The Essure Procedure Overview

The Essure procedure is made up of 2 components: the Essure insert placement procedure (“procedure”) and the Essure Confirmation Test. Both are equally important, and instructions for completing each should be followed exactly.

Watch the Essure procedure

IMPORTANT:

Bayer is providing this information to you for informational and educational purposes only. This is not intended for training. You and your staff must be properly trained in all aspects of providing the Essure procedure. For complete placement procedure, please refer to Instructions for Use and Physician Training Manual.

Overview of Placement Procedure

NOTE: The following overview is not intended to substitute for the complete Essure Placement Procedure. Please refer to Section XIII of the Essure Instructions for Use for complete details.

INTRODUCE

Hysteroscopically visualize and assess both fallopian tube ostia. Note: Vaginoscopy may be used as an alternative approach.

The placement procedure for Essure

Place introducer through working channel.

The placement procedure for Essure

Carefully insert Essure catheter.

PLACE

The placement procedure for Essure

Advance the catheter until the black positioning marker is at the tubal ostium. If excessive resistance occurs, i.e., the catheter does not advance toward tubal ostium and/or catheter bends or flexes excessively, or if several minutes have passed, terminate the procedure to avoid perforation or placement into a false passage. If the tube is blocked or the catheter cannot be advanced to the positioning marker, the procedure should be terminated. If insert placement is not successful after 10 minutes of attempted cannulation per tube, the procedure should be terminated.

The placement procedure for Essure

Stabilize the Essure handle to the hysteroscope to prevent inadvertent forward movement. Roll thumbwheel back so black positioning marker moves towards you until reaching hard stop.

The placement procedure for Essure

Stop and check placement of insert. The entire gold band must be just outside the ostium with the green release catheter in view. If the gold band is not visible, do not deploy; reposition the catheter, ensuring that the gold band is in view, prior to deployment.

The placement procedure for Essure

Press button to release thumbwheel. Insert will not yet expand.

The placement procedure for Essure

Roll thumbwheel back to a hard stop, which detaches the insert allowing it to expand within the fallopian tube.

DOCUMENT

Document placement and visible coils under hysteroscopic visualization.

The placement procedure for Essure

Ideally, 3 to 8 coils should be trailing into the uterine cavity. Inserts showing 0 to 17 trailing coils should be left in place. With 18 or more visible coils, removal may be attempted. Removal of insert may not be possible; attempted removal of inserts having fewer than 18 trailing coils may cause insert to fracture or patient injury.

Withdraw Essure catheter.

Repeat steps with second catheter for contralateral ostium.

After 3 months, verify placement with Essure Confirmation Test.

Essure inserts are intended to be left in place permanently. If removal is necessary, please see Instructions for Use for more information.

Bayer has developed a comprehensive training program—the Clinical Pathway—to help you and your staff integrate the Essure procedure into your practice.

Request a Bayer Sales Consultant today to learn more about Essure and start the Clinical Pathway.

Next: Learn about the Essure TVU/HSG Confirmation Test Algorithm