As of this writing there are a number of lawsuits underway against Bayer Pharmaceuticals due to the Mirena IUD migrating in some patients and, troublingly, the manufacturer’s alleged minimization of this very real risk. So who is the typical plaintiff in a Mirena IUD migration lawsuit? It’s a woman who suffered an injury due to the device and/or who believes she has been placed at risk for harm due to the manufacturer’s insufficient warning. Many have alleged that the device’s warning and other documentation deliberately downplayed the risk of the device migrating (ie moving around) which they maintain amounts to false advertising.
So what is a Mirena and why is it moving such a big deal? A Mirena is a type of intrauterine device (IUD), typically implanted in the uterus in a ob-gyn’s office. It releases a constant stream of the hormone levonorgestrel. These hormones provide birth control effectiveness on par with other hormonal methods of contraception, and a device lasts 5 years before needing removal/replacement.
The controversy with Mirena is that it was marketed as a safe and stable method of birth control with relatively rare side effects, yet allegations are emerging that the company had recieved many more complaints than it let on. Complications from Mirena migrating outside of the uterus can be quite serious and can include perforation of the uterus, perforated and/or blocked intestines, ectopic pregnancy, internal infection, abscesses, and pain, among others. Additional complications are that once migrated it typically needs to be surgically removed, and because the device is plastic it can difficult to locate using imaging technology.
Mirena has been used in Europe since 1991, and was approved by the US Food and Drug Administration (FDA) in 2000. In 2009 the FDA sent a letter to Bayer admonishing the company for overstating the benefits of the device. Recent reports place the number of complaints sent to the FDA about the device at over 70,000.
The Levensten Law Firm focuses its practice on injuries from defective drugs and medical devices. If you’ve been harmed by Mirena contact us to schedule a free consultation.