The Essure System is used for women who desire an incision-less permanent birth control (female sterilization) by, an occlusion of the fallopian tubes with the use of trans-cervical bilateral insertion of blocking coils in directly into the lumen of the tubes.

http://www.essure.com

Benefits:

• No incisions are required
  Unlike the incision methods of tubal ligation, the Essure procedure does not require incisions. It also does not involve cutting, crushing, or burning of the fallopian tube. Because there are no incisions, the Essure procedure does not result in any visible scar.
• Can be performed without general anesthesia
  The Essure procedure can be performed with or without general anesthesia. In the first clinical trial, general anesthesia was used in only 4% of procedures and most patients had a local block and intravenous sedation only.
• Essure does not contain hormones
• Effective
  The one-year and two-year failure rates established in the Essure clinical trials were both 0%.
• Rapid recovery
  Women were typically discharged from the medical facility 45 minutes after the procedure. 92% of working women who participated in the second Essure study resumed work in 24 hours or less after the day of the procedure.
• High patient satisfaction
• Patient comfort with wearing - patient and partner cannot feel essure system
• Low procedure adverse event rare
  This trans-cervical approach is much safer for women who would otherwise have a relative contraindication for transabdominal tubal sterilization like prior abdominal/pelvic surgery with adhesions or an obese midsection.

Contraindications for Use:

The Essure Permanent Birth Control System should not be used in any patient who is:

• Unsure about desire to end fertility, this procedure is irreversible.
• Patients in whom only one micro-insert can be placed (including PTO and unicornuate uterus).
• Patients who have previously undergone a tubal ligation.

• Pregnancy or suspected pregnancy.
• Delivery or termination of a pregnancy (< 6 weeks before placement).
• Active or recent upper or lower pelvic infection or abnormal pap smear that has not been evaluated.
• Known allergy to contrast media, or known hypersensitivity to nickel confirmed by skin test.
• Although not a contraindication, placement of Essure micro-inserts into women who are undergoing immunosuppressive therapy (e.g., systemic corticosteroids or chemotherapy) is discouraged, because the immunosuppressive therapy is expected to negatively affect the tissue response to Essure that leads to tubal occlusion.

Patient Education:

• Patients should be aware that this product is intended only to prevent pregnancy. It does not protect against either HIV infection or other sexually transmitted diseases.
• The procedure should be considered irreversible. Removal of the micro-inserts requires surgery.
• Like all methods of birth control, the Essure procedure should not be considered 100% effective.
• Successful placement of both micro-inserts will not be possible in all women.
• Patients must use another method of birth control for at least 3 months after the procedure.
• An HSG (hysterosalpingogram x-ray) is to be conducted 3 months post-op to evaluate micro-insert location and tubal occlusion.
• There is a mandatory waiting period of 3 months after the procedure during which the patient must use another form of contraception.
• The Essure procedure is newer than other procedures (no published data beyond 2 years; all materials widely used in other medical applications).
• Pain, bleeding and other risks - refer to Patient Information Booklet.

Patient Scheduling:

Micro-insert placement should be performed during the early proliferate phase of the menstrual cycle to:

• Decrease potential for micro-insert placement in a patient with an undiagnosed (luteal phase) pregnancy.
• Enhance visualization of the fallopian tube ostia.

In women with menstrual cycles shorter than 28 days, the day of ovulation must be carefully calculated to reduce the potential of a luteal phase pregnancy. Micro insert placement should NOT be performed during menstruation.