Trends in copper versus hormonal intrauterine device breakage reporting within the United States’ Food and Drug Administration Adverse Event Reporting System

• Published in: Contraception (Stoneham) Vol. 118; p. 109909
• Main Authors: Latack, Kyle R., Nguyen, Brian T.
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01-02-2023
• Subjects: Copper; Female; Humans; Intrauterine devices; Intrauterine Devices - adverse effects; Intrauterine Devices, Copper - adverse effects; Intrauterine Devices, Medicated - adverse effects; IUD-removal; LARC; Pharmacovigilance; United States; United States Food and Drug Administration; United States; IUD-removal; Pharmacovigilance; LARC; Intrauterine devices
• ISSN: 0010-7824; 1879-0518
• DOI: 10.1016/j.contraception.2022.10.011

To examine trends in national reporting of broken intrauterine devices (IUDs).
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).
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.
National pharmacovigilance data suggests disproportionate breakage in copper versus hormonal IUDs though the true prevalence of breaks cannot be calculated from this dataset.