Important Safety Alerts

This is an update to the safety alerts on "Eurogine SL Intrauterine Devices" issued on 28 February and 22 August 2018.

The Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom has posted an updated medical device safety alert concerning intrauterine devices (IUDs), manufactured by Eurogine SL. The affected devices are identified as the following:

• Model:
  • Ref. 01030000 ANCORA 375 Cu Normal
  • Ref. 01030400 ANCORA 375 Ag Normal
  • Ref. 01030200 ANCORA 250 Cu Mini
  • 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. 01040000 GOLD T Maxi
  • Ref. 01040100 GOLD T Normal
  • Ref. 01040200 GOLD T Mini
• Lot: 0114, 0216, 0217, 0415, 0417, 0614, 0616, 0917, 1113, 1114, 1115, 1116

The affected devices distributed in Hong Kong are as follows:

• ANCORA 375 Cu Normal [Lots: 0614 and 1116]
• NOVAPLUS T380 Cu Normal [Lot: 0114, 0216, 0217, 0415, 0417, 0614 and 1113]
• NOVAPLUS T380 Ag Normal [Lot: 0415]

According to the manufacturer, an increase in horizontal arm breaks (one or both) was observed at the time of extraction of the ANCORA IUD model. The technical research that was carried out concluded that the breakage is a result of a deficient manufacturing by the supplier of the raw material that constitutes the IUDs frame. The mixture between the polymer and barium sulfate (material that confers the radiopacity characteristic to the product for X-ray detection) was correct in its proportion, but not in its dispersion, thus promoting the random appearance of barium sulfate agglomerates that, located in especially critical areas of the frame, could weaken it until it breaks.

Initially, most of the cases reported were breakages in extraction of the Ancora model. Subsequently, cases of breakage in extraction and in situ with total or partial spontaneous expulsion of the 3 models of IUDs (ANCORA, NOVAPLUS and GOLD T) have been reported. Besides, case of pregnancies possibly related to breakages have been reported. No case of uterine perforation have been reported.

Basing on the additional information, the manufacturer has made the following recommendations:

• Given the low incidence rate known, premature removal of the IUD is not recommended and it is confirmed that the affectation of the raw material is random and occurs in a low percentage of cases. However, in the follow-up visits of the patients, it is advisable to inform/remind them about the way to identify a possible spontaneous expulsion of the IUD and the signs, which indicate that it is necessary to go to the doctor.
• In the case of programmed extractions, it is recommended to carry out a slow and constant pulling of the threads and verify that the IUD is complete.
• In the event of a breakage, while extraction or in situ, and when a piece remains in the uterus:
  • Inform the user that contraceptive protection could be compromised and the need to use other contraceptive methods.
  • Confirm the location of the fragment by ultrasound; if this is inconclusive, consider an abdominal x-ray. It has been reported that the fragment can often be extracted with a Mathieu Extractor Clamp or similar.
  • Wait, if there is no medical reason or urgency that indicates otherwise, enough time (2-3 menstruations) to enable spontaneous expulsion with menstruation. It has been reported that the expulsion of the fragment with menstruation often occurs.
  • Perform a hysteroscopy; new confirmation of location of the fragment by image diagnostic prior to the intervention is recommended; an expulsion could have occurred and the intervention could be avoided.
• As a general criterion, paracervical block and/or oral medication is recommended, always under medical prescription, to reduce the patient's anxiety during the intervention and subsequent discomfort.
• Intrauterine devices have a high rate of effectiveness. Before inserting an IUD, the woman should be given complete information about benefits, risks, contraindications, adverse effects, symptoms and signs that could make it necessary to consult with a physician, and on how to perform self-checks for presence verification of the tensile threads. Likewise, the physician should register the model and size of the IUD, date of insertion, expected date of extraction and traceability, and transmit the information to the user to preserve it.

For details, please refer to the following MHRA website:
https://www.gov.uk/drug-device-alerts/field-safety-notice-06-to-10-january-2020

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

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

Posted on 16 January 2020