Hologic, a leading medical device manufacturer, has faced significant regulatory challenges with its Biozorb implantable radiographic markers. In December, the Food and Drug Administration (FDA) issued a warning letter highlighting safety concerns. The FDA inspection revealed that Hologic failed to meet critical design requirements, particularly regarding the absorbability of the plastic spacer component. This issue was compounded by reports indicating that the device did not dissolve as expected over nearly five years. Consequently, Hologic ceased manufacturing and distribution of the Biozorb device in September 2024, initiating a market recall in October.

The Biozorb devices were used in breast tissue for marking tumor excision sites, aiding in monitoring and future treatments. Since 2015, over 91,500 units have been sold. Despite multiple recalls in 2023 due to adverse events like pain, infection, and device migration, Hologic’s corrective actions were delayed. The FDA's concerns extended to the device's design, which did not adequately address patient anatomy and surgical requirements. Additionally, Hologic lacked verification testing to ensure the polylactic acid spacer material was absorbed by the body. The agency urged Hologic to identify at-risk patients for potential removal of the implants.

Safety Concerns and Regulatory Actions

The FDA's warning letter in December underscored critical safety issues with Hologic's Biozorb device. Inspections revealed that Hologic failed to meet essential design criteria, particularly concerning the absorbability of the plastic spacer. Reports indicated that this component did not dissolve as intended, persisting for almost five years. Following these findings, Hologic halted production and distribution of the Biozorb device in September 2024, initiating a comprehensive market recall in October.

Since its acquisition in 2018 from Focal Therapeutics, Biozorb has been widely used in breast cancer treatments, with over 91,500 units sold since 2015. However, the device faced multiple recalls in 2023 due to adverse events such as pain, infection, and device migration. The FDA raised concerns about the device's design, noting it did not adequately consider patient anatomy and surgical needs. Verification testing was lacking, especially regarding the absorbability of the polylactic acid used in the spacer. Furthermore, Hologic's response to adverse event reports was delayed, with investigations only beginning in May 2024, despite a spike in complaints in September 2023. The FDA emphasized the need for Hologic to conduct a retrospective review of all complaints and identify patients who may benefit from explantation.

Patient Safety and Future Steps

The Biozorb device was designed to mark tumor excision sites in breast tissue, facilitating monitoring and subsequent treatments. However, its failure to meet design standards and absorbability requirements led to significant safety concerns. The FDA highlighted that Hologic's device did not adequately address patient-specific anatomical variations or surgical requirements, raising questions about its effectiveness and safety. Moreover, the lack of verification testing on the polylactic acid spacer material further exacerbated these concerns.

Despite discontinuing the sale of Biozorb, the FDA remains vigilant about patient safety. The agency advised Hologic to identify individuals at risk of adverse events and consider removing the implant. Adverse events reported included infections requiring antibiotic treatment or explantation, occurring more than 30 days post-implantation. Hologic is conducting a thorough retrospective review of all Biozorb complaints to determine reportability and take appropriate action. The FDA's guidance underscores the importance of addressing patient safety comprehensively, ensuring that any remaining risks are mitigated effectively.