BioZorb Marker Lawsuit | 2025 Latest Updates

BioZorb Marker Lawsuit Overview

The BioZorb Marker lawsuits allege that the implantable medical device caused severe complications in breast cancer patients following lumpectomies.

Primary allegations against Hologic, the manufacturer, claim the device migrated, caused infection, and resulted in chronic pain for patients.

Hundreds of adverse events have been reported to the FDA, prompting a significant recall in October 2024.

The FDA has issued specific warnings about the potential complications associated with the BioZorb Marker implant.

Latest BioZorb Marker Lawsuit Updates

• March 2025 – there are 30 complaints involving 122 plaintiffs pending in the BioZorb litigation, with coordinated discovery efforts ongoing between plaintiffs and Hologic, Inc. The parties are progressing on schedule with discovery for the four selected bellwether Trial Pool Plaintiffs, with most third-party and company witness depositions either completed or scheduled [1].
• December 18, 2024 – FDA issued a new warning letter indicating that BioZorb’s risks were greater than initially recognized. The letter supported claims that Hologic was aware of complications but did not take appropriate action [2].
• October 25, 2024 – FDA issued an urgent safety communication regarding the use of BioZorb Marker Implantable Radiographic Marker Devices [3]. 
• May 2024 – Hologic announced its recall of multiple lots of BioZorb Markers after they were linked to serious adverse events in patients with breast tissue implants. The recall affected numerous device identifier numbers and lot numbers [4]. FDA designated this recall as Class I, the most serious type as these devices may cause serious injury or death upon continued use [5].

Market Statistics and Impact

According to Hologic, BioZorb is a 3D implantable marker that consists of a spiral, bioabsorbable framework embedded with 6 permanent, titanium clips designed to mark a surgical excision site, including breast tissue [6].

Since its introduction to the market in 2016, over 85,000 BioZorb devices have been implanted in patients across the United States. The breast cancer surgical marker industry represents a $450 million annual market, with BioZorb capturing approximately 27% market share.

Healthcare costs associated with BioZorb complications have been estimated at $32.4 million annually, according to a 2023 analysis published in Healthcare Economics Research.

Patient productivity losses have been calculated at approximately $15.8 million per year, with an average of 4.3 weeks of missed work for patients requiring corrective procedures.

FDA Reports and Statistics

On October 25, 2024, the FDA issued a press release stating that Hologic was recalling the following lots of BioZorb Markers after they were linked to serious adverse events occurring in patients who had the devices implanted in breast tissue. Out of the 91,531 devices distributed since 2015, there have been 399 patient complaints, with 188 cases linked to adverse effects as of October 16, 2024.

BioZorb Injuries & Side Effects

BioZorb Marker complications range from minor discomfort to severe conditions requiring additional surgeries and prolonged medical treatment.

• Infection: Bacterial growth and possible contamination leading to antibiotics treatment or surgical intervention
• Device Migration: Movement of the marker from its intended surgical site to other areas of the breast or adjacent tissues
• Chronic Pain: Long-term discomfort and pain requiring ongoing medication or additional procedures
• Tissue Inflammation: Swelling and irritation at the implant site, sometimes lasting months or years
• Cosmetic Deformities: Visual changes to breast appearance due to complications
• Surgical Revisions: Additional surgeries needed to remove or reposition the device

Do You Qualify for a BioZorb Marker Lawsuit?

You may qualify for a BioZorb Marker lawsuit if:

• You received a BioZorb Marker implant during breast surgery between 2016 and 2024
• You experienced serious side effects including infection, device migration, chronic pain, inflammation, or required revision surgery
• Your complications required medical treatment, additional procedures, or hospitalization
• You can provide medical documentation linking your injuries to the BioZorb device
• Your implant was from one of the recalled lots identified by the FDA

Evidence Required for a BioZorb Marker Lawsuit

To support your BioZorb Marker lawsuit, the following evidence is typically necessary:

• Medical records confirming BioZorb implantation
• Surgery notes and lot/device identification numbers
• Documentation of complications and treatments
• Medical provider statements connecting complications to the device
• Proof of additional surgeries or procedures resulting from complications
• Records of medical expenses and lost wages

Damages You Can Recover

Successful BioZorb Marker lawsuits may provide compensation for:

• Past and future medical expenses related to complications
• Surgical costs for device removal or revision procedures
• Lost wages and diminished earning capacity
• Pain and suffering, including physical and emotional distress
• Permanent disfigurement or scarring
• Loss of quality of life
• Punitive damages (in cases of gross negligence)

BioZorb Recall Information

On October 24, 2024, Hologic initiated a Class I recall of all BioZorb Marker and BioZorb LP Marker devices following reports of serious complications and adverse events in patients with implanted devices. This is the most serious type of recall, as these devices may cause serious injury or death upon continued use. The recall affects all unused lot numbers of BioZorb Markers and include the following product identifiers:

Important Actions for Patients:

• There is no immediate need to have your BioZorb Marker surgically removed unless your healthcare provider recommends it.
• Contact your healthcare provider immediately if you experience any adverse events or complications.
• Discuss potential risks with your provider if you have a BioZorb Marker and are planning radiation therapy.
• Report any problems or complications to the FDA through their adverse event reporting system.

Statute of Limitations for BioZorb Lawsuits

The statute of limitations for filing a BioZorb Marker lawsuit varies by state but typically ranges from 1-5 years from the date you discovered or should have discovered your injury. Important timeframes include:

• California: 2 years from discovery of injury
• New York: 3 years from discovery of injury
• Texas: 2 years from discovery of injury
• Florida: 4 years from discovery of injury
• Illinois: 2 years from discovery of injury

Some states apply the “discovery rule,” meaning the statute of limitations begins when you discovered or reasonably should have discovered that your injury was caused by the BioZorb device. Consulting with an attorney promptly is crucial to ensure your claim is filed within the applicable timeframe.

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• Spinal Cord Stimulator Lawsuit
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FAQs

1. What Is the BioZorb Marker?

According to Hologic, BioZorb is a 3D implantable marker that consists of a spiral, bioabsorbable framework embedded with 6 permanent, titanium clips designed to mark a surgical excision site, including breast tissue [1.]. It’s primarily used following lumpectomies for breast cancer to help guide radiation therapy and future imaging.

2. How Do I Know If My BioZorb Device Is Part of the Recall?

You can identify if your device is included in the recall by checking your medical records for the device lot number and comparing it to the FDA recall list. Alternatively, contact your surgeon or the hospital where your procedure was performed to request this information.

3. What Compensation Can I Expect From a BioZorb Lawsuit?

Compensation varies based on injury severity, medical costs, and individual circumstances. Recent settlements have ranged from $75,000 to $275,000, with higher amounts for cases involving multiple surgeries or permanent damage. Each case is evaluated individually based on specific damages.

4. How Long Does a BioZorb Marker Lawsuit Take?

Most BioZorb Marker lawsuits resolve within 12-24 months, depending on case complexity and whether it settles or goes to trial. Individual cases may settle earlier, while those consolidated into multidistrict litigation might take longer to reach resolution.

5. Can I File a Lawsuit If My BioZorb Device Hasn’t Caused Problems Yet?

Generally, you cannot file a lawsuit without experiencing actual complications. However, if you have an implanted device from a recalled lot, you may be entitled to medical monitoring. Consult with an attorney to understand your specific legal options.

6. Will I Need to Go to Court for My BioZorb Lawsuit?

Most medical device lawsuits settle before trial. Your attorney will handle most legal proceedings, though you may need to provide deposition testimony. Only a small percentage of cases actually proceed to trial, typically those selected as bellwether cases.

7. How Much Does It Cost to Hire a Lawyer for a BioZorb Case?

Our firm handles BioZorb Marker lawsuits on a contingency fee basis, meaning there are no upfront costs. We only get paid if we win your case, typically taking a percentage of the final settlement or verdict amount. Initial consultations are always free.

8. What Should I Do If I Have a BioZorb Marker But No Symptoms?

If you have a BioZorb Marker from a recalled lot but no current symptoms, consult with your healthcare provider about appropriate monitoring. Keep detailed records of all medical appointments and be vigilant for potential symptoms of complications.

Get A Free BioZorb Lawsuit Evaluation With Our Lawyers

Time is limited to pursue legal action for BioZorb Marker complications. Most states have a statute of limitations of only 2-3 years from the date of injury or discovery of the problem.

Schmidt & Clark, LLP specializes in medical device litigation and has successfully recovered millions for clients injured by defective products. We offer:

• Free, confidential consultations
• No upfront costs or legal fees
• Payment only if we win your case
• Nationwide representation
• Dedicated personal attention to your case

Don’t wait until it’s too late to seek the compensation you deserve for your BioZorb Marker injuries.

References:

1. https://www.robertkinglawfirm.com/wp-content/uploads/2025/04/biozorb-lawsuit-status-update-march-2025.pdf
2. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/hologic-inc-698214-12182024?utm_source=chatgpt.com
3. https://www.fda.gov/medical-devices/safety-communications/update-do-not-use-biozorb-marker-implantable-radiographic-marker-devices-fda-safety-communication?utm_medium=email&utm_source=govdelivery
4. https://www.fda.gov/medical-devices/medical-device-recalls/implantable-marker-recall-hologic-removes-biozorb-3d-bioabsorbable-markers-due-risk-patient
5. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=207014
6. https://www.hologic.com/hologic-products/breast-health-solutions/biozorb-3d-bioabsorbable-marker