Study on the Association of Uterine Perforation and IUD expulsion With Breastfeeding Status at the Time of IUD insertion and Postpartum Timing of IUD Insertion in Electronic Medical Record Databases – A Post-marketing Requirement for Mirena

The Food and Drug Administration (FDA) has required Bayer AG to conduct a post-marketing study in the U.S. to determine the incidence of uterine perforation and IUD expulsion by type of intrauterine device (IUD) used. The goal of this study is to quantify the risk of uterine perforation and IUD expulsion by: (1) breastfeeding status at the time of IUD insertion, (2) time periods postpartum when the IUD was inserted (e.g., 6 weeks or less, after 6 weeks and up to 14 weeks, more than 14 weeks and up to 52 weeks, or more than 52 weeks), and (3) type of IUD.

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