Real-world experience with the IUB Ballerine MIDI copper IUD: an observational, single-centre study in Israel.

Real-world experience with the IUB Ballerine MIDI copper IUD: an observational, single-centre study in Israel.

Baram, Ilan;Aharon, Arnon;Klein, Rinat;Shkolnik, Ketty;
the european journal of contraception & reproductive health care : the official journal of the european society of contraception 2019 pp. 1-5
268
baram2019realworldthe

Abstract

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. In this retrospective, observational study, conducted in a single clinic in Israel, healthy women ( = 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. 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% ( = 6) and the pregnancy rate was 0.57% ( = 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. 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.

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