A Breakthrough Technology
The Essure procedure is performed by a trained gynecologist. A soft, flexible micro-insert is placed into each fallopian tube through your body's natural pathways. In clinical testing, the total procedure took about 35 minutes, with only 15 minutes required to place the micro-inserts into the fallopian tubes. Most women were able to leave the facility 45 minutes after the procedure.
In the Pivotal Trial of Essure, 92% of working women resumed work in 24 hours or less after the day of the procedure. In fact, many women resumed normal physical activities the same day they had the procedure.
 Essure Works With Your Body
Unlike tubal ligation (having your tubes tied) or vasectomy, the Essure procedure does not require incisions or punctures to the body and there is no cutting, clipping, suturing, or burning of tubes.
During the three months after the procedure, your body and the micro-insert work together to form a tissue barrier that prevents sperm from reaching the egg. The micro-inserts do not contain or release hormones and are made with the same materials used in other medical products for many years. For example, these materials have been used in blood vessel grafts, heart valve replacements, and abdominal repair.
Safety and Effectiveness
The Essure procedure has undergone significant clinical testing in the United States, Europe, and Australia. Data from clinical testing show that Essure was 99.80% effective in preventing pregnancy after three years of follow-up. Additionally, 92% of women who relied on Essure rated their long-term satisfaction with Essure as "somewhat satisfied" to "very satisfied" at 3 years of follow-up.
The Essure Procedure: Key Risks and Considerations
As with all medical procedures, Essure may not be suitable for all women and there are risks associated with Essure. The following are the key risks associated with Essure:
- The procedure should be considered irreversible
- Like all methods of birth control, the Essure procedure should not be considered 100% effective
- Not all women who undergo the Essure procedure will achieve successful placement of both micro-inserts
- You must use another method of birth control for at least three months after the procedure
- The Essure procedure is newer than other procedures
- Removal of the Essure micro-inserts would require surgery
Essure Procedure Overview
|
About an hour before the procedure,
you are given medication to reduce
tubal spasms and uterine cramping
during the procedure.
Step 1
After a local anesthetic is applied to the cervix, the doctor inserts a narrow telescope, called a hysteroscope,through your vagina and cervix (the entrance to the uterus from the vagina)and into the uterus. The doctor may need to gently expand the opening of your cervix and may insert an instrument to do this. The hysteroscope is attached to a video camera and monitor so the doctor is able to see exactly what he or she is doing. Fluid, called normal saline (salt
water), flows through the hysteroscope
and into your uterus. The fluid is used to
expand the uterus so the doctor can see
the openings to your fallopian tubes. You
might feel cramping from this.
|
 |
|
Step 2
A narrow inserter, called a catheter,
is passed through the hysteroscope
and into your fallopian tube. The
micro-insert is attached to the end
of the inserter.
|
|
|
Step 3
The micro-insert is placed in the
fallopian tube and the inserter is
removed. The process is repeated in the
other fallopian tube. The entire
procedure should take about 35 minutes,
with only 15 minutes typically required
to place the micro-inserts into the
fallopian tubes.
|
|
|
Step 4
During the next 3 months, tissue will
begin to grow into the micro-inserts,
eventually blocking your fallopian
tubes. You will need to use another form
of birth control during this period until
your doctor confirms that the procedure
has worked.
After 3 months, you need to have a test
called a hysterosalpingogram (HSG).
This test is required before your doctor
can tell you whether you may begin
relying on Essure for contraception.
During an HSG, your doctor fills your
uterus with dye and then takes an x-ray
to see if the dye remained in your uterus
or traveled down your fallopian tubes.
The purpose of this test is to make sure
that both of your tubes are blocked and
that both of the micro-inserts are in the
correct position.
Note: Always call your doctor if you
have any unusual pain, bleeding, or
other symptoms. |
 |
Frequently Asked Questions
Who has the procedure? Women
How effective is the procedure?
99.93% at one-year
99.86% by two-years
99.80% at three-years
Data not available beyond 3 years
How is the surgical procedure performed?
The device is routed through the vagina, cervix and uterus into the fallopian tubes, where the devices are placed. No incisions are required.
How long does the procedure take?
Average procedure time is 35 minutes
How many visits to the doctor does it require, and what type of follow-up is required?
Three visits. One consultation visit, one visit to place the micro-inserts, and one follow-up visit at 3 months to check for tubal occlusion and proper micro-insert location.
How is pain or discomfort typically controlled during the procedure?
Local anesthetic and/or intravenous sedation
Can I rely on it right away?
No. There is a three-month waiting period when another form of contraception must be used. You will need a hysterosalpingogram (a special kind of x-ray) before you can rely on Essure. The purpose of this test is to make sure that both of your tubes are blocked and both of your devices are in the correct position. You must continue to use another form of contraception until your doctor instructs you that you can rely on Essure for birth control.
What should I be doing to help the recovery process after the procedure?
• Rest for 45 minutes following the procedure before going home. Follow your doctor's instructions to report any unusual pain, bleeding or high fever
• Consider having someone to drive you home
When can I return to regular activities?
Typically, within 1-2 days of the procedure.
What are the typical temporary effects following the procedure?
• Cramps (like menstrual cramps)
• Discharge (like a light menstrual flow or spotting)
• Mild nausea or vomiting associated with the procedure
• Fainting or light-headedness following the procedure
What are the major risks of the procedure?
• You may become pregnant several years after undergoing the procedure.
• Ectopic pregnancy occurs more often in women who have had a sterilization, if they become pregnant.
• For a percentage of women (14% in clinical studies) it may not be possible to place the micro-inserts in the fallopian tubes during the first placement procedure
• Despite micro-insert placement, a small percent of women (3% in the clinical studies at the 3-month follow-up) may not be able to rely on the micro-inserts for birth control due to incorrect position of the devices or lack of tubal blockage.
• Although death and serious injury following hypervolemia were not reported in the Essure clinical trials, hypervolemia can lead to serious injury and death.
|
