The Food and Drug Administration (FDA) has issued a strong warning against the use of Hologic Inc.’s BioZorb Marker products, urging healthcare facilities to immediately return all unused lots. This action comes in the wake of a voluntary recall initiated by Hologic for its BioZorb Marker and BioZorb LP Marker, implantable devices designed to mark specific sites within soft tissues, such as breast tissue.
The recall was triggered by reports of serious adverse events experienced by patients, ranging from pain and infection to device migration, among others. The BioZorb Marker, originally introduced as a radiographic tool for marking soft tissue locations, consists of a dissolvable plastic component and a permanent titanium metal part. While it assists in marking areas for future medical procedures, the FDA emphasizes that it is not approved for filling tissue space, enhancing cosmetic results, or serving as a radiation treatment marker.
In February, Hologic alerted healthcare providers about potential risks associated with the BioZorb Marker. However, the recent recall significantly expands upon that initial warning, mandating the return of all unused BioZorb devices as a preventive measure. The FDA and Hologic have outlined critical steps for healthcare providers, recommending against implanting any new BioZorb Markers, quarantining existing devices, and engaging in open discussions with patients who already have the implant about the potential risks.
This comprehensive guidance aims to prioritize patient safety, given the documented complications arising from BioZorb devices in breast tissue, ranging from minor rashes to severe issues like device erosion through the skin. Since its launch in 2015, approximately 91,531 units of BioZorb have been sold, with 399 complaints reported as of October 2024. Of these complaints, 188 cases were directly linked to adverse effects.
Following this news, HOLX stock experienced a decline of 0.95%, closing at $80.14 on Friday. The FDA’s proactive approach to address the potential dangers associated with the BioZorb Marker highlights the agency’s commitment to ensuring the safety of medical devices and the well-being of patients. Healthcare providers are urged to adhere to the recall guidelines and prioritize patient safety by taking the necessary steps to manage the BioZorb Marker situation effectively.