FDA Warning Letter to Hologic, Inc.

January 17, 2025
KBA Attorneys
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BioZorb Recall – FDA Warning Letter to Hologic, Inc.: What It Reveals About the BioZorb Device

Update concerning the BioZorb recall. On December 18, 2024, the U.S. Food and Drug Administration (FDA) issued a warning letter to Hologic, Inc., raising serious concerns about the BioZorb® implantable radiographic marker.

Key Takeaways from the FDA Warning Letter

The FDA’s warning letter (read the full letter here) highlights several deficiencies in Hologic’s management of the BioZorb device. These include:

Failure to Report Adverse Events

One of the primary issues cited in the letter is Hologic’s failure to adequately report adverse events associated with the BioZorb marker. The FDA’s Medical Device Reporting (MDR) regulations require manufacturers to notify the agency of any device-related incidents that could pose risks to patient health. According to the FDA, Hologic failed to meet this critical obligation, leaving patients and healthcare providers uninformed about potential complications.

This could support our failure to warn product liability claims. It could also provide an exception to preemption to the extent it applies.

Noncompliance with Post-Market Surveillance Requirements

The letter also points out deficiencies in Hologic’s post-market surveillance. Manufacturers are required to monitor their devices’ performance in real-world settings to ensure continued safety and effectiveness. The FDA noted that Hologic did not maintain adequate systems to track and address issues with the BioZorb device once it was on the market.

Manufacturing Process Issues

Hologic’s manufacturing practices were another area of concern. The FDA identified deficiencies that could compromise the safety and quality of the BioZorb marker. Proper manufacturing controls are essential to ensure devices function as intended, and any lapses can have serious consequences for patient safety.

Implications for Patients

Patients who have had the BioZorb device implanted may be at risk of:

Severe inflammation or foreign body reactions.
Device migration, which can necessitate additional surgical interventions.
Long-term complications requiring device removal.

If you have experienced any of these symptoms, consult your healthcare provider immediately. Reporting adverse events to the FDA’s MedWatch program can also help improve device safety. Contact KBA Attorneys right away.

What’s Next for Hologic, Inc.?

The FDA’s warning letter requires Hologic to:

Submit a detailed corrective action plan within 15 working days of receiving the letter.
Address all identified deficiencies, including improving adverse event reporting, post-market surveillance, and manufacturing processes.
Demonstrate compliance with FDA regulations to avoid further enforcement actions, such as fines, product seizures, or injunctions.

The FDA’s actions indicate that it is closely monitoring the situation to ensure patient safety.

Why This Matters

The FDA’s warning letter serves as a reminder of the critical role regulatory oversight plays in safeguarding public health. When manufacturers fail to comply with safety standards, patients can face significant risks. The BioZorb recall underscores the importance of holding companies accountable for their products.

Learn More

For additional information, visit the FDA’s resources:

Legal Options for Patients

If you or a loved one has been harmed by the BioZorb marker, you may have legal options. Defective medical devices can lead to significant physical, emotional, and financial burdens. At Ketterer, Browne & Associates, we are here to help. Contact us today for a free consultation to explore your legal rights.

Final Thoughts

The FDA’s warning letter to Hologic, Inc. is a stark reminder of the importance of regulatory compliance in ensuring medical device safety. By staying informed and taking action, patients can protect their health and seek justice when harmed by negligent manufacturers.