The Essure procedure is only appropriate if you are sure you do not want any more children, would like to have permanent birth control, and believe you will not change your mind. If there is any chance you may want to have children in the future, you should choose another form of birth control. You should avoid making this choice during times of stress, such as a divorce or after a miscarriage, and NEVER while under or due to pressure from a partner or others.

YOU SHOULD NOT USE the Essure Permanent Birth Control System if you:

• Are uncertain about your desire to end fertility
• Are pregnant or suspect that you are pregnant
• Have delivered a baby, had a miscarriage, or had an abortion within 6 weeks before the Essure micro-insert placement procedure
• Have an active or recent pelvic infection
• Have an unusual uterine shape (for example, a uterus with only one tube or a divided uterus)
• Have a known allergy to dye (contrast media)
• Have a known hypersensitivity or allergy to nickel as confirmed by skin test
• Are unwilling to use another method of contraception for at least 3 months after the Essure micro-insert placement procedure
• Are unwilling to undergo an HSG approximately 3 months after your Essure placement procedure to make sure that your tubes are blocked and the devices are in the correct positions
• Have had a prior tubal ligation
  
  

Note: If you are currently undergoing immunosuppressive therapy (eg, taking steroid medication such as prednisone, undergoing chemotherapy, etc), you should discuss this in detail with your physician, since the Essure micro-inserts may not be effective in patients undergoing immunosuppressive therapy. Also, if you have previously had abdominal or pelvic surgery, please discuss this with your physician prior to undergoing an Essure placement procedure.

If you decide you want to have the Essure procedure performed, you will undergo a general examination and laboratory tests (for example, a PAP smear) to evaluate whether you are a good candidate for the procedure. It may turn out that the Essure procedure is not an option for you.

You should be aware that there are other methods of birth control, both temporary/reversible and permanent. Table 1 on the following page shows pregnancy rates for various birth control methods. This information is being presented to assist you in your choice of contraception during the 3-month waiting period until the HSG is performed after placement of the Essure micro-inserts. Table 2 provides information regarding some of the characteristics of the 3 forms of permanent birth control: Essure, tubal ligation, and vasectomy. Your doctor will explain these alternative methods to you and advise you whether Essure is a suitable option for you. It is your right to decide what method suits you. If, at any time before the start of the Essure procedure, you decide not to have it, you should tell your doctor and cancel the procedure. You do not have to provide any explanation or reason for your decision.