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Objectives: The objectives were to identify and compare the incidence of uterine perforation and other medically adverse events associated with levonorgestrel-releasing intrauterine systems (LNG-IUSs, releasing 20 mcg LNG daily) and copper intrauterine devices (IUDs) under routine conditions of use in a study population representative of typical users., Methods and Materials: This is a multinational, prospective, non-interventional cohort study with new users of LNG-IUSs and copper IUDs. In addition to a baseline questionnaire, women and their treating health care professional completed a single follow-up questionnaire after 12 months. All patient-reported outcomes were validated by the treating physicians., Results: A total of 61,448 women in six European countries were followed between 2006 and 2013 for more than 68,000 women-years of observation (70% LNG, 30% copper devices). Overall, 81 uterine perforations were reported: 61 for LNG-IUSs [1.4 per 1000 insertions (95% confidence interval {CI}: 1.1-1.8)] and 20 for copper IUDs [1.1 per 1000 insertions (95% CI: 0.7-1.7)], for an adjusted risk ratio (RRadj) of 1.6 (95% CI: 1.0-2.7) when adjusted for age, body mass index, breastfeeding at time of insertion and parity. Breastfeeding at time of insertion was associated with a sixfold increase (RR 6.1, 95% CI: 3.9-9.6), with no differences between LNG and copper IUD users. Sixty-three of the total 81 perforations were associated with previously suspected risk factors (e.g., breastfeeding, time since last delivery ≤36 weeks). No perforations led to serious illness or to injury of intra-abdominal or pelvic structures., Conclusions: Uterine perforation incidence in this study was low, with a benign clinical course thereafter. The LNG-IUSs and copper IUDs did not have clinically important differences in perforation rates., Implications: The European Active Surveillance Study on Intrauterine Devices is the first large-scale, prospective, non-interventional study to compare the perforation risk in LNG-IUS and copper IUD users. It is the first to examine the independent roles that breastfeeding status and postpartum status have on perforation risk. Conducted during routine clinical practice, the findings are generalizable to broader populations., (Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.)

Objectives: The objective was to measure the rate of unintended pregnancies in women using levonorgestrel-releasing intrauterine systems (LNG IUSs, releasing 20 mcg LNG daily) and copper intrauterine devices (IUDs) in a typical population of IUD users and to describe associated complications., Methods: A multinational, prospective, non-interventional cohort study of new users of LNG IUS and copper IUDs was performed. Following a baseline survey, study participants and their physicians completed one follow-up questionnaire after 12 months. A multifaceted four-level follow-up procedure minimized loss to follow-up. Patient-reported outcomes were validated by the treating physicians., Results: A total of 61,448 women with a newly inserted IUD were enrolled in six European countries between 2006 and 2012. The copper IUD cohort contained more than 30 different types. Validated 1-year follow-up information for 58,324 users between 18 and 50 years of age (70% using LNG IUS, 30% using copper IUDs) was collected. A total of 118 contraceptive failures occurred (26 LNG, 92 copper). Both types of IUD were highly effective, with overall Pearl indices of 0.06 [95% confidence interval (CI): 0.04-0.09] and 0.52 (95% CI: 0.42-0.64) for LNG IUS and copper IUDs, respectively. The adjusted hazard ratio for LNG IUS vs. copper IUDs was 0.16 (95% CI: 0.10-0.25). Tenty-one pregnancies (7 LNG IUS, 14 copper IUD) were ectopic, yielding an adjusted hazard ratio for ectopic pregnancy of 0.26 (95% CI: 0.10-0.66)., Conclusions: The contraceptive failure rate was low with both IUDs. However, the LNG IUS was associated with a significantly lower risk of pregnancy, including ectopic pregnancy, than the copper IUDs., Implications: To our knowledge, this is the first large-scale, multinational, prospective epidemiological study to measure and compare the contraceptive effectiveness of LNG IUSs and copper IUDs during routine clinical practice. Clinicians and patients should be aware of differences in rates of unintended pregnancies and associated complications in relation to IUD us., (Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.)