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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).