Important Safety Alerts

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: -

• Model: ANCORA [Lots: 0114, 0614, 1114, 0415]:
  • Ref. 01030000 ANCORA 375 Cu Normal
  • Ref. 01030400 ANCORA 375 Ag Normal
  • Ref. 01030200 ANCORA 250 Cu Mini
• IUD to be replaced as preventive action [Lots: 1115, 0616, 1116, 0216, 0217, 0417, 0917, 1113, 0114, 0614, 0415]:
  • Ref. 01010500 NOVAPLUS T 380 Ag Normal
  • Ref. 01010600 NOVAPLUS T 380 Ag Mini
  • Ref. 01010700 NOVAPLUS T 380 Ag Maxi
  • Ref. 01020100 NOVAPLUS T 380 Cu Normal
  • Ref. 01020200 NOVAPLUS T 380 Cu Mini
  • Ref. 01030000 ANCORA 375 Cu Normal
  • Ref. 01030400 ANCORA 375 Ag Normal
  • Ref. 01030200 ANCORA 250 Cu Mini
  • Ref. 01040000 GOLD T Maxi
  • Ref. 01040100 GOLD T Normal
  • Ref. 01040200 GOLD T Mini

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.

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:

• Wait for a sufficient period of time to allow the spontaneous expulsion of the fragment during menstruation.
• If it does not occur, remove the fragment with a Mathieu Extractor Gripper or similar through the cervical canal
• In the last case, assess the need to perform a hysteroscopy to remove the fragment

According to the local supplier, the affected products are distributed in Hong Kong. Besides, the local supplier has received several reports of adverse incidents associated with the additional lots happened in past few months with the same cause which triggered the recall. Therefore, the affected users are recommended to stop using the affected products on hand.

Product replacement is on-going.

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

Posted on 22 August 2018