FDA Advisory Committee Panel Meets To Revisit Safety Of Essure Contraceptive Device – On September 24, 2015, the U.S. Food and Drug Administration (FDA) will hold a public meeting of the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee to discuss data regarding the safety and effectiveness of the contraceptive device Essure. Marketed by Bayer HealthCare, Essure is a permanent birth control method for women. Essure is a Class III medical device and was approved by the FDA on November 4, 2002.
According to the Essure Medical Devices Advisory Committee meeting agenda posted by the FDA, the meeting will convene at 8:00 am on September 24, 2015, at the following address:
Food and Drug Administration – White Oak Campus
Building 31 – The Great Room Room
1503 Silver Spring, MD
The FDA invites feedback from presenters, panel members and the public to “inform recommendations and next steps about Essure.”
The meeting format will include presentations by Bayer HealthCare and the FDA, followed by questions from the Medical Devices Panel members. The Panel will publically discuss and deliberate the information presented, and address questions regarding the safe and effective use of Essure, including for example, adverse events, product effectiveness, labeling revisions, device insertion and removal, need for additional studies, and the benefit-risk profile of Essure.
For a copy of the meeting materials available to the public, please see 2015 Meeting Materials of the Obstetrics and Gynecology Devices Panel To Review Essure.
To learn more about Essure Lawsuits and Complications, visit Essure Lawsuit.
Obtain a Free Medical Device Lawsuit Evaluation From The Law Firm of Eric Weinberg – Essure Lawsuits
If you or a loved one has been seriously injured by a medical device including the Essure contraceptive system, and you have a question regarding Essure Lawsuits, please call our attorneys at 1-877-934-6274 for a free legal case evaluation. You can also contact our law firm by submitting the “Free Legal Case Evaluation Form” found on this page.
