Essure

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 below

Bayer logo
As a result of Bayer’s voluntary business decision in 2018 to discontinue the sales
and marketing of Essure, the device is no longer available for implantation. There
are no changes in the safety profile or effectiveness of Essure.
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.

IMPORTANT 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

For help with questions about Essure, please call (toll-free) 1-888-84-BAYER (1-888-842-2937)

Click here to report an adverse event

Click here if you are a US healthcare professional seeking medical information

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 side effects or quality complaints of products to the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088. For Bayer products, you can report these directly to Bayer by clicking here.

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