This platform wants to inform about the dangers of hormonal IUDs and to connect women all over Europe
The German official information for Mirena had been changed.
- The information for gynecologist doesn't longer include the following sentence:
"These levels (meaning the serum concentrations of the hormone Levonorgestrel d.V.) are lower than in other established applications of levonorgestrel. Therefore, only minor effects on the metabolism are observed."
- The missing LNG serum levels of Mirena after 14 days of insertion has been included (Bayer had to hand out the number). It is 414 pg/ml! More than ever assumed.
- The side effects nervousness, decreased libido and weight gain which hadn’t been listed in the German patient information will soon be included.
19.6.2017 - GERMANY
Due to a petition, that has been submitted to the German Drug Controlling Agency (Bundesinstitut für Arzneimittel und Medizinprodukte - BfArM) the European Medicines Agency (EMA) is now validating, if presumable psychiatric side effects of the hormonal IUD, such as panic attacks, anxiety, sleep disorders, mood swings, restlessness and nervousness have to be added to the package insert.
Regarding this issue Bayer was interviewed, but the answers were insufficient. Now Bayer has to submit further information.Article in German
There has been a huge media wave about the risks of hormonal IUDs in France. An Association has been founded (SVH), The french ansm has contacted the association and there is a national examination about the risks of hormonal IUDs.