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

About Essure

Essure is for women who desire permanent birth control. With Essure, the fallopian tubes are bilaterally occluded and placement can be performed without incisions or general anesthesia.

Using a hysteroscopic approach, the Essure® inserts are placed in the proximal section of each of the fallopian tubes.

The Essure® insert is a spring-like device that expands and conforms to the varied shapes of the fallopian tube. PET fibers within the device elicit tissue in-growth.

Features of Essure

  • The procedure is commonly performed in the office setting
  • Incisions and general anesthesia are not required for the procedure to place the inserts
    • Both the hysteroscopic and vaginoscopic approaches avoid surgical entry into the peritoneal cavity
  • Return to normal activity within 1 to 2 days
    • The majority of women (60%) return to normal activity within 1 day or less, and more than 75% return to normal activities within 2 days

Mechanism of Action for Essure

placement of Essure

Over the next 3 months following placement, the Essure® inserts elicit a benign occlusive tissue in-growth response, facilitating insert retention and pregnancy prevention.

Tubal occlusion is attributed to the space-filling design of the device and the benign occlusive tissue response. PET fiber causes tissue in-growth into and around the insert, facilitating insert retention, and resulting in tubal occlusion and contraception.

Patients must use alternative contraception for at least 3 months post-procedure until a satisfactory Essure Confirmation Test is documented. Physician must counsel patients regarding the risk of pregnancy (including ectopic pregnancy) attributable to non-compliance during all steps of the Essure procedure. Ensure patient is supplied with the most effective means of contraception for which she is a candidate during this time frame.

See Instructions For Use for additional Mechanism of Action information.

LEARN ABOUT THE ESSURE PROCEDURE

Watch the video

Request a Bayer Sales Consultant

Submit your request

Which Patients May Be COUNSELED ON Essure?

Get the facts

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.