Is it effective?

The Essure procedure is 99.80% effective based on 4 years of follow-up.

How do women rate the procedure?

In clinical testing involving about 700 women, the majority of women rated their comfort with the Essure procedure as “good” to “excellent” within one week. After the first week, almost all women rated their satisfaction with the Essure procedure as “good” to “excellent.”

What are the micro-inserts made of?

The micro-inserts are made from polyester fibers, nickel-titanium, and stainless steel. These materials have been studied and used in medical devices, such as cardiac stents, for many years.

Is it reversible?

The procedure is permanent and not reversible. It is only meant to be used by women who are sure they do not want any more children.

Reversal may require surgery and there is no data on the safety and effectiveness of reversing the Essure procedure.

How long does the procedure take?

In clinical testing, the average time to place a micro-insert into both fallopian tubes was about 10 minutes. Because an Essure procedure is performed without incisions or general anaesthesia, most women were able to go home within 45 minutes after the procedure.

When does it start working?

During the first 3 months following the procedure, your body and the micro-inserts work together to form a natural barrier that prevents sperm from reaching the egg. You will need to use another form of contraception during this time. After 3 months, a doctor performs an Essure Confirmation Test which confirms placement of the micro-inserts. Until your doctor confirms placement, you cannot rely on Essure for your contraceptive needs.

How long before I can resume regular physical activities?

In the Essure Pivotal Trial, women were typically able to leave the clinic within 45 minutes after the procedure and almost all women resumed normal activities within 24 hours of the procedure.

What happens to my eggs?

Because the micro-inserts do not contain hormones, your ovaries continue to produce eggs after the Essure procedure. Your eggs are naturally absorbed by your body.

Will my periods change after the Essure procedure?

The Essure procedure does not contain hormones, so your body continues its natural cycle. Some women in the clinical studies reported temporary changes in their periods. These changes were likely the result of discontinuing hormone-based contraception. Very few women reported permanent changes. These temporary/permanent changes included the following:

• Periods that were lighter or heavier than normal
• Periods that were shorter or longer than normal
• Spotting or bleeding between periods

Speak with your physician about any menstrual changes you may experience as a result of changes in your contraceptive methods or to understand the hormonal age-related changes that naturally occur.

Does it result in menopause?

The Essure micro-inserts do not cause menopause as it does not interfere with the natural cycles of your body.

How is the Essure procedure different from having a tubal ligation?

Usually performed under general anaesthesia, a laparoscopic tubal ligation is typically performed in an operating room. Gas is used to expand the abdomen so the doctor can reach the organs easily. The doctor then cuts into the abdomen so the surgical tools can be inserted to perform the procedure. The fallopian tubes are blocked by clamping with metal clips or plastic rings (which are left in the body), cutting away a section of the tube, or burning a portion of the tube.

Methods of Tubal Ligation

• Cauterization - uses electrical current to burn and block each fallopian tube
• Ring or band - a section of each fallopian tube is folded together and that section is tied or bound with a ring or band. The rings or bands remain inside the body
• Clip/clamp - the tube is crushed together so the sperm cannot pass through the fallopian tube. The clips/clamps remain inside the body
• Ligation - a portion of each tube is tied or bound in two places and the section in between is cut away and removed

The surgery is completed by closing the cuts on the skin with stitches or metal staples.

After returning home, women typically take 4-6 days before they can resume regular activities. Women may have the following symptoms for a few days:

• Cramps (like menstrual cramps)
• Discharge (like menstrual flow)
• Mild nausea or vomiting associated with the general anaesthesia or the procedure
• Sharp pains in the neck or shoulder (caused by the gas inserted into the abdomen)
• Pain in the incision site
• A sore scratchy throat if a breathing tube was used
• Feeling tired and achy
• Bloated abdomen
• Bruising around the incision

The Essure procedure differs from a tubal ligation because it does not involve incisions and can be performed without general anaesthesia in a clinic. Recovery time at home is typically less than 1 to 2 days, and women often return to regular activities the very same day. Recovery may include the following symptoms:

• Cramps (like menstrual cramps)
• Discharge (like a light menstrual flow or spotting)
• Mild nausea or vomiting (related to anaesthesia, if used)
• Fainting or light-headedness following the procedure (related to anaesthesia, if used)

What are the risks and complications associated with a tubal ligation?

Because incisions are made in the abdomen and a laparoscope is inserted blindly into the abdomen, complications may include:

• Infection
• Bleeding
• Damage to blood vessels, nerves, or muscles
• Damage to the bladder, uterus, or bowel, requiring surgical repair
• Blood clots
• Failure of the procedure resulting in pregnancy
• In rare cases, death

What are the key risks and complications associated with general anaesthesia?

Following general anaesthesia, some people may experience the following:

• Negative reaction to the medication
• Nausea
• Slowness of the anaesthesia to wear off
• A sore throat if a tube is used during the general anaesthesia
• Seizure or heart attack
• High temperature
• Confusion
• Death

Is Essure also an alternative to vasectomy for a couple?

Vasectomy is a surgical operation with associated risks. A vasectomy requires that the man's scrotum is cut or punctured, the vas deferens cut, and burning or clipping the ends of the vas deferens closed.

A vasectomy takes about 15 to 30 minutes, and recovery is usually about 2 days. The man may also need to apply ice packs to the scrotum and wear an athletic supporter for several days to prevent swelling and bruising. The couple must use an alternative form of contraception, typically for 3 months or until a sperm count test or series of tests demonstrates that the vasectomy was successful.

A 6 month sperm test is recommended, as well as follow-up tests every 10 years.

What are some key risks and complications associated with vasectomy?

• Bruising on the scrotum
• Infection of the incision/puncture in the scrotum
• Painful testicles (epididymitis)
• Sperm may leak into the surrounding tissue forming small lumps (granuloma) in the scrotum

What are some risks associated with the Essure procedure?

• Failure to place 1 or both devices in the correct location
• Failure to obtain tubal occlusion by 3 months after the procedure
• Cramps (like menstrual cramps)
• Temporary pain and/or discharge (like a light menstrual flow or spotting)
• Mild nausea or vomiting (only if procedure is performed under general anaesthesia)
• Fainting or light-headedness following the procedure (only if the procedure is performed under anaesthesia)

Is Essure right for me?

The Essure procedure should be the first permanent contraceptive consideration for all women.

Key considerations of the Essure procedure are the following:

• The Essure procedure is permanent and not reversible
• Like all methods of contraception, the Essure procedure should not be considered 100% effective
• You must use another form of contraception for at least three months after the procedure until your doctor advises you that your Essure Confirmation Test has confirmed that the micro-inserts are correctly placed
• Removal of the Essure micro-inserts may require surgery