In 2000 the FDA approved an intrauterine device (IUD) that was produced and marketed under the name Mirena by the Bayer Pharmaceutical Company. It was designed to be vaginally inserted into the uterus by the user. Once in place, it released hormones that would cause mucus to thicken on the uterine walls to inhibit the traveling and decrease the survival, of sperm, leading to greatly reduced chances of pregnancy. Since its approval by the FDA in 2000, reports of adverse effects have been in excess of 45,000. These negative reports ranged from the expulsion of the device to vaginal hemorrhaging. In cases of expulsion, the device had actually migrated into the abdominal cavity with the result being perforation of the uterine wall and the need for emergency surgery.
Aside from expulsion, uterine perforation and hemorrhaging have been among many other adversities related to the use of the Mirena IUD. Another is potentially fatal ectopic pregnancy, a pregnancy occurring in the fallopian tubes. In some women, Mirena use may also lead to pelvic inflammatory disease. (PID)
Many women, who have suffered due to the adverse effects of the Mirena IUD, are proceeding with legal action against Bayer Pharmaceuticals for compensation for medical expenses and pain and suffering. Most of the suits claim that Bayer was aware of the possible adverse effects of Mirena and did not take the appropriate steps to warn the users.
In 2009 the FDA approved the device for treatment of excessive blood flow during the menstrual cycle and, in that same year, warned Bayer Pharmaceuticals against the potential dangers to users of the device. They stated that the “Simple Style” program, touted by Bayer as making the user “look and feel great,” failed to warn of the possibilities of infection and the increased chances of miscarriage, should the user become pregnant.
In 2012, due to the number of lawsuits filed, Bayer asked a Federal judge for consolidation of the suits. That motion was denied. Today there are suits filed in courts, by experienced defective drug attorneys across the country, claiming that Bayer is responsible for the following:
- Failing to provide warnings about the adverse effects of Mirena, including spontaneous migration that could occur at any time during its 5 year period of use, not only after insertion.
- Concealing the harmful side effects of the product.
- Engaging in a deceptive advertisement.
- Knowingly producing and promoting a product that was well known as being defective.
- Claiming benefits falsely and deceptively.
If you have been experiencing side effects and are using the Mirena IUD, it is important that you contact your physician immediately. Ignoring the signs, like discomfort, abnormal bleeding, abdominal pain, or any other symptoms, can result in serious complications like uterine perforation, infection, damage to the liver, spleen or bladder and possible permanent infertility.
If you are a woman who is currently using the Mirena IUD, it is advisable to have it removed if you are experiencing any pain, abnormal bleeding, or any of these other serious side-effects. The described symptoms after removal don’t happen to every woman and are not dangerous, as long as suicidal thoughts do not become acute. On the other hand, a migrating IUD (one that moves from its intended location) can lead to internal injuries, multiple surgeries, miscarriage, and possible sterility.