Essure Tubal ligation [1] Vasectomy
Who has the procedure? Women Women Men
How effective is the procedure? 99.81% at one-year
99.78% by two-years
Data not available beyond 2 years		 99.45% at one-year
99.16% by two-years
99.15% at 10 years		 99.85% at one-year
How is the surgical procedure performed? The device is routed through the vagina, cervix and uterus into the fallopian tubes, where the devices are placed. No incisions are required. The fallopian tubes are either cut, burned (cauterized) or clamped using either:
• Laparoscopic tubal ligation (most common method), where 1-3 incisions are made in the abdomen to access the fallopian tubes using a telescope type device. The tubes are then blocked with clips or rings or burned.
• Open surgery (called a laparotomy or mini-laparotomy), which requires a larger incision (usually 2 – 3 inches) in the abdomen.		 The two tubes (the vas deferens) that carry sperm from the testicles to the penis are cut or blocked. This is achieved by:
• Making a small incision in the scrotum. This is the most common method
• Making a small puncture in the scrotum
How long does the procedure take? Average procedure time is 35 minutes Average procedure time is 30-45 minutes for laparoscopic method. May be longer if open surgery Average procedure time is 15–30 minutes
How many visits to the doctor does it require, and what type of follow-up is required? Three visits. One consultation visit, one visit to place the micro-inserts, and one follow-up visit at 3 months to check for tubal occlusion and proper micro-insert location. Three visits. One consultation visit, one visit to perform the tubal ligation, and one follow-up visit at approximately 2 weeks to check the incisions. Three visits. One consultation visit, one visit to perform the vasectomy, and one follow-up visit at 3 months to make sure that the vasectomy was effective.
How is pain or discomfort typically controlled during the procedure? Local anesthetic and/or intravenous sedation General anesthetic, spinal block or epidural anesthesia is typically used Local or general anesthetic
Can I rely on it right away? No. There is a three-month waiting period when another form of contraception must be used. You will need a hysterosalpingogram (a special kind of x-ray) before you can rely on Essure. The purpose of this test is to make sure that both of your tubes are blocked and both of your devices are in the correct position. You must continue to use another form of contraception until your doctor instructs you that you can rely on Essure for birth control. Yes. You may resume intercourse when you have recovered from the procedure, following your doctor’s advice, typically about a week after the procedure. No. There is a 2-3 month waiting period required to flush out any existing sperm. Sperm counts are taken to demonstrate the success of vasectomy i.e. when the sperm count is zero. You must use another method of contraception until then.
What should I be doing to help the recovery process after the procedure? • Rest for 45 minutes following the procedure before going home. Follow your doctors instructions to report any unusual pain, bleeding or high fever
• Consider having someone to drive you home		 • Most women are ready to go home 2-4 hours after the procedure
• Must have someone to drive you home
• The incision will need to be kept dry for a few days
• Follow your doctor’s instructions to report any unusual pain, bleeding or high fever		 • Rest for about 30 minutes following surgery
• Consider having someone to drive you home
• Apply ice packs to the scrotum and wear supportive underwear to minimize bruising/swelling
• Follow your doctor’s instructions to report any unusual pain, bleeding or high fever
When can I return to regular activities? Typically, within 1-2 days of the procedure. For laparoscopic tubal ligation, typically within 4-6 days. For tubal ligation performed by an open procedure, typically within 9-10 days. Typically, in 2 days.
What are the typical temporary effects following the procedure? • 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		 • Cramps (like menstrual cramps)
• Discharge (like a menstrual flow)
• Mild nausea or vomiting associated with 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		 • Swelling and bruising. If this occurs it usually resolves within two weeks following procedure
• A dull ache in the testicles that usually fades during the first week
What are the major risks of the procedure? • You may become pregnant several years after undergoing the procedure.
• Ectopic pregnancy occurs more often in women who have had a sterilization, if they become pregnant.
• For a percentage of women (14% in clinical studies) it may not be possible to place the micro-inserts in the fallopian tubes during the first placement procedure
• Despite micro-insert placement, a small percent of women (3% in the clinical studies at the 3-month follow-up) may not be able to rely on the micro-inserts for birth control due to incorrect position of the devices or lack of tubal blockage.
• Although death and serious injury following hypervolemia were not reported in the Essure clinical trials, hypervolemia can lead to serious injury and death.		 • You may become pregnant several years after undergoing the procedure.
• Ectopic pregnancy occurs more often in women who have had a sterilization, if they become pregnant.
• Major complications such as infections, bowel injuries, bleeding, burns, or complications from anesthesia occur in about 2%2 of women who have the operation by laparoscopy and in about 6%2 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.		 • Pregnancy may occur several years after undergoing the procedure.
• 1.6% of men experience bruising on the scrotum1
• 1.5% of men experience infection of the incision/puncture in the scrotum1
• Painful testicles (epididymitis) is experienced in about 1.4% of men1
• Sperm may leak into the surrounding tissue (less than 1% leakage rate1) forming small lumps (granuloma). This process generally subsides spontaneously, although pain medication may be required

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[1] Information taken from Contraceptive Technology, 17th Edition, ardent Media, New York, 1998, and the ACOG Patient Education Brochure, AP035, Sterilization by Laparoscopy, April 2000.
[2] Jamieson DJ. Complications of Interval Laparoscopic Tubal Sterilization: Finding from the United States Collaborative Review of Sterilizaton. Obstet Gynecol 2000; 96:997-1002.
[3] Layde PM. Risk Factors for Complications of Interval Tubal Sterilization by Laparotomy. Obstet Gynecol 62:180, 1983.