Has there been FDA action regarding the Mirena IUS?

In 2008, the FDA approved additions to safety labels on Mirena packaging to include warnings that addressed long-term effects and congenital anomalies, possibility of miscarriage after long-term use of Mirena, cautions about perforation and partial or complete expulsion of the IUD, and a warning against use by breast cancer patients.

The FDA sent warning letters to Bayer HealthCare Pharmaceuticals in March and December 2009 accusing the manufacturer of overstating the benefits of its Mirena IUS contraceptive and downplaying its serious risks. The letters asked the firm to cease using existing print and online promotional material and to revise the content of future promotional material for the Mirena IUS.

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