Paying for Essure      Research      Frequently Asked Questions

	What is Essure? Is it safe? Is it effective? Is it proven? How long does the procedure take? How much does it cost? Does it hurt? When does it start working? How long before I’m back on my feet again? How is Essure different from having your tubes tied? Is Essure reversible? Could Essure also be an alternative to vasectomy for a couple? How do I find a doctor who can do this procedure? What are some key considerations with Essure? What is Essure? Essure is a medical procedure designed to provide permanent birth control for women. Unlike tubal ligation (having your tubes tied) there are no incisions into the abdomen, no burning and/or cutting of the fallopian tubes, and there are no sutures to take care of or remove. The procedure can be performed without general anesthesia by a trained gynaecologist using a visually guided method called hysteroscopy. Using a hysteroscope, the Essure delivery system is inserted vaginally and passes through the cervix into the fallopian tube where a micro-insert is released. In clinical trials, the average time spent using a hysteroscope to place a micro-inserts into the fallopian tubes was about 15 minutes, with a total procedure time of about 30 minutes. Most women were able to leave the medical facility about 45 minutes later. Over three months, your fallopian tubes and the micro-inserts work together to form a biological blockage that prevents sperm from reaching the egg. back to top Is it safe? Although Essure is relatively new, the science behind it has been around for many years. Essure is soft and flexible, made from the same medical grade materials that have been successfully used for years in long-term applications such as heart-valve replacements and cardiovascular grafts. As with all medical procedures and birth control options, there are risks. However, in two clinical studies involving more than 700 women, there was a low rate of complications, none of which were life-threatening. What’s more, in clinical trials, 88% of women rated their tolerance of the procedure as “good” to “excellent,” and six months after the Essure procedure, 99% of women rated their comfort as “good” to “excellent”. Learn More... back to top Is it effective? Yes. Clinical studies of Essure conducted in Australia, Europe, and the United States have shown a 99.8%[1] effectiveness rate. Keep in mind that no method of birth control is or can be expected to be 100% effective. back to top Is it proven? The micro-insert technology has been tested in several clinical trials in Australia, Europe, and the United States in more than 900 women. Data obtained from two of these trials (phase II and pivotal trial) support a 99% effectiveness rate. Furthermore, Essure is made from the same medical grade materials that have been successfully used for years in long-term applications such as heart-valve replacements and cardiovascular grafts. Learn More... back to top How long does the procedure take? In clinical trials, the average time spent using a hysteroscope to place a micro-insert into each fallopian tube was about 15 minutes and the total procedure time was about 30 minutes. Because an Essure procedure is performed without incisions and typically without general anesthesia, recovery is expected to be rapid. In the pivotal trial, most women were able to leave the facility about 45 minutes after the procedure. back to top How much does it cost? All Australian health insurance companies cover the Essure procedure. The only out -of-pocket expense could be the “gap” charged by your gynaecologist. If you have any problems with your insurance company, tell them that Essure is listed on the Commonwealth Prosthesis List 'C.' It is always best to check the level of cover with your health fund. Right now, there are a thirty five public hospitals offering Essure throughout Australia. As we are working to make Essure available in major public hospitals across Australia you can phone 1800 785 336 for a list of public hospitals offering Essure or click the "Learn More" link below. Learn More... back to top Does it hurt? Many women in clinical trials have described the pain and/or discomfort associated with an Essure procedure as similar to period pain or like a pap smear. In the Pivotal Trial, 96% of women reported, immediately after the procedure, that average pain during the procedure as ‘none’ to ‘moderate’ and 4% reported ‘severe’ pain. Just before leaving the facility, 88% of women in the pivotal trial rated their tolerance of the Essure procedure as “good” to “excellent.” Six months or more after the procedure, 99% of women in the Pivotal Trial reported their comfort with the Essure micro-inserts as “good” to “excellent.” back to top When does it start working? Like vasectomy, there is a waiting period after the procedure, typically three months, during which you must use a different method of birth control to prevent pregnancy. You should not rely on the Essure micro-inserts for birth control until you have had a pelvic x-ray three months after your procedure, and your physician has informed you that the results are satisfactory. In some women, the x-ray findings will indicate that an additional test should be performed to verify proper positioning of the micro-inserts and blockage of the fallopian tube. This additional test is called a hysterosalpingogram (HSG), which involves filling the uterus with dye under x-ray. If an HSG is recommended, women should not rely on the micro-inserts until they have had the HSG and their doctor has said that they may rely on the micro-inserts for birth control. back to top How long before I’m back on my feet again? In the Pivotal Trial, women were able to leave the facility 45 minutes after the procedure and 92% of working women had returned to work within a day or less, not counting the day of the procedure. In fact, many women have told us that they were able to resume normal physical activities the same day they had the procedure. Learn More... back to top How is Essure different from having your tubes tied? Tubal ligation (having your tubes tied) is performed in a surgical theater, typically with the patient under general anesthesia. One to three abdominal punctures are made. After returning home, women typically take 4.4 days[2] before they can resume regular activities. According to the Royal Australian and New Zealand College of Obstetrics and Gynaecologists, you will most likely experience: •tiredness •muscle pain •mild nausea •pain or discomfort at the puncture site •pain in the shoulders and neck from the carbon dioxide used to inflate the abdomen during the procedure •cramps similar to period cramps •a sensation of swelling in the abdomen You should expect to remain off work for about three days. An Essure procedure can be performed in a day surgery room in about 30 minutes, typically without general anesthesia. No incisions are made. Recovery time at home is typically day, though it is not unusual for a woman to return to regular activities the very same day. During your recovery you should expect a small amount of bleeding and cramping, similar to a normal period. Learn More... back to top Is Essure reversible? The Essure procedure is designed to provide permanent birth control and is not expected to be reversible. back to top Could Essure also be an alternative to vasectomy for a couple? Yes. They are both intended to provide permanent birth control. Vasectomies, like tubal ligations, are surgical operations with associated risks. In a vasectomy procedure, the man’s scrotum is incised or punctured and the vas deferens is cut and the ends are either burned or clipped. Like Essure, a vasectomy procedure is quick, typically about 20 minutes, and recovery is usually about three days. The man may also need to apply ice packs to the scrotum to prevent swelling, and wear an athletic supporter for several days to keep from opening the entry wound in the scrotum. The couple must use an alternative form of birth control, typically for 12 weeks, until a test of semen demonstrates that the vasectomy was successful. Learn More... back to top How do I find a doctor who can do this procedure? There are more than 100 gynaecologists in Australia trained on the Essure procedure, with more being trained all the time. Keep in mind that you must first receive a referral from a general practitioner in order to visit a gynaecologist who performs the Essure procedure. Learn More... back to top What are some key considerations with Essure? • Because Essure is not reversible, you first need to be certain that permanent birth control is the right decision for you. • For three months after the procedure, which may occasionally be longer, women must use another method of birth control. • The procedure is one of the newest birth control alternatives, and while the data demonstrate that Essure is effective, no method of birth control is or can be expected to be 100% effective. Additionally, the research on Essure has not involved as many patients or as long a follow-up period as other birth control methods. • Along with Essure’s unique benefits, it is important that you understand that like all medical procedures, there are risks. In the Pivotal Trial adverse events which prevented women from relying on Essure occurred in 3.9% of cases: o 2.9% of women experienced explusion of the micro-inserts. About two-thirds of these women had a second procedure which was successful. The remainder did not have a second procedure and elected to use another form of birth control. o < 1% rate of perforation of the fallopian tube and/or uterus o < 1% rate of unstatisfactory location of the micro-inserts Other adverse events occurred in less than 1% of cases and include fainting, over-absorption of saline, vaginal bleeding, and ongoing pain/discomfort or menstrual changes. In clinical studies of laparoscopic tubal ligation, surgical complications/injury to the patient occurred in 1.7%[3] of cases consisting primarily of injury to fallopian tube, perforation of the uterus, and injuries to the bowel. A separate study of laparoscopic tubal ligation found that the most common result of complications was unintended major surgery (laparotomy) in 1.1%[4] of cases. In tubal ligations done under laparotomy, an open abdomen procedure, the overall complication rate was 5.7%[5]. • Your Essure procedure may not be successful. In the Pivotal Trial, micro-inserts were placed in 92% of women attempted. Reasons for failed placements include previously undiagnosed tubal stenosis, cervical stenosis, poor visualization of the ostium and endometrium blocking the opening of the tube. • After the procedure, you may not be able to rely on the micro-inserts for permanent birth control. In the Pivotal Trial, 89% of women attempted were able to rely on the micro-inserts for permanent birth control with about 2% having a second Essure procedure before relying on the micro-inserts for permanent birth control. • You should only decide to have an Essure procedure after speaking to your doctor, who will provide more detailed information about these risks and the appropriateness of Essure in your particular situation. Your doctor may advise you that you are not a good candidate for an Essure procedure. • To speak to a registered nurse about Essure, call 1800 785 336. back to top [1] First year 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] Destafano F, Greenspan JR, Dicker RC, et al, “Complications of Interval Laparoscopic Tubal Sterilization”, Obstet Gynecol 61:26, 1983. [4] Peterson, Xia, Hughes, et al, “The risk of pregnancy after tubal sterilization: Findings from the US Collaborative Review of Sterilization”, Am J Obstet Gynecol 1996; 174:1161-70. [5] Bhiwandiwala, Mumford, Feldblum, “A comparison of different laparoscopic sterilization occlusion techniques in 24,439 procedures”, AM J OBSTET GYNECOL, 144:319, 1982. Talk to a registered nurse to get more information about Essure. Call 1 800 785 336.		Find an Essure trained gynaecologist who is right for you, or find a knowledgeable general practitioner who can give you a referral.

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