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Objectives
Intrauterine devices (IUDs) are a commonly used form of female contraception. While
insertion/removal is typically uncomplicated, the media has drawn attention to reports
of IUDs breaking upon removal, with particular concern about increased likelihood
of breakage with copper IUDs. We used national pharmacovigilance data to examine trends
in the reporting of broken IUDs.
Methods
We examined the Food and Drug Administration Adverse Event Reporting System (FAERS)’s
reports for IUDs, with interest in “breakage.” We explored associations of breakage
with IUD type (copper vs. hormonal), year reported, reporter (consumer vs. clinician),
and patient characteristics (age and weight).
Results
We identified 170,360 adverse reports for all types of IUDs (43,230 copper and 127,130
hormonal). 9.59% (n=4,147) of copper IUD adverse events were breakages. In contrast,
1.69% (n=2,147) of adverse events for hormonal IUDs were breakages. In a disproportionality
analysis comparing breakage reports for copper IUDs to hormonal IUDs, adverse events
for copper vs. those for hormonal IUDs were 6.18 times more likely (95% CI, 5.86–6.52)
to be a breakage report. IUD breakages were also associated with older, heavier-weight
individuals. Finally, breakage reports were disproportionately filed by clinicians
compared with non-clinicians (OR, 1.36; 95% CI, 1.29–1.43).
Conclusions
National pharmacovigilance data show disproportionate breakage in copper vs. hormonal
IUDs. Long term surveillance using publicly collected data may reveal events that
occur after prolonged use. This data can supplement patients’ anecdotal experiences
and help provide better counseling.
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Copyright
© 2022 Published by Elsevier Inc.
