Important Safety Alerts

Important Safety Alerts

Medical Device Safety Alert: Eurogine S.L. Intrauterine Devices

28 Feb 2018

Medical device manufacturer, Eurogine S.L., has issued a medical device safety alert concerning its intrauterine devices (IUD). The affected devices are identified as the following: -

An increase in breaks in the horizontal arms (one or both) was observed at the time of the extraction of the IUD model ANCORA. After the investigation carried out, it can be concluded that the main cause that has generated this situation is a deficient manufacturing of the raw material by the manufacturer/supplier. The mixture between the polymer and Barium Sulphate was correct in proportion, but agglomerates have appeared in a random way that can embitter the product, in spite that this parameter is controlled and certified by the manufacturer of the raw material.

According to the manufacturer, the reported ruptures have mostly occurred at the moment of the extraction of the IUD and in the same area of the structure that is the angle of union of the horizontal arms with the vertical axis. This is the part that suffers the greatest mechanical stress in all the IUDs in "Ω" shape, at the time of insertion but especially in the extraction. The combination between the extraction system (torsion of the arms) and possible agglomerations of Barium Sulphate in the torsion zone can cause the breakage of the device.

Based on the current data and the nature of the breakage, the efficacy of the IUD is not affected and therefore premature removal of the device is not recommended. For programmed extractions, it is recommended to perform a slow and constant traction when pulling the threads. Product replacement is on-going.

In the event that a rupture should occur and a fragment remains inside the uterus, monitor by ultrasound and assess at the physician's discretion the possibility of:

According to the local supplier, the affected products are distributed in Hong Kong.

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 28 February 2018

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