On October 25, 2024, the U.S. Food and Drug Administration (FDA) issued a critical advisory, cautioning consumers, healthcare professionals, and medical facilities against the use of BioZorb Markers and BioZorb LP Markers, two implantable radiographic devices designed for breast tissue applications.
This warning follows a voluntary recall by the manufacturer, Hologic, after the devices were associated with serious adverse effects (AEs) in patients.
The recall stems from growing concerns over patient safety. Although initially introduced as a helpful tool for radiographic imaging and treatment planning, BioZorb Markers became the subject of complaints from patients and healthcare providers.
These complaints highlighted complications that included:
- Persistent pain
- Infections
- Skin rashes
- Erosion of the device into surrounding areas
- Seromas (fluid buildup at the implant site)
- Migration or movement of the device within breast tissue
- General discomfort or heightened awareness of the device
Between 2015 and October 2024, 91,531 BioZorb devices were distributed globally. Of these, 399 complaints were officially recorded, with 188 directly linked to adverse effects. Although this accounts for less than 0.5% of the devices sold, the recall was issued as a precautionary step to mitigate further risks. Importantly, the recall applies only to unused devices, while implanted markers will remain under clinical surveillance.
