Wednesday, 08 February 2017 08:07

Label Changes On Essure Permanent Birth Control System

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The National Agency for Food and Drug Administration and Control has been notified about the Essure labeling which now includes the addition of a boxed warning and a Patient Decision Checklist, both intended to support patient counseling and understanding of benefits and risks associated with Essure, as well as what to expect during and after the Essure procedure. The boxed warning includes safety statements to clearly communicate significant side effects or adverse outcomes associated with this device and information about the potential need for removal.

The Patient Decision Checklist provides key information about the device, its use, and safety and effectiveness outcomes, of which the patient should be aware and discuss with her doctor as she considers her sterilization options. Bayer also incorporates important modifications to the patient counseling and device removal sections of the labeling to provide physicians with additional guidance in these critical areas.

Adverse event associated with the use of this product should be reported to the nearest NAFDAC office, NAFDAC PRASCOR (20543 TOLL FREE from all networks) or via This email address is being protected from spambots. You need JavaScript enabled to view it.

NAFDAC………Safeguarding the health of the nation!!!

Read 5714 times Last modified on Wednesday, 08 February 2017 08:12

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