The recall by Hologic is a correction rather than a product removal. Credit: Tada Images/Shutterstock.com.

The US Food and Drug Administration (FDA) has classified the recent Hologic BioZorb Marker recall as a Class I event, indicating a high risk of serious injury or death.

BioZorb Marker’s manufacturer Hologic has initiated the recall due to complications reported with the implanted devices, including pain, infection, and the need for additional medical treatment.

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Designed to be used to mark soft tissue for future medical procedures, the BioZorb Marker has been distributed from 29 April 2019 to 1 April 2024.

The recall affects various model numbers, with 53,492 devices recalled in the US. The device, implanted into breast tissue, consists of a permanent titanium component and a resorbable plastic material.

Patients have reported 71 injuries, though no deaths have been associated with the device.

The reported complications include pain, infection, rash, device migration, device erosion, seroma, discomfort, and other issues related to feeling the device within the breast. These issues have sometimes necessitated additional medical interventions to remove the device.

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The recall is a correction rather than a product removal, and Hologic has communicated with affected customers through an Important Medical Device Safety Notification sent on 13 March 2024.

The notification advised patients implanted with the BioZorb Marker to contact their healthcare provider if they experience any adverse events.

This recall may affect individuals who have been implanted with the BioZorb marker, those who receive radiation guided by the marker, and those undergoing systemic cancer treatments that could be delayed due to complications with the device.

Last month, Hologic agreed to acquire Endomagnetics (Endomag), a developer of breast cancer surgery technologies, for nearly $310m.

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