martes, 15 de noviembre de 2016

Consumer Information for Medical Devices Update: FDA approves Essure labeling with important safety information for patients and physicians

FDA Logo
On November 15, 2016, the U.S. Food and Drug Administration approved important labeling changes for Bayer Healthcare’s Essure permanent birth control device and completed our investigation of the trade complaint regarding allegations first made in a Citizen Petition
Bayer revised the physician instructions for use and patient labeling consistent with FDA’s recently finalized guidance:  Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization.   
Essure labeling 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.
The Agency wants women and health care providers to be thoroughly informed about Essure in order to make educated decisions about whether or not Essure is right for them.  Patients are encouraged to discuss all available sterilization and birth control options with their health care providers before making treatment decisions.  The addition of the Patient Decision Checklist can be used to facilitate these important discussions.
Today’s actions follow a series of activities as we continue to evaluate Essure safety concerns. The agency will continue to review adverse event reports, peer-reviewed scientific literature, and information from patients, health care professionals, gynecologic and medical professional societies, the post-market surveillance study, and other sources.  We will continue to provide updated information on this important women’s health issue as it becomes available.
For more information, please visit:

Thank you,
Food and Drug Administration
Center for Devices and Radiological Health

No hay comentarios: