Essure® is not right for everyone. Prior to placement, you should review your health history with your healthcare provider and be aware of the risks that are associated with Essure. For more information, talk to your healthcare provider and read the information below.
Essure is NOT right for you if:
- You suspect you are pregnant
- You have only one fallopian tube
- You have one or both fallopian tubes closed or obstructed
- You have had your “tubes tied” (tubal ligation)
- You are allergic to contrast dye used during X-ray exams
- You are unwilling to undergo the Essure Confirmation Test
- You are uncertain about ending your fertility
Before having the Essure procedure, make sure you:
- Are not or have not been pregnant within the past 6 weeks
- Do not have an active or recent pelvic infection
- Are not in the second half (weeks 3 and 4) of your menstrual cycle. During that time, there is an increased risk of being pregnant prior to having the Essure procedure
You should speak to your doctor if:
- You are taking or receiving therapy that suppresses your immune system. Examples include chemotherapy or corticosteroids, such as prednisone. Therapy that suppresses the immune system may make the Essure procedure less effective for birth control
- You have, or think you have, a nickel allergy
What if I become pregnant after having Essure placed?
No birth control method is 100% effective. If you do become pregnant after Essure, the risks to you, the fetus, the pregnancy and childbirth are unknown. Women who have the Essure procedure are more likely to have an ectopic pregnancy if they get pregnant. Ectopic pregnancy is when the pregnancy occurs outside of the uterus. Ectopic pregnancies can be very serious or life threatening. If you think you are pregnant after you have had Essure placed, call your healthcare provider.
What are warnings, precautions and other potential risks of Essure
WARNING: Be sure you are done having children before you undergo the Essure procedure. Essure is a permanent method of birth control.
- The younger a woman is when she chooses to end her fertility, the more likely she is to regret her choice later.
WARNING: You must continue to use another form of birth control until you have your Essure Confirmation Test and your doctor tells you that you can rely on Essure for birth control.
- You can rely on Essure for birth control only after your doctor has reviewed your Essure Confirmation Test results and told you that you may rely. If you rely on Essure for birth control before having your Essure Confirmation Test, you are at risk of getting pregnant
- Talk to your doctor about which method of birth control you should use for the 3 months after the procedure. Some women can remain on their current birth control. Other women, such as those using an intrauterine device or contraceptive (IUD or IUC), will need to switch to another method.
- It may take longer than 3 months for Essure to completely block the fallopian tubes, requiring a repeat confirmation test at 6 months. Make sure to continue using an alternate form of birth control up until your doctor has reviewed your Essure Confirmation Test results and confirmed that you can rely on Essure for birth control.
Risks: During the Essure procedure
- You may experience mild to moderate pain.
- Your doctor may be unable to place one or both Essure inserts correctly.
- In rare cases, part of an Essure insert may break off. Your doctor may remove the piece or let it leave your body during your period.
- In rare cases, part of an Essure insert may puncture the fallopian tube. Surgery may be necessary to repair the puncture.
- Your body may absorb a large amount of the salt water solution used during the procedure.
- Your doctor may recommend a local anesthesia, which numbs the cervix. Ask your doctor about the risks associated with this type of anesthesia.
Risks: Immediately following the procedure
- You may experience mild to moderate pain and/or cramping, vaginal bleeding, and pelvic or back discomfort for a few days after the procedure. Some women experience nausea and/or vomiting or fainting. You should arrange to have someone available to take you home after the procedure.
- In rare instances, an Essure insert may be expelled from the body. This is usually detected during the Essure Confirmation Test.
Risks: During the Essure Confirmation Test
- Because one of the Essure Confirmation Tests requires an x-ray, you may be exposed to very low levels of radiation if an x-ray is performed. This is standard with most x-rays.
- In rare instances, women may experience spotting and/or infection.
- There are reports of chronic pelvic pain in women, possibly related to Essure.
- There are reports of the Essure insert migrating into the lower abdomen and pelvis. If this happens, it may be necessary to surgically remove the migrated device.
- No birth control method is 100% effective. There is a chance that you can become pregnant after completing the Essure procedure. In the clinical trials for Essure, no pregnancies were reported for women who had the Essure inserts for up to 5 years. Although successful pregnancies have been reported with Essure devices in place, if you do become pregnant, the risks to you, the fetus, the pregnancy and childbirth are unknown.
- Women who have the Essure procedure are more likely to have an ectopic pregnancy if they get pregnant. Ectopic pregnancy is when the pregnancy occurs outside of the uterus. The pregnancy usually happens in one of the fallopian tubes. Ectopic pregnancies can be very serious or life-threatening.
- If you have the NovaSure® procedure, a procedure that removes the lining of the uterus to lighten or stop menstrual bleeding, after the Essure procedure, it is unknown if this will affect the blockage in your tubes, and your risk of pregnancy may increase.
- The Essure insert is made of materials that include a nickel-titanium alloy. Once placed inside the body, small amounts of nickel are released from the inserts. 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.
- The safety and effectiveness of reversing the Essure procedure are not known.
- The safety and effectiveness of in vitro fertilization (IVF) after the Essure procedure are not known.
- The risks to you and your fetus if you get pregnant after the Essure procedure are not known.
Call your healthcare provider if you experience pain, bleeding, fever, vaginal discharge, or other symptoms following the procedure.
Talk to your doctor about Essure and whether it is right for you.
IMPORTANT: Essure inserts do not protect against HIV or other sexually transmitted diseases.