Possible risk from contraceptive coils from the manufacturer Eurogine S.L.

Safety warnings | Medical devices | 28/09/2020

The Federal Office for Safety in Health Care (BASG) informs with this letter about a possible hazard of intrauterine devices (IUD) for contraception of the manufacturer Eurogine S.L..

Intrauterine devices ("contraceptive coils") are medical devices for the prevention of pregnancy.

The manufacturer of the medical devices in question already initiated recalls of certain lots of its products in February/March 2018 due to reports received regarding the defect pattern "fractures of the side arms". In October 2019, the manufacturer sent further information to gynecologists and obstetricians, pointing out the possibility of IUD rupture even without manipulation (spontaneous ruptures that can go unnoticed) and the proposed procedure in such a case. In April 2020, on the instructions of the BASG, another information was issued to specialists in gynecology and obstetrics, with the recommendation of the BASG to inform the carriers of its IUDs or to actively invite them to control and discuss the best individual medical decision.

Affected patients are advised to contact their attending physician if necessary.

Furthermore, we would like to remind you once again of the obligation to notify health care professionals. According to § 70 MPG, any incident that could lead to a serious health impairment or death of a patient, user or third party must be reported immediately to the Federal Office for Safety in Health Care. The reporting forms can be found online at www.basg.gv.at/marktbeobachtung/meldewesen/medizinprodukte.

Patients have the option of submitting a report via informal email to medizinprodukte@basg.gv.at. It would be important to provide the name of the product, the lot number, the date of implantation and explantation or, if known, the date of spontaneous expulsion of the IUD.

Medical devices 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
Manufacturer Eurogine S.L.
Batch number(s) Lots: 0114/0614/1114/0415/1115/0216/0616/1116/0217/0417/0917

Further inquiry note