MedWatch - The FDA Safety Information and Adverse Event Reporting ProgramEssure Permanent Birth Control System by Bayer Healthcare: FDA Announcement - Label ChangesAUDIENCE: Patient, Consumer, OBGYN, Risk Manager ISSUE: 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. BACKGROUND: 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. RECOMMENDATION: The FDA recommends that health care providers thoroughly discuss available sterilization and birth control methods with their patients, including their benefits and risks. The Decision Checklist included in the Final Guidance can help to facilitate these discussions and ensure patients understand the benefits and risks. 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. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
For more information, please visit:
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm Update your subscriptions, modify your e-mail address, or stop subscriptions at any time on your Subscriber Preferences Page. You will need to use your email address to log in. If you have questions or problems with the subscription service, please visit subscriberhelp.govdelivery.com. This service is provided to you at no charge by U.S. Food & Drug Administration (FDA).
|
