INTRODUCTION: Uterine perforation is a potentially serious complication of intrauterine device (IUD) use. The aim of the study was to determine uterine perforation rates in women using IUDs.
METHODS: Large, comparative, multinational, prospective, noninterventional cohort study with new users of different types of IUDs: levonorgestrel IUDs and copper IUDs. The combined cohort included more than 60,000 women in six European countries (Germany, Austria, United Kingdom, Finland, Poland, and Sweden). The study was conducted from 2006 to 2013. Both the women and their treating physicians received follow-up questionnaires 12 months after enrolment. All patient-reported outcomes of interest were validated by the women's treating physicians. A multifaceted, four-level follow-up procedure ensured low loss-to-follow-up rates. The analysis was based on Cox regression models comparing the cohorts.
RESULTS: By March 2013, 61,380 women were recruited (70% levonorgestrel IUDs, 30% copper IUDs). The interim results showed 49 perforations with levonorgestrel IUDs (1.1/1,000 insertions, 95% confidence interval [CI] 0.8–1.5) and 17 with copper IUDs (0.9/1,000 insertions, 95% CI 0.5–1.5). The respective relative risk (RR) for the two user cohorts was 1.2 (95% CI 0.7–2.1). Forty-seven of the 66 perforations were associated with potential risk factors for perforation. Breastfeeding at time of insertion led to a sixfold increase in total perforation risk (RR 6.1, 95% CI 3.6–10.1), with no differences between levonorgestrel IUD and copper IUD users. None of the perforations led to serious illness or injury to a viscus.
CONCLUSIONS: Perforation rates for the levonorgestrel IUD and copper devices are low and do not differ significantly.
Financial Disclosure: Klaas Heinemann, MD, PhD, MSC, MBA—The study was a post-authorization safety study (PASS) which was requested by the European Medicines Agency (EMA). It was supervised by an independent Safety Monitoring and Advisory Board. The study was supported by an unconditional grant from Bayer Healthcare. Carolyn L. Westhoff, MD, MSc—This author has relevant financial relationships with the following commercial interests: DSMB Member Honarium—Bayer. David A. Grimes, MD—This author has relevant relationships with the following commercial interests: Committee Member: Scientific Monitoring and Advisory Committees (Data Safety Monitoring Boards): Bayer-sponsored studies. Sabine Moehner, PhD—The study was a post-authorization safety study (PASS) requested by the European Medicines Agency (EMA). It was supervised by an independent Safety Monitoring and Advisory Board. The study was supported by an unconditional grant from Bayer Healthcare.
© 2014 by The American College of Obstetricians and Gynecologists.