Hologic has received a warning letter from the U.S. Food and Drug Administration (FDA) for not addressing violations related to the company’s BioZorb 3D bioabsorbable radiographic markers.
The letter follows a previous warning by the FDA to consumers, healthcare providers, and healthcare facilities not to use the markers as well as a voluntary recall by Hologic, both issued in October. To date, 252 injuries related to the markers have been reported.
“We reviewed your firm’s response and concluded that it is not adequate,” the FDA said in a warning letter posted December 18.
The FDA noted that is aware that the BioZorb product line was put on a stop ship notice on September 29, 2024, and that Hologic will not continue to manufacture the product. However, Hologic has not ensured that the following risks have been mitigated for patients that already have the Biozorb device implanted: the potential of device interference with detection of cancer recurrence or new cancers, whether in-vivo radiation treatments can impact the performance of the device, and the ability of the device to resorb into the patient’s body.
“Your firm should address the contribution of the device design to adverse events and identify those patients who may be at risk for adverse events and therefore potentially benefit from intervention by device explanation,” the letter states.