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Risks of Uterine Perforation and Expulsion Associated With Intrauterine Devices
Michael J Fassett1, Susan D Reed, Kenneth J Rothman
1Department of Obstetrics & Gynecology, Kaiser Permanente West Los Angeles Medical Center, Los Angeles, the Department of Clinical Science and the Department of Health Systems Science, Kaiser Permanente Bernard J. Tyson School of Medicine, and the Department of Research & Evaluation, Kaiser Permanente Southern California, Pasadena, and the Division of Research, Kaiser Permanente Northern California, Oakland, California; the Department of Obstetrics and Gynecology, University of Washington School of Medicine, Seattle, Washington; RTI Health Solutions, Research Triangle Park, North Carolina; Bayer AG, Berlin, Germany; Bayer AG and Bayer OY, Espoo, Finland; Bayer Pharmaceuticals, Whippany, New Jersey, and the Department of Obstetrics and Gynecology, Indiana University School of Medicine, and the Regenstrief Institute, Indianapolis, Indiana.
Objective:
The APEX-IUD (Association of Perforation and Expulsion of Intrauterine Devices) study evaluated the association of postpartum timing of intrauterine device (IUD) insertion, breastfeeding, heavy menstrual bleeding, and IUD type (levonorgestrel-releasing vs copper) with risks of uterine perforation and IUD expulsion in usual clinical practice. We summarize the clinically important findings to inform counseling and shared decision making.
Methods:
APEX-IUD was a real-world (using U.S. health care data) retrospective cohort study of individuals aged 50 years and younger with IUD insertions between 2001 and 2018 and with electronic health record data. Cumulative incidences of uterine perforation and IUD expulsion were calculated. Adjusted hazard ratios (aHRs) and 95% CIs were estimated from proportional hazards models with control of confounding.
Results:
Among the study population of 326,658, absolute risk of uterine perforation was low overall (cumulative incidence, 0.21% [95% CI 0.19-0.23%] at 1 year and 0.61% [95% CI 0.56-0.66% at 5 years]) but was elevated for IUDs inserted during time intervals within 1 year postpartum, particularly among those between 4 days and 6 weeks postpartum (aHR 6.71, 95% CI 4.80-9.38), relative to nonpostpartum insertions. Among postpartum insertions, IUD expulsion risk was greatest for insertions in the immediate postpartum period (0-3 days after delivery) compared with nonpostpartum (aHR 5.34, 95% CI 4.47-6.39). Postpartum individuals who were breastfeeding had a slightly elevated risk of perforation and lowered risk of expulsion than those not breastfeeding. Among nonpostpartum individuals, those with a heavy menstrual bleeding diagnosis were at greater risk of expulsion than those without (aHR 2.84, 95% CI 2.66-3.03); heavy menstrual bleeding also was associated with a slightly elevated perforation risk. There was a slightly elevated perforation risk and slightly lower expulsion risk associated with levonorgestrel-releasing IUDs compared with copper IUDs.
Conclusion:
Absolute risk of adverse outcomes with IUD insertion is low. Clinicians should be aware of the differences in risks of uterine perforation and expulsion associated with IUD insertion during specific postpartum time periods and with a heavy menstrual bleeding diagnosis. This information should be incorporated into counseling and decision making for patients considering IUD insertion.
Funding Source:
Bayer AG.
Clinical Trial Registration:
EU PAS register, EUPAS33461.
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