Complications of Mirena

Mirena has been linked to complications that may require surgery. In rare cases, women with certain brain injuries from Mirena may need surgery to drain excess fluid from the skull and decrease intracranial pressure.

What is Mirena?

Mirena is a contraceptive implant manufactured by Bayer HealthCare Pharmaceuticals called an Intrauterine Device (IUD). Mirena was first approved by the FDA in 2000 to prevent pregnancy, and in 2009, it was also approved to treat heavy menstrual bleeding. Mirena is used by more than 2 million women in the United States.

Mirena is implanted through a woman’s cervix into her vagina. The device is a T-shaped piece of plastic, which rests inside a woman’s pear-shaped uterus. It releases the hormone levonorgestrel, which reduces the chance of pregnancy by thickening the cervical mucous and thinning the lining of the uterus. Mirena is effective for up to five years. It contains 52-mg of levonorgestrel.

Over 100+ Mirena Brain Injury Lawsuits

Bayer is facing over 100 lawsuits from women who developed brain injuries from levonorgestrel, the hormone in Mirena. These rare neurological side effects can elevate cerebrospinal fluid levels inside the skull, which puts pressure on the brain. Side effects may include headache, migraines, double-vision, vision problems, and blindness.

Brain Injuries Linked to Levonorgestrel

Mirena and Headaches

In clinical trials, 16% of women on Mirena had headaches or migraines. These side effects are also the most common symptom of Intracranial Hypertension (IH) or Pseudotumor Cerebri (PTC).

Mirena Complications in More than 10% of Women

In addition to headaches or migraines, at least 10% of women with Mirena can expect to experience changes in menstrual bleeding, which usually involves missed menstrual periods. Some women with Mirena stop bleeding during menstruation. Other common complications include abdominal pain and ovarian cysts. Approximately 12% of women on Mirena develop ovarian cysts, which are fluid-filled sacs that grow in the ovaries. They are normally harmless and resolve without treatment in a couple months. However, in some cases, they can cause abdominal pain and may require surgery.

Mirena Complications in 5-10% of Women

About 5-10% of women on Mirena suffer from acne, headaches, migraines, depressed mood, or heavy and prolonged menstrual bleeding.

Mirena Complications in Less than 5% of Women

In clinical trials, less than 5% of women with Mirena suffered the following complications:

Vaginal discharge
Breast pain, tenderness
Nausea
Nervousness
Inflammation of cervix, vulva or vagina
Pelvic pain during your period
Back pain
Weight increase
Decreased sex drive
High blood pressure
Pain during intercourse
Anemia
Unusual hair growth or loss
Skin irritations (such as hives, rash, eczema or itching)
Feeling bloated
Swelling of hands and feet
Expulsion

Rare But Serious Mirena Complications

Perforation of the uterus is a serious but rare complication that requires surgical removal of Mirena. The prescribing information for Mirena warns that this can occur during insertion of the Mirena (about one in 1,000-10,000 insertions). Uterine perforation can also occur if Mirena migrates spontaneously or embeds itself in the uterine wall. If Mirena migrates outside the uterus, it can perforate the intestines. Long-term complications include scarring and infertility.

Pelvic Inflammatory Disease (PID): This is an infection that moves beyond the cervix and into the reproductive organs. It is most often caused by sexually-transmitted bacteria such as chlamydia and gonorrhea. Severe cases may require surgery to remove the uterus (hysterectomy), cause infertility, or even death.

Ectopic pregnancy: This is a life-threatening pregnancy that occurs outside the womb (such as the fallopian tubes, cervix, or ovaries). About half of all pregnancies that occur with Mirena are ectopic pregnancies.