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

Contraception, 118, 109909

DOI 10.1016/j.contraception.2022.10.011 PMID 36328095

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.

Topics

copper IUD breakage adverse event reporting, hormonal versus copper intrauterine device breakage rates, FDA adverse event reporting system IUD complications, IUD device breakage pharmacovigilance data, copper IUD fracture removal complications, intrauterine device safety FAERS database analysis, Paragard copper IUD breakage reports, hormonal IUD Mirena breakage comparison copper, Latack Nguyen IUD breakage FDA reporting trends, contraceptive device adverse events national surveillance
PMID 36328095 36328095 DOI 10.1016/j.contraception.2022.10.011 10.1016/j.contraception.2022.10.011

Cite this article

Latack, K., & Nguyen, B. (2023). Trends in copper versus hormonal intrauterine device breakage reporting within the United States' Food and Drug Administration Adverse Event Reporting System. *Contraception*, *118*, 109909. https://doi.org/10.1016/j.contraception.2022.10.011

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