FDA Flags Hologic’s Biozorb Markers: Manufacturing Halted Amid Safety Concerns

Hologic received an FDA warning letter in December regarding its Biozorb implantable radiographic markers after failing to meet key design requirements. The FDA found that the plastic spacer component, intended to dissolve in the body, did not resorb as expected, with one complaint noting it remained intact for nearly five years. Hologic ceased manufacturing the device in September 2024 and instructed customers to quarantine unused units in October. The company has been collaborating with the FDA to address the concerns, which include adverse events such as pain, infection, device migration, and implant removal.

The FDA's inspection of Hologic’s Massachusetts facility raised issues regarding Biozorb’s design, including its suitability for different patient anatomies and the lack of testing on radiation treatment effects. Hologic received a significant spike in complaints in September 2023 but delayed root cause investigations until May 2024. The FDA has urged Hologic to identify patients at risk for adverse events and consider implant removal. Despite Biozorb's market withdrawal, safety concerns persist for implanted patients, prompting further action from the company and regulators.