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FDA Meeting on Essure Permanent Birth Control

Office of Women's Health, FDA

July 2015
www.fda.gov/womens

Public Advisory Committee Meeting on Essure Permanent Birth Control

On September 24, 2015, the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee will discuss the risks and benefits of Bayer HealthCare's Essure System for permanent female sterilization. The meeting will be open to the public.

FDA is convening this committee to seek expert scientific and clinical opinion on the risks and benefits of the Essure System. The committee will be asked to evaluate currently available scientific data pertaining to the safety and effectiveness of the Essure System, such as events related to implant perforation/migration, device removal, chronic pain, allergic reactions, and unintended pregnancy. The committee will be asked to provide recommendations regarding appropriate device use, product labeling, and potential need for additional postmarket clinical studies.

Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. FDA is opening a docket for interested persons to submit electronic or written comments regarding this meeting. The docket number is FDA-2014-N-0736.

Date and Time: September 24, 2015, from 8 a.m. to 6 p.m.

Location:          

FDA White Oak Campus,

10903 New Hampshire Ave., Bldg. 31 the Great Room (Rm. 1503)

Silver Spring, MD 20993-0002

 

View Meeting Announcement and Procedures for Submitting Comments:

http://www.fda.gov/AdvisoryCommittees/Calendar/ucm455642.htm

 

View Federal Register Notice:

https://federalregister.gov/a/2015-17985


This email was sent to using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420 Powered by GovDelivery

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