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

Kyle R Latack; Brian T Nguyen

doi:10.1016/j.contraception.2022.10.011

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

Contraception. 2023 Feb:118:109909. doi: 10.1016/j.contraception.2022.10.011. Epub 2022 Oct 31.

Authors

Kyle R Latack¹, Brian T Nguyen²

Affiliations

¹ Department of Obstetrics and Gynecology, University of Michigan, Ann Arbor, MI, United States. Electronic address: kyle.latack@gmail.com.
² Department of Obstetrics and Gynecology, Section of Family Planning, University of Southern California, Los Angeles, CA, United States.

PMID: 36328095
DOI: 10.1016/j.contraception.2022.10.011

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.

Keywords: IUD-removal; Intrauterine devices; LARC; Pharmacovigilance.

MeSH terms

Copper
Female
Humans
Intrauterine Devices* / adverse effects
Intrauterine Devices, Copper* / adverse effects
Intrauterine Devices, Medicated* / adverse effects
United States
United States Food and Drug Administration

Substances

Copper