Keep this in mind:
•Mirena is not appropriate for everyone
•Share your health history with your healthcare provider before placement
•There are some serious but uncommon side effects associated with Mirena
•Review possible common side effects of Mirena after placement
•Although uncommon, pregnancy while using Mirena can be life threatening and may result in loss of pregnancy or fertility
•For more safety information you should know about Mirena, continue reading below
Only you and your healthcare 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 or might be pregnant; Mirena cannot be used as an emergency contraceptive
•Have had a serious pelvic infection called pelvic inflammatory disease (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
•Multiple sexual partners or your partner has multiple sexual partners
•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 a liver tumor
•Have breast cancer or any other cancer that is sensitive to progestin (a female hormone), now or in the past
•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, polyethylene, silica, barium sulfate or iron oxide
•Have had a heart attack
•Have had a 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 breastfeeding
•Have severe migraine headaches
•Pelvic inflammatory disease (PID). Some IUD users get a serious pelvic infection called pelvic inflammatory disease. PID is usually sexually transmitted. You have a higher chance of getting PID if you or your partner have sex with other partners. PID can cause serious problems such as infertility, ectopic pregnancy or pelvic pain that does not go away. 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 healthcare 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.
•A life-threatening infection called sepsis, including Group A streptococcal sepsis (GAS), may occur within the first few days after Mirena is placed. Call your healthcare provider immediately if you experience severe pain or unexplained fever shortly after Mirena is placed.
•Perforation. Mirena may become attached to (embedded) or go through the wall of the uterus. This is called perforation. If this occurs, Mirena may no longer prevent pregnancy. If perforation occurs, Mirena may move outside the uterus and can cause internal scarring, infection or damage to other organs. Surgery may be needed to have Mirena removed. The risk of perforation is increased in breastfeeding women.
•Placement discomfort. Pain, bleeding or dizziness may occur during and after placement. This is common. Let your healthcare provider know if your symptoms are severe or do not stop within 30 minutes after placement.
•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 think that Mirena has come out, use a back-up form of birth control such as condoms and spermicide and call your healthcare provider.
More than 10% of Mirena users may experience:
•Missed menstrual periods. About 20% of women stop having periods after 1 year of Mirena (levonorgestrel-releasing intrauterine system) use. Your periods will return once Mirena is removed. If you do not have a period for 6 weeks during Mirena use, contact your healthcare provider to rule out pregnancy.
•Changes in bleeding. Your monthly 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 and spotting 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 healthcare provider to rule out pregnancy.
Call your healthcare 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 healthcare provider if the pain is persistent.
•Cysts on the ovary. These cysts may develop as long as Mirena is in place. They 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:
• Depressed mood
•Heavy or prolonged menstrual bleeding.
Less than 5% of Mirena users may experience:
• Vaginal discharge
• Breast pain or tenderness
• Inflammation of cervix, vulva or vagina
• Pelvic pain during your period
• Back pain
• Weight increase
• Decreased sex drive
• Pain during intercourse
• Unusual hair growth or loss
• Skin irritations (such as hives, rash, eczema or itching)
• Feeling bloated
• Swelling of hands and feet
Every individual responds differently to medication, so talk to your healthcare provider about your individual risk factors and to see if Mirena is right for you.
Mirena (levonorgestrel-releasing intrauterine system) does not protect against STDs (sexually transmitted diseases) 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 healthcare provider.
Less than 8 in 1,000 women (0.8%) become pregnant over the course of the five years using Mirena. One risk of becoming pregnant while using Mirena is called ectopic pregnancy. This means that the pregnancy is not in the uterus. It may occur in the fallopian tubes. Signs of ectopic pregnancy may include unusual vaginal bleeding or abdominal pain. Ectopic pregnancy is an emergency that requires immediate medical attention and often requires surgery. Ectopic pregnancy can cause internal bleeding, infertility and even death, so it is important to call your healthcare provider right away if you think that you're pregnant.
There are also risks if you become 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 healthcare provider may try to remove Mirena, even though removing it may cause a miscarriage. If Mirena cannot be removed, talk with your healthcare provider about the benefits and risks of continuing the pregnancy.
Indications & Usage
Mirena (levonorgestrel-releasing intrauterine system) is a hormone-releasing system placed in your uterus to prevent pregnancy for as long as you want for up to 5 years. Mirena also treats heavy periods in women who choose intrauterine contraception.
Important Safety Information
Only you and your healthcare provider can decide if Mirena is right for you. Mirena is recommended for women who have had a child.
- Don't use Mirena if you have a pelvic infection, get infections easily or have certain cancers. Less than 1% of users get a serious infection called pelvic inflammatory disease. If you have persistent pelvic or abdominal pain, see your healthcare provider.
- Mirena may attach to or go through the wall of the uterus and cause other problems. If Mirena comes out, use back-up birth control and call your healthcare provider.
- Although uncommon, pregnancy while using Mirena can be life threatening and may result in loss of pregnancy or fertility.
- Ovarian cysts may occur but usually disappear.
- Bleeding and spotting may increase in the first 3 to 6 months and remain irregular. Periods over time usually become shorter, lighter or may stop.
Mirena does not protect against HIV or STDs.
Available by prescription only.
For important risk and use information about Mirena, please see the Full Prescribing Information.
Skyla (levonorgestrel-releasing intrauterine system) is a hormone-releasing IUD that prevents pregnancy for up to 3 years.
Important Safety Information
- If you have a pelvic infection, get infections easily, or have certain cancers, don't use Skyla. Less than 1% of users get a serious pelvic infection called PID.
- If you have persistent pelvic or stomach pain or if Skyla comes out, tell your doctor. If Skyla comes out, use back-up birth control. Skyla may attach to or go through the uterus and cause other problems.
- Pregnancy while using Skyla is uncommon but can be life threatening and may result in loss of pregnancy or fertility. Ovarian cysts may occur but usually disappear.
- Bleeding and spotting may increase in the first 3 to 6 months and remain irregular. Periods over time usually become shorter, lighter, or may stop.
Skyla does not protect against HIV or STDs.
Only you and your healthcare provider can decide if Skyla is right for you. Skyla is available by prescription only.
For important risk and use information about Skyla, please see the Full Prescribing Information.
Essure® is permanent birth control that works with your body to create a natural barrier against pregnancy.
Important Safety Information
Essure is not right for you if you are uncertain about ending your fertility, can have only one insert placed, suspect you are pregnant or have been pregnant within the past 6 weeks, have had your tubes tied, have an active or recent pelvic infection, or have a known allergy to contrast dye.
Tell your doctor if you are taking immunosuppressants or think you may have a nickel allergy.
WARNING: You must continue to use another form of birth control until you have your Essure Confirmation Test (3 months after the procedure) and your doctor tells you that you can rely on Essure for birth control. For some women, it can take longer than three months for Essure to be effective, requiring a repeat confirmation test at 6 months. Talk to your doctor about which method of birth control you should use during this period. Women using an intrauterine device need to switch to another method. If you rely on Essure for birth control before receiving confirmation from your doctor, you are at risk of getting pregnant.
WARNING: Be sure you are done having children before you undergo the Essure procedure. Essure is a permanent method of birth control.
During the procedure: In clinical trials some women experienced mild to moderate pain (9.3%). Your doctor may be unable to place one or both Essure® inserts correctly. In rare cases, part of an Essure insert may break off or it may puncture the fallopian tube requiring surgery to repair. If breakage occurs, your doctor may remove the piece or let it leave your body during your period. Your doctor may recommend a local anesthetic. Ask your doctor about the risks associated with this type of anesthesia.
Immediately following the procedure: In clinical trials some women experienced mild to moderate pain (12.9%) and/or cramping (29.6%), vaginal bleeding (6.8%), and pelvic or back discomfort for a few days. Some women experienced nausea and/or vomiting (10.8%) or fainting. You should arrange to have someone take you home after the procedure. In rare instances, an Essure insert may be expelled from the body.
During the Essure Confirmation Test: You will be exposed to very low levels of radiation, as with most x-rays. In rare instances, women may experience spotting and/or infection.
Long-term Risks: There are reports of chronic pelvic pain in women possibly related to Essure. An Essure insert may migrate into the lower abdomen and pelvis and may require surgery for removal. No birth control method is 100% effective. Women who have Essure are more likely to have an ectopic pregnancy (pregnancy outside the uterus) if they get pregnant. This can be life-threatening. The Essure insert is made of materials that include a nickel-titanium alloy. Patients who are allergic to nickel may have an allergic reaction to the inserts. Symptoms include rash, itching and hives.
The safety and effectiveness of Essure has not been established in women under 21 or over 45 years old.
Essure does not protect against HIV or other sexually transmitted diseases.
Talk to your doctor about Essure and whether it is right for you.
You can also report any adverse events or product technical complaints involving the Essure system immediately by calling 877-ESSURE1 (877-377-8731).