Mirena: An Overview
Mirena is one form of a long-acting birth control called an intrauterine device (IUD). The IUD is globally the most popular form of birth control with an estimated 150 million users. Manufactured by Bayer Pharmaceuticals, Mirena was approved by the Food and Drug Administration (FDA) in 2000 and is one of only two IUD’s approved for use in the United States. In 2009, the FDA expanded Mirena’s approval to treat heavy menstrual bleeding in women already using an IUD.
Mirena must be inserted by a medical provider. The system includes a T-shaped body made from plastic and a cylinder-shaped steroid reservoir. Mirena works by slowly releasing levonorgestrel, the progestin hormone, into the uterus each day. Because Mirena thins the lining of the uterus, it also decreases menstrual bleeding.
Clinical trials have proven that Mirena is extremely effective in preventing pregnancy. In the studies, 1,169 women 18-35 years of age used Mirena for up to 5 years. The pregnancy rate over the 5 years was 0.7 per 100 women, or 0.7 percent. After Mirena was removed, 80 percent of women who wanted to become pregnant were able to do so within a year after removing Mirena.
Unfortunately, the drug does not come without a fair share of serious side effects and problems. Some of the most serious health issues associated with Mirena include migration of the device from the uterus, device expulsion, pregnancy complications if a woman becomes pregnant while the IUD is inserted, ectopic pregnancy (an egg becomes fertilized outside the uterus) and pelvic inflammatory disease (PID). PID can cause infertility. Other less-severe, but still inhibiting side effects, are: acne, weight change, nausea, mood changes, breast tenderness, vaginal discharge and abnormal bleeding patterns.
Several lawsuits have been filed against Bayer for the serious medical, physical and emotional problems resulting from use of Mirena. The lawsuits also specify Bayer knew of the risks and failed to disclose the dangers associated with using the IUD. Bayer is also accused of using deceptive marketing practices in advertising Mirena to the public. The FDA did issue a warning to Bayer for deceiving advertising practices; however, Mirena is still on the market today and available for use.
The lawyers at Nolan Law Group are currently evaluating Mirena IUD cases. If you or someone you know has suffered an injury after using Mirena, please Contact Us or call 312-630-4000.