Biozorb Markers Class Action Lawsuit

Recall Details and Affected Products

The recalled products are:

• BioZorb Marker and BioZorb LP Marker – implantable radiographic markers used to mark soft tissues (such as breast tissue) for future medical procedures; has two components: a permanent titanium metal component and a resorbable plastic component intended to be resorbed in the body after 1 year or longer. Multiple sizes including F0405 (4cm x 5cm), F0404 (4cm x 4cm), F0331 (1cm x 3cm x 3cm), F0231, F0221, F0304 (3cm x 4cm), F0303 (3cm x 3cm), F0203 (2cm x 3cm), and F0202 (2cm x 2cm).

Hologic recalled all unused BioZorb Markers on October 24, 2024, due to complications and adverse events reported with implanted devices. The FDA classified this as a Class I recall, the most serious type, indicating the device may cause serious injury or death. Complications include pain, infection, rash, device migration, device erosion through the skin, fluid buildup (seroma), and the need for additional medical treatments. There have been 252 reported injuries and no reports of death. Recall announced October 24, 2024 [1].

The FDA has not cleared or approved the use of BioZorb Markers to fill space in the tissue or to improve cosmetic outcomes after procedures, or as a marker for radiation treatment, though the device was allegedly marketed for these off-label uses.

Health Risks

• Chronic pain at the implant site.
• Infection requiring medical treatment or antibiotics.
• Device migration (moving from where it was originally placed).
• Device erosion (breaking through the skin).
• Fluid buildup under the skin (seroma).
• Rash or skin reactions.
• Device failing to resorb as intended, leaving painful masses.
• Need for additional surgeries to remove the device.
• Scarring and disfigurement.

Symptoms of a Problem

• Persistent pain at the implant site months or years after surgery.
• Hardened masses or lumps that can be felt under the skin.
• Visible device components protruding from the skin.
• Redness, swelling, or signs of infection.
• Fluid accumulation requiring drainage.
• Device visible on imaging that has not resorbed after 1-2 years.

What Consumers Should Do

1. Contact your healthcare provider if you have a BioZorb Marker implanted and experience any adverse symptoms.
2. Monitor for signs of pain, infection, migration, or other complications.
3. Be aware that there is no need to have the device removed unless your healthcare provider recommends it.
4. Report any problems or complications to the FDA through MedWatch.
5. Keep all medical records, surgical notes, and imaging showing the BioZorb implant.
6. Document any additional surgeries or treatments needed due to complications.
7. If you experienced complications requiring device removal, preserve documentation of all related medical expenses.

Potential for a Biozorb Markers Class Action Lawsuit

Patients who received BioZorb Markers may join a class action lawsuit. Claims could include:

• The device failed to resorb as promised, leaving painful masses requiring surgical removal.
• Hologic failed to adequately warn patients and doctors about risks including chronic pain, infection, and device migration.
• The company promoted off-label uses (tissue filling, cosmetic enhancement) not approved by the FDA.
• Design defects made the device inherently unsafe for its intended use.
• Hologic delayed reporting adverse events to the FDA.
• The device caused permanent scarring, disfigurement, and emotional distress.

You could get compensation for medical expenses, additional surgeries, pain and suffering, emotional distress, lost wages, and permanent disfigurement. Severe injury cases could exceed $500,000, and cases involving gross negligence may include punitive damages potentially reaching over $1 million. The first bellwether trial is scheduled for September 8, 2025.

Do I Have a Biozorb Markers Class Action Lawsuit?

Our law firm handles product liability cases nationwide. We are taking new cases about BioZorb Markers.

Free Case Review: If you received a BioZorb Marker implant and experienced chronic pain, infection, device migration, non-resorption, scarring, or required additional surgeries, contact us today. You may get compensation through a Biozorb Markers Class Action Lawsuit.

References

1. https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/implantable-marker-recall-hologic-removes-biozorb-3d-bioabsorbable-markers-due-risk-patient
2. https://www.lawsuit-information-center.com/biozorb-lawsuit.html