Allergan Breast Implant Lawsuit in Hawaii

BIA-ALCL stands for breast implant-associated anaplastic large cell lymphoma. It is a rare cancer of the immune system — specifically a T-cell lymphoma — that develops in the fluid or scar tissue capsule surrounding a breast implant, not in the breast tissue itself. The FDA has definitively established that BIA-ALCL is associated with textured breast implant surfaces, and Allergan's BIOCELL macro-textured surface in particular. As of June 2023, 1,079 of 1,264 globally reported BIA-ALCL cases (85%) involved Allergan BIOCELL implants. The FDA determined that women with Allergan BIOCELL implants face approximately a 6x higher risk of developing BIA-ALCL compared to women with implants from other manufacturers. The working hypothesis is that the BIOCELL surface's macro-texture creates a chronic inflammatory micro-environment that, over years, can trigger malignant T-cell transformation. This is why the recall targeted Allergan's BIOCELL surface specifically, not breast implants generally.

All BIOCELL textured breast implants and tissue expanders were recalled on July 24, 2019. The major recalled products include: Natrelle 410 Highly Cohesive Anatomically Shaped implants (all styles: FM, FF, MM, MF, ML, LL, LM, LF, FX, MX, LX — the most widely implanted recalled model); Natrelle Silicone-Filled Textured implants (styles TRL, TRM, TRF, TRX, TSL, TSM, TSF, TSX); Natrelle Saline-Filled Textured implants (styles 163, 168, 363, 468); Natrelle Inspira Textured implants; McGhan Textured Breast Implants (predecessor brand under same recall); and BIOCELL Tissue Expanders (Natrelle 133 series). Smooth-surface Allergan implants — including smooth Natrelle Inspira and Microcell lines — were NOT recalled. If you are unsure whether your implants are BIOCELL, request your implant identification card from your surgeon or review your operative report for the style number.

No. BIA-ALCL is the primary claim in MDL 2921, but it is not the only basis for filing. Women who underwent explant surgery to remove recalled Allergan BIOCELL implants — even without a BIA-ALCL diagnosis — may have claims for surgery costs, lost wages, pain and suffering, and the distress of undergoing an unplanned surgical procedure. Women experiencing breast implant illness (BII) symptoms attributed to their BIOCELL implants are also included in MDL 2921, though BII claims face greater legal challenges than BIA-ALCL claims. If you have BIOCELL implants and are monitoring without removal, and you later develop BIA-ALCL, your statute of limitations typically begins at diagnosis. Consult an attorney to understand your current options based on your specific situation.

The most common first symptom of BIA-ALCL is late-onset seroma — a sudden, persistent accumulation of fluid around the implant that appears an average of 8 to 10 years after implant placement. Unlike normal post-surgical seroma that resolves within months of the original implant surgery, BIA-ALCL-related seroma appears late and does not resolve on its own. Other symptoms include: breast swelling, asymmetry, or a noticeable change in implant shape; a palpable lump in the breast or armpit; breast pain or tenderness; skin rash or redness over the implant area; and swollen lymph nodes in the armpit. If you have Allergan BIOCELL implants and experience any of these symptoms — especially late-onset fluid accumulation — contact your plastic surgeon immediately and request an ultrasound-guided aspiration to test the fluid for lymphoma cells. Early detection dramatically improves outcomes.

No global Allergan settlement has been announced as of February 2026. The first bellwether trial in MDL 2921 is scheduled for October 2026 and will be the primary driver of settlement negotiations. Based on comparable medical device mass tort MDLs — including metal-on-metal hip implant cases and hernia mesh litigation — individual claim values depend heavily on the severity of injury. BIA-ALCL Stage IA cases treated with surgical excision only are estimated in the $50,000 to $300,000 range. Stage II–III cases requiring chemotherapy are estimated at $300,000 to $1,500,000. Stage IV metastatic BIA-ALCL cases may command $1,000,000 to $3,000,000 or more. Wrongful death claims from BIA-ALCL carry the highest values. Women who underwent explant surgery without a cancer diagnosis have lower valuations, primarily covering surgery costs, lost wages, and distress. Women who received implants for post-mastectomy reconstruction following breast cancer may present particularly compelling damages narratives.

Yes. Having your BIOCELL implants removed does not bar you from filing a claim. In fact, many claimants in MDL 2921 had their implants removed before or after the 2019 recall and are seeking compensation for the surgery costs, emotional distress, and disruption to their lives caused by having to undergo an unplanned explantation. If you were diagnosed with BIA-ALCL before your implants were removed, your cancer claim proceeds regardless of implant status. The key question is whether your claim is within the applicable statute of limitations, which depends on your state and the date you knew or should have known of the BIOCELL connection to your injury. An attorney can evaluate your specific situation, including whether MDL tolling agreements protect your claim if you previously enrolled.

MDL 2921 — In re Allergan BIOCELL Textured Breast Implant Products Liability Litigation — is a federal multidistrict litigation consolidating Allergan breast implant cases from across the United States in the U.S. District Court for the District of New Jersey. It was created by the Judicial Panel on Multidistrict Litigation in December 2019 and is presided over by Judge Brian R. Martinotti. An MDL is not a class action — each plaintiff retains an individual claim and individual damages. The MDL consolidates pretrial proceedings (discovery, expert testimony, motions) to avoid duplicative proceedings across hundreds of individual cases. Bellwether trials — individual cases tried to provide settlement data — are the next major milestone, with the first trial scheduled for October 2026. If Allergan and plaintiffs' leadership reach a global settlement, each enrolled plaintiff will be evaluated for compensation based on their specific diagnosis and damages under a settlement grid negotiated between the parties.

BIA-ALCL is not breast cancer. This distinction matters legally and medically. Breast cancer originates in the breast tissue — in the ductal or lobular cells of the mammary gland. BIA-ALCL originates in the immune system — specifically in T-lymphocytes that accumulate in the fluid or scar tissue capsule surrounding the implant. BIA-ALCL is a lymphoma, classified under non-Hodgkin lymphomas, not under breast cancer. This means it is treated by oncologists specializing in lymphoma, not breast cancer oncologists, and it responds to lymphoma-specific treatments (CHOP chemotherapy, brentuximab vedotin) rather than breast cancer treatments (tamoxifen, HER2-targeted therapy). Legally, this distinction reinforces the directness of the causal link to Allergan's product — BIA-ALCL does not arise from breast tissue genetics or family history; it arises from the implant's interaction with the immune system.

The statute of limitations varies by state but is typically 2 to 3 years from the date you knew or should have known that your Allergan BIOCELL implants caused your injury — the discovery rule. For BIA-ALCL, this typically means from the date of diagnosis. For explant costs, it may mean from the date of surgery or from the July 2019 recall (whichever is later under your state's discovery rule). Key deadlines: California — 2 years from discovery (CCP § 335.1); Texas — 2 years from discovery (Tex. Civ. Prac. § 16.003); Florida — 2 years from discovery (§ 95.11(3)(a)); New York — 3 years from discovery for personal injury. The District of New Jersey (where MDL 2921 is pending) applies the law of the state where the implant was placed. MDL 2921 tolling agreements have preserved many claims, but these do not automatically apply to new claimants. Consult an attorney immediately — do not attempt to self-evaluate complex tolling questions.

Yes — this is a central allegation in MDL 2921. The FDA first publicly communicated a possible link between breast implants and BIA-ALCL in January 2011. French regulators identified a disproportionate risk specifically from Allergan's BIOCELL implants and recalled them in December 2018 — a full year before the U.S. recall. Despite accumulating case reports in the FDA's MAUDE database showing a marked overrepresentation of Allergan BIOCELL implants in BIA-ALCL cases throughout the early 2010s, Allergan did not strengthen its BIA-ALCL warning language in a way plaintiffs' attorneys argue was adequate, and did not initiate a U.S. recall until July 2019. The 8-year gap between FDA's first warning (2011) and Allergan's recall (2019) is the core of failure-to-warn claims in MDL 2921. Plaintiffs allege Allergan prioritized BIOCELL sales over patient safety during this period.

Key evidence for an Allergan claim includes: (1) Implant identification — your implant card (given at time of surgery), operative report, or surgeon records confirming Allergan BIOCELL product name and style number; (2) Medical records — pathology report confirming BIA-ALCL diagnosis with staging, or surgical records for explant procedure; (3) Treatment records — oncology records, chemotherapy administration records, imaging studies (ultrasound, PET-CT), and surgical reports; (4) Economic damages documentation — medical bills, insurance explanation of benefits, pay stubs and records of missed work, out-of-pocket expenses. You do not need the implants themselves (which will have been removed and likely sent to pathology). Your attorney can obtain medical records, operative reports, and implant identification information with your authorization. Women who had implants placed at multiple facilities or by multiple surgeons should gather records from all treating providers.

Treatment for BIA-ALCL depends on disease stage at diagnosis. For Stage IA (disease confined to seroma fluid or inner capsule), the recommended treatment is complete en bloc capsulectomy — surgical removal of the implant together with the entire surrounding fibrous capsule in one intact specimen. This approach is curative in the majority of Stage IA cases, with high rates of complete remission without chemotherapy. For Stage IB–III disease (capsule involvement, lymph node spread), surgery is followed by systemic chemotherapy, typically CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone). Brentuximab vedotin — a CD30-targeted antibody-drug conjugate — has shown strong efficacy in BIA-ALCL and is used in some regimens. Stage IV disease may require autologous stem cell transplant in eligible patients. The NCCN (National Comprehensive Cancer Network) guidelines recommend referral to a lymphoma specialist with BIA-ALCL experience. After treatment, regular PET-CT surveillance is recommended to monitor for recurrence.