Objective To evaluate the initial safety and effectiveness of the Intrauterine Ball, a copper intrauterine device which upon insertion in the uterus takes a three dimensional spherical form. Study Design Fifteen women were followed for one 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 post insertion) for a reason not related to the device. There were no perforations, expulsions, mal-positions 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.

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Objective: The aim of the study was to assess efficacy, safety and patient acceptability of the intrauterine ball (IUB) Ballerine MIDI copper intrauterine device (IUD), using real-world data collected from users and physicians.Study design: Retrospective analysis of two cross-sectional survey studies conducted in seven private clinics in Israel or Switzerland, and in one Swiss hospital between January and October 2018. Participants were healthy women who had the non-hormonal IUB Ballerine MIDI inserted >12 months before enrolment. In total, 382 participants and their 19 physicians completed questionnaires relating to device insertion, user experience and performance.Results: Mean age at insertion was 31.8±7.1 years, the survey was answered 16.0±4.7 months following IUB insertion. Most women were married (56.8%) and multigravid (83.5%). In 20 (5.2%) cases premature removal was due to desire to conceive. Excluding these women, the >12-month continuation rate was 71%. The expulsion rate was 17 (4.5%) and pregnancy rate was 4 (1.1%). The IUB was associated with high tolerability, 31% of current users reported no menstrual cramps/pain or light (34%) to moderate (20%) dysmenorrhea. The majority of women (69%) reported moderate to high satisfaction with the device, and 79% said they would recommend it to friends and relatives. Physicians reported in 87% of procedures the device was simple to deploy, with no difficulties encountered.Conclusions: The IUB Ballerine MIDI was demonstrated to be safe, effective and highly accepted in a cohort of women in different clinical settings and among a socioeconomically and demographically diverse population of contraception seekers.