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Severe Mirena Complications
The following are serious, but uncommon side effects of Mirena 1:
- Pelvic inflammatory disease (PID). Some IUD users get a serious pelvic infection called pelvic inflammatory disease. PID is usually sexually transmitted. PID can cause serious problems such as infertility, ectopic pregnancy or constant pelvic pain. PID is usually treated with antibiotics. More serious cases of PID may require surgery. A hysterectomy (removal of the uterus) is sometimes needed. In rare cases, infections that start as PID can even cause death.
- Tell your health care provider right away if you have any of these signs of PID: long- lasting or heavy bleeding, unusual vaginal discharge, low abdominal (stomach area) pain, painful sex, chills, or fever.
- Life-threatening infection. Life-threatening infection can occur within the first few days after Mirena is placed. Call your health care provider if you develop severe pain within a few hours after placement.
- Embedment. Mirena may adhere to the uterine wall. This is called embedment. If embedment occurs, Mirena may no longer prevent pregnancy and you may need surgery to have it removed.
- Perforation. Mirena may go through the uterus. This is called perforation. If your uterus is perforated, Mirena may no longer prevent pregnancy. It may move outside the uterus and can cause internal scarring, infection, or damage to other organs, and you may need surgery to have Mirena removed.
Common Side Effects Associated with Mirena:
- Discomfort during placement. Dizziness, faintness, bleeding or cramping may occur during placement. This is common. Let your health care provider know if the cramping is severe.
- Expulsion. Mirena may come out by itself. This is called expulsion. You may become pregnant if Mirena comes out. If you notice that Mirena has come out, use a backup birth control method like condoms and call your health care provider.
- Missed menstrual periods. About 2 out of 10 women stop having periods after 1 year of Mirena use. The periods come back when Mirena is removed. If you do not have a period for 6 weeks during Mirena use, contact your health care provider.
- Changes in bleeding. You may have bleeding and spotting between menstrual periods, especially during the first 3 to 6 months. Sometimes the bleeding is heavier than usual at first. However, the bleeding usually becomes lighter than usual and may be irregular. Call your health care provider if the bleeding remains heavier than usual or if the bleeding becomes heavy after it has been light for a while.
- Cyst on the ovary. Approximately 12% (12 out of 100) of women using Mirena develop a cyst on the ovary. These cysts usually disappear on their own in a month or two. However, cysts can cause pain and sometimes cysts will need surgery.
This is not a complete list of possible side effects with Mirena. For more information, ask your health care provider.
Device Warnings and Precautions
Take precaution when using Mirena. There are issues you should discuss with your doctor before using Mirena. 2
The Mirena drug label includes warnings regarding ectopic pregnancy, intrauterine pregnancy, sepsis, pelvic inflammatory disease, irrelgular bleeding, amenorrhea, embedment, ovarian cysts and breast cancer.
It is important before using Mirena to tell your doctor if you:
- Have had a heart attack or stroke
- Were born with heart disease or have problems with your heart valves
- Have problems with blood clotting or take medicine to reduce clotting
- Have high blood pressure
- Recently had a baby or if you are breast feeding
- Have diabetes (high blood sugar)
- Use corticosteroid medications on a long-term basis
- Have severe migraine headaches.
- Who should not use Mirena?
Do not use Mirena if you:
- Might be pregnant
- Have had a serious pelvic infection (PID) unless you have had a normal pregnancy after the infection went away
- Have an untreated pelvic infection now
- Have had a serious pelvic infection in the past 3 months after a pregnancy
- Can get infections easily. For example, if you have:
- More than one sexual partner or your partner has more than one partner
- Problems with your immune system
- Intravenous drug abuse.
- Have or suspect you might have cancer of the uterus or cervix
- Have bleeding from the vagina that has not been explained
- Have liver disease or liver tumor
- Have breast cancer now or in the past or suspect you have breast cancer
- Have an intrauterine device in your uterus already
- Have a condition of the uterus that changes the shape of the uterine cavity, such as large fibroid tumors
- Are allergic to levonorgestrel, silicone, or polyethylene
Call your healthcare provider if you have any concerns about Mirena. Be sure to call if you:
- Think you are pregnant.
- Have pelvic pain or pain during sex.
- Have unusual vaginal discharge or genital sores.
- Have unexplained fever.
- Might be exposed to sexually transmitted diseases (STDs).
- Cannot feel Mirena‘s threads.
- Develop very severe or migraine headaches.
- Have yellowing of the skin or whites of the eyes. These may be signs of liver problems.
- Have a stroke or heart attack.
- Or your partner becomes HIV positive.
- Have severe vaginal bleeding or bleeding that lasts a long time.
- Mirena Full Prescribing Informaiton, Mirena.com, revised February 2013, available at http://labeling.bayerhealthcare.com/html/products/pi/Mirena_PI.pdf, accessed August 15, 2013
- Mirena Patient Insert, Mirena.com, revised October 2009, available at http://labeling.bayerhealthcare.com/html/products/pi/mirena_patient_insert.pdf, accessed August 15, 2013