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Safety Considerations with Mirena^®

Only you and your health care provider can decide if Mirena (levonorgestrel-releasing intrauterine system) is right for you. As the two of you discuss your options, there are a number of things you should consider—like your general health, current or past health conditions, sexual history and the possibility that you'd like to have more children in the future.

Mirena is not appropriate for women who:

• Are pregnant or might be pregnant
• Have had a serious pelvic infection called pelvic inflammatory disease (PID) unless they have since had a normal pregnancy
• 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
• leukemia
• AIDS
• intravenous drug abuse
• Have or suspect they might have cancer of the uterus or cervix
• Have bleeding from the vagina that has not been explained
• Have liver disease or a liver tumor
• Have breast cancer now or in the past, or suspect they have breast cancer
• Have an intrauterine device in the uterus already
• Have a condition that changes the shape of the uterus, such as large fibroid tumors
• Are allergic to levonorgestrel, silicone or polyethylene

Tell your health care provider if you:

• Recently had a baby or if you are breastfeeding
• Have ever had pelvic inflammatory disease (PID)
• Have ever had an ectopic pregnancy
• Have diabetes (high blood sugar)
• Have heart disease or a congenital heart condition
• Have problems with blood clotting or have taken medicine to reduce clotting
• Have high blood pressure

Mirena may be associated with serious but uncommon side effects:

• Pelvic inflammatory disease (PID). Use of Mirena and other IUDs has been associated with an increased risk of PID. The percentage of women who develop PID while using Mirena is less than 1%. The risk is highest shortly after placement—especially within the first 20 days—and if you have a vaginal infection at the time of placement. After the first 20 days, the risk of PID is reduced.

PID is an infection of the uterus and other organs of the upper reproductive system. It is caused by bacterial infections that are usually sexually transmitted, such as gonorrhea or chlamydia, that travel beyond the vagina and cervix into the uterus and other organs in the reproductive system. The risk of PID is greater if you or your partner have sex with multiple partners. If not treated quickly and appropriately, PID can lead to serious problems, including infertility, ectopic pregnancy or constant pelvic pain. 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.

Before placement of Mirena, be sure to tell your health care provider if you have signs of a vaginal infection or PID. Signs of PID include long-lasting or heavy bleeding, unusual vaginal discharge, abdominal or pelvic pain or tenderness, or painful sex, chills or fever.

After placement, contact your health care provider if any of these symptoms listed above occur and persist.

• A rare life-threatening infection like sepsis may occur within the first few days after Mirena is placed. As of September 2006, 9 sepsis cases out of an estimated 9.9 million Mirena users had been reported. Call your health care provider immediately if you experience severe pain or unexplained fever after Mirena is placed.
• Embedment is when Mirena attaches to the uterine wall. If embedment occurs, Mirena may no longer prevent pregnancy and you may need surgery to have it removed.
• Perforation. Mirena may go through (perforate) the uterine wall. If your uterus is perforated, Mirena may no longer prevent pregnancy. It may move outside the uterus and can cause scarring, infection or damage to other organs. Surgery may be needed to have Mirena removed.

Possible side effects of Mirena may include:

• Discomfort during placement. Dizziness, 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 and no longer prevent pregnancy. Symptoms of partial or complete expulsion may include bleeding, pain and an increase in menstrual flow. If this occurs, Mirena may be replaced within 7 days of a menstrual period after pregnancy has been ruled out. If you notice Mirena has come out, use a backup form of birth control like condoms and call your health care provider.

More than 10% of Mirena users may experience:

• Missed menstrual periods. About 2 out of 10 women stop having periods after 1 year of Mirena use. Your 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 to rule out pregnancy.
• Changes in bleeding. Your period may become irregular and you may have bleeding and spotting between menstrual periods, especially during the first 3 to 6 months. A few women have heavy bleeding during this time. After your body adjusts, periods usually get lighter and the number of bleeding days is likely to decrease, but may remain irregular. Or you may even find that your periods stop altogether. In which case, you should contact your health care provider to rule out pregnancy.

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.

• Pelvic and/or abdominal pain may occur. Talk to your health care provider if the pain is persistent.
• Cyst on the ovary. These cysts may develop as long Mirena is in place. They are generally harmless and usually disappear in a month or two. However, cysts can cause pain and may sometimes require surgery.

Between 5% and 10% of Mirena users may experience:

• Headache/Migraine
• Acne
• Depressed mood
• Heavy or prolonged menstrual bleeding

Less than 5% of Mirena users may experience:

• Vaginal discharge
• Breast pain or 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

Every individual responds differently to medication, so talk to your health care provider about your individual risk factors and to see if Mirena is right for you.

Mirena does not protect against STDs or HIV. So, if while using Mirena you think you or your partner might be at risk of getting an STD, use a condom and call your health care provider.

What if I become pregnant while using Mirena?

Unfortunately, no birth control method, including Mirena or even getting your tubes tied, is 100% perfect. If you do get pregnant while using a birth control method, there can be risks to you and your baby. Here we talk about the risks of getting pregnant while Mirena is still in place.

Less than 8 in 1,000 women become pregnant over the course of the five years using Mirena. One risk of getting pregnant using Mirena is called ectopic pregnancy, when the pregnancy is not in the uterus. It may occur in the fallopian tubes. Signs of ectopic pregnancy may include unusual bleeding or abdominal pain. Ectopic pregnancy is an emergency that requires immediate medical attention and often surgery. Ectopic pregnancy can cause internal bleeding, infertility and even death. Call your health care provider right away if you think that you're pregnant.

There are also risks if you get pregnant while using Mirena and the pregnancy is in the uterus. Severe infection, miscarriage, premature delivery and even death can occur with pregnancies that continue with an intrauterine device (IUD). Because of this, your health care provider may try to remove Mirena, even though removing it may cause a miscarriage. If Mirena cannot be removed, talk with your health care provider about the benefits and risks of continuing the pregnancy.