Management and Outcomes of Complications Related to BioZorb Use in Breast-Conserving Surgery: A Retrospective Single-Center Case Series Analysis.

Background: BioZorb (Hologic, Inc) is an implantable fiducial marker used in breast-conserving surgery. Since the US Food and Drug Administration (FDA) approved BioZorb in 2012, numerous adverse effects have been reported, prompting the FDA to issue a warning about potential risks on February 27, 2024. BioZorb was subsequently recalled, and on October 25, 2024, the FDA classified the recall as a Class 1, the most serious category, because of the risk of severe injury or death associated with the device. Limited research is available on the management of BioZorb-related complications. Methods: In a retrospective medical records review of 296 patients who had BioZorb placed and had more than 30 days of follow-up in the electronic medical record, we identified the patients who were treated for BioZorb complications from January 2012 to February 2025. Results: With an average follow-up of 38.4 months, 13 patients (4%) experienced device-related complications, identified at a median of 6.2 months. Most affected patients had multiple complications, with the most common being chronic pain (54%), surgical site infection (39%), and wound dehiscence (31%). BioZorb was removed in 62% of patients; the remainder of the patients were managed nonoperatively. Conclusion: We identified several complications associated with the use of BioZorb in our patient population, and most of the patients who experienced complications required device removal. Because complications can develop many years after the initial surgery, surgeons should be aware of the existence of complications and the varied presentations. To our knowledge, this study is the first report on the management of BioZorb complications and subsequent outcomes, providing valuable insights for surgeons.