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What is Mirena?
Mirena is a small, flexible hormone-releasing device inserted into the uterus to prevent pregnancy. The female hormone released by the device, levonorgestrel, thickens the cervical mucus to prevent sperm from reaching or fertilizing the egg.
The U.S. Food and Drug Administration (FDA) approved Mirena for use as a contraceptive in 2000 and for use in treating heavy menstrual bleeding in IUD users in 2009.
The FDA’s Division of Drug Marketing, Advertisin and Communications (DDMAC< now known as the Office of Prescription Drug Promotion), sent warning letters to Bayer in 2009, alleging that Bayer was:
- Overstating Mirena’s effectiveness
- Sponsoring misleading online links
- Downplaying the serious health risks associated with Mirena usage
- Failing to communicate risks information to women and doctors
The graphic contains information from the U.S. Food and Drug Administration (FDA) and other sources, including AdverseEvents.com, which tracks adverse events reports to the FDA.
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