Abstract
Objective To examine trends in national reporting of broken intrauterine devices (IUDs).
Study design We enumerated IUD device "breakage" reports in the Food and Drug Administration Adverse Event Reporting System from inception (1998) until February 2022. We explored associations of breakage with IUD type (copper versus hormonal), year reported, reporter (consumer versus clinician), and patient characteristics (age and weight).
Results We identified 4144 breakage reports for copper versus 2140 for hormonal IUDs. Among the 170,215 adverse events reported, breaks were disproportionately reported for copper (9.6%) versus hormonal (1.7%) IUDs.
Conclusion National pharmacovigilance data suggests disproportionate breakage in copper versus hormonal IUDs though the true prevalence of breaks cannot be calculated from this dataset.
iud breakage rate copper vs hormonal, intrauterine device break removal, copper iud device failure, hormonal iud breakage comparison, iud adverse events fda database, contraceptive device breakage statistics, larc device safety copper iud, iud fragmentation pharmacovigilance, paragard breakage rate
Keywords
United States, Female, Humans, Intrauterine Devices, Medicated, Copper, United States Food and Drug Administration, IUD-removal, LARC, Pharmacovigilance