Essure® Sterilization

The Essure procedure is the first and only FDA approved female sterilization procedure to have zero pregnancies in the clinical trials. The Essure procedure is permanent and not reversible. Any woman interested in this procedure should be sure that they do not want children in the future.

How does Essure work?

A hysteroscope is used to place small coil-like micro-inserts into the fallopian tubes. During the 3 months following the procedure, scar tissue will begin to grown around the micro-inserts, blocking the fallopian tubes. This provides permanent protection from pregnancy. An HSG test is done 3 months after the procedure to confim occlusion of the fallopian tubes. Patients should use an alternate form of birth control for the 3 months following the procedure, until the HSG test is performed.

Effectiveness

The Essure procedure is 99.8% effective and is irreversible. None of the women studied in trials became pregnant over a 1-5 year follow up.

Benefits

• No incision required
• No need for general anesthesia
• Procedure takes approximately 35 minutes to perform
• Procedure is performed on an outpatient basis
• No hormones or silicone to interfere with your body (unlike pills, the patch, the ring, and some IUDs, Essure does not contain hormones or interfere with your natural menstrual cycle)
• Average post-recovery time is 45 minutes
• Most employed patients return to work after 24 hours

Indications

Essure is recommended for women who want a permanent birth control solution and who are positive about their decision to not have any more children.

Contraindications

You should not use Essure if you:

• Are unsure about your decision to become sterile
• Cannot have the micro-inserts placed in both of your fallopian tubes
• Had a tubal ligation
• Have a known allergy to dye
• Have a sensitivity to nickel as shown by skin testing
• Are unwilling to have the follow-up HSG test performed
• Are unwilling to use alternative birth control during the 3 month post procedure period
• Are pregnant or think you might be pregnant
• Have active or recent upper or lower pelvic infection

Please note that not ALL women who undergo the Essure procedure will acheive successful placement of both microinserts. It is imperative that the patient undergo the HSG testing to be sure of placement and occlusion.

Patients who have had a delivery or termination of pregnancy should wait at least 6 weeks before undergoing the Essure procedure.

Risks or Complications

• Irreversible
• No form of birth control should be considered 100% effective, including the Essure procedure
• Another form of birth control MUST be used for 3 months after the procedure
• Does not protect against STDs and AIDS

The following are side effects that may occur during the procedure:

• Mild to moderate pain
• Increased risk of pregnancy if the procedure is performed during the second half of the menstrual cycle
• Side effects from the type of anesthesia used during the procedure
• A small chance of tubal perforation during the placement of the Essure micro-inserts

The following are side effects that may occur following the procedure:

• Pain and/or cramping
• Bleeding or spotting
• Nausea or vomitting due to type of anesthesia
• Pelvic, back, or abdominal pain

Additional information can be found at www.Essure.com, as well as patient success stories, information on clinical trials, and a comparison of Essure vs. Tubal Ligation and Vasectomy.

Source: 2005 Conceptus Incorporated, www.Essure.com

Tubal Ligation (Sterilization)

What is Tubal Sterilization?

• In a tubal ligation or "getting tubes tied", both fallopian tubes are closed using one of the following methods:
  1. Cut
  2. Tied
  3. Sealed with a ring or clip or electric current
  4. Insertion of a coil (Essure)
• This prevents the egg from moving down the fallopian tubes, which prevents fertilization.

There are many different methods used to perform a tubal sterilization, the two most common methods used are laparoscopy and minilaparotomy. Anesthesia (pain relief) is used for surgery, and many patients are likely to return home the same day as the procedure.

Note: both methods have the same risks and success rates.

Advantages

• Long term cost effectiveness
• Nothing to buy or remember to take
• No need for interruptions during intercourse
• Permancence
• Lack of long-term side effects
• Non-hormonal
• Less than 1% failure rate

Disadvantages

• Not easily reversible if a woman changes her mind
• Initial high cost
• 10%-65% higher risk of ectopic pregnancy if method fails
• No protection from sexually transmitted diseases (STD's)--including HIV and AIDS
• Carries risk due from surgical problems as well as anesthesia

Side Effects

There are side effects and risks that accompany all surgical procedures, including tubal ligations. Often, side effects may occur due to the anesthesia used during surgery. Some of the more common side effects related to anesthesia are:

• Pain in the abdomen
• Fatigue
• Nausea

(Side effects from anesthesia most often fade within 1-3 days after surgery)

Common surgery related Side Effects

• Dizziness
• Abdominal Pain
• Gassy or bloated feeling
• Sore throat
• Nausea
• Changes in bowel movements
• Shoulder Pain

Serious Complications

• Infections
• Bowel injuries
• Bleeding
• Burns
• Complications from anesthesia
• Death (leading cause is from anesthesia) < 1-2 out of 100,000 procedures>

Sources: Sterilization for Women and Men. Committee on Patient Education of the American College of Obstetrics and Gynecology. c. 2001  AND Hatcher, Robert A. MD, MPH et. al. Contraceptive Technology 17th ed. Ardent Media INC. New York C. 1998