Medical Device recall: USFDA classifies recall of this implant as ‘Most Serious’

While the March 2024 this medical device recall initiated by Hologic wasn't a product removal but a correction, the USFDA now classifies it as "most serious."

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Medical Device recall
Medical Device recall

Last Updated on June 7, 2024 by The Health Master

Medical Device recall

The U.S. Food and Drug Administration (USFDA) has escalated the seriousness classification of the medical device recall on Hologic’s BioZorb Marker, a device implanted in breast tissue during certain procedures.

This action underscores the importance of heightened vigilance by both doctors and patients to identify and address potential side effects.

USFDA Urges Increased Monitoring for BioZorb Marker

While the March 2024 this medical device recall initiated by Hologic wasn’t a product removal but a correction, the USFDA now classifies it as “most serious.”

This emphasizes the potential for complications associated with the BioZorb Marker.

The BioZorb Marker is typically implanted before procedures like radiation therapy for breast cancer.

Its function is to mark the location of lumpectomies or other tissue removals, aiding in future examinations.

However, the USFDA has received concerning reports of:

  • Pain
  • Infection
  • Other complications arising from patients feeling the medical device within the breast tissue

Patient Reporting and Doctor Monitoring Crucial

The USFDA emphasizes the importance of both patients and doctors being proactive in monitoring for side effects.

Here’s a breakdown of the key takeaways:

Patients:

If you have received a BioZorb Marker placement, be particularly attentive to any changes or discomfort in the breast area. Report any pain, infection signs (redness, swelling), or other concerns to your doctor promptly.

Doctors:

The USFDA urges healthcare providers to actively monitor patients who have received BioZorb Markers.

This includes scheduling regular check-ups to assess for potential complications and ensuring patients are aware of the reporting process for any side effects.

Early detection and intervention are crucial for minimizing risks associated with the BioZorb Marker.

By working together, doctors and patients can ensure optimal post-procedure care and successful outcomes.

Current Statistics and Previous Warnings

As of now, the USFDA has received 71 reports of injuries related to the BioZorb Marker, with no fatalities.

It’s important to note that the USFDA previously issued a warning in February 2024 to both patients and healthcare providers regarding the potential for serious complications with the medical device.

This heightened classification by the USFDA serves as a reminder of the importance of ongoing vigilance in medical device safety.

By prioritizing open communication between patients and doctors, we can work towards minimizing risks and ensuring the best possible outcomes for breast cancer patients.

Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.

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