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
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Article Info
Publication History
Published online: October 30, 2022
Accepted:
October 21,
2022
Received in revised form:
October 13,
2022
Received:
April 4,
2022
Publication stage
In Press Corrected ProofIdentification
Copyright
© 2022 Elsevier Inc. All rights reserved.
