Mirena IUD is a type of contraception approved by the FDA in 2000. More than 2 million American women and 15 million women worldwide currently use the popular birth control device, according to the National Law Journal. In July 2008, the FDA approved changes to Mirena’s labeling to reflect the complaints received by the federal agency. As of August 2012, the FDA received over 47,222 adverse event reports with regard to this intrauterine device.
What is Mirena?
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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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