⚡ Quick Answer
What is the BioZorb lawsuit? Breast cancer patients sued Hologic, Inc. alleging its BioZorb tissue marker — a spiral plastic spacer with six titanium clips implanted at the lumpectomy site to guide radiation therapy — was defectively designed. The plastic frame was supposed to fully dissolve within about a year. Instead, lawsuits allege it routinely failed to resorb, remaining a hard, painful mass in the breast for years, migrating from the surgical site, eroding through the skin, and causing infections, seromas, scarring, and second surgeries to remove it. Hologic pulled BioZorb from the market in October 2024 under an FDA Class I recall — the most serious recall category — and the FDA issued a warning letter finding Hologic never properly verified the device would actually be absorbed by the body. Roughly 200 cases were consolidated before Judge Allison D. Burroughs in the U.S. District Court for the District of Massachusetts.
Who Qualifies for a BioZorb Lawsuit
Eligibility focuses on breast cancer patients who received a BioZorb tissue marker during lumpectomy or breast-conserving surgery and experienced documented complications. You can pursue a claim for yourself or on behalf of a loved one.
Qualifying Criteria:
How the BioZorb Device Caused Harm
The BioZorb 3D Bioabsorbable Marker, made by Hologic (originally developed by Focal Therapeutics, acquired by Hologic in 2018), is a spiral-shaped spacer made of polylactic acid plastic holding six permanent titanium clips. Surgeons implanted it in the lumpectomy cavity to mark the tumor site for targeted radiation and future imaging. The plastic frame was marketed as fully resorbing within roughly a year, leaving only the tiny clips behind. Lawsuits allege the device failed at exactly that core promise — and that Hologic knew and failed to warn. Five core allegations run through the claims:
1. The Device Failed to Dissolve as Promised
The central design defect alleged in every BioZorb claim: the polylactic acid spacer routinely failed to resorb on the advertised timeline — or at all. Women reported a hard, palpable, often painful mass remaining at the surgical site for years. The FDA's December 2024 warning letter found Hologic failed to properly verify the device would actually be absorbed by the body, citing one complaint of a device that had not dissolved after nearly five years.
2. Migration and Erosion Through the Skin
Because the rigid spiral frame persisted in soft breast tissue, the device could shift from the original surgical site or work its way outward — in the most severe cases eroding through the skin. Migration also defeats the device's stated purpose: a marker that moves no longer accurately marks the tumor site for radiation targeting or future imaging.
3. Infection, Seroma, and Chronic Pain in Cancer Survivors
The persistent foreign body triggered infections, seromas (fluid buildup around the device), rashes, chronic pain, and in some reported cases tissue necrosis — inflicted on women already enduring breast cancer treatment and recovery. Many described being unable to sleep on their side, fear that the lump was a cancer recurrence, and repeated imaging and biopsies to rule out new tumors.
4. Undisclosed Radiation Risks
Later-filed complaints allege the device may amplify the skin radiation dose during the very radiation therapy it was designed to guide — potentially contributing to skin reactions, scarring, and disfiguring effects such as telangiectasias (visible spider veins) — risks plaintiffs allege were never disclosed to patients or physicians.
5. Failure to Warn and Regulatory Violations
BioZorb reached the market through the FDA's 510(k) clearance pathway without clinical trials. Lawsuits allege Hologic failed to warn patients and surgeons about non-resorption, migration, and erosion risks it knew about from mounting complaints. The FDA's December 2024 warning letter cited violations including inadequate design validation and failures in complaint review and corrective action — findings that plaintiffs argue render the device adulterated under federal regulations.
Injuries & Complications Recognized in BioZorb Claims
The strongest claims involve complications documented in medical records — surgical notes, imaging reports, treatment records — directly tied to the BioZorb device. These are the complications cited in the litigation and the FDA recall:
BioZorb Lawsuit Settlement Factors
A global settlement resolving the roughly 200 pending BioZorb cases was confirmed by the court in February 2026, on the eve of the first bellwether trial. Settlement amounts and terms are confidential. For claims being evaluated now, compensation potential depends on several key factors:
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Removal or revision surgery — claims involving a documented second surgery to remove or revise the device are the strongest and typically highest-value cases
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Severity of complications — erosion through the skin, serious infection, tissue necrosis, and disfigurement typically yield higher compensation than pain alone
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Documentation strength — operative reports identifying the BioZorb device, imaging showing the undissolved marker or migration, infection treatment records, and removal surgery records are essential
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Duration of complications — how long the device persisted without dissolving and how long symptoms lasted before resolution or removal
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Economic losses — out-of-pocket costs for removal surgery, infection treatment, imaging, biopsies, lost wages, and ongoing care
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Evidence of company knowledge — the FDA warning letter findings on buried complaints and inadequate design validation strengthen failure-to-warn claims across the litigation
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Litigation posture — Hologic chose to settle globally rather than face the first jury trial after the court found plaintiffs presented a triable causation case and denied summary judgment
Disclaimer: The February 2026 settlement terms are confidential and applied to cases pending in the litigation. Nothing on this page is a guarantee of qualification, compensation, or outcome. Actual results depend on case-specific facts, applicable deadlines, and litigation developments.
Deadlines for Filing a BioZorb Lawsuit
Each state has strict statutes of limitations for product liability and personal injury claims — typically 1 to 4 years. In many states, the discovery rule means the clock may not start until you knew (or reasonably should have known) the BioZorb device caused your injury — for many women, that moment came with the 2024 recall and FDA warnings, not the original surgery. Missing your deadline permanently bars your claim.
| State | Standard SOL | Discovery Rule | Key Notes |
|---|---|---|---|
| Massachusetts | 3 years | Yes | Hologic's home state; all federal BioZorb cases were consolidated in the District of Massachusetts before Judge Allison D. Burroughs |
| California | 2 years | Yes | Discovery rule applies to latent device injuries; 2-year window from when injury and its cause were reasonably discoverable |
| New York | 3 years | Yes | 3 years from discovery of the injury for latent-effect claims involving implanted devices |
| Texas | 2 years | Yes | Discovery rule recognized for inherently undiscoverable injuries such as internal device failure |
| Florida | 2 years | Yes | Florida shortened its negligence SOL from 4 to 2 years in 2023 — timing analysis is critical for Florida claimants |
| Louisiana | 1 year | Yes | Among the shortest deadlines in the nation — Louisiana claimants should act immediately |
| Tennessee | 1 year | Yes | 1-year personal injury deadline with discovery rule; immediate evaluation needed |
| All Other States | Typically 2–4 years | Varies | Many states apply discovery rules to implanted device claims. Do not assume it is too late — consult an attorney immediately to confirm your deadline. |
Because the BioZorb recall and FDA warnings did not occur until 2024, many women only recently learned their pain, lump, or infection was tied to a defective device rather than normal post-surgical healing. Discovery rules may significantly extend filing windows. Do not assume it is too late without speaking to an attorney.
BioZorb Lawsuit Updates — 2026
Last updated June 2026. We update this section with new settlement developments, court orders, regulatory actions, and claim filing news.
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February 2026 🔴 NewCourt Confirms Global Settlement of Pending BioZorb Cases: The court confirmed a global settlement resolving the roughly 200 BioZorb lawsuits pending in the District of Massachusetts. The agreement came together in the weeks after Judge Burroughs stayed all litigation deadlines in December 2025 — just before the first bellwether trial was set to open on January 20, 2026. Settlement amounts and terms have not been publicly disclosed. The agreement binds the plaintiffs who were part of the litigation; women with BioZorb implants and documented complications who never filed must have their claims evaluated individually before state deadlines expire.
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December 2, 2025Judge Burroughs Stays All Litigation Deadlines: Weeks before the first bellwether trial, the court pauses all deadlines and denies all pending motions without prejudice, leaving them open for renewal — a move widely read as a signal that settlement negotiations were underway between Hologic and plaintiffs' leadership.
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October 2025Four Bellwether Trials Scheduled January–April 2026: Judge Burroughs issues scheduling orders setting four bellwether trials: the first beginning January 20, 2026 (Kimberly Taylor's claim), followed by trials on February 23, March 30, and April 27. Roughly 200 BioZorb lawsuits are pending in the federal court system at this point.
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September 2, 2025Summary Judgment Denied — Causation Goes to the Jury: Judge Burroughs denies Hologic's motion for summary judgment, finding plaintiffs presented a triable question on whether BioZorb markers caused their injuries. The ruling clears the path for the bellwether trials and significantly increases settlement pressure on Hologic.
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August 2025New Lawsuit Alleges Undisclosed Radiation Risks: A newly filed complaint alleges BioZorb may amplify the skin radiation dose during radiation therapy, potentially contributing to scarring, skin reactions, and disfiguring telangiectasias — risks plaintiffs allege Hologic never disclosed. The case joins more than 100 others consolidated in Massachusetts.
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December 18, 2024FDA Issues Warning Letter to Hologic: FDA inspectors find Hologic violated federal manufacturing regulations — including failing to verify the plastic spacer is actually absorbed by the body and failing to properly review and act on complaints. One cited complaint described a device that had not dissolved after almost five years. The FDA states Hologic should identify implanted patients who may be at risk and could benefit from removal.
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October 24, 2024Hologic Pulls BioZorb From the Market — FDA Class I Recall & "Do Not Use" Warning: Hologic recalls all lots of unused BioZorb and BioZorb LP Markers and removes the device from the market. The FDA classifies the action as a Class I recall — its most serious — citing 71 reported injuries, and issues a safety communication advising providers to stop using the devices. Hologic discloses 399 complaints (188 tied to adverse events) out of 91,531 devices sold since 2015.
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August–September 2024Cases Consolidated; Bellwether Process Begins; Shipments Halted: BioZorb lawsuits are consolidated for coordinated proceedings before Judge Allison D. Burroughs in the U.S. District Court for the District of Massachusetts — Hologic's home district. Each side selects five potential bellwether trial candidates. Hologic quietly stops shipping BioZorb in September.
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February–May 2024Hologic Safety Notice and First Recall; FDA Designates Class I: Hologic alerts healthcare providers to reported risks including pain, infection, migration, erosion, and seroma (February 27), then issues a voluntary recall of the BioZorb 3D Bioabsorbable Marker (March 13). The FDA classifies the recall as Class I, citing risk of serious injury.
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November 4, 2022First BioZorb Lawsuit Filed: A group of breast cancer survivors files the first product liability complaint against Hologic in Massachusetts state court, alleging the BioZorb marker caused injuries and side effects never disclosed in the device's instructions for use. Additional complaints follow, eventually growing to roughly 200 plaintiffs.
Find Out If You Qualify — Free Case Review
Attorneys are evaluating BioZorb complication claims nationwide. You pay nothing unless compensation is recovered.
Start My Free Case ReviewHow the BioZorb Lawsuit Process Works
Attorneys accept BioZorb cases on contingency — you pay nothing unless compensation is recovered.
- Free confidential consultation — Discuss your lumpectomy, the BioZorb implant, and your complications with an attorney at no cost. No records are required before reaching out.
- Confirming the device — Your operative report identifies the implanted marker by name, and BioZorb's six titanium clips appear in a distinctive spiral pattern on mammograms and X-rays. Your attorney can help obtain surgical and imaging records confirming a BioZorb marker was placed.
- Documenting your complications — Your attorney gathers medical records showing pain, migration, erosion, infection, seroma, scarring, or failure to resorb — and, in the strongest cases, the operative report from a second surgery to remove or revise the device.
- Deadline analysis — Your attorney determines your state's statute of limitations and whether the discovery rule extends your window — critical for women who only connected their symptoms to BioZorb after the 2024 recall and FDA warnings.
- Determining the legal pathway — Claims are brought under product liability (design defect, failure to warn) and negligence theories — the same theories that survived Hologic's summary judgment motion in September 2025 and drove the February 2026 global settlement of pending cases.
- Filing or resolution — Your attorney pursues the path available for your claim — whether filing suit, joining any coordinated proceedings, or negotiating directly — informed by the settlement framework established in the existing litigation.
- Expert support — Breast surgeons, radiation oncologists, and biomaterials experts substantiate that the device failed to resorb as designed and caused your specific complications.
- Settlement or trial — Hologic settled the first wave of cases globally rather than face a jury. Each claim's resolution depends on its individual facts, documentation, and the applicable deadlines.
Frequently Asked Questions
What is the BioZorb breast tissue marker?
BioZorb is an implantable radiographic marker made by Hologic (originally Focal Therapeutics), placed in breast tissue during lumpectomy surgery to mark the tumor site for radiation therapy and future imaging. It consists of a spiral-shaped plastic (polylactic acid) spacer holding six permanent titanium clips.
The plastic frame was marketed as fully dissolving within about a year, leaving only the clips. Lawsuits allege the device frequently failed to resorb — remaining a hard, palpable, painful mass for years — and migrated, eroded through the skin, or caused infection, seroma, and scarring.
Why was the BioZorb marker recalled?
In October 2024, Hologic recalled all lots of BioZorb Markers and withdrew the device from the market after complaints of pain, infection, rash, device migration, erosion through the skin, seroma, and removal surgeries. The FDA classified it as a Class I recall — the most serious category — and issued a Do Not Use safety communication.
Of 91,531 devices sold since 2015, Hologic reported 399 complaints with 188 tied to adverse events. In December 2024, the FDA issued a warning letter finding Hologic failed to verify the device would actually be absorbed by the body — citing one device that had not dissolved after almost five years.
Can I still file a claim after the February 2026 settlement?
The global settlement confirmed in February 2026 resolved the roughly 200 cases already pending in the litigation. That agreement binds the plaintiffs who were part of those cases — it does not automatically extinguish claims by women who never filed.
If you have a BioZorb implant and documented complications but never pursued a claim, your eligibility must be evaluated individually and quickly — state statutes of limitations continue to run, and some are as short as one year. The settlement is the strongest signal yet that Hologic resolves these claims rather than fighting them in front of juries.
What complications qualify for a BioZorb lawsuit?
Documented complications cited in the litigation include chronic breast pain, device migration, erosion through the skin, infection, seroma (fluid buildup), scarring and fibrosis, failure of the device to dissolve, rash and skin reactions, disfigurement, and radiation-related skin damage including telangiectasias.
The key word is documented — complications reflected in your medical records, imaging, or treatment history. Your attorney can help obtain those records if you don't have them in hand.
Do I need to have had the device removed to file a claim?
No. Removal or revision surgery is not required to qualify. Women with documented complications such as pain, migration, erosion, infection, seroma, or scarring may qualify even if the device remains implanted.
That said, cases involving a documented second surgery to remove or revise the device are typically the strongest and most valuable claims — if you had removal or revision surgery, mention it in your case review.
How much is a BioZorb lawsuit worth?
The February 2026 global settlement terms are confidential, so no public per-case values exist. Compensation in implanted device cases generally reflects the severity of complications, whether removal or revision surgery was required, medical expenses, pain and suffering, disfigurement, and documentation strength.
Claims involving a documented removal surgery, erosion through the skin, serious infection, or disfigurement are typically valued highest. No outcome is guaranteed, and every claim depends on its individual facts.
How do I know if I have a BioZorb implant?
Check your lumpectomy operative report or surgical records, which identify any implanted marker by name. BioZorb's six titanium clips are also visible on mammograms and X-rays in a distinctive spiral arrangement, and many women can feel the undissolved device as a firm lump at the surgical site.
Your surgeon, oncologist, or imaging center can confirm whether a BioZorb marker was placed. An attorney can also help obtain these records as part of a free case review — you don't need them in hand to get started.
