FDA Recommends Boxed Warning, Patient Checklist for Essure

Posted On December 23rd, 2016 By CSSFIRM.COM

635786345469083294-essure-againThe U.S. Food and Drug Administration (FDA) has recommended a boxed warning for Bayer’s Essure, along with the inclusion of a patient checklist that highlights possible adverse events associated with the permanent contraception device.

These additions to Essure labeling are intended to support patient counseling and understanding of the benefits and risks connected with Essure, and also provide patients information about what to expect during and after they receive the Essure implant.

The aim of the boxed warning is to clearly communicate the significant side effects and adverse outcomes that have been associated with Essure, and provide information about the potential need for removal of the device. The Patient Decision Checklist provides specific information about the Essure device, its use, and safety and effectiveness outcomes that should be discussed between a patient and her medical professional.

What is Essure?

The FDA approved Essure – permanent birth control without surgery – in 2002. The device consists of a delivery system and nickel-containing permanent implants. Two metal coils are inserted through the vagina, and implanted within each fallopian tube, where they stimulate the growth of scar tissue, resulting in a tubal occlusion and sterilization of the woman.

Adverse Events

Over the past several years, the FDA has been investigating a growing number of adverse events associated with Essure. This review led the FDA to convene a meeting of the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee on September 24, 2015 to hear expert opinions as well as patient experiences related to the risks and benefits of Essure.

On the basis of this meeting and the comments received, the FDA concluded that some women are not receiving or comprehending information explaining the risks of benefits of permanent birth control implants like Essure, and as a result, issued the boxed warning and decision guide.

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