Important Safety Information


WARNING: Some patients implanted with the Essure System for Permanent Birth Control have experienced and/or reported adverse events, including perforation of the uterus and/or fallopian tubes, identification of inserts in the abdominal or pelvic cavity, persistent pain, and suspected allergic or hypersensitivity reactions. If the device needs to be removed to address such an adverse event, a surgical procedure will be required. This information should be shared with patients considering sterilization with the Essure System for Permanent Birth Control during discussion of the benefits and risks of the device. Continue reading below

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With over 99% efficacy at preventing pregnancy,* Essure® is the only FDA-approved permanent birth control with a procedure that can be performed in an office setting without general anesthesia.

*Based on clinical study data in women told to rely.

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After hysteroscopically assessing both ostia for patency and accessibility, insert the introducer through the sealing cap of the scope's working channel. Your assistant may initially thread the Essure device through the introducer while you hold the hysteroscope. Once the Essure system is advanced halfway, take over advancing the catheter. The dry flow introducer remains in the working channel throughout the procedure. Slowly and steadily advance the Essure delivery system into the fallopian tubes. Advance until the black positioning marker reaches the tubal ostium. Use one hand to stabilize the Essure system handle against the hysteroscope camera. This prevents inadvertent movement of the Essure system. With the black marker still at the ostium, rotate the thumbwheel back to a hard stop on the catheter handle. This step is inscribed as '1' on the handle as a reminder. You will see the black marker move towards the hysteroscope. This is normal. Depicted as step 2 on the handle, stop and check the positioning of the Essure system. The gold band should be seen just outside the ostium. The distal tip of the green release catheter should just be in view. The wound down micro insert should be exposed. If necessary, reposition the Essure catheter so that the gold band is just outside the tubal ostium. Corresponding to the inscribed symbol '3,' press the button on the system handle. As depicted by symbol ‘4’, rotate the thumbwheel back to a hard stop. This expands the outer coils, and detaches the Essure microinsert. Withdraw the Essure system, and document the number of proximal coils for your records.

With over 99% efficacy at preventing pregnancy,*
Essure® is the only FDA-approved permanent birth control with a procedure that can be performed in an office setting without general anesthesia.

*Based on clinical study data in women told to rely.

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INDICATION

Essure is indicated for women who desire permanent birth control (female sterilization) by bilateral occlusion of the fallopian tubes.

Important Safety Information

WARNING: Some patients implanted with the Essure System for Permanent Birth Control have experienced and/or reported adverse events, including perforation of the uterus and/or fallopian tubes, identification of inserts in the abdominal or pelvic cavity, persistent pain, and suspected allergic or hypersensitivity reactions. If the device needs to be removed to address such an adverse event, a surgical procedure will be required. This information should be shared with patients considering sterilization with the Essure System for Permanent Birth Control during discussion of the benefits and risks of the device.

Caution: Federal law restricts this device to sale by or on the order of a physician. Device to be used only by physicians who are knowledgeable hysteroscopists; have read and understood the Instructions for Use and Physician Training Manual; and have successfully completed the Essure training program, including preceptoring in placement until competency is established, typically 5 cases.

Contraindications

Essure is contraindicated in patients who are uncertain about ending fertility, can have only one insert placed (including contralateral proximal tubal occlusion or suspected unicornuate uterus), have a known abnormal uterine cavity that makes visualization of the tubal ostia impossible, and/or abnormal tubal anatomy or previous tubal ligation (including failed ligation), are pregnant or suspect pregnancy, delivered or terminated a pregnancy less than 6 weeks prior to the Essure procedure, have an active upper or lower genital tract infection, have unexplained vaginal bleeding, have a gynecological malignancy, or have a known allergy to contrast media.

General Warnings

Pregnancy Risk

Procedure Warnings

MRI Information

The Essure insert was determined to be MR-conditional according to the terminology specified in the American Society for Testing and Materials (ASTM) International, Designation: F2503-05.

Adverse Events

The most common (≥10%) adverse events resulting from the placement procedure were cramping, pain, and nausea/vomiting. The most common adverse events (≥3%) in the first year of reliance were back pain, abdominal pain, and dyspareunia.

This product does not protect against HIV infection or other sexually transmitted diseases.

Prescription Only

Report any adverse events or product technical complaints involving Essure® immediately by calling 888-84-BAYER (888-842-2937).

You are also encouraged to report negative side effects or quality complaints of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.