Consilient Health is launching the next generation IUD, an innovative Intrauterine Ball, IUB™ Ballerine®, a well-tolerated⁴, hormone free, long-lasting reversible contraceptive.

The IUB™ Ballerine® is a novel copper coil and is comprised of copper beads with a total exposed copper surface of 300mm² strung on a flexible Nitinol (nickel/titanium alloy), PET- coated frame. Prior to insertion it is loaded in linear form into a 3.2mm diameter insertion tube and introduced into the uterus by using a push rod. As the IUB™ is released from the insertion tube into the uterus it coils into a spherical shape. Pure elemental copper is incorporated as an ancillary active substance. A monofilament blue polypropylene double tail thread (up to 20cm long) is attached to one end of the IUB frame to aid detection and removal of the device.⁵

The IUB™ Ballerine® has a unique three-dimensional ball like structure which means:

1. The IUB™ Ballerine® is designed to adapt to the uterus, while being large enough and voluminous not to pass through the cervix internal os, thereby reducing the probability of expulsion⁶.
2. During insertion – the tip of the IUB™ Ballerine® turns 180 degrees as it exits the insertion tube, away from the uterine fundus, thereby reducing the risk of fundal perforation during insertion⁴.
3. Malpositioning within the uterine cavity, including rotation or embedment in the myometrium, is reduced through the unique symmetric spherical shape of the IUB™ Ballerine®⁴.
4. The IUB™ Ballerine® uses the thinnest insertion tube currently on the market⁷, at only 3.2mm in diameter.

Commenting on the launch, women’s health expert, Deirdre Lundy said: “This is an innovative and welcome development in IUCD contraception. Unlike traditional framed IUCD, this device comprises a thin length of ‘Nitinol’ wire with 17 tiny copper beads along its length. The tensile wire is stretched straight inside a very slim introducing tube. Once the tube and device are placed at the fundus of the womb, the tube is gently removed and the tensile wire rolls up into a little ball – adapting to the shape of the intrauterine cavity. The copper beads provide contraception for 5 years. Placement should be much kinder as the width of the introducing tube is significantly slimmer than that employed by typical IUCDs.”

IUB™ Ballerine® is GMS reimbursable and covered under the Free Contraception Scheme.

 

1. Baram I, et Contraception. 2014.
2. Kurz KH (1984) Cavimeter uterine measurements and IUD clinical correlation. In: Zatuchni GI, Goldsmith A, Sciarra JJ, Intrauterine Contraception: Advances and Future Prospects. Philadelphia: Harper and Row, 142–162.
3. Bastidas, J. M. et al., 2019. Copper and Nickel Release Kinetics Determination of CU- IUDS in Simulated Uterine Fluid.  National Centre for Metallurgical Research (CENIM), p 16.
4. Real world safety & performance data for IUB™ Ballerine, OCON Medical Ltd.
5. Ballerine IFU
6. Baram et al, 2019
7. FSRH Clinical Guideline: Intrauterine Contraception (April 2015, amended September 2019).

 

IE-CH-1095, Date of preparation December 2022.