Objective: To evaluate the initial safety and effectiveness of the intrauterine ball (IUB), a copper intrauterine device that, upon insertion in the uterus, takes a three-dimensional spherical form. Study Design: Fifteen women were followed for 1 year, with follow-up visits at 1, 3, 6, 9 and 12 months. Results: The physician reported that all devices were very easy to insert. One subject discontinued before the 6-month visit (at 119 days after insertion) for a reason not related to the device. There were no perforations, expulsions, malpositions or complications, or pregnancies. Conclusion: No safety or efficacy concerns were raised. Implications: Due to its form and deployment process the IUB is expected to ease insertion and reduce perforation, malposition and expulsion rates and may also reduce dysmenorrhea and menorrhagia. (C) 2014 Elsevier Inc. All rights reserved.
