Association between intrauterine device type and risk of perforation and device expulsion: results from the Association of Perforation and Expulsion of Intrauterine Device study

Gatz, Jennifer; Armstrong, Mary Anne; Postlethwaite, Debbie; Raine‐Bennett, Tina; Chillemi, Giulia; Alabaster, Amy; Reed, Susan D.; Ichikawa, Laura; Getahun, Darios; Fassett, Michael J.; Shi, Jiaxiao; Xie, Fagen; Chiu, Vicki; Im, Theresa M; Takhar, Harpreet; Wang, Jinyi; Saltus, Catherine W.; Ritchey, Mary E.; Asiimwe, Alex; Pisa, Federica Edith; Schoendorf, Juliane; Wahdan, Yesmean; Zhou, Xiaolei; Hunter, Shannon; Anthony, Mary S.; Peipert, Jeffrey F.

doi:10.1016/j.ajog.2022.03.062

Cited by 5 publications

(8 citation statements)

References 16 publications

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“…12,13 The study also evaluated risks of IUD expulsion and uterine perforation in individuals with heavy menstrual bleeding and by IUD type (copper IUDs vs levonorgestrel-releasing intrauterine systems [LNG-IUDs]). 14,15 Although APEX-IUD was conducted to address a postmarketing requirement from the U.S. Food and Drug Administration, data from the study were also used to address questions raised by the European Medicines Agency about specific demographic, reproductive, and medical risk factors associated with IUD expulsion. The objective of this analysis of APEX-IUD data was to determine the extent to which six variables of interest to the European Medicines Agency were independent risk factors for IUD expulsion among individuals with no record of delivery in the past year-age, race and ethnicity, parity, BMI, history of heavy menstrual bleeding, and history of dysmenorrhea-and the extent to which these risk factor associations differed for LNG-IUD compared with copper IUD users.…”

Section: Resultsmentioning

confidence: 99%

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Demographic, Reproductive, and Medical Risk Factors for Intrauterine Device Expulsion

Anthony

Zhou

Schoendorf

et al. 2022

Obstetrics &Amp; Gynecology

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Section: Resultsmentioning

confidence: 99%

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confidence: 99%

Demographic, Reproductive, and Medical Risk Factors for Intrauterine Device Expulsion

Anthony

Zhou

Schoendorf

et al. 2022

Obstetrics &Amp; Gynecology

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“…Healthcare providers must also assess patients in their medical history for cervical or uterine cancer, as these conditions may impact IUD eligibility and require specialized management. Furthermore, counseling regarding potential side effects such as expulsion and perforation may be needed to ensure informed decision-making (Gatz et al, 2022). Consideration of these factors allows providers to effectively determine IUD eligibility and provide appropriate contraceptive care to patients.…”

Section: Iud Eligibilitymentioning

confidence: 99%

Empowering Patients: The Role of Education in Pain Alleviation during IUD Insertion

Estevez,

Hem-Lee-Forsyth,

Viechweg

et al. 2024

IJMRA

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The discomfort and apprehension associated with the Intrauterine Device (IUD) insertion procedure presents a challenge to its widespread acceptance as a contraceptive modality, notwithstanding its established efficacy. Healthcare providers play a pivotal role in addressing this challenge through the provision of comprehensive educational interventions targeting young women regarding the intricacies of IUD insertion. Such proactive educational endeavors hold promise in fostering heightened acceptance and utilization of the IUD, thereby reducing the rates of unintended pregnancies. This paper delineates strategic interventions aimed at fostering IUD adoption, bolstered by empirical evidence attesting to its efficacy in curbing rates of unplanned pregnancies, childbirths, and induced abortions, particularly within the demographic of young women.

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“…Large cohort studies have evaluated the risk of IUD-related uterine perforation in European and U.S. populations. 4–8 The European Active Surveillance Study for Intrauterine Devices observed an increased risk of uterine perforation with IUD insertions within 36 weeks of delivery and with breastfeeding near the time of IUD insertion. 4,5 In response to these findings, this retrospective cohort study, APEX-IUD (Association of Perforation and Expulsion of Intrauterine Devices), was initiated as a postmarketing requirement by the U.S. Food and Drug Administration to evaluate the incidence of IUD-related uterine perforation and IUD expulsion and their association with postpartum timing and breastfeeding status at IUD insertion among U.S. individuals.…”

mentioning

confidence: 99%

“…Prior publications have described the study methods, outcome validation, and results of these analyses in detail. [6][7][8][9][10][11] A separate analysis, requested by the European Medicines Association, evaluated whether certain demographic, reproductive, and medical variables, including younger age at IUD insertion, race and ethnicity, body mass index (BMI, calculated as weight in kilograms divided by height in meters squared), parity, history of heavy menstrual bleeding, and history of dysmenorrhea, were independent risk factors for IUD expulsion among nonpostpartum individuals. 12 The aim of this article is to summarize the clinically important findings from previous APEX-IUD publications to inform counseling, shared decision making, and consent for individuals who use or are considering IUD use (Box 1).…”

mentioning

confidence: 99%

Risks of Uterine Perforation and Expulsion Associated With Intrauterine Devices

Fassett

Reed

Rothman

et al. 2023

Obstetrics &Amp; Gynecology

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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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Association between intrauterine device type and risk of perforation and device expulsion: results from the Association of Perforation and Expulsion of Intrauterine Device study

Cited by 5 publications

References 16 publications

Demographic, Reproductive, and Medical Risk Factors for Intrauterine Device Expulsion

Demographic, Reproductive, and Medical Risk Factors for Intrauterine Device Expulsion

Empowering Patients: The Role of Education in Pain Alleviation during IUD Insertion

Risks of Uterine Perforation and Expulsion Associated With Intrauterine Devices

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