Association between intrauterine device type and risk of perforation and device expulsion: results from the Association of Perforation and Expulsion of Intrauterine Device study. 2022

Jennifer L Gatz, and Mary Anne Armstrong, and Debbie Postlethwaite, and Tina Raine-Bennett, and Giulia Chillemi, and Amy Alabaster, and Maqdooda Merchant, and Susan D Reed, and Laura Ichikawa, and Darios Getahun, and Michael J Fassett, and Jiaxiao M Shi, and Fagen Xie, and Vicki Y Chiu, and Theresa M Im, and Harpreet S Takhar, and Jinyi Wang, and Catherine W Saltus, and Mary E Ritchey, and Alex Asiimwe, and Federica Pisa, and Juliane Schoendorf, and Yesmean Wahdan, and Xiaolei Zhou, and Shannon Hunter, and Mary S Anthony, and Jeffrey F Peipert
Regenstrief Institute, Indianapolis, IN. Electronic address: jenngatz@regenstrief.org.

Intrauterine devices, including levonorgestrel-releasing and copper devices, are highly effective long-acting reversible contraceptives. The potential risks associated with intrauterine devices are low and include uterine perforation and device expulsion. This study aimed to evaluate the risk of perforation and expulsion associated with levonorgestrel-releasing devices vs copper devices in clinical practice in the United States. The Association of Perforation and Expulsion of Intrauterine Device study was a retrospective cohort study of women aged ≤50 years with an intrauterine device insertion during 2001 to 2018 and information on intrauterine device type and patient and medical characteristics. Of note, 4 research sites with access to electronic health records contributed data for the study: 3 Kaiser Permanente-integrated healthcare systems (Northern California, Southern California, and Washington) and 1 healthcare system using data from a healthcare information exchange in Indiana (Regenstrief Institute). Perforation was classified as any extension of the device into or through the myometrium. Expulsion was classified as complete (not visible in the uterus or abdomen or patient reported) or partial (any portion in the cervix or malpositioned). We estimated the crude incidence rates and crude cumulative incidence by intrauterine device type. The risks of perforation and expulsion associated with levonorgestrel-releasing intrauterine devices vs copper intrauterine devices were estimated using Cox proportional-hazards regression with propensity score overlap weighting to adjust for confounders. Among 322,898 women included in this analysis, the incidence rates of perforation per 1000 person-years were 1.64 (95% confidence interval, 1.53-1.76) for levonorgestrel-releasing intrauterine devices and 1.27 (95% confidence interval, 1.08-1.48) for copper intrauterine devices; 1-year and 5-year crude cumulative incidence was 0.22% (95% confidence interval, 0.20-0.24) and 0.63% (95% confidence interval, 0.57-0.68) for levonorgestrel-releasing intrauterine devices and 0.16% (95% confidence interval, 0.13-0.20) and 0.55% (95% confidence interval, 0.44-0.68) for copper intrauterine devices, respectively. The incidence rates of expulsion per 1000 person-years were 13.95 (95% confidence interval, 13.63-14.28) for levonorgestrel-releasing intrauterine devices and 14.08 (95% confidence interval, 13.44-14.75) for copper intrauterine devices; 1-year and 5-year crude cumulative incidence was 2.30% (95% confidence interval, 2.24-2.36) and 4.52% (95% confidence interval, 4.40-4.65) for levonorgestrel-releasing intrauterine devices and 2.30% (95% confidence interval, 2.18-2.44) and 4.82 (95% confidence interval, 4.56-5.10) for copper intrauterine devices, respectively. Comparing levonorgestrel-releasing intrauterine devices with copper intrauterine devices, the adjusted hazard ratios were 1.49 (95% confidence intervals, 1.25-1.78) for perforation and 0.69 (95% confidence intervals, 0.65-0.73) for expulsion. After adjusting for potential confounders, levonorgestrel-releasing intrauterine devices were associated with an increased risk of uterine perforation and a decreased risk of expulsion relative to copper intrauterine devices. Given that the absolute numbers of these events are low in both groups, these differences may not be clinically meaningful.

UI MeSH Term Description Entries
D007433 Intrauterine Device Expulsion Spontaneous loss of INTRAUTERINE DEVICES from the UTERUS. IUD Expulsion,Intrauterine Device Expulsions
D007434 Intrauterine Devices Contraceptive devices placed high in the uterine fundus. Contraceptive Devices, Intrauterine,Contraceptive IUD,Contraceptive IUDs,IUD, Unmedicated,Unmedicated IUDs,Contraceptive Device, Intrauterine,Device, Intrauterine,Device, Intrauterine Contraceptive,Devices, Intrauterine,Devices, Intrauterine Contraceptive,IUD, Contraceptive,IUDs, Contraceptive,Intrauterine Contraceptive Device,Intrauterine Contraceptive Devices,Intrauterine Device,Unmedicated IUD
D007435 Intrauterine Devices, Copper Intrauterine contraceptive devices that depend on the release of metallic copper. Copper Intrauterine Devices,Copper-Releasing IUDs,IUD, Copper Releasing,Copper Intrauterine Device,Copper Releasing IUD,Copper-Releasing IUD,Device, Copper Intrauterine,Devices, Copper Intrauterine,IUD, Copper-Releasing,IUDs, Copper-Releasing,Intrauterine Device, Copper
D007436 Intrauterine Devices, Medicated Intrauterine devices that release contraceptive agents. Hormone-Releasing IUDs,IUD, Hormone Releasing,Intrauterine Devices, Hormone-Releasing,Intrauterine Devices, Progesterone-Releasing,Medicated Intrauterine Devices,Device, Hormone-Releasing Intrauterine,Device, Medicated Intrauterine,Device, Progesterone-Releasing Intrauterine,Devices, Hormone-Releasing Intrauterine,Devices, Medicated Intrauterine,Devices, Progesterone-Releasing Intrauterine,Hormone Releasing IUD,Hormone-Releasing IUD,Hormone-Releasing Intrauterine Device,Hormone-Releasing Intrauterine Devices,IUD, Hormone-Releasing,IUDs, Hormone-Releasing,Intrauterine Device, Hormone-Releasing,Intrauterine Device, Medicated,Intrauterine Device, Progesterone-Releasing,Intrauterine Devices, Hormone Releasing,Intrauterine Devices, Progesterone Releasing,Medicated Intrauterine Device,Progesterone-Releasing Intrauterine Device,Progesterone-Releasing Intrauterine Devices
D003271 Contraceptive Agents, Female Chemical substances or agents with contraceptive activity in females. Use for female contraceptive agents in general or for which there is no specific heading. Contraceptives, Female,Agents, Female Contraceptive,Female Contraceptive Agents,Female Contraceptives
D005260 Female Females
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D012189 Retrospective Studies Studies used to test etiologic hypotheses in which inferences about an exposure to putative causal factors are derived from data relating to characteristics of persons under study or to events or experiences in their past. The essential feature is that some of the persons under study have the disease or outcome of interest and their characteristics are compared with those of unaffected persons. Retrospective Study,Studies, Retrospective,Study, Retrospective
D014595 Uterine Perforation A hole or break through the wall of the UTERUS, usually made by the placement of an instrument or INTRAUTERINE DEVICES. Perforation, Uterine,Perforations, Uterine,Uterine Perforations
D016912 Levonorgestrel A synthetic progestational hormone with actions similar to those of PROGESTERONE and about twice as potent as its racemic or (+-)-isomer (NORGESTREL). It is used for contraception, control of menstrual disorders, and treatment of endometriosis. 18,19-dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17alpha)-(-)-,l-Norgestrel,Capronor,Cerazet,D-Norgestrel,Microlut,Microval,Mirena,NorLevo,Norgeston,Norplant,Norplant-2,Plan B,Vikela,duofem,D Norgestrel,Norplant 2,Norplant2,l Norgestrel

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