Essure® is not right for everyone. Talk to your doctor about Essure and if it is right for you. Review the Patient-Doctor Discussion Checklist in the Patient Information Book with your doctor before deciding to have the Essure procedure. For more information, talk to your doctor and read the information below.
Essure is NOT right for you if:
- You are uncertain about ending your fertility
- 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 have unexplained vaginal bleeding
- You have suspected or known cancer of the female reproductive organs
You should wait to have the Essure procedure if:
- You are or have been pregnant within the past 6 weeks
- You have an active gynecological infection
- You are 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 may have, a history of metal allergies or an allergy to polyester fibers, nickel, titanium, platinum, silver-tin, or stainless steel or any other components of the Essure system
- You are currently using an IUD for birth control
- You have already had, or are considering a procedure to reduce bleeding from the uterus (such as endometrial ablation) tell your doctor as it may affect the Essure procedure
- The ablation procedure should not be performed on the same day as your Essure placement procedure
- If you have Essure placed, your doctor must confirm that it is in a satisfactory location (via the Essure Confirmation Test) before performing an ablation procedure
Talk to your doctor about the Essure procedure and if it is right for you. Refer to the Patient-Doctor Discussion Checklist and review it with your doctor.
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 can 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.
- It can take longer than three months for the Essure procedure to be effective. In rare cases, it has taken up to 6 months. Make sure to continue using an alternate form of birth control 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 during placement. Your doctor will remove the piece, if appropriate.
- There is a risk of perforation of the uterus or fallopian tube by the hysteroscope, the Essure system or other instruments used during the procedure. In the original premarket studies, perforation due to the Essure insert occurred in 1.8% of women. A perforation may lead to bleeding or injury to the bowels or bladder, which may require surgery.
- 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 headaches nausea and/or vomiting or dizziness and/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 (a modified HSG) 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.
- The following additional risks are associated with the modified HSG: some women may experience nausea and/or vomiting, dizziness and/or fainting, cramping, pain or discomfort. In rare instances, women may experience spotting and/or infection
- Pain (e.g. acute or persistent) of varying intensity and length of time may occur and continue following Essure placement. Women with a history of pain prior to placement of Essure are more likely to experience both acute and persistent pelvic pain following Essure placement. In addition to pain associated with Essure, unrelated gynecological (for example: endometriosis, adenomyosis) or nongynecological (for example: irritable bowel syndrome, interstitial cystitis) conditions may result in pain. Contact your doctor if you are experiencing significant pain or if the pain persists
- There are reports of an Essure insert being located in the lower abdomen and pelvis. If this happens, you cannot rely on Essure for birth control and surgery may be necessary to remove the insert
- Patients with known hypersensitivity to polyester fibers, nickel, titanium, stainless steel (iron, chromium nickel), platinum, silver-tin and or any of the components of the Essure system may experience an allergic reaction to the insert. This includes patients with a history of metal allergies. In addition, some patients may develop an allergy to nickel or other components of the insert following placement. Symptoms reported in women using Essure that may be associated with an allergic reaction include hives, rash, swelling and itching. There is no reliable test to predict who may develop a reaction to the inserts
- If you and your doctor decide that the inserts should be removed after placement, surgery will be necessary. This may include looking in the uterus (hysteroscopy), removal of the insert alone, removal of the insert with the fallopian tube, and/or, in complicated cases, removal of the uterus (hysterectomy). The doctor who placed Essure may not be the doctor performing the removal
- No birth control method is 100% effective. There is a chance that you can become pregnant after completing the Essure procedure. In the most recent clinical trial, three women out of 503 (0.6%) became pregnant within the first year of relying on Essure. While successful pregnancies with healthy deliveries have been reported with Essure devices in place, there have been reports of pregnancy loss, pre-term labor, premature delivery, stillbirth, neonatal complications, and genetic and developmental abnormalities in pregnancies with Essure. You should contact your doctor immediately if you think you may be pregnant
- Ectopic pregnancies may occur with Essure. 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 endometrial ablation, 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 effect your risk of pregnancy
- Other symptoms have been reported to FDA by women implanted with Essure, although they were not seen in the clinical trials supporting Essure approval. The more common symptoms reported include headache, fatigue, weight changes, hair loss and mood changes such as depression. It is unknown if these symptoms are related to Essure or other causes
- 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. There are limited data related to the effects, including risks, of Essure inserts on in vitro fertilization (IVF)
Call your healthcare provider if you experience pain, bleeding, fever, abnormal 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.