Breast Marker Recall 2024

As a Radiology nurse, part of what we do is perform chart reviews for patients with implants to ensure patient safety and device compatibility for MRI.

This week I came across a device for the first time in the 9+ years in this department.

It’s called BioZorb marker by Hologic. This is a device placed in the breast tissue to target current and/or future treatment areas. It’s made from plastic (intended to dissolve) and titanium (permanent).

Why is this a concern…

Most titanium breast markers are safe and compatible with MRI imaging with no restrictions.

If a patient simply said they have a titanium breast marker that usually wouldn’t raise any flags.

However BioZorb does have some restrictions, it’s only safe for a 1.5Tesla MRI magnet under specific conditions. (See links)

In addition, this device is actively being litigated due to serious adverse events:

1️⃣ Migration (movement out of position)

2️⃣ Pain/infection/rash

3️⃣ Device erosion (breaking through skin)

4️⃣ Seroma (fluid buildup)

If you or someone you know has this device:

✅ Monitor for adverse symptoms

✅ Discuss with MD any concerns

✅ Always report the name of the BioZorb marker when filling out screening forms for MRI imaging.

🚨 FDA recall

🚨 BioZorb MRI safety