Clinical imaging · 2026
Adverse events of implantable breast tissue and biopsy-site markers: a cross-sectional analysis of the FDA MAUDE database (2010-2025).
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Erdem Fatih, Güngör Candan
Аннотация
PURPOSE: To characterize the spectrum, severity and temporal pattern of adverse events reported for implantable breast markers, and to compare reported-problem profiles across device subtypes, localization technologies and clip brand families.
METHODS: We analyzed the U.S. FDA Manufacturer and User Facility Device Experience (MAUDE) database, a national passive post-market surveillance system. Reports under product code NEU (implantable soft-tissue marker) received during 2010-2025 were retrieved via openFDA, deduplicated and restricted to breast markers after excluding non-breast devices. Device- and patient-problem codes were compared across device subtypes, localization technology classes and clip brand families (chi-square; Fisher exact test). MAUDE has no usage denominator, so incidence was not estimated.
RESULTS: Of 1503 reports, 51.8% involved biopsy-site clips, 39.9% BioZorb and 8.3% localization devices; 65.0% were injuries. Reporting rose sharply in 2023-2025, driven almost entirely by BioZorb (81% postdating the February 2024 FDA communication). BioZorb reports were far more likely than other markers to describe pain (odds ratio [OR] 52.5), infection (OR 27.6), severe local tissue effects (OR 69.3) and deformity (OR 275). Profiles differed within subtypes: radar reflectors were malfunction-predominant with no migration reports, whereas RFID tags accounted for most localization-device migration; among clips, HydroMark and CeleroMark/SMark reports had the highest proportions of allergic or cutaneous complaints.
CONCLUSION: Complications were reported for all categories of implantable breast markers, with distinct profiles by device technology and brand family. The recent reporting surge reflects recall-driven reporting of BioZorb complications.
METHODS: We analyzed the U.S. FDA Manufacturer and User Facility Device Experience (MAUDE) database, a national passive post-market surveillance system. Reports under product code NEU (implantable soft-tissue marker) received during 2010-2025 were retrieved via openFDA, deduplicated and restricted to breast markers after excluding non-breast devices. Device- and patient-problem codes were compared across device subtypes, localization technology classes and clip brand families (chi-square; Fisher exact test). MAUDE has no usage denominator, so incidence was not estimated.
RESULTS: Of 1503 reports, 51.8% involved biopsy-site clips, 39.9% BioZorb and 8.3% localization devices; 65.0% were injuries. Reporting rose sharply in 2023-2025, driven almost entirely by BioZorb (81% postdating the February 2024 FDA communication). BioZorb reports were far more likely than other markers to describe pain (odds ratio [OR] 52.5), infection (OR 27.6), severe local tissue effects (OR 69.3) and deformity (OR 275). Profiles differed within subtypes: radar reflectors were malfunction-predominant with no migration reports, whereas RFID tags accounted for most localization-device migration; among clips, HydroMark and CeleroMark/SMark reports had the highest proportions of allergic or cutaneous complaints.
CONCLUSION: Complications were reported for all categories of implantable breast markers, with distinct profiles by device technology and brand family. The recent reporting surge reflects recall-driven reporting of BioZorb complications.