BioZorb Marker Recall, Complications, and Lawsuits

Recent federal recalls and hundreds of reported complications have raised serious concerns about the BioZorb Marker, a medical device used in breast cancer treatment.

The BioZorb Device

The BioZorb Marker is a medical device used in breast cancer treatment. Manufactured by Hologic Inc., it’s designed to mark the site of tumor removal, aiding in radiation targeting and post-surgical imaging.

The device consists of two main components: a bioabsorbable spiral structure that gradually dissolves over 12-18 months, and six titanium clips that remain permanently in the breast tissue. These permanent clips serve as long-term indicators of the surgical site for future imaging and treatment planning.

Safety Recalls and Regulatory Actions

In December 2024, federal regulators issued their most serious type of recall for BioZorb Markers and BioZorb LP Markers due to potential risks of injury, following Hologic’s October 2024 urgent recall of all unused devices.

In October 2024, Hologic issued an urgent recall notice stating:

“Hologic, Inc. announced a recall for removal of all lots of unused BioZorb Markers. This update replaces the recommendations provided on March 13, 2024, by Hologic, Inc.”

Earlier that year, Hologic issued initial safety guidance. In this notice, Hologic advised:

“Patients who had already had the device implanted to monitor themselves for symptoms of an adverse reaction and report any complications to breasthealth.support@hologic.com and to the FDA’s MedWatch Adverse Event Reporting program.”

BioZorb Complications and Health Risks

Healthcare providers and patients have reported several complications associated with BioZorb implants. According to FDA documentation from December 2024, these issues include:

  • Pain and discomfort
  • Infections
  • Skin rashes
  • Device movement from original placement
  • Device breaking through skin
  • Fluid accumulation
  • Additional medical procedures needed to address complications

As of October 2024, manufacturer data showed 399 reported issues, with 188 resulting in adverse health effects. Federal regulators documented 71 injury reports during this period.

Legal Deadlines and Options

Legal time limits for filing BioZorb claims vary by state, typically ranging from one to four years after discovering a complication. In most states, the time period begins when a patient discovers or reasonably should have discovered their injury. The 2024 recalls may affect these deadlines in some states, potentially extending the time available to file claims.

Understanding these deadlines can be complex, as they depend on various factors including state laws, when complications were discovered, and how recalls might affect the timeline.

Individuals who have experienced complications from a BioZorb Marker may be able to seek legal recourse if they can document:

  • Receipt of a BioZorb Marker or BioZorb LP Marker during breast cancer surgery
  • Medical complications directly linked to the device
  • Treatment records for related issues such as infections, device movement, or additional surgeries
  • Supporting documentation like medical imaging, correspondence with healthcare providers, and impact on daily activities

Potential Compensation

People affected by BioZorb complications may be able to seek compensation for several types of harm. This typically includes medical costs for treating complications and lost income or reduced earning capacity. Patients may also seek compensation for physical pain and discomfort, emotional distress, and any long-term effects or permanent changes resulting from complications. The specific amount of compensation depends on individual circumstances and various legal factors.

Documenting Your Case

When considering legal action, maintaining comprehensive records is essential to support your case. Start by gathering all medical documentation related to your BioZorb implantation and any subsequent complications you’ve experienced. This should include your complete treatment history, with particular attention to follow-up procedures or additional surgeries that became necessary due to complications.

Visual evidence can provide important support for your case, including medical imaging and photographs of visible complications where applicable. Financial documentation is also crucial – keep detailed records of all medical expenses, including treatments, medications, and related travel costs, as well as documentation of any lost wages or income due to your medical situation.

Consider maintaining a personal record of your experience, noting how symptoms have affected your daily activities and quality of life. This contemporaneous documentation can help provide context about the impact of complications over time. Healthcare provider correspondence, including emails, letters, and visit summaries, can also help establish the timeline and extent of your medical issues.

Status of BioZorb Litigation

As of January 2025, over 80 cases against Hologic, Inc. are proceeding through the U.S. District Court for the District of Massachusetts under Judge Allison D. Burroughs. The court has implemented a systematic approach to manage these cases efficiently, selecting ten representative cases for initial review. From these, four cases have been chosen for early trials, with the first scheduled to begin September 8, 2025, and the second planned for January 2026.

A significant development occurred on January 3, 2025, when Judge Burroughs rejected Hologic’s request to dismiss the cases. The court found sufficient questions about whether surgeons would have recommended the device if they had received different risk information. While these cases aren’t formally designated as a Multi-District Litigation (MDL, a process for handling multiple similar cases efficiently), Judge Burroughs is managing them similarly to streamline the process.

Report Adverse Events

Consider reporting adverse events to the FDA’s MedWatch program, as this helps create an official record of complications. The BioZorb Marker situation continues to evolve through ongoing litigation and regulatory actions.