Real-world experience with the IUB Ballerine MIDI copper IUD: an observational study in the French-speaking region of Switzerland

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.

Methods: In this retrospective, observational study, conducted in the French-speaking region of Switzerland, healthy women (n= 207) who had had an IUB Ballerine MIDI inserted ≥12 months before enrolment, and their physicians completed questionnaires relating to device insertion, user experience and outcome. Questions relating to current menstrual patterns, physical comfort and product satisfaction were only posed to women still using the device.

Results: The mean age at insertion was 30.8 ± 7.2 years, with an average 14.2 ± 2.9 month lapse from time of insertion until study commencement. At the time of the study, 140 (67.6%) women were still using the device. The expulsion rate was 5.3% (n= 11) and the pregnancy rate was 1.4% (n= 3). Most of the women still using the device reported no to moderate pain or cramps (80.7%). The majority of women reported moderate to high (65.7%) satisfaction with the device, with 81.4% claiming they would recommend it to friends and relatives. Over 84.8% of physicians reported that the device was easy to insert, with no difficulties encountered during the procedure.

Conclusions: The IUB Ballerine MIDI was demonstrated to be safe and acceptable in different clinical settings and risk groups among a socioeconomically and demographically diverse study population.

摘要

目的：本研究的目的是评估宫内球形IUB Ballerine MIDI铜制宫内节育器（IUD）的可接受性, 采用使用者和医师搜集来的真实数据。

方法：在瑞士法语地区进行回顾性观察性研究, 健康女性 (n=207)植入IUB Ballerine MIDI 12个月且之前未植入过类似节育器。并且使用者的医生完成关于宫内节育器植入、使用者体验和结果的调查问卷。问卷的问题只针对在使用该设备的女性主要包括当前月经模式、身体舒适度和产品满意度的问题。

结果：平均植入年龄为30.8±7.2岁, 从植入到研究开始时间间隔为14.2±2.9个月。在研究期间, 140名（67.6%）女性仍在使用该设备。排卵率为5.3%（n=11）, 妊娠率1.4%（n=3）。大多数仍在使用该设备的女性报告称没有中度疼痛或抽筋（80.7%）。大多数女性对该设备的满意度中到高度（65.7%）, 81.4%的女性表示会向朋友和亲戚推荐该设备。超过84.8%的医生报告表明, 该设备易于植入, 在过程中没有遇到困难。

结论：IUB Ballerine MIDI在不同的临床环境和不同的风险人群中被证明是安全的和可接受的。

Keywords:

• Contraceptive
• IUB
• IUB Ballerine MIDI
• IUD
• LARC

Acknowledgements

The authors thank Y. Posen for her editorial assistance in the preparation of this article.

Disclosure statement

KS serves as vice president of Clinical Affairs at OCON Healthcare. AA is a clinical consultant at OCON Healthcare. MY, MV and CG declare no conflict of interest.

Additional information

Funding

The study and article-processing costs were funded by OCON Healthcare.