Quoted from http://www.bloomberg.com/news/2013-01-28/bayer-sued-over-alleged-hidden-risks-of-mirena-contraceptive-1-.html
Bayer Sued Over Alleged Hidden Risks of Mirena ContraceptiveBy Sophia Pearson - Jan 28, 2013 4:08 PM ET
Bayer AG (BAYN) was sued over claims the German drugmaker failed to provide disclosures and warnings regarding the health risks associated with its popular contraceptive Mirena.
The label for Mirena, an intrauterine device that prevents pregnancy for as long as five years, doesn’t warn that it can can become embedded in the body or cause an ectopic pregnancy, Pennsylvania resident Tricia Prendergast said in a complaint filed in federal court in Philadelphia. Prendergast required surgery to remove the device after complications, according to her complaint....
Mirena, approved by the Food and Drug Administration in December 2000, is made of flexible plastic designed for insertion in the uterus, where it releases a synthetic progestogen that inhibits pregnancy, according to the complaint. More than 15 million women worldwide use the product, including more than 2 million in the U.S., Prendergast said in the complaint.