FDA warns Hologic over implant device following safety concerns

Photo | Grant Welker Hologic's Marlborough headquarters

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Marlborough-based medical device manufacturer Hologic has been issued a warning letter from the U.S. Food and Drug Administration concerning its BioZorb Marker, a device originally recalled in March.

The Dec. 18 warning cites safety concerns regarding the implantable BioZorb device used to mark soft tissue for future medical procedures. The FDA claims Hologic failed to ensure the device’s design was up to current good manufacturing practice requirements. The warning furthermore states the company neglected to ensure BioZorb’s design addressed its intended patient use or translated into specific production specifications and that Hologic failed to maintain procedures for implementing corrective and preventive actions.

“We have been closely coordinating with the FDA and are taking all necessary steps to resolve this matter in a comprehensive and timely manner. Ensuring safe, effective and high-quality products is our most important priority and we are committed to maintaining robust quality systems and procedures to fulfill this commitment,” Hologic said in a Friday email to WBJ.

The notice follows an FDA inspection from July 30, 2024, through September 24, 2024.

The investigation came after a 2023 uptick in patient reports said the Hologic device was causing adverse effects and complications including discomfort, deformity, sleep dysfunction, and tissue damage.

Hologic issued a notice of possible health risks linked to its BioZorb Marker and BioZorb LP Marker implantable devices in February and initiated a recall in March. The FDA categorized the recall as a Class I recall, the most severe kind, with the agency stating the use of the BioZorb may cause serious injuries or death, according to an October statement from the FDA.

Hologic voluntarily removed all lots of unused BioZorb Marker and BioZorb LP Marker devices in October. A recall notice from the FDA that same month reported 71 injuries and no deaths as a result of the device.

The FDA provided Hologic 15 business days to respond with next steps to address the violations, along with an explanation as to how the company would prevent the same or similar violations from occurring in the future.

Mica Kanner-Mascolo is a staff writer at Worcester Business Journal, who primarily covers the healthcare and diversity, equity, and inclusion industries.