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FDA says Bayer downplayed risks of Mirena side effects

April 16th, 2013

The U.S. Food and Drug Administration (FDA) has said that Bayer Pharmaceuticals downplayed the risks associated with its Mirena intrauterine device (IUD) in advertising materials. The Mirena contraceptive IUD has since come under fire for possible severe side effects.

Bayer advertised Mirena as an IUD contraceptive that would help women look and feel great while improving their sex life. The FDA countered that Mirena studies revealed at least 5% of women reported a lowered libido, and it was “very common” for women to report side effects such as nausea, headache, abdominal pain and nervousness.

Bayer is also facing Mirena lawsuits alleging that the IUD caused severe side effects when the device migrated from the uterus and attached to other tissue. Other Mirena side effects include uterine perforation and ectopic pregnancy, a fatal condition in which a fetus develops outside of the uterus.


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