Spherical Ball-Shaped Intrauterine Device Long-Acting Reversible Contraception: Post-marketing Pharmacovigilance Assessment

Objective: Pharmacovigilance assessment of a novel intrauterine spherical ball-shaped copper intrauterine device (Spherical Copper 300 mm2 intrauterine device [IUD]; OCON Medical Ltd., Modiin, Israel]) using data collected from both users and healthcare providers. Study Design: Pharmacovigilance reports of undesirable side effects (events) were collected and evaluated based on healthcare providers who completed pharmacovigilance reporting related to device insertion and outcomes. Results: Data was reviewed from 111,022 insertions from 23 countries. Insertions were performed by multiple types of providers: nurse practitioners, midwives, general practitioners, and obstetrician-gynaecologists. Out of 111,022 insertions, a total of 496 accumulative pregnancies were reported over a period of 70 months, for an effectiveness of 99.6% (n=110,706) over the reported period. Few complications were reported. Of those reported, expulsion rate was 3.30% (n=3,619), with median time from insertion to expulsion of 7 weeks (0–60 weeks), perforation rate of 0.05% (n=60), and pelvic inflammatory disease rate of 0.02% (n=23). Conclusions: The Spherical Copper 300 mm2 IUD was used in a diverse group of women by a variety of medical providers. Spherical Copper 300 mm2 IUD use suggests high efficacy and safety with infrequent complications. The Spherical Copper 300 mm2 IUD is an additional option for women desiring reliable, reversible, long-acting, and non-hormonal contraception. Implications: Females interested in a safe and highly effective, long-acting, reversible contraceptive method would benefit from additional options. Currently, the T-shaped Copper 380 mm2 IUD is the most prevalent, non-hormonal, long-acting, reversible contraceptive method for females, with over 99% effectiveness. The Spherical Copper 300 mm2 IUD offers an alternative contraceptive option for females who do not desire exogenous oestrogen or progestin exposure.