January 2, 2013 — A woman from Kentucky has filed a Mirena lawsuit against Bayer in the U.S. District Court for the Western District of Kentucky. The woman, Kara Sweet, is alleging that Mirena, a hormone-releasing intra-uterine contraceptive (IUD), is defective because it caused her to suffer a uterine perforation. Bayer is facing dozens of lawsuits from women whose Mirena spontaneously perforated their uterus and migrated into their abdomen after the device was implanted.
Kara Sweet was implanted with the Mirena birth control in December 2009. In January 2012, she was examined by a doctor for a routine examination. She complained of pain and cramps in her bowel and uterine area. The doctor ordered an ultrasound and an X-ray, which located Mirena in her pelvis, between her rectum and vagina. She required surgery to remove Mirena.
The lawsuit alleges that Mirena is defective and unreasonably dangerous “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.
Uterine perforation is one of the most serious complications of the Mirena IUD. If it is not diagnosed quickly, there is a higher risk that Mirena will migrate outside the uterus and into the abdomen. It may perforate the intestines, blood vessels, or other organs. Surgery is necessary to remove Mirena.
Unfortunately, many women who decided to get the Mirena birth control were unaware of the risk of spontaneous uterine perforation. The FDA has sent Bayer two warning letters for advertising Mirena without providing adequate risk information. One of these warning letters was sent in response to the “Simple Style” program, which was marketed toward “busy moms” to help them “look and feel great.” The FDA noted that these claims were unsubstantiated and omitted risk information.