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| GLOSSARY | HOW DOES ESSURE WORK? | BENEFITS OF ESSURE THE ESSURE PROCEDURE | IS ESSURE RIGHT FOR YOU? RISKS | HOW IS THE ESSURE PROCEDURE PERFORMED? |
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The procedure should be considered irreversible
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There are no data on the safety or effectiveness of surgery to reverse the Essure procedure. What is known is that any attempt to surgically reverse the Essure procedure will require major surgery and has a poor chance for success. Essure is only meant to be used by women who are certain they no longer want to have children. There are also no data on the safety or effectiveness of in vitro fertilization (IVF) after the Essure procedure has been performed.
Studies have shown that women under the age of 30 are more likely to regret their decision to be sterilized. If you are under 30 years old, this decision should be considered carefully, especially since the Essure procedure should not be considered reversible at any age. |
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Like all methods of birth control, the Essure procedure should not be considered 100% effective
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No method of birth control is 100% effective, and there is a small chance you can become pregnant, even many years after you undergo the procedure. The risk of unintended pregnancy, even years after the procedure, also exists for patients who chose incisional tubal ligation or vasectomy. Also, because any type of tubal ligation affects the fallopian tube, where a pregnancy begins before it moves into the uterus, there is an increased risk of a tubal pregnancy (ectopic pregnancy occurring in the fallopian tube), should you become pregnant.
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Not all women who undergo the Essure placement procedure will achieve successful placement of both micro-inserts
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Approximately 1 out of every 7 women in the Essure clinical studies did not achieve successful placement of both micro-inserts during the first placement procedure. Some of these women chose to undergo a second placement procedure, achieved successful placement of both micro-inserts during the second procedure, and subsequently were able to rely on Essure for contraception. If you do not receive successful placement of both micro-inserts during the first procedure, you should talk with your doctor about whether to undergo a second placement procedure or to rely on other methods of birth control.
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You must use another method of birth control for at least 3 months after the procedure
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It takes at least 3 months before your doctor can advise you whether you can begin relying on Essure for contraception. You will need to visit your doctor 3 months after your Essure procedure to have an evaluation performed. This evaluation is called a hysterosalpingogram (HSG), and it is performed to make sure that both of your Essure micro-inserts are in the correct location and that both of your tubes have been blocked. The HSG involves injection of contrast (dye) into your uterus so that an X ray can be taken. It is important that you do not rely on Essure for contraception until your doctor has performed this test and has told you that you may rely on Essure for contraception. If you rely on Essure for contraception before completing this evaluation, you may get pregnant or have an ectopic pregnancy (pregnancy outside of your uterus). Ectopic pregnancies can be life threatening. Because of this 3-month waiting period, you will need to talk to your doctor (before the procedure is performed) about another contraceptive method to use with Essure during this time. During this 3-month period, intrauterine devices (IUDs) and intrauterine systems (IUSs) cannot be used.
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The Essure procedure is newer than other procedures
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Essure is one of the newest methods of permanent birth control, so it has not been studied in as many women or for as long as most birth control methods. Over 600 clinical study participants have relied on Essure for contraception for 1 year, and approximately 200 of them have relied on Essure for 2 years. There are very little data on the safety of or the chance of pregnancy with Essure beyond this time frame. Once longer-term data are available, the information on the safety of and chance of getting pregnant while using Essure may be different than the data based on 1 or 2 years of use.
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Removal of the Essure micro-inserts requires surgery
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If the Essure micro-inserts need to be removed for any reason after they have been placed in your body, major surgery will be required. This surgery will require an abdominal incision and, most likely, general anesthesia.
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As with all procedures, there are risks associated with Essure
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You should be aware of these risks and discuss them in detail with your doctor before you make your decision. Some of the risks associated with Essure have already been discussed above, but additional risks, such as pain and bleeding following the Essure placement procedure as well as risks associated with future medical procedures that you may undergo after your Essure placement procedure, are discussed in the Risks section at the end of this booklet. Please read the Risks section at the end of this booklet carefully. In addition to the risks previously discussed, other risks and considerations are also discussed. Some of the risks discussed in this booklet were experienced by women in the clinical studies of Essure. Some of the risks were not among those reported during the clinical trials, but should still be considered as potential risks of Essure. You should talk to your doctor about the likelihood of these risks, particularly in relation to your own situation.
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