Health alert of the possible breakage of the IUDs manufactured by Eurogin

The Spanish Medicines Agency and Health Products (AEMPS), under the Ministry of Health, has warned of an increase in breakages in certain models and batches of intrauterine devices (IUDs) manufactured by Eurogin, so health professionals are recommended to follow up on carriers, and, to these, go to your healthcare professional in case of intermenstrual or postcoital bleeding, pain in intercourse or abdominal pain.

"Given the low incidence rate known, premature extraction is not recommended of the IUD and it is confirmed that the affectation of the raw material is random and occurs in a low percentage of cases, "says the company that has issued an informative note where it admits that" cases of pregnancies possibly related to breakage have been reported ", but "No cases of uterine perforation have been reported."

Affected Models

The affected models are Ancora, Novaplus and Gold T, and lots 0114, 0614, 1114, 0415, 1115, 0216, 0616, 1116, 0217, 0417 and 0917. All affected models began to be marketed in 2014 and were withdrawn from the market in February 2018, so users who have had an IUD of these models after that date are not affected by this security note.

The company conducted an investigation that concluded that the breakage is due to "poor" manufacturing by the IUD armor supplier

The company has reported that technical research was conducted that concluded that the break is consequence of "poor manufacturing" by the supplier of the raw material that constitutes the IUD armor.

"The mixture between the polymer and barium sulfate (material that confers the radiopacity characteristic to the product for X-ray detection) was correct in proportion, but not in its dispersion, thus promoting the random appearance of barium sulfate agglomerates that, located in especially critical areas of the armor, could weaken it until it breaks, "they explain.

Initially, most of the reported cases were ruptures in extraction of the Ancora model. Subsequently, cases of rupture in extraction and rupture in situ with total or partial spontaneous expulsion of the other two models have been reported.

Breaks in the IUD arms

The problem observed was a increased horizontal arm breaks (one or both) at the time of IUD removal, so its effectiveness was not affected and, therefore, premature removal of the devices was not recommended.

Although initially most of the reported cases were ruptures in the extraction, later cases of both rupture in the extraction, as well as in situ rupture with total or partial spontaneous expulsion of the IUDs have been reported.

The problem observed was an increase in breaks in the horizontal arms (one or both) at the time of IUD extraction

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%. These rates are lower than the known expulsion rates for any IUD.

The break in situ could generate total or partial expulsion of the IUD. The symptoms that might suggest an 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.

Recommendations for users

Doctors are reminded that in case of a rupture – in extraction or in situ – and that a fragment remains in the uterus, the user must first be informed that the contraceptive protection could be compromised and the need to use other contraceptive methods; confirm the location of the fragment by ultrasound; and if this is inconclusive, consider an abdominal x-ray.

It is advisable to wait, if there is no medical reason or urgency that indicates otherwise, sufficient time (2-3 menstruations) to allow spontaneous expulsion with menstruation. It has been reported that the expulsion of the fragment with menstruation usually occurs; and perform hysteroscopy; new diagnostic confirmation by location image of the fragment prior to the intervention is recommended; there could have been an expulsion and discard the intervention.

To the users, that is to say only to those carriers of one of the affected IUDs, they are recommended continue their usual follow-up reviews and if you have abdominal pain, intermenstrual or postcoital bleeding, pain in intercourse, or notice any changes, including traction threads, go to your healthcare professional.

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