctors. Internal documents and regulatory data suggest Allergan was aware of safety signals before the recall.
Why BIOCELL Is Different
Allergan's BIOCELL uses a "salt-loss" texturing process that creates a more aggressive, macro-textured surface than other implants. The FDA found this texture carries six times the BIA-ALCL risk compared to other textured implants.
The lawsuits typically allege failure to warn, design defect, negligence, and in some cases fraud or misrepresentation. Many plaintiffs claim they were never told they were receiving textured implants specifically, or were not informed about the particular risks of BIOCELL texturing versus smooth implants.
2 What Is BIA-ALCL?
Important: BIA-ALCL Is NOT Breast Cancer
BIA-ALCL is a type of non-Hodgkin lymphoma—a cancer of the immune system, specifically T-cells. It develops in the scar tissue (capsule) that naturally forms around breast implants, not in the breast tissue itself. The World Health Organization officially designated BIA-ALCL as a distinct disease in 2016.
Common Symptoms
3 BIA-ALCL by the Numbers
FDA Medical Device Report Data (June 2024)
| Total Unique BIA-ALCL Cases | 1,380 |
| Total Deaths Reported | 64 |
| Cases with Textured Implants | 1,010 (73%) |
| Cases Attributed to Allergan | 1,182 (86%) |
| Cases Attributed to Mentor | 75 (5%) |
| U.S. Cases | 588 (43%) |
| Median Age at Diagnosis | 53 years |
Note: FDA data has limitations including potential underreporting and incomplete information. Actual case numbers may be higher.
Estimated Incidence
Risk estimates range from:
patients with textured implants
Allergan-Specific Risk
Per FDA July 2019 assessment:
vs. other textured implant manufacturers
4 FDA Actions & The 2019 Recall
| Year | FDA Action |
|---|---|
| 2011 | First identified possible association; issued safety communication |
| 2016 | WHO officially designated BIA-ALCL as distinct disease |
| Feb 2019 | Updated safety communications with emerging data |
| Mar 2019 | Public advisory committee meeting on breast implant safety |
| Jul 24, 2019 | Requested Allergan voluntary recall—worldwide recall issued |
| Oct 2021 | Strengthened requirements: mandatory patient checklists, boxed warnings |
The Recall Details
- Classification: Class I — the most serious, indicating reasonable probability of serious adverse health consequences or death
- Scope: All BIOCELL textured breast implants and tissue expanders (Natrelle, McGhan 410)
- Quantity: 4,026,287 devices worldwide
- Distribution: All 50 U.S. states, Puerto Rico, and international markets
5 Recalled Products
If you're unsure about your implant type, contact your surgeon or request your surgical records.
6 Treatment & Prognosis
When Caught Early
- Most patients treated successfully with surgery alone
- Total capsulectomy (removal of implant and scar capsule) is standard
- BIA-ALCL is often curable when diagnosed and treated promptly
Advanced Disease
- If spread to lymph nodes or other areas, may require chemotherapy
- Radiation therapy in rare cases
- Can be fatal if not treated promptly or if disease has spread
Diagnosis requires CD30 immunohistochemistry testing. If you have symptoms (persistent swelling, pain, mass, asymmetry), seek evaluation promptly. Standard imaging may include ultrasound or MRI to check for fluid or masses.
7 Who May Qualify
You may be eligible to file a lawsuit if you meet these criteria:
Had Allergan BIOCELL Textured Implants
Received any of the recalled Natrelle or McGhan BIOCELL textured products for augmentation, reconstruction, or revision
Diagnosed with BIA-ALCL
Confirmed diagnosis of Breast Implant-Associated Anaplastic Large Cell Lymphoma through proper testing (CD30 IHC positive)
OR Required Explant Surgery
Had implants removed due to complications like capsular contracture, rupture, or other serious issues related to the textured surface
Have Medical Documentation
Can obtain surgical records or other documentation identifying your implant type and any complications
8 Frequently Asked Questions
Should I have my implants removed even without symptoms?
What symptoms should I watch for?
How is BIA-ALCL diagnosed?
Is it too late to file a lawsuit?
Who owns Allergan now?
How is this different from the 1990s silicone implant lawsuits?
What compensation might be available?
Sources & References
6 official sources citedJudicial Panel on Multidistrict Litigation (JPML) — Official MDL statistics
FDA BIA-ALCL Q&A — Questions and answers about BIA-ALCL
FDA Medical Device Reports — BIA-ALCL case data (updated February 2025)
FDA Recall Database — Official recall information (Z-2460-2019)
American Society of Plastic Surgeons — Breast implant safety information
Court records and JPML case statistics. Data current as of May 2026.
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Every case is unique, and results depend on the specific facts and circumstances involved. Past settlement amounts and case outcomes do not guarantee similar results in your case. If you believe you have a legal claim, you should consult with a licensed attorney in your jurisdiction who can evaluate your specific situation.