Adverse events of implantable breast tissue and biopsy-site markers: a cross-sectional analysis of the FDA MAUDE database (2010-2025).

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.