Hologic Recalls Soft Tissue Marker Device BioZorb, FDA Issues Warning After Almost 400 Complaints

On Friday, the FDA warned against using Hologic Inc.’s HOLX BioZorb Marker products and urged healthcare facilities to return all unused lots.

This follows Hologic’s voluntary recall of the BioZorb Marker and BioZorb LP Marker, implantable devices intended for marking sites in soft tissues like breast tissue.

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The recall comes in response to reports of serious adverse events in patients, including pain, infection, and device migration, among others.

The BioZorb Marker, introduced as a radiographic tool for marking soft tissue sites, consists of a dissolvable plastic component and a permanent titanium metal part.

While it helps mark areas for future medical procedures, the FDA emphasized it is not approved to fill tissue space, enhance cosmetic results, or serve as a radiation treatment marker.

In February, Hologic alerted healthcare providers about potential risks, but the recent recall expands on that, mandating the return of all unused BioZorb devices as a preventive action.

The FDA and Hologic outlined essential steps for healthcare providers, recommending against implanting BioZorb Markers, quarantining existing devices, and discussing associated risks with patients who already have the implant.

This guidance aims to ensure patients’ safety, given the documented complications of BioZorb devices in breast tissue, which range from minor rashes to severe issues such as device erosion through the skin.

Since BioZorb’s launch in 2015, approximately 91,531 units have been sold, with 399 complaints reported as of October 2024.

Among these, 188 cases were linked to adverse effects.

Price Action: HOLX stock is down 0.95% at $80.14 at the last check on Friday.

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