San Diego, CA September 9, 2015– On September 24 the FDA will convene to review and evaluate data concerning the safety and effectiveness of Essure, a permanent birth control device on the market. While this FDA public hearing has been discussed online at great length, what exactly can we expect from this meeting?
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Who will hold the FDA Essure meeting?
The FDA will be holding the meeting of the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee to discuss the risks and benefits of Bayer’s Essure System. The Obstetrics and Gynecology Devices Panel reviews and evaluates data related to the safety and effectiveness of marketed and investigational in vitro devices for use in clinical laboratory medicine and makes appropriate recommendations to the Commissioner of Food and Drugs.
Roster of the Obstetrics and Gynecology Devices Panel
Chairperson
Thommaso Falcone, M.D.
Expertise: Reproductive Medicine
Term: 02/01/2015 – 01/31/2018
Professor and Chairman
Dept. of Obstetrics and Gynecology
Cleveland Clinic Foundation
9500 Euclid Ave. – A81
Cleveland, OH 44195
Designated Federal Official
Shanika Craig
Center for Devices and Radiological Health
Office of Device Evaluation
10903 New Hampshire Ave.
WO 66 Room #1613
Silver Spring, MD 20993
Acting Industry Representative
James Gardner, M.D., M.B.A. #
Expertise: Regulatory Affairs
Term: 08/26/2013 – 01/31/2017
Director of Reimbursement and
Medical Science Officer
Cook, Inc.
750 Daniels Way
Bloomington, IN 47402
Ann J. Davis, M.D.
Expertise: Reproductive Endocrinology
Term: 02/01/2015 – 01/31/2019
Hoover, AL 35226
Cheryl B. Iglesia, M.D.
Expertise: Obstetrics and Gynecology
Term: 08/22/2013 – 01/31//2017
Section Director, FPMRS
Washington Hospital Center
106 Irving Street NW, Suite 2100 N
Washington, DC 20010
Lisa E. Moore, M.D.
Expertise: Maternal-Fetal Medicine
Term: 03/19/2012 to 01/31/2016
Associate Professor
University of New Mexico
Dept of OB/GYN
Div. of Maternal Fetal Medicine
MSC 10-5580 1 UNM
Albuquerque, NM 87131
Deborah L. Myers, M.D.
Expertise: Pelvic Floor Disorder
Term: 01/16/2015 – 01/31/2018
Director, Div. of Urogynecology and
Reconstructive Pelvic
Women & Infants Hospital of Rhode Island
695 Eddy Street
Providence, RI 02903
Denise M. Elser, M.D., FACOG
Expertise: Urogynecology
Term: 01/16/2015 to 01/31/2018
Medical Director
Women’s Health Institute of Illinois, LTD
5716 W 95th Street
Oak Lawn, IL 60453
Where will the FDA Essure meeting be held?
The FDA Advisory Committee Meeting will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (Room 1503), Silver Spring, Maryland 20993-0002.
The FDA will be opening a docket for interested persons to submit electronic or written comments regarding the meeting and the Essure System. The docket number is FDA-2014-N-0736. The meeting will be on September 24th, 2015, from 8 a.m. to 6 p.m.
What’s on the agenda for the FDA Essure meeting?
On September 24th, the committee will discuss the risks and benefits of Bayer Healthcare’s Essure System for permanent birth control. Essure, which was approved back in 2002, consists of a delivery system and nickel coils that are inserted into the fallopian tubes. Essure is implanted without a skin incision and through the vagina, within each fallopian tube. The coils react and grow scar tissue, which over time results in tubal occlusion.
The FDA is convening with this committee to seek expert scientific and clinical opinion on the risks and benefits of the Essure System. They will be asked to evaluate currently available scientific data regarding the safety and effectiveness of the implant such as events related to migration/perforation, device removal, chronic pain, allergic reactions, and unintended pregnancy. In addition, the committee will be asked to provide recommendations regarding appropriate device use, product labeling, and potential need for additional clinical studies.
The FDA plans to make background material available to the public no later than two business days before the meeting. If the FDA is unable to post this background information on its website, it will be made public at the location of the committee meeting, and will be posted after the panel. Background material is available here. Remember to scroll down to the correct advisory panel.
There will be a live Webcast of the September 24th meeting of the panel. Further information about the Webcast will be made available at least two days in advance of the meeting at the following website: https://collaboration.fda.gov/ogdp2015/
Can anyone attend the FDA Essure meeting?
The FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate people with disabilities or special needs. If you would like to attend the hearing and require special accommodations, please contact Ann Marie Williams at [email protected] at least 7 days in advance of the meeting.
Public Conduct during FDA Advisory Meetings
While the public is welcome to join in on FDA advisory meetings, there are rules of conduct that need to be followed in order to keep the process moving in an orderly fashion. In order to ensure that the meeting is a safe and secure environment, that the right of free speech is protected, and that the ability of FDA Advisory Committees and Panels to accomplish their objectives is not disrupted, here are a few rules of conduct:
- An interested person who wishes to be assured of the right to make an oral presentation during the Open Public Hearing portion of an advisory committee meeting should register with FDA before the meeting. See 21 CFR 14.29(b). Those who have not registered before the meeting will only be invited to speak at the discretion of the Chair, and should submit their request to FDA officials at the registration desk on the day of the meeting.
- Open Public Hearing participants who are designated to speak may be questioned only by the Chair or other members of the Committee.
- Audience members may not present comments or questions to the Committee unless recognized by the Chair.
- Attendees at the meeting are asked to maintain order and not display behavior that is disruptive to the meeting (i.e., shouting from the audience, loud outbursts).
- The committee Chair or Designated Federal Officer will note on the record any disruptive behavior and will ask the person to cease the behavior or else leave the meeting room.
If you plan to attend the FDA Essure panel, or will be presenting, please follow these rules of conduct in order to have a civil and informational meeting that brings light to the dangers of the Essure System.
If you or someone you love is suffering side effects from the Essure Implant, contact our Essure lawyers today, click the banner below to access the Essure Claim Evaluation form.
Source: FDA.gov
