Breast Implant Cancer Lawsuit: Allergan Biocell BIA-ALCL MDL 2921 and First Trial

BIA-ALCL is not breast cancer. It is a T-cell lymphoma, a cancer of the immune system, that develops in the fluid or scar tissue around an implant. The MDL court described it as often appearing as a late-onset seroma, a buildup of fluid that causes swelling of the breast, which if untreated can spread and be fatal. Treatment usually means removing the implant and the surrounding capsule, sometimes with chemotherapy or radiation.

The lawsuits say Allergan's Biocell textured breast implants cause BIA-ALCL and that Allergan failed to meet FDA conditions of approval, including conducting safety studies, reporting adverse events, and updating warnings. According to the court, many plaintiffs are breast cancer survivors or women who had preventive mastectomies and received the implants during reconstruction. Some plaintiffs have BIA-ALCL, others had implants removed, and others still have them.

On July 24, 2019, Allergan announced a voluntary worldwide recall of Biocell textured breast implants and tissue expanders, after the FDA requested it because of BIA-ALCL. The recall covered dozens of models, including Natrelle 410 shaped implants, Natrelle INSPIRA textured styles, certain Natrelle saline styles, and Natrelle 133 tissue expanders.

Allergan denies liability. These are allegations; no jury has ruled.

The 2021 opinion notes that the case involves dozens of recalled Biocell models and three groups of plaintiffs: those diagnosed with BIA-ALCL, those who had implants removed, and those who still have them. Plaintiffs also pleaded class claims, including for medical monitoring, which the court narrowed. Only 16.7% of plaintiffs had a BIA-ALCL diagnosis at that time, according to the court, so most people in the litigation then were women with recalled implants but no cancer.

The federal cases are centralized as In re: Allergan Biocell Textured Breast Implant Products Liability Litigation, MDL No. 2921, Case No. 2:19-md-2921, in the District of New Jersey before Judge Brian R. Martinotti. The JPML created it on December 18, 2019.

In a 121-page opinion on March 19, 2021, Judge Martinotti granted Allergan's motions in part and denied them in part. He dismissed strict liability and negligent failure to warn claims to the extent they rested on Allergan's failure to warn of BIA-ALCL on its label or to conduct post-approval studies for most Biocell implants, but other claims survived, and tissue expanders and implants sold before the 2000 approval were treated differently. He also dismissed a proposed nationwide medical monitoring class, noting that only 16.7% of plaintiffs then had a BIA-ALCL diagnosis.

On July 13, 2026, the court picked Henson v. Allergan as the first bellwether trial, to start November 2, 2026, with Rabin v. Allergan next. Separate cases are pending in state courts.

The six bellwether candidates were Villareal, Henson, Dowland, Morales-Hernandez, Drake, and Rabin. In the July 13, 2026 opinion, the court also found the parties had consented to trying the bellwether cases in New Jersey, and denied motions by four plaintiffs to change the trial venue listed in their short form complaints. The JPML counted 1,585 cases filed over the life of the MDL.

The strongest claims involve:

• Allergan Biocell products. Textured implants or tissue expanders on the recall list. Your implant card or operative report will show the style.
• A BIA-ALCL diagnosis confirmed by pathology.
• Treatment such as explant and capsulectomy, chemotherapy, or radiation, and any reconstruction afterward.

Women with recalled implants but no diagnosis face a harder path. The FDA did not recommend removing textured implants in women without symptoms, and the 2021 ruling found that in several states people without a diagnosis cannot get medical monitoring relief. Some such claims remain in the MDL, but their value is uncertain.

Symptoms associated with breast implant illness, such as fatigue or joint pain, are a separate issue and are not the focus of this MDL.

If you are unsure whether your implants were Biocell, check whether they were textured and made by Allergan or McGhan; the implant card lists the style number, which can be matched against the recall list. Implants placed during reconstruction after mastectomy are just as relevant as cosmetic implants.

No Biocell case has gone to trial and there is no settlement, so there is no verified payout amount. The November 2, 2026 bellwether will be the first real signal. In mass torts, value usually depends on:

• whether you were diagnosed with BIA-ALCL and its stage;
• treatment beyond removal, such as chemotherapy or radiation;
• costs of explant and reconstruction;
• emotional distress, especially for women who had implants after breast cancer.

Of 64 BIA-ALCL deaths in FDA reports through June 30, 2024, the median time from the last implant to diagnosis was 9 years, which is why many claims involve implants placed long ago. Contingency fees and insurer liens usually come out of any recovery. See class action vs. mass tort.

Women who received Biocell implants in reconstruction after breast cancer may have especially significant damages if BIA-ALCL required removing the reconstruction and starting over. Those facts, and whether a second cancer diagnosis required chemotherapy or radiation, are likely to matter in how bellwether juries view these cases.

The FDA first identified a possible link between breast implants and ALCL in 2011. As of June 30, 2024, it had received 1,380 medical device reports of BIA-ALCL from the U.S. and abroad, and 64 reported deaths. The agency warns that these reports cannot establish incidence or cause on their own.

Biocell implants were mostly sold under FDA premarket approval (PMA), granted in 2000, 2006, and 2013, while tissue expanders came through the less rigorous 510(k) process. That distinction drives preemption: under Riegel v. Medtronic, claims against PMA devices that would add to federal requirements are preempted, so plaintiffs focus on claims that parallel federal duties, such as failing to report adverse events or manufacturing defects. That is why the 2021 ruling treated 510(k) tissue expanders and pre-2000 implants differently.

For how bellwether trials work, see what an MDL is.

Each claim is governed by the plaintiff's state statute of limitations, commonly two or three years, usually running from diagnosis or from when you knew or should have known the implant caused harm. Defendants will likely argue that the July 2019 recall put many women on notice, so claims from pre-2019 diagnoses or removals may face timing defenses.

A new BIA-ALCL diagnosis starts its own clock in most states. If you were diagnosed recently, talk to an attorney promptly.

Because the FDA's death reports show a median of nine years from the last implant to diagnosis, many women diagnosed now had implants placed before the 2019 recall. That gap between surgery and diagnosis is exactly why the discovery rule matters in these cases.

Keep the date of any seroma drainage, biopsy, or pathology result, since that is often the date an attorney will use.

Bring those dates to any case review.

The recall list is long. Among the products Allergan listed on July 24, 2019 were:

• Natrelle saline breast implant styles 168, 363, and 468;
• Natrelle and McGhan 410 shaped implants, including 410 Soft Touch styles;
• Natrelle 510 Dual-Gel and Natrelle INSPIRA textured styles;
• certain Natrelle and McGhan round gel styles, plus Komuro, Ritz Princess, and 150 double lumen implants;
• Natrelle 133 and 133 Plus tissue expanders.

Allergan said its smooth and MICROCELL implants and tissue expanders were not affected, and that the FDA and other health authorities had not recommended removing or replacing textured implants in patients without symptoms.

What the FDA's death reports show

Many death reports did not specify the implant surface, so the 53% textured figure is a floor, not a full count. The FDA stresses that device reports alone cannot establish how common BIA-ALCL is.

Why the approval history matters

According to the court, many Biocell models were sold under three premarket approvals granted May 20, 2000, November 17, 2006, and February 20, 2013, which came with conditions such as post-approval studies and adverse event reporting. Tissue expanders were cleared through the 510(k) process, and some devices were used under investigational exemptions. Those different pathways are why some claims survived the 2021 ruling and others did not.

1. Find your implant card or ask your surgeon for the implant record to confirm the manufacturer and style.
2. Watch for symptoms such as new swelling, a lump, or fluid around the implant, and see your doctor if they appear.
3. Talk to your surgeon before any removal; follow medical advice, not legal strategy.
4. Keep pathology and operative records if you have a seroma drained or implants removed.
5. Do not trust payout claims. No settlement exists.

In a case review, expect questions about when and why your implants were placed (augmentation or reconstruction), the manufacturer and style, any symptoms such as swelling or a lump, whether a seroma was tested, and what surgery or treatment followed. A pathology report showing BIA-ALCL, often with CD30 testing, is the key document for the strongest claims. If you do not have your implant card, the surgeon's office or hospital usually has the device record.

Independent attorneys who handle breast implant cases can check your records and deadline. A free case review takes about two minutes. Related: the Dupixent T-cell lymphoma lawsuit and the hernia mesh lawsuit.