Is it effective? 
How do women rate the procedure?
What are the micro-inserts made of?
Is it reversible?
How long does the procedure take?
When does it start working?
How long before I can resume regular physical activities?
How is the Essure procedure different from having your tubes tied?
What happens to my eggs?
Does it result in menopause?
Could Essure also be an alternative to vasectomy for a couple?
What are the key risks and considerations with Essure?
What are some key risks associated with tubal ligation?
What are some key risks associated with vasectomy?
Is Essure right for me?
Q: Is it effective?
A: Essure has been demonstrated in clinical testing to be 99.8% [1] effective after two years of follow-up. Over 600 clinical study participants have relied on Essure for contraception for one year, and over 200 of them have relied on Essure for two years. There are very little data on the safety or the chance of pregnancy with Essure beyond this time frame. Once these longer-term data are available, the information on the safety and chance of getting pregnant may be different than the data based on one or two years of use. No method of birth control is 100% effective and there is a small chance you could become pregnant, even many years after you had the procedure. Q: How do women rate the procedure?
A: In clinical testing involving about 700 women, almost all women rated their comfort with Essure as “good” to “excellent” within one week of the procedure. After the first week, almost all women rated their satisfaction with Essure as “good” to “excellent”.
Q: What are the micro-inserts made of?
A: The micro-inserts are made from polyester fibers and metals (nickel-titanium, and stainless steel). These materials have been studied and used in the heart and other areas of the human body (e.g., heart valve replacements, blood vessel grafts, and abdominal repair) for many years.
Q: Is it reversible?
A: The procedure should be considered irreversible. It is only meant to be used by women who are certain they no longer want to have children.
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. Additionally, there are no data on the safety or effectiveness of in vitro fertilization (IVF) after the Essure procedure has been performed. Q: How long does the procedure take?
A: In clinical testing, the average time to place a micro-insert into both fallopian tubes was about 15 minutes and the total procedure time was about 35 minutes. Because an Essure procedure is performed without incisions or general anesthesia, most women were able to leave the facility about 45 minutes after the procedure.
Q: When does it start working?
A: You must use another method of birth control for at least three months after the procedure 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 the evaluation 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 test involves injection of contrast (dye) into your uterus so that an x-ray picture 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. IUDs or IUSs cannot be used during this time period.
Q: How long before I can resume regular physical activities?
A: In the Essure Pivotal Trial, women were typically able to leave the facility 45 minutes after the procedure and almost all working women resumed work in 24 hours or less after the day of the procedure. The majority of women returned to normal activities in 1 – 2 days, but many women reported that they were able to resume normal physical activities the same day as the procedure.
Q: How is the Essure procedure different from having your tubes tied?
A: In a laparoscopic tubal ligation, 1 – 3 abdominal incisions are made with the patient under general anesthesia. The fallopian tubes are blocked by clamping with a metal clip or plastic rings, removal of a section of the tube, or burning a portion of the tube.
After returning home, women typically take 4-6 days [2] before they can resume regular activities. According to the American College of Obstetrics & Gynecology, after returning home, 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 anesthesia or the procedure
- Pains in the neck or shoulder
- Pain in the incision
- A scratchy throat if a breathing tube was used
- Feeling tired and achy
- Swollen abdomen, which resolves as gases are absorbed
- Bruising around the incision that fades
An Essure procedure can be performed without general anesthesia or incisions. Recovery time at home is typically 1-2 days, though it is not unusual for a woman to return to regular activities the very same day. During your recovery, you should expect: - 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
Q: What happens to my eggs?
A: After an Essure procedure, your ovaries will continue to produce eggs, until menopause. The unfertilized eggs will be absorbed by your body.
Q: Does it result in menopause?
A: No. Essure does not cause menopause.
Q: Could Essure also be an alternative to vasectomy for a couple?
A: Yes. They are both intended to provide permanent birth control. Vasectomies are surgical operations with associated risks. In a vasectomy, the man's scrotum is incised or punctured, the vas deferens is cut, and the ends are either burned or clipped.
A vasectomy is quick, typically about 15 -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 birth control, typically for 12 weeks, until a sperm count demonstrates that the vasectomy was successful.
Q: What are the key risks and considerations with Essure?
A: 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
Q: What are some key risks associated with tubal ligation?
A: *Tubal ligation is 99.2% effective after two years of follow-up. No method of birth control is 100% effective and there is a small chance you could become pregnant, even many years after you had the procedure. - Major complications such as infections, bowel injuries, bleeding, burns, or complications from anesthesia occur in about 2% [3] of women who have the operation
by laparoscopy and in about 6% [4] of women who have the operation by laparotomy (open procedure). Internal bleeding is the most common and may require an open operation to stop the bleeding. - Other injuries such as damage to the bladder or burns to the bowel may also require additional surgery.
- Other risks such as blood clots and death, are rare.
Q: What are some key risks associated with vasectomy?
A: *Vasectomy is 99.85% [5] effective after one-year of follow-up. No method of birth control is 100% effective and there is a small chance you could become pregnant, even many years after you had the procedure. - 1.6% [5] of men experience bruising on the scrotum.
- 1.5% [5] of men experience infection of the incision/puncture in the scrotum.
- Painful testicles (epididymitis) is experienced in about 1.4% [5] of men.
- Sperm may leak into the surrounding tissue (less than 1% [5] leakage rate) forming small lumps (granuloma). This process generally subsides spontaneously, although pain medication may be required.
Q: Is Essure right for me?
A: 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 under pressure from a partner or others. YOU SHOULD NOT USE ESSURE 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 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 a hysterosalpingogram (HSG) approximately 3 months after your Essure placement procedure to make sure that your tubes are blocked and the devices are in the correct position
- Have had a prior tubal ligation.
NOTE: If you are currently undergoing immunosuppressive therapy (e.g., taking steroid medication such as prednisone, or undergoing chemotherapy), 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 an Essure placement procedure. If you decide you want the Essure procedure, you will have 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.
 View pregnancy rates for various other 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.
[1] Effectiveness rate determined based on combined data from Phase II and Pivotal clinical trials, sponsored by Conceptus.
[2] Fraser RA, Hotz SB, Hurtig JB, Hodges SN, Moher D, "The prevalence and impact of pain after day-care tubal ligation surgery", Elsevier, 39 (1989) 189 201.
[3] Jamieson D, et al, “Complications of Interval Laparoscopic Tubal Sterilization: Findings From the United States Collaborative Review of Sterilization”, Obstet Gynecol 2000; 96:997-1002.
[4] Layde P, et al, “Risk Factors for Complications of Interval Tubal Sterilization by Laparotomy”, Obstet Gynecol 62:180, 1983. Major complications include unintended major surgery, blood transfusion, oral temperature greater than 38C on at least two days after the procedure (excluding the first 24 hours after surgery), life-threatening event, rehospitalization between discharge and follow-up interview, and death occurring within 42 days of the surgery.
[5] Hatcher RA, et al, “Contraceptive Technology 17th Edition”, Ardent Media, New York, 1998. 
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