ABSTRACT
Objective: The aim of the study was to assess the acceptability of the intrauterine ball IUB Ballerine MIDI copper intrauterine device (IUD), using real-world data collected from users and physicians in Israel.Methods: In this retrospective, observational study, conducted in a single clinic in Israel, healthy women (n = 175) who had had the device inserted ≥12 months prior to enrolment, and their physician, completed questionnaires relating to device insertion, user experience and performance.Results: The mean age at insertion was 32.8 ± 6.7 years; most women were married (80.6%) and multigravid (89.1%). At the time of the study, 131 (74.9%) women were still using the device; in 13 cases (7.4%), premature removal was due to desire to conceive. The 12 month continuation rate, excluding the women seeking to conceive, was 90.1%. The expulsion rate was 3.4% (n = 6) and the pregnancy rate was 0.57% (n = 1). Most of the women still using the device reported no to moderate pain or cramps (90.0%) and moderate to high (72.6%) satisfaction with the device; 76.3% said they would recommend it to friends and relatives. Most of the insertion procedures (86.9%) were uneventful and none required cervical dilation.Conclusion: The IUB Ballerine MIDI raised no major safety concerns and was both effective and highly accepted in a cohort of women, covering a broad age range, treated in a gynaecology clinic in Israel.
Subject(s)
Intrauterine Devices, Copper/statistics & numerical data , Patient Acceptance of Health Care/statistics & numerical data , Adolescent , Adult , Female , Humans , Intrauterine Devices, Copper/adverse effects , Israel/epidemiology , Pain/epidemiology , Pain/etiology , Patient Satisfaction , Pregnancy , Retrospective Studies , Young AdultABSTRACT
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.
