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O18Trends in copper versus hormonal intrauterine device breakage reporting within the us food and drug administration adverse event reporting system

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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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