The Spanish Agency for Medicines and Health Products (Aemps) has issued an alert to health centers about the withdrawal of certain references and lots of intrauterine devices (IUDs) Ancora, Novaplus and Gold, manufactured by Eurogine.

The problem observed was an increase in breaks in the horizontal arms (one or both) at the time of IUD removal, so that their effectiveness was not affected and, therefore, premature removal of the devices was not recommended, As reported by Aemps, which depends on the Ministry of Health, on its website.

Although initially most of the reported cases were fractures in the extraction, later cases of both fractures have been reported when they were removed and of "in situ" rupture with total or partial spontaneous expulsion of the IUDs.

The updated rate of occurrence of breakage in the extraction of the affected models and lots is 0.25% and that of "in situ" rupture / spontaneous expulsion is 0.08%, lower than the known expulsion rates for any IUD .

Breaking "in situ" could result in the total or partial expulsion of the IUD. Symptoms that might suggest expulsion are: traction threads absent or longer than expected, abdominal pain, intermenstrual or postcoital bleeding, or pain in intercourse. While some expulsions are asymptomatic.

In case of rupture and expulsion of the IUD, contraceptive protection could be compromised, the Aemps warns.

The batches of the affected IUD models began to be commercialized in 2014 and were withdrawn from the market in February 2018, so the alert does not affect users who have been placed after that date.

The affected products are: 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 and Ref. 01010600 NOVAPLUS T 380 Ag Mini.

Also: 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 and Ref. 01040200 GOLD T Mini.

The lots are: 0114, 0614, 1114, 0415, 1115, 0216, 0616, 1116, 0217, 0417 and 0917.

According to the criteria of The Trust Project

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