Mirena is an intrauterine device (IUD) used as a reversible method of birth control. Its manufacturer, Bayer HealthCare Pharmaceuticals, received approval to launch Mirena from the U.S. Food and Drug Administration (FDA) in 2000. One Mirena device can control pregnancy for up to five years.
While Mirena has proven an effective contraceptive for millions of women, many have experienced dangerous and fatal side effects. These side effects can include uterine perforation, ectopic pregnancy, and pelvic inflammatory disease. A number of lawsuits have been filed against Bayer from harmed Mirena patients.
What Is Mirena?
IUDs like Mirena are small, T-shaped plastic devices that are implanted into the uterus. Mirena contains the synthetic hormone levonorgestrel, which is often used in contraceptives such as birth control pills. However, Mirena releases a smaller amount of hormones than birth control pills since the hormone is directly released into the uterus as opposed to orally.
Mirena is extremely effective at preventing pregnancy. Contraceptive pills can have a failure rate of up to 30 percent due to the need to take them at the same time each day. It is extremely easy for a user to miss a day or fail to take the pill at the same time each day. Mirena’s failure rate is less than 1 percent.
Mirena side effects range from mild to severe. Among the most dangerous side effects is the device’s ability to migrate from its intended position. In many cases, the Mirena device perforated the uterine wall and migrated to other parts of the body. The device has been found in the pelvis, abdominal cavity, blood vessels, and bladder.
Mirena migration can cause infection, severe pain, and organ damage. In most cases, emergency surgery must be performed to locate and remove the device, as well as repair internal damage that occurred from the migration. Several Mirena users have reported the need for an X-ray or ultrasound to find the migrated device.
Other Mirena Side Effects
Mirena can also cause other serious side effects, such as spontaneous expulsion from the uterus. This could result in pregnancy if the Mirena user is not aware of the expulsion. Mirena users who become pregnant can experience complications such as premature delivery, miscarriage, and ectopic pregnancy.
Ectopic pregnancy occurs when the egg attaches itself and becomes fertilized outside of the uterus. Ectopic pregnancy most commonly occurs in the fallopian tubes, but can also occur in the cervix or abdominal cavity. Ectopic pregnancies cannot carry to term and must typically be surgically removed to prevent serious complications.
Pelvic Inflammatory Disease
Pelvic inflammatory disease (PID) is often the result of a bacterial infection in the ovaries, uterus, or fallopian tubes. If left untreated, PID can cause permanent damage to the female reproductive system. PID can also result in infertility.
Other Mirena side effects include:
- Weight change
- Mood changes
- Vaginal discharge
- Breast tenderness
- Abnormal vaginal bleeding
A number of lawsuits have been filed against Bayer HealthCare Pharmaceuticals for harm caused by Mirena. Many plaintiffs claim that Bayer failed to adequately warn the public of the serious side effects such as migration and uterine perforation. Additionally, several plaintiffs claim that Bayer was aware of Mirena side effects, yet continued to market and sell a defective device. Bayer has also been accused of misleading advertising practices by overstating the benefits of using Mirena.
The FDA has received more than 45,000 adverse event reports from Mirena users. It is projected that Bayer will pay millions in Mirena lawsuit settlements. The company has already paid roughly $400 million to settle thousands of lawsuits over its oral contraceptives Yaz and Yasmin.