Medical Device MDL-2921 Actively Recruiting • District of New Jersey

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.

Last Updated: October 1, 2026
14 min read
JPML Data Verified
8 sources cited

Key Takeaways

  • June 2026: AbbVie reached an agreement to resolve substantially all U.S.-based BIA-ALCL lawsuits, which will be dismissed with prejudice; about 1,300 other cases remain in the MDL
  • The first surgical-explant bellwether trial is set for October 19, 2026
  • 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
1,370
Pending Actions
1,380
BIA-ALCL Cases (FDA)
86%
Linked to Allergan
4M+
Devices Recalled

Key Facts (October 2026)

Pending Lawsuits 1,370 cases in federal MDL
BIA-ALCL Agreement June 2026: AbbVie agreed to resolve substantially all U.S.-based BIA-ALCL lawsuits (to be dismissed with prejudice)
Other Cases (per AbbVie) About 1,300 in the MDL, about 475 in state courts, and about 1,080 outside the U.S.
First Bellwether Trial October 19, 2026 (surgical explant; CMO 37); final pretrial conference October 6
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

Case Count Trend

The docket grew through July 2026, then fell from 1,496 to 1,377 in the August 2026 report and has held at about 1,370 since. AbbVie reached an agreement in June 2026 to resolve substantially all U.S.-based BIA-ALCL lawsuits. The current count is 8% above January 2025.

Jan 25
1,266
Feb 25
1,301
Mar 25
1,332
Apr 25
1,409
May 25
1,425
Jun 25
1,431
Jul 25
1,456
Aug 25
1,462
Sep 25
1,460
Oct 25
1,465
Nov 25
1,477
Dec 25
1,481
Jan 26
1,482
Feb 26
1,481
Mar 26
1,481
Apr 26
1,485
May 26
1,488
Jun 26
1,489
Jul 26
1,496
Aug 26
1,377
Sep 26
1,370
Oct 26
1,370

Source: JPML MDL Statistics Reports, January 2025-October 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

Persistent breast swelling (most common)
Late seroma (fluid collection) years after surgery
Pain in the breast area
Mass or lump near the implant
Breast asymmetry (size difference)
Capsular contracture (hardening)
Key Timeframe: Symptoms typically appear 8 years after implant placement on average, though the range is 0-40 years. If you notice changes years after your surgery, seek medical evaluation.

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:

1 in 3,817 to 1 in 30,000

patients with textured implants

Allergan-Specific Risk

Per FDA July 2019 assessment:

6x Higher Risk

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
Important: The recall removes unused products from suppliers and doctors. The FDA does NOT recommend routine removal for women with implants who have no symptoms. If you have concerns, discuss your specific situation with your doctor.

5 Recalled Products

Natrelle Saline-Filled BIOCELL Textured Breast Implants
Natrelle Silicone-Filled BIOCELL Textured Breast Implants
Natrelle Inspira Silicone-Filled BIOCELL Textured Breast Implants
Natrelle 410 Highly Cohesive Anatomically Shaped BIOCELL Implants
Natrelle 133 Plus Tissue Expander (Textured)
Natrelle 133 Tissue Expander with Suture Tabs (Textured)

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

BIA-ALCL Claims and the June 2026 Agreement: AbbVie reported that in June 2026 it reached an agreement to resolve substantially all U.S.-based BIA-ALCL lawsuits, which will be dismissed with prejudice. The roughly 1,300 cases still in the MDL are other claims, and the first bellwether trial (October 19, 2026) is a surgical-explant case. If you have a BIA-ALCL diagnosis, ask an attorney how the agreement applies to you.
Don't Know Your Implant Type? Many patients don't know whether they received textured or smooth implants. Contact your surgeon, request your operative notes, or check if you received any device registration cards. In June 2020, Allergan launched a campaign to help patients identify recalled products.

8 Frequently Asked Questions

Should I have my implants removed even without symptoms?
The FDA does NOT recommend routine removal for patients without symptoms. However, this is a personal decision that should be made with your healthcare provider based on your individual circumstances, risk tolerance, and peace of mind. Some women choose prophylactic explantation while others prefer monitoring.
What symptoms should I watch for?
Watch for persistent swelling, pain, lumps, asymmetry, hardening, or fluid accumulation around the implant—especially if these occur years after your surgery. These symptoms don't necessarily mean you have BIA-ALCL, but they warrant prompt medical evaluation with proper testing.
How is BIA-ALCL diagnosed?
Diagnosis requires CD30 immunohistochemistry testing on fluid or tissue samples from around the implant. If fluid or a mass is found via ultrasound or MRI, a needle biopsy is typically performed. Regular breast cancer screening (mammograms) does not detect BIA-ALCL—specific testing is required.
Is it too late to file a lawsuit?
Cases are still being filed. The statute of limitations varies by state and typically runs from the date you knew or should have known about your injury and its connection to the implants. Given the evolving nature of this litigation, consult with an attorney to understand your specific deadline.
Who owns Allergan now?
AbbVie Inc. completed its acquisition of Allergan plc in May 2020 for approximately $63 billion. Allergan Aesthetics, including the breast implant business, now operates as part of AbbVie. Both Allergan entities and AbbVie may be named as defendants in litigation.
How is this different from the 1990s silicone implant lawsuits?
The 1990s litigation involved claims of autoimmune diseases from silicone gel leakage—claims that large epidemiological studies ultimately did not support. BIA-ALCL litigation is different: the WHO has recognized BIA-ALCL as a distinct cancer entity, the FDA found a six-fold increased risk with Allergan products, and a Class I recall was issued. The scientific foundation here is stronger.
What compensation might be available?
Potential compensation varies widely based on individual circumstances and may include medical expenses (past and future), lost wages, pain and suffering, and in some cases punitive damages. In June 2026, AbbVie reached an agreement to resolve substantially all U.S.-based BIA-ALCL lawsuits, which will be dismissed with prejudice, according to its August 2026 quarterly report. About 1,300 other cases remain in the MDL. The court has also built settlement infrastructure: Case Management Order No. 38 (December 24, 2025) created a Qualified Settlement Fund, with BrownGreer as administrator and retired Judge Diane Welsh as mediator, and CMO 37 (October 14, 2025) set the first surgical-explant bellwether trial for October 19, 2026. CMO 42 (July 14, 2026) named the first two bellwether cases, Henson and Rabin. Individual case outcomes depend on factors like injury severity, treatment required, and case-specific evidence.

Sources & References

8 official sources cited

Judicial 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

AbbVie Inc. — Form 10-Q for the quarter ended June 30, 2026 (filed August 3, 2026)

U.S. District Court, D.N.J. — MDL-2921 Case Management Orders No. 37 (October 14, 2025), No. 38 (December 24, 2025) and No. 42 (July 14, 2026)

Court records and JPML case statistics. Data current as of October 2026.

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