Essure is a permanent birth control procedure that works with your body to create
a natural barrier against pregnancy.
Important Safety Information
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. Your doctor will confirm that the inserts are
properly placed and both of your fallopian tubes are blocked. If you rely on Essure
for birth control before having your Essure Confirmation Test, you are at risk of
- 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 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 up until your doctor has reviewed your Essure Confirmation
Test results and confirmed that you can rely on Essure for birth control.
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.
During the procedure: You may experience mild to moderate pain,
your doctor may be unable to place one or both Essure inserts correctly, part of
an Essure insert may break off or puncture the fallopian tube requiring surgery
to repair the puncture, or your body may absorb a large amount of the salt water
solution. Your doctor may recommend a local anesthesia which numbs the cervix. Ask
your doctor about the risks associated with this type of anesthesia.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. Some women
experience nausea and/or vomiting or fainting. 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 rare reports of chronic pelvic pain
in women who have had Essure. In rare instances, an Essure insert may migrate through
the fallopian tubes into the lower abdomen and pelvis. It may be necessary to surgically
remove the migrated device if the patient is experiencing an adverse event. 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 have the NovaSure® procedure, a
procedure that removes the lining of the uterus to lighten or stop menstrual bleeding,
after the Essure procedure, your risk of pregnancy may increase. 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
Unknown Risks: 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, of in vitro fertilization (IVF) after the procedure,
or to you and your fetus if you get pregnant after the procedure are not known.
Adverse Events: During the procedure, the most common problem reported
was mild to moderate pain (9.3%). Some of the women in the study reported moderate
pain (12.9%) and/or cramping (29.6%) on the day of the procedure. A smaller percentage
of women reported nausea/vomiting (10.8%) and vaginal bleeding (6.8%).
Essure inserts do not protect against HIV or other sexually transmitted diseases.
Talk to your doctor about the Essure procedure and whether it is right for you.