RESUMO
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.
