Understanding the BioZorb Lawsuit: What You Need to Know
The BioZorb lawsuit is a new, and quickly developing defective medical device case, that once again is exposing giant pharmaceutical companies for producing dangerous products and failing to warn the public about it.
What is BioZorb?
BioZorb is a small medical implant used in the treatment of breast cancer after a lumpectomy to help doctors target radiation therapy. Once a woman has undergone a lumpectomy, they often need radiation treatment to kill any cells that could not be cut out; BioZorb is a device to help that radiation be more accurate.
BioZorb is made of a dissolvable material with tiny metal clips inside, but some patients have reported painful complications because the implant does not always dissolve as expected and leads to severe complications such as chronic pain, infections, device migration, and eventually, more surgeries for many breast cancer patients.
Plaintiffs claim that Hologic failed to warn about these risks (sound familiar?), misrepresented the device’s safety, and engaged in off-label use, pushing the FDA to issue warnings and a growing number of lawsuits.
As this lawsuit unfolds, we will keep you updated.
Severe Complications and Injuries from BioZorb
Although BioZorb was marketed as an innovative solution to aid in breast cancer recovery, reports from patients suggest otherwise. Many women implanted with the device have suffered from:
- Chronic Pain: Persistent discomfort at the implantation site, often requiring pain management or surgical removal.
- Device Migration: Cases where the BioZorb marker moved from its intended location, leading to additional complications and sometimes interfering with cancer detection.
- Infections: Severe infections at the implant site, in some cases necessitating hospitalization.
- Scarring and Disfigurement: Tissue damage that has led to permanent cosmetic concerns.
- Failure to Resorb: While marketed as bioabsorbable, the device has remained in some patients for years, necessitating further medical intervention.
- Interference with Radiation Therapy: Some reports indicate that BioZorb may cause complications when combined with radiation treatment, an essential part of breast cancer therapy.
- Additional Surgeries: In some cases, women have had to undergo additional, previously unneeded surgeries to fix the damage caused by BioZorb.
FDA Recall on BioZorb
The U.S. Food and Drug Administration (FDA) has played a critical role in exposing the risks associated with BioZorb. In May 2024, the FDA classified Hologic’s notification to healthcare providers as a Class I recall—the most severe recall designation, indicating a high risk of serious injury or death.
The recall and subsequent warning letter from the FDA identified several deficiencies in BioZorb’s design, testing, and safety protocols. The agency found that Hologic failed to conduct adequate testing to confirm that the device would fully resorb in the body as claimed. Furthermore, the FDA cited the company for neglecting to report serious adverse events within the required timeframe, raising concerns about how long the manufacturer may have concealed evidence of BioZorb’s risks.
Legal Allegations Against Hologic
Lawsuits against Hologic allege that the company was negligent in designing, manufacturing, and marketing BioZorb. Key allegations include:
Failure to Warn
Hologic allegedly misled both doctors and patients by not fully disclosing the potential risks of BioZorb. Many surgeons were informed that the device would resorb within six to twelve months, but real-world cases have shown that in some patients, BioZorb remained intact for years, causing pain and requiring removal.
Defective Design
The BioZorb device’s structure and material have been questioned, with plaintiffs arguing that the combination of PLA and titanium clips increases the likelihood of complications, including migration and chronic inflammation.
Off-Label Promotion
While the FDA cleared BioZorb solely for use as a radiographic marker, lawsuits claim that Hologic aggressively marketed the device as a cosmetic enhancement that would help fill the space left after lumpectomy procedures. This alleged off-label promotion, if proven, could significantly impact the outcome of the litigation.
Recent Updates in the BioZorb Lawsuit 2025
February 1, 2025 - No MDL Yet, but Consolidation Likely
As of early 2025, there is still no Multi-District Litigation (MDL) for BioZorb lawsuits, but legal experts believe consolidation is inevitable.
A motion has not been filed with the Judicial Panel on Multidistrict Litigation (JPML) yet, but the growing number of cases makes centralizing the cases into an MDL the practical next step. By consolidating these cases, it will streamline pretrial proceedings, reduce redundancy, and improve efficiency in handling shared evidence and expert testimonies, making the process more efficient for literally everyone involved.
January 29, 2025 - FDA Issues Stronger Warning
The FDA issued a new warning letter stating that BioZorb’s risks were more significant than previously understood. The letter reinforced allegations that Hologic knew about complications yet failed to act.
January 16, 2025: Key Legal Ruling in Favor of Plaintiffs
A major turning point in the BioZorb litigation came when Judge Allison Burroughs denied Hologic’s motion for summary judgment. In this case, a South Carolina woman alleged that BioZorb caused severe complications, leading to multiple surgeries. Hologic argued that additional warnings would not have changed the surgeon’s decision to use the device. However, the judge ruled that a reasonable jury could find that stronger warnings might have prevented the plaintiff’s injuries, allowing the case to proceed to trial.
December 2024: First Bellwether Trials Scheduled
As of December 2024, over 100 BioZorb lawsuits had been filed, with more expected to be filed soon. Judge Burroughs, who oversees the U.S. District Court for the District of Massachusetts, has allowed for the bellwether trial process to proceed in which four representative cases will be selected and are set to begin in September 2025. These bellwether trials will provide insight into how juries might rule on future cases and potentially encourage settlement negotiations.
May 2024 – Class I Recall Issued
The FDA has designated Hologic’s BioZorb recall as Class I, their most serious type of recall, due to risks of severe injury or death. The FDA cited reports of device migration, failure to fully dissolve, infections, and chronic pain in patients.
Potential BioZorb Settlement Predictions
Although the BioZorb lawsuits are still in the very early stages, legal experts and mass tort lawyers can predict the general settlement amount ranges based on comparable medical device cases.
Individual settlements may range between $150,000 and $500,000 for moderate cases, while more severe cases involving multiple surgeries, permanent disfigurement, or significant emotional distress could exceed $500,000.
In trial settings, jury verdicts could reach into the millions, particularly if punitive damages are awarded due to Hologic’s alleged misconduct, however, most are likely to be solved out of court through negotiations.
The Impact of BioZorb Lawsuits on Medical Device Safety
The BioZorb case underscores broader concerns about how medical devices receive FDA approval and whether manufacturers adequately test their products before marketing them to vulnerable patient populations. Many plaintiffs argue that the 510(k) approval process, which allows devices to be cleared based on “substantial equivalence” to existing products, is insufficient for high-risk implants like BioZorb. This lawsuit could prompt regulatory changes and stricter oversight of medical devices moving forward.
What Should Women Affected by BioZorb Do?
If you or a loved one received a BioZorb implant and experienced complications such as chronic pain, infection, or the need for additional surgeries, you may be entitled to compensation. Lawsuits are being filed on behalf of patients nationwide, and there are time limits (statutes of limitations) for filing a claim.
Seeking legal counsel promptly is crucial to preserving your right to compensation.
Contact a BioZorb Lawyer Today
The BioZorb lawsuit is more than just another defective medical device case—it is an important reminder that pharmaceutical companies have a responsibility to ensure their patients are safe.
With the FDA’s involvement and growing legal action, Hologic faces serious accountability for its alleged failure to disclose the real risks of BioZorb.
Our legal team is actively investigating BioZorb cases and helping victims seek justice. If you believe you were harmed by a BioZorb implant, fill out our simple form. There are no upfront costs, and we only collect fees if we win your case.