Hologic warned over recalled BioZorb implants

Despite pulling its BioZorb implantable radiographic markers off the market following hundreds of complaints and dozens of reported injuries, the US Food and Drug Administration (FDA) sent a warning letter to Hologic last month raising issues with its design controls and corrective and preventive action (CAPA) procedures.

Hologic initially initiated a voluntary correction for its BioZorb Markers in February 2024, which FDA later labeled a Class I recall. By October, the company updated the recall to call for the removal of all unused lots of the devices and FDA sent out a safety communication advising health care providers not to use the devices. According to Hologic, the company received 399 complaints, of which 188 were associated with adverse events at the time of the removal in October; FDA’s recall notice cites 71 reported injuries, and no deaths associated with the device.

The warning letter comes after FDA investigators spent nearly two months inspecting the firm’s Marlborough, MA facility last year. In its warning letter, FDA acknowledged Hologic’s decision to stop manufacturing and shipping the product; however, it took issue with the fact that the company did not plan to conduct design studies to understand the issues affecting the device, raising questions about the safety of the device in patients who have already had one implanted.

“You have not appropriately evaluated your device design to ensure the following risks are mitigated for patients that already have the Biozorb device implanted, such as and not limited to: 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,” FDA wrote.

“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 explantation,” the agency added.

FDA also raised concerns that Hologic had failed to establish and maintain procedures to control the product's design to ensure that it met requirements. While the company has said it will review and revise design control procedures that focus on its remaining breast and skeletal health (BSH) products, the agency noted it has not provided documentation that includes a retrospective review of the products and any remediation efforts that may be a result of its findings.

Hologic was also warned for failing to establish and maintain procedures to implement CAPAs. More specifically, the agency said the company failed to implement requirements for analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data that could help signal potential deficiencies in the products and other quality problems.

“We understand that you will be reviewing and revising your CAPA procedures moving forward,” said FDA. “However, you have not described how you will be able to prevent this lack of oversight of your implementation of CAPA procedures in the future.”

FDA noted that Hologic had received about a half dozen adverse event reports in 2020 and reminded the company of its obligation to submit a report to the agency within 30 days of receiving information that reasonably suggests its product may have contributed to serious injury or death.

While Hologic said it has initiated corrective actions to address the underlying reasons for not reporting the adverse events on time, FDA said it had not provided any documentation or evidence that it had implemented the corrective actions.

“Your firm should take prompt action to address any violations identified in this letter,” said FDA. “Failure to adequately address this matter may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties.”

Hologic was given fifteen business days to respond to FDA’s warning letter.

BioZorb recall notice

FDA warning letter

Hologic warned over recalled BioZorb implants

Related topics

Recommended content

Welcome to the new RAPS Digital Experience