It is BioZorb Marker is an implantable radiographic marking device that is designed to be used in soft tissue sitesparticularly in breast-conserving surgeries (e.g. lumpectomy, for example) to identify the surgical site for later imaging or radiation treatment. The device is comprised of two primary components comprising a bio-absorbable spiral of polymer that is designed to be resorbed by the body after one year or more as well as a set of small titanium clips that serve as markers within the tissue.

Its manufacturer of the device is Hologic, Inc. (which bought the original developer, Focal Therapeutics). The FDA issued an Class I recall of all unusable products that use BioZorb Marker, and BioZorb the LP Marker on the month of October 2024. This is the most severe type of recall. It indicates an “reasonable probability that use of the device will cause serious adverse health consequences or death.”

As per the FDA safety announcement as well as the recall notification, the most common complications reported included device movement (movement) devices eroding (protrusion of the skin) and fluid accumulation (seroma) infections discomfort and pain and other adverse reactions.

What Are the Allegations in the Lawsuits?

The lawsuits brought against Hologic (and involving their BioZorb Marker technology) typically make the following assertions:

1. Design defect Plaintiffs assert that the design of the device (bio-absorbable spiral of polymer and titanium clips) is extremely dangerous or was not properly examined for long-term durability in breast tissue, so that the anticipated resorption/fate of the material was not accurately portrayed or was not properly analyzed.
2. Inadequate warning (inadequate marketing and labeling) – It is claimed that Hologic was not adequately advising surgeons or patients about the dangers of migration and long-term residual marker irritation through the skin or the necessity of removal. The advertising of BioZorb is also said to have promoted the use of BioZorb (such as cosmetic tissue fillers) that for which FDA approval was not given.
3. Infraction / violation of the warranty Plaintiffs assert that Hologic owed a duty to ensure that the equipment was secure for the intended use as well as to check post-market performance, but lacked in fulfilling those obligations.
4. Manufacturing and regulatory lapses – Some complaints comprise accusations of insufficient clinical information and inadequate reporting of adverse events or manufacturing control issues. For instance, Hologic received a FDA warning letter that cited deficiencies with regard to quality assurance and adverse event reporting.

The legal basis for liability is common to medical device product liability defective design Failure to warn manufacturing defect (where relevant) and negligence.

Litigation Status & Key Developments

• In 2024-25 in 2024-25, more than 100 lawsuits are brought by patients who were given the BioZorb implant, but later suffered complications. According to some reports, there are “over 120” or “nearly 400” complaints.
• The FDA’s recall on the 24th of October 24 2024 of all unused BioZorb Marker devices, followed by the safety announcement “Do Not Use” marked an important regulatory trigger.
• The litigation is progressing towards the bellwether phase: a set of cases that are representative of trials in the early stages is being developed by the U.S. District Court for the District of Massachusetts (presided by Judge Allison D. Burroughs). In August, for instance. 2025 reports are indicating trial dates for the year 2026.
• A crucial decision: On the 28th of September 2024, 2024, the Court refused to grant Hologic’s request to dismiss a summary judgment case, finding that the plaintiff’s allegations were sufficient to show that a warning might have influenced the behavior of doctors.
• Although the lawsuits are being combined in a case management (bellwether) manner but they are have not necessarily be part of any formal multidistrict lawsuit (MDL) or a class-action.

Why It Matters

For Patients

Patients with breast cancer who undergo lumpectomy, or partial mastectomy and who have a device such as BioZorb implanted are hoping for the marker to help with the treatment process and later not pose any additional risk. When instead the device causes pain, migration, revision surgery, or cosmetic disfigurement, the impact is significant: additional surgeries, infection risk, delayed cancer therapy, emotional/psychological harm.

For Healthcare Providers

Radiation oncologists and surgeons must be aware of the safety of devices and informed consent. If an instrument is known to carry a threat (or one that is discovered) patients should be aware. The advertising of the device to be used for non-label uses (e.g. cosmetic filling, rather than only marking tissues) causes concern about the physician’s knowledge of the true risk profiles.

For Medical Device Manufacturers

This case emphasizes the necessity of rigorous tests prior to market and continuous post-market monitoring for implantable devices. The approval process through FDA 510(k) will require the demonstration the existence of “substantial equivalence” but may not necessarily require a new clinical trial or a new device (e.g. the an innovative titanium marker with a new coil) the possibility of failures that are not apparent must be controlled. The stakes for litigation and regulatory approval are very high.

For the Legal Landscape

The BioZorb Marker case exemplifies an trend Implantable medical devices which are more recent than biomaterials or metals that are combined and are often utilized to treat cancer may be the focus of multi-plaintiff or mass litigation. The recall and safety announcements came before huge verdicts suggests that settlement pressure could rise.

Key Legal Considerations & Challenges

• Causation Plaintiffs must prove the evidence that injuries (migration erosion, infected or pain) were the result of the BioZorb Marker, not by other causes (e.g. the previous treatment, radiation therapy and individual patient variation).
• Compelling hazard or pre-existing condition A lot of patients have had breast surgery chemotherapy, radiation therapy, or surgery, so the distinction between harm from a device and treatment side effects can be a difficult.
• Design and labeling manufacturers will argue that the device functioned in accordance with the design and was approved by the manufacturer and that plaintiffs’ most compelling claims might be the lack of warning or deceitful marketing, rather than a pure design defect.
• Statute of Limitations Each state has different deadlines to file claims for product liability. patients must file their claims before these deadlines run out.
• Settlement Dynamics with bellwether trials coming up parties might agree to early settlements; however, without a substantial public settlement at this point, the case value is only speculation.
• There is no class action or MDL (yet): The absence of a formal class action or MDL, means that each plaintiff’s situation remain individual, which could slow resolution and making outcomes uncertain.

Looking Ahead

The first bellwether trial will be held in 2026 both plaintiffs as well as defendants will use the results to determine settlement strategies. If juries favor plaintiffs, and award substantial amounts of damages Hologic might choose a larger settlement. In the event that they do not choose to, case could last for a long time, with each case being litigated separately (albeit with coordinated case-management).

Potential claimants (patients who received a BioZorb Marker and later suffered complications) should consult experienced medical-device attorneys, gather their surgical/radiation/treatment history, documentation of the implant, adverse events, and revise timelines carefully.

From a wider perspective from a broader perspective, this case highlights the importance of safety for devices as well as the significance of titanium/metal markers in implants and the possibility of prolonged adverse events, regardless of “low-risk” implants.