The FAMHP has been informed of the temporary suspension of the CE marking (proof of conformity) of the IUB™ Ballerine® (intrauterine device) from the manufacturer Ocon Medical ltd as of 16 July 2021, due to the unsatisfactory results of the assessment of the device. Taking into account this suspension and in line with the monitoring of vigilance data, there are no arguments to date to justify the recall of the devices still on the market.
The decision by the notified body to suspend the CE marking means that no new batch can be placed on the market by the manufacturer but IUDs that have already been sold can still be used. However, if the manufacturer is able to transmit the information requested by the notified body within the next few months, the CE marking could be restored.
IUB™ Ballerine® is a copper intrauterine device (IUD) with a spherical shape, as opposed to the common T-shaped IUD. As with current IUDs, there is a wire attached to the tip of the structure to facilitate the detection and removal of the device. The FAMHP has received complaints about this IUD, in particular about spontaneous expulsions and perforations, whether or not associated with pregnancies. These are known risks of all types of copper IUDs. Other European competent authorities in countries where IUBTM Ballerine® devices are distributed, have received similar complaints.
Women who have questions about their IUB™ Ballerine® can contact their general practitioner or gynaecologist who provides their gynaecological follow-up. The general practitioner should, as always, weigh the benefits of the IUBTM Ballerine® against the risks. During the suspension of the CE marking and in anticipation of further data, the FAMHP recommends the use of alternative solutions to the insertion of this IUD.
Consultation with other European competent authorities is underway to actively exchange information on IUDs. As soon as more information become available, the communication will be updated.