January 2, 2013 — Bayer is facing yet another Mirena lawsuit from a woman who suffered a spontaneous uterine perforation more than two years after she was first implanted with the Mirena birth control. The lawsuit was filed by Kara Sweet in the U.S. District Court for the Western District of Kentucky. She alleges that Bayer failed to adequately warn about the risks associated with Mirena, a hormone-releasing Intra-Uterine Device (IUD).
According to the lawsuit, Kara Sweet had the Mirena IUD inserted on December 1, 2009. One year later, a check-up found that it was in its proper position. In December 2010, she had another check-up, but she complained of pain and cramps in her bowel and uterine area. When an ultrasound failed to detect the IUD in her uterus, the doctor ordered an X-ray, which located the IUD between her vagina and rectum. On January 31, 2012, she underwent surgery to locate and remove Mirena.
She is seeking compensation for her injuries because Mirena is unreasonably dangerous. Furthermore, she alleges that Mirena is defective “because its labeling fails to adequately warn consumers and prescribers of, among other things, the risk of migration of the product post-insertion, uterine perforation post-insertion,” and more.
Bayer is facing dozens of lawsuits from women who were injured after their Mirena spontaneously perforated their uterus, migrated into their abdomen, and required surgical removal. If Mirena migrates, it may damage blood vessels, damage the intestines, and cause severe pain, bleeding, and other complications.
Many lawsuits allege that Bayer did not warn them about this risk. In fact, the FDA sent Bayer two warning letters in 2009 for advertising Mirena without providing information about serious side effects.