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. 2023 Sep 1;142(3):641-651.
doi: 10.1097/AOG.0000000000005299. Epub 2023 Aug 3.

Risks of Uterine Perforation and Expulsion Associated With Intrauterine Devices

Michael J Fassett  1 , Susan D Reed, Kenneth J Rothman, Federica Pisa, Juliane Schoendorf, Yesmean Wahdan, Jeffrey F Peipert, Jennifer Gatz, Mary E Ritchey, Mary Anne Armstrong, Tina Raine-Bennett, Debbie Postlethwaite, Darios Getahun, Jiaxiao M Shi, Fagen Xie, Vicki Y Chiu, Theresa M Im, Harpreet S Takhar, Jinyi Wang, Mary S Anthony
Affiliations

Risks of Uterine Perforation and Expulsion Associated With Intrauterine Devices

Michael J Fassett et al. Obstet Gynecol. .

Abstract

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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Conflict of interest statement

Financial Disclosure Susan Reed has received funding from the National Institutes of Health (NIH) and Bayer, as well as royalties from UpToDate on chapters related to endometrial hyperplasia. Jeffrey F. Peipert receives research support from Bayer, Merck, and CooperSurgical, and has served on advisory boards for Bayer, CooperSurgical, and OCON. Darios Getahun receives research support from NIH, NIEH, DHHS, NICHD, Patient-Centered Outcomes Research Institute, Garfield Memorial Fund, Bayer AG, and HOLOGIC, Inc. Jennifer Gatz disclosed money was paid to her institution from Cook, Lily, and Janssen. Michael J. Fassett receives research support from Garfield Memorial Fund, Bayer AG, and HOLOGIC, Inc. Federica Pisa, Juliane Schoendorf, and Yesmean Wahdan are employees of Bayer, the marketing authorization holder for 3 IUD brands, among others, that were included in this study. Jinyi Wang and Mary S. Anthony are employed at RTI Health Solutions, and Mary E. Ritchey was employed at RTI Health Solutions at the time the analysis was conducted. This organization worked under contract with Bayer to conduct the analyses. No payment or support of any kind was received for drafting or review of this manuscript. Tina Raine-Bennett, an employee of KPNC during the conduct of the study, is currently an employee of Medicines360, a marketing authorization holder for one of the IUD brands included in this study. The other authors did not report any potential conflicts of interest.

Figures

Fig. 1.
Fig. 1.. Adjusted hazard ratios (HRs) for uterine perforation and intrauterine device (IUD) expulsion, by risk factor. Adjusted HRs were calculated using Cox models weighted with propensity score overlap weights. *For the postpartum timing risk factor, the following variables were included in the propensity score models for adjustment: IUD type, menorrhagia, age (tertiles), race and ethnicity, recent smoker (uterine perforation only), duration of look-back period (quartiles, uterine perforation only), calendar year of IUD insertion, body mass index (categorical), dysmenorrhea, uterine leiomyomas, parity, concomitant gynecologic procedure, difficult insertion, health care professional experience, site, calendar year×site, parity×site, age (tertiles)×site, and recent smoker×site (uterine perforation only). HMB, heavy menstrual bleeding; LNG, levonorgestrel. †For the breastfeeding risk factor, the following variables were included in the propensity score models for adjustment: postpartum timing, IUD type, menorrhagia, age (tertiles), race/ethnicity, recent smoker (uterine perforation only), duration of look-back period (quartiles, uterine perforation only), calendar year of IUD insertion, BMI (categorical), dysmenorrhea, uterine fibroids, parity, cesarean delivery any time before the index date (uterine perforation only), cesarean delivery for the most recent delivery (uterine perforation only), concomitant gynecologic procedures, difficult insertion, healthcare professional experience, live birth in 52 weeks before IUD insertion, site, and postpartum×site interaction. ‡For the HMB risk factor, the following variables were included in the propensity score models for adjustment: postpartum status (4 categories), breastfeeding status, IUD type, age (continuous for perforation, tertiles for expulsion), race/ethnicity, recent smoker (uterine perforation only), duration of look-back period (quartiles, uterine perforation only), calendar year of IUD insertion, BMI (categorical), dysmenorrhea, uterine fibroids, parity, cesarean delivery any time before the index date (only for perforation), cesarean delivery for the most recent delivery, live birth for the most recent delivery, concomitant gynecologic procedure, indicator of difficult IUD insertion, healthcare professional experience (quartiles), research site, and age (continuous for perforation and tertile for expulsion)×site interaction. §For the IUD type risk factor, the following variables were included in the propensity score models for adjustment: postpartum status (4 categories), breastfeeding status, menorrhagia diagnosis in the last 52 weeks, age (tertiles), race/ethnicity, recent smoker (uterine perforation only), duration of look-back period (quartiles, uterine perforation only), calendar year of IUD insertion (categorical), BMI (categorical), dysmenorrhea, uterine fibroids, parity, cesarean delivery at any time before the index date, cesarean delivery for the most recent delivery (uterine perforation only), live birth for the most recent delivery, concomitant gynecologic procedure, indicator of difficult IUD insertion, healthcare professional experience (quartiles), live birth in 52 weeks before IUD insertion, research site, and postpartum×site interaction (IUD expulsion only).
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References

    1. Winner B, Peipert JF, Zhao Q, Buckel C, Madden T, Allsworth JE, et al. Effectiveness of long-acting reversible contraception. N Engl J Med 2012;366:1998–2007. doi: 10.1056/NEJMoa1110855 - DOI - PubMed
    1. Buhling KJ, Zite NB, Lotke P, Black K. INTRA Writing Group. Worldwide use of intrauterine contraception: a review. Contraception 2014;89:162–73. doi: 10.1016/j.contraception.2013.11.011 - DOI - PubMed
    1. Hubacher D, Kavanaugh M. Historical record-setting trends in IUD use in the United States. Contraception 2018;98:467–70. doi: 10.1016/j.contraception.2018.05.016 - DOI - PubMed
    1. Heinemann K, Reed S, Moehner S, Do Minh T. Risk of uterine perforation with levonorgestrel-releasing and copper intrauterine devices in the European Active Surveillance Study on Intrauterine Devices. Contraception 2015;91:274–9. doi: 10.1016/j.contraception.2015.01.007 - DOI - PubMed
    1. Barnett C, Moehner S, Do Minh T, Heinemann K. Perforation risk and intra-uterine devices: results of the EURAS-IUD 5-year extension study. Eur J Contraception Reprod Health Care 2017;22:424–8. doi: 10.1080/13625187.2017.1412427 - DOI - PubMed

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