Trends in use of and complications from intrauterine contraceptive devices and tubal ligation or occlusion

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1 Howard et al. Reproductive Health (27) 4:7 DOI.86/s RESEARCH Open Access Trends in use of and complications from intrauterine contraceptive devices and tubal ligation or occlusion Brandon Howard *, ElizaBeth Grubb 2, Maureen J. Lage 3 and Boxiong Tang 4 Abstract Background: Long-acting reversible contraceptives such as intrauterine devices (IUDs) are highly effective in preventing pregnancy, cost effective, and increasing in popularity. It is unclear whether changes in IUD use are associated with changes in rates of irreversible tubal sterilization. In this analysis, we evaluate changes in rates of tubal sterilization, insertion of copper or levonorgestrel (LNG) IUDs, and related complications over time. Methods: Data were obtained from a retrospective claims database (Optum TM Clinformatics TM Data Mart) of women aged 5 to 45 years who underwent insertion of copper or or tubal sterilization between //26 and 2/3/2. Outcomes of interest included annual rates of insertion or sterilization and annual rates of potential complications and side effects. Results: The number of women included in the analysis each year ranged from,87,675 to 2,6,96. Between 26 and 2, copper IUD insertion claim rates increased from.8 to.25% and insertion claim rates increased from.63 to.5%, while sterilization claims decreased from.78 to.66% (P <. for all comparisons). Increases in IUD insertion were apparent in all age groups; decreases in tubal sterilization occurred in women aged 2 to 34 years. The most common side effects and complications were amenorrhea ( %), heavy menstrual bleeding ( %), and pelvic pain ( %). Significant increases in claims of certain complications associated with IUD insertion or sterilization were also observed. Conclusion: Between 26 and 2, a decrease in sterilization rates accompanied an increase in IUD insertion rates, suggesting that increasing numbers of women opted for reversible methods of long-term contraception over permanent sterilization. Keywords:, Levonorgestrel IUD, Tubal sterilization Plain English summary Long-acting reversible contraceptives such as intrauterine devices (IUDs) are among the most effective options for preventing pregnancy, and their popularity is increasing. However, whether changes in IUD use are associated with changes in rates of tubal sterilization, a largely irreversible and permanent contraceptive option, is unclear. In this study, we evaluated changes in rates of tubal sterilization, insertion of two different types of IUDs (copper or levonorgestrel [LNG] IUDs) and side effects associated with these devices over time. Data * Correspondence: Brandihoward@gmail.com Teva Global Medical Affairs, 4 Moores Road, Frazer, PA 9355, USA Full list of author information is available at the end of the article were obtained from an insurance claims database that included women aged 5 to 45 years who underwent insertion of copper or insertion or tubal sterilization between //26 and 2/3/2. Approximately 2 million women were included in the database each year. Between 26 and 2, copper IUD insertion rates increased from.8 to.25% and insertion rates increased from.63 to.5%, while sterilization claims decreased from.78 to.66%. Increases in IUD insertion were apparent in all age groups; decreases in tubal sterilization occurred in women aged 2 to 34 years. Results from our study suggest that increasing numbers of women are opting for copper and s over permanent sterilization. The Author(s). 27 Open Access This article is distributed under the terms of the Creative Commons Attribution 4. International License ( which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( applies to the data made available in this article, unless otherwise stated.

2 Howard et al. Reproductive Health (27) 4:7 Page 2 of 7 Background Intrauterine devices (IUDs) are the most common method of reversible contraception [, 2], used by approximately 4.3% of reproductive-aged women worldwide [3]. However, they are used only by 6.4% of American women using contraception [4]. Two commonly used IUDs in the US include the copper T38A IUD (copper IUD) and the levonorgestrel 2-mcg-releasing intrauterine device (). Both IUDs have been shown to be cost effective, have few contraindications, and are well tolerated [5 9]. Although the use of both IUDs is low in the US compared with the rest of the world, data suggest that use has substantially increased in recent years [, ]. Factors that may affect IUD use, including changes in rates of tubal sterilization, complications, or side effects have not been investigated. In this report, we compare the use and complications associated with the copper IUD,, and tubal sterilization using data obtained from the Optum Clinformatics Data Mart database. Methods The Optum Clinformatics Data Mart database is a large database of medical claims, pharmacy claims, lab results, and administrative data that contains information on patient characteristics, inpatient and outpatient encounters, and outpatient prescription drug coverage throughout the US. The database includes approximately 3 million unique individuals each year. Most individuals Table Rate of IUD insertion and tubal sterilization over time Year Total N n (%) n (%) n (%) 26,97, (.8) 2,28 (.63) 4,887 (.78) Age 5 to 9 y 293, (.2) 26 (.7) 38 (.) Age 2 to 24 y 22,95 33 (.5) 257 (.57) 45 (.2) Age 25 to 34 y 566, (.3) 623 (.) 6642 (.7) Age 35 to 45 y 827, (.6) 4325 (.52) 7756 (.94) 27,94,3 383 (.2) 6,789 (.87) 4,769 (.76) Age 5 to 9 y 299, (.3) 46 (.4) 42 (.) Age 2 to 24 y 224, (.8) 83 (.8) 444 (.2) Age 25 to 34 y 583, (.34) 8533 (.46) 647 (.) Age 35 to 45 y 832, (.6) 627 (.72) 782 (.94) 28 2,, (.22) 24,276 (.2) 4,667 (.73) Age 5 to 9 y 38,3 2 (.3) 69 (.22) 2 (.) Age 2 to 24 y 237, (.9) 2845 (.2) 4 (.7) Age 25 to 34 y 65, (.38) 2,545 (2.4) 6473 (.5) Age 35 to 45 y 84, (.8) 896 (.97) 7763 (.92) 29 2,6, (.24) 24,8 (.23) 4,88 (.74) Age 5 to 9 y 32,43 93 (.3) 777 (.25) 37 (.) Age 2 to 24 y 237, (.9) 292 (.23) 394 (.7) Age 25 to 34 y 625, (.4) 2,64 (2.2) 6232 (.) Age 35 to 45 y 84, (.2) 85 (.) 828 (.98) 2,87, (.28) 2,639 (.) 3,33 (.7) Age 5 to 9 y 289, (.5) 677 (.23) 37 (. Age 2 to 24 y 222,82 55 (.25) 2 (.94) 243 (.) Age 25 to 34 y 574, (.48),36 (.8) 5485 (.95) Age 35 to 45 y 783, (.23) 7545 (.96) 7548 (.96) 2,99, (.25) 22,35 (.5) 2,56 (.66) Age 5 to 9 y 295,377 6 (.4) 762 (.26) 24 (.) Age 2 to 24 y 265,89 6 (.23) 2648 (.) 28 (.) Age 25 to 34 y 575, (.43),694 (.86) 52 (.89) Age 35 to 45 y 772,39 54 (.2) 793 (.3) 754 (.93) P Value for Trend Over Time in the Overall Population <. <. <.

3 Howard et al. Reproductive Health (27) 4:7 Page 3 of 7 included in the database are commercially insured. The database is fully compliant with the Health Insurance Portability and Accountability Act. This study evaluated claims from January, 26, to December 3, 2, among women aged 5 45 years as of the index date, defined as the insertion date of copper IUD (Healthcare Common Procedure Coding System [HCPCS] code J73) or (HCPCS code J732), or date of sterilization by tubal ligation/tubal occlusion, based on receipt of International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes 66.2 or 66.3 or Current Procedure Terminology codes 586, 5865, 586, 5865, 5687, or Outcomes of interest included the rate of copper IUD insertion, insertion, and tubal sterilization by year (26 2) and by age group (ages 5 9, 2 24, 25 34, and 35 45), and changes in rate of potential complications and side effects over time. Complications and side effects were assessed based on receipt of ICD-9-CM codes for the following conditions: uterine perforation, pelvic inflammatory disease, post-insertion infection, dysmenorrhea, heavy menstrual bleeding (HMB), menorrhagia, anemia, ovarian cyst, pelvic pain, and amenorrhea. All analyses were conducted using SAS, version 9.3 (SAS Institute Inc., Cary, NC, USA). Chi square analyses were used to analyze categorical variables; analyses of variance were used to evaluate continuous variables. Findings with associated P values <.5 were considered statistically significant. Results The number of women included in the analysis each year ranged from,87,675 to 2,6,96. Rates of tubal sterilization decreased and rates of insertion of both copper and s increased between 26 and 2 (Table, Fig. ). The percentage of women who underwent tubal ligation/tubal occlusion decreased from.78% (4,887/,97,748) in 26 to.66% (2,56/,99,36) in 2 (P <.), while rates of copper IUD insertion increased Fig. Rate of claims related to copper IUD insertion, insertion, and tubal sterilization by year of insertion/sterilization a b c d Rate in Women Aged 5 to 9 Years Rate in Women Aged 2 to 24 Years Rate in Women Aged 25 to 34 Years Rate in Women Aged 35 to 45 Years Fig. 2 Rate of claims related to copper IUD insertion, insertion, and tubal sterilization by year of insertion or sterilization in women aged 5 to 9 years (a), 2 to 24 years (b), 25 to 34 years (c),and35to45years(d)

4 Howard et al. Reproductive Health (27) 4:7 Page 4 of 7 Table 2 Complications and side effects associated with IUD insertion and tubal sterilization over time Complications/Side Effect n (%) n (%) n (%) Amenorrhea (ICD ) Total (26 2) 2385 (8.99) ab 977 (7.53) ac 75 (.67) bc (8.92) 94 (7.82) 638 (.) (.2) 278 (7.6) 64 (.93) (9.2) 873 (7.72) 7 (.59) (9.2) 845 (7.44) 658 (.4) (8.62) 58 (7.36) 429 (.73) (8.2) 622 (7.36) 37 (.92) P Value Anemia (ICD-9 28.xx) Total (26 2) 595 (2.24) b 2832 (2.35) c 23 (3.32) bc (.94) 279 (2.32) 435 (2.92) (2.5) 386 (2.3) 433 (2.93) 28 6 (2.37) 538 (2.22) 492 (3.35) 29 9 (2.44) 6 (2.42) 53 (3.45) 2 35 (2.57) 52 (2.48) 48 (3.6) 2 9 (.92) 57 (2.35) 469 (3.73) P Value Dysmenorrhea (ICD ) Total (26 2) 733 (2.76) ab 399 (3.24) ac 249 (4.2) bc 26 9 (2.6) 378 (3.4) 587 (3.94) (2.5) 566 (3.37) 59 (4.) (2.95) 723 (2.98) 598 (4.8) (2.86) 87 (3.25) 647 (4.35) 2 37 (2.6) 692 (3.35) 649 (4.87) 2 4 (2.99) 743 (3.37) 66 (4.82) P Value <. Heavy Menstrual Bleeding (ICD ) Total (26 2) 37 (5.6) ab 24 (8.46) ac 7328 (2.3) bc (5.9) 48 (8.7) 687 (.33) (5.2) 46 (8.37) 75 (.85) (5.) 846 (7.6) 922 (3.) (5.26) 992 (8.3) 245 (3.74) 2 26 (4.98) 88 (9.) 26 (5.7) (4.85) 23 (9.22) 97 (5.69) P Value.3527 <. <. Infection (ICD x) Total (26 2) 5 (.6) 88 (.7) c 8 (.3) c 26 4 (.2) 2 (.) 2 (.) 27 (.3) 4 (.8) 2 (.) 28 6 (.3) 5 (.6) 7 (.5) 29 2 (.4) 25 (.) 4 (.3) 2 (.) 4 (.7) 4 (.3)

5 Howard et al. Reproductive Health (27) 4:7 Page 5 of 7 Table 2 Complications and side effects associated with IUD insertion and tubal sterilization over time (Continued) 2 2 (.4) 8 (.4) 5 (.4) P Value Menorrhagia (ICD ) Total (26 2) 53 (.2) ab 528 (.44) ac 4 (.68) bc 26 2 (.35) 48 (.4) 88 (.59) 27 6 (.6) 58 (.35) 94 (.64) 28 (.25) 84 (.35) 92 (.63) 29 2 (.25) 89 (.36) 9 (.8) 2 8 (.5) 2 (.59) 2 (.9) 2 4 (.9) 28 (.58) 26 (.) P Value.8 <. <. Ovarian Cyst (ICD ) Total (26 2) 57 (4.36) ab 634 (5.26) ac 4324 (7.6) bc 26 4 (4.5) 539 (4.48) 45 (7.2) (4.8) 786 (4.68) 99 (6.7) 28 2 (4.72) 268 (5.22) 76 (7.34) (4.29) 4 (5.64) 39 (6.98) (4.25) 42 (5.53) 3 (7.53) 2 29 (4.68) 25 (5.47) 9 (7.25) P Value.597 <..975 Pelvic Inflammatory Disease (ICD-9 64.xx 66.xx) Total (26 2) 553 (9.5) ab 9 63 (5.8) ac 62 (8.48) bc 26 3 (.38) 4 (.33) 64 (.43) 27 2 (.32) 53 (.32) 66 (.45) (.5) 74 (.3) 69 (.47) 29 5 (.3) 6 (.24) 54 (.37) 2 2 (.23) 49 (.24) 4 (.3) 2 8 (.38) 58 (.26) 25 (.2) P Value Pelvic Pain (ICD , 789.) Total (26 2) 3222 (2.5) ab 3 89 (.52) ac 8323 (3.78) bc (.2) 395 (.6) 987 (3.35) (2.25) 95 (.4) 997 (3.52) (.6) 2729 (.24) 976 (3.47) (2.88) 2897 (.68) 27 (4.23) 2 66 (2.6) 249 (.72) 88 (4.3) (2.7) 2536 (.5) 792 (4.27) P Value Perforation of Uterine Wall (ICD , 665.3) Total (26 2) 42 (.55) ab 558 (.29) ac 387 (.64) bc 26 4 (.6) 42 (.8) 57 (.38) 27 5 (.34) 76 (.5) 76 (.5) (.7) 3 (.24) 9 (.62) (.8) 39 (.29) 9 (.8)

6 Howard et al. Reproductive Health (27) 4:7 Page 6 of 7 Table 2 Complications and side effects associated with IUD insertion and tubal sterilization over time (Continued) 2 98 (.87) 37 (.49) 3 (.77) 2 87 (.86) 33 (.42) 9 (.87) P Value.4.23 <. abc Chi square pairwise comparisons between groups with the same superscript, P <.5. The pairwise comparisons were done for the total for each complication/ side effect across years 26 2 and not for the individual years from.8% (3,454/,97,748) to.25% (4,682/,99,36) (P <.) and rates of insertion increased from.63% (2,28/,97,748) to.5% (22,35/,99,36) (P <.) from 26 to 2, respectively. Increases in IUD insertion and decreases in tubal sterilization rates were apparent in most age groups (Table, Fig. 2). The greatest decreases in rates of sterilization occurred in women ages Although insertion of either IUD in adolescents ages 5 9 was rare, the copper IUD insertion rate doubled and the insertion rate more than tripled in this age group between 26 and 2. Rates of complications or side effects were low and are shown in Table 2. The most common side effects and complications were amenorrhea ( %), HMB ( %), and pelvic pain ( %). Significant increases over time were observed in rates of perforation of the uterine wall in all groups, HMB and menorrhagia with and tubal sterilization, dysmenorrhea and anemia with sterilization, and ovarian cysts with. A significant decrease in pelvic inflammatory disease was observed over time among women who underwent sterilization. Discussion Results indicate that tubal sterilization rates decreased and IUD insertion rates increased between 26 and 2. These findings were noted across all age groups, with the exception of sterilization in women ages 35 45, the rates of which were constant. By 28, insertion rates of exceeded rates of sterilization in every age group, including women ages Importantly, substantial increases in insertion rates for both the copper and s were seen in younger women, including adolescents. Results suggesting an increase in IUD use are consistent with data from the National Survey of Family Growth, which showed that from 22 to 23, the prevalence of IUD use increased from 2. to.3% among female contraceptive users aged 5 44 years [2]. The prevalence of female sterilization in the same population decreased from 27. to 25.% over the same time period. In a separate analysis of sexually active women aged 5 24 years, IUD use increased from.2 to 2.5% in teens ages 5 9 and from 2. to 5.4% in women aged 2 24 years, although the increase was primarily observed in parous women []. Another retrospective cohort study found that IUD insertion rates increased nearly 7-fold between 22 and 29 [6]. Importantly, women experienced few complications with either IUD. Differences in complication rates between IUDs were of minimal clinical significance. The most frequent complications in both IUD groups were menstrual disorders and pelvic pain; however, patients who underwent tubal sterilization reported these adverse effects more frequently than IUD users. The most serious complications associated with IUD use, such as uterine perforation and pelvic inflammatory disease, were reported in fewer than 2% of women. Limitations of the study included its observational, retrospective nature, lack of representation of women without health insurance, and nature of claims databases. Despite these limitations, our findings confirm recent data suggesting a shift toward long-acting reversible contraceptive methods and away from permanent methods. Copper IUD and insertion and tubal sterilization were associated with a low rate of complications. Conclusions Our analysis of a retrospective claims database supported an increase in women selecting reversible methods of longterm contraception over permanent tubal sterilization, as shownbyanincreaseincopperiudandlngiudinsertion rates and decreased sterilization rates between 26 and 2. Younger women showed substantial increases in IUD insertion rates. Among all women, rates of complications or side effects were low. Abbreviations HCPCS: Healthcare Common Procedure Coding System; HMB: Heavy menstrual bleeding; ICD-9-CM: International Classification of Diseases, Ninth Revision, Clinical Modification; IUD: Intrauterine device; LNG: Levonorgestrel Acknowledgement The authors thank Nicole Cooper of MedVal Scientific Information Services, LLC, for providing medical writing and editorial assistance. This manuscript was prepared according to the International Society for Medical Publication Professionals Good Publication Practice for Communicating Company- Sponsored Medical Research: the GPP2 Guidelines and the International Committee of Medical Journal Editors Uniform Requirements for Manuscripts Submitted to Biomedical Journals. Funding This analysis was sponsored by Teva Branded Pharmaceutical Products R&D, Inc. Medical writing assistance was provided by MedVal Scientific Information Services, LLC (Skillman, NJ), and was funded by Teva Branded Pharmaceutical Products R&D, Inc. (Frazer, PA). Teva provided a full review of the article.

7 Howard et al. Reproductive Health (27) 4:7 Page 7 of 7 Availability of data and materials The datasets generated during and/or analyzed during the current study are available in the Optum Clinformatics Data Mart database. Authors contributions Study concept and design: BH, EG, ML, BT. Acquisition, analysis, or interpretation of data: All authors. Drafting of manuscript: All authors. Critical revisions of manuscript for important intellectual content: All authors. Statistical analysis: ML. Final approval of manuscript: All authors.. Whitaker AK, Sisco KM, Tomlinson AN, Dude AM, Martins SL. Use of the intrauterine device among adolescent and young adult women in the United States from 22 to 2. J Adolesc Health. 23;53: Daniels K, Daugherty J, Jones J, Mosher W. Current contraceptive use and variation by selected characteristics among women aged 5 44: United States, Natl Health Stat Report. 25;86: 4. Competing interests Brandon Howard was an employee of Teva Global Medical Affairs at the time this work was conducted; ElizaBeth Grubb was an employee of Teva Global Health Economics & Outcomes Research at the time this work was conducted; Maureen J. Lage is the managing member of HealthMetrics Outcomes Research and was compensated by Teva Branded Pharmaceutical Products, R&D, Inc. for her work on this project. Boxiong Tang is an employee of Teva Global Health Economics & Outcomes Research. Consent for publication Not applicable. Ethics approval and consent to participate Not applicable. Publisher s Note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. Author details Teva Global Medical Affairs, 4 Moores Road, Frazer, PA 9355, USA. 2 Teva Global Health Economics & Outcomes Research, Nall Ave, Overland Park, KS 662, USA. 3 HealthMetrics Outcomes Research, River Reach Dr., Bonita Springs, FL 3434, USA. 4 Teva Global Health Economics & Outcomes Research, 4 Moores Road, Frazer, PA 9355, USA. Received: 24 August 26 Accepted: 3 May 27 References. D Arcangues C. Worldwide use of intrauterine devices for contraception. Contraception. 27;75(6 suppl):s Kaneshiro B, Aeby T. Long-term safety, efficacy, and patient acceptability of the intrauterine copper T-38A contraceptive device. Int J Women s Health. 2;2: Buhling KJ, Zite NB, Lotke P, Black K. Worldwide use of intrauterine contraception: a review. Contraception. 24;89: Branum A, Jones J. Trends in long-acting reversible contraception use among U.S. women aged NCHS Data Brief. 25;88: National Center for Chronic Disease Prevention and Health Promotion. U.S. selected practice recommendations for contraceptive use, 23: adapted from the World Health Organization selected practice recommendations for contraceptive use, 2nd edition. Morb Mortal Wkly Rep. 23;62: Berenson AB, Tan A, Hirth JM, Wilkinson GS. Complications and continuation of intrauterine device use among commercially insured teenagers. Obstet Gynecol. 23;2: Foster DG, Rostovtseva DP, Brindis CD, Biggs MA, Hulett D, Darney PD. Cost savings from the provision of specific methods of contraception in a publicly funded program. Am J Public Health. 29;99: Trussell J, Henry N, Hassan F, Prezioso A, Law A, Filonenko A. Burden of unintended pregnancy in the United States: potential savings with increased use of long-acting reversible contraception. Contraception. 23; 87: Trussell J, Hassan F, Lowin J, Law A, Filonenko A. Achieving cost-neutrality with long-acting reversible contraceptive methods. Contraception. 25;9: Xu X, Macaluso M, Ouyang L, Kulczycki A, Grosse SD. Revival of the intrauterine device: increased insertions among US women with employersponsored insurance, Contraception. 22;85:55 9. Submit your next manuscript to BioMed Central and we will help you at every step: We accept pre-submission inquiries Our selector tool helps you to find the most relevant journal We provide round the clock customer support Convenient online submission Thorough peer review Inclusion in PubMed and all major indexing services Maximum visibility for your research Submit your manuscript at

Patient Awareness and Understanding of Intrauterine Devices

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