In the present analysis of real-world user experience, the non-hormonal IUB Ballerine MIDI, proved safe and simple to deploy achieving proper positioning, regardless of patient parity. Due to the spherical IUB downward curving away from the uterine fundus upon insertion, there were no reports of uterine perforation. Overall, the IUB was found suitable and highly effective in a cohort of women in different clinical settings and among a socioeconomically and demographically diverse population of contraception seekers.
There was a high user-reported tolerability, most women describing none/light or moderate dysmenorrhea and more than two-thirds being highly satisfied or satisfied, following mean duration of use of 15.6 ± 4.4 months. Indeed, reduced discomfort, likely due to the three-dimensional IUB’s elasticity to conform to the uterine anatomy, lead to high (71%) continuation rates. These positive outcomes are expected to extend duration of use, as compared with other LARC methods, subsequently reducing unintended pregnancy rates. Our results are similar to previously reported among copper IUD users, with 2-year continuation rates between 70%-77% [14, 15], and considerably higher than self-reported adherence to oral contraceptives (43%-52%) .
The IUB expulsion rate was low 17(4.5%) compared to the overall reported > 12 months copper IUD expulsion rates (4%-10%) [17, 18]. Additionally, compared to high discontinuation rates often due to dislocation (20%) that have been reported within the first year with the copper T shape IUD , dislocation rates of the IUB were low (5.5%), likely due to improved uterine dimensional compatibility.
Failure was rare, four women (1.1%) conceived while using the device, which aligns with the pregnancy rates reported for other intrauterine contraceptives [20, 21].
Increased awareness, promotion and access to LARCs in recent years by governments, health protection agencies and family planning organizations worldwide are believed to underlie the recent marked global decrease in the incidence of unintended pregnancies [1, 2]. Nonetheless, worldwide surveys and reviews have identified several barriers to provision of LARC methods to women seeking contraception. Among these, the healthcare providers associated factors include, gaps in knowledge and appropriate training, as well as clinician reluctance to provide intrauterine contraception, particularly to young, nulliparous and single women [22–24].
Continuation rates are greatly impacted by user expectations . Not all women are well prepared for the immediate and future side effects they may experience with the IUD. Physicians anticipatory advice is of great value adding to a higher acceptance rate of LARCs . Providing pre-insertion counselling and anticipatory guidance about short- and long-term side effects and potential treatment for these side effects will lead to higher continuation rates .
Well-informed users, together with positive provider attitudes and high-quality family planning counselling are likely to have influenced the sustainability of the IUB use reported in the current study.
The vast majority of women were satisfied with the IUB (69%) and would recommend it to others (79%). Notably a higher majority (85%) of the younger users < 35 stated following their positive experience they would recommend the IUB to friends and relatives.
4.1 Limitations and strengths
Reliance on subjective, retrospective user ratings is a key limiting element inherent to the study design. Nonetheless, the presented real-world evidence of IUB acceptance and performance is likely broadly generalizable as the current analysis encompassed a diverse study population, covering a broad age range, gravidity statuses, obstetrics histories, clinical settings, geographic regions and cultures, healthcare systems and socioeconomic ranks. Moreover, given the involvement of 19 physicians, practitioner preferences and attitudes were likely divergent which further strengthens the validity of the outcomes.