The U.S. Food and Drug Administration (FDA) has classified the recall of Hologic's BioZorb Marker as a Class I event, indicating the highest risk of serious injury or death. This recall, initiated by Hologic in March, is a correction rather than a product removal. The FDA's classification underscores the seriousness of complications associated with the device, which is implanted in soft tissue such as breast tissue.
The BioZorb Marker, which Hologic acquired from Focal Therapeutics in 2018, is used to mark soft tissue for future medical procedures, such as radiation treatment for breast cancer. The device comprises a permanent titanium component and a resorbable plastic component. It is sterile and intended for one-time use. The recall affects nine models distributed between April 29, 2019, and April 1, 2024, including 53,492 devices.
Hologic initiated the recall following reports of pain, infection, rash, device migration, device erosion, seroma, discomfort, and other complications related to the presence of the device in the breast. These issues have sometimes required additional medical treatment to remove the device. To date, there have been 71 reported injuries but no deaths linked to the BioZorb marker.
In a letter sent to affected customers on March 13, 2024, Hologic advised patients to contact their healthcare providers if they experience any adverse events following the placement of the BioZorb Marker. Patients were also encouraged to discuss the benefits and potential risks of implantable breast tissue markers with their healthcare providers. Complaints and complications should be reported to Hologic at breasthealth.support@hologic.com and to the FDA’s MedWatch Adverse Event Reporting program.
Healthcare providers are urged to be aware of serious adverse events associated with the BioZorb marker. They should inform patients about the benefits and risks of using these devices and continue to monitor patients who have an implanted BioZorb marker for signs of any adverse events. Reports of complications experienced by patients should also be submitted to Hologic and the FDA.
The FDA had previously issued a warning in February about the potential risks of serious complications from the use of the BioZorb marker. This recall does not remove the product from the market but aims to correct the issues associated with it. Hologic maintains that the BioZorb Marker continues to be offered and used safely and successfully for patients undergoing radiation treatment following breast-conserving surgery, emphasizing that patient safety remains their top priority.
This recall may impact individuals who have been implanted with the BioZorb Marker, those receiving radiation guided by the marker, and patients undergoing systemic cancer treatments that could be delayed due to complications with the device. Hologic has reiterated the importance of patient and healthcare provider vigilance in monitoring and reporting any adverse events related to the BioZorb marker.
(Input from various sources)
(Rehash/ Susmita Bhandary/MSM)