FDA ANNOUNCEMENT JUNE 24, 2015
FDA plans to hold a meeting of the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee to discuss the risks and benefits of Bayer HealthCare’s Essure System for permanent female sterilization. The meeting will be held on September 24, 2015, at the FDA’s White Oak Campus, at 10903 New Hampshire Avenue, Silver Spring, MD 20993. At this meeting, the FDA invites feedback from presenters, panel members and the public.
In addition, FDA updated its Essure Web Page to include:
Regulatory history information, such as important labeling updates since Essure was approved in 2002
Essure benefits and risks
FDA activities section that includes information about the upcoming advisory committee meeting
An updated summary of Medical Device Reports (MDR) received through May 31, 2015
A summary of Post-Approval Study findings
Information for Patients and Physicians, including more information about what patients and providers should include in MedWatch reports.
The administrators of the Essure Problems Facebook page are feeling very encouraged about this announcement. Not only have several important side effects and warnings been added to the FDA’s Essure page, but they also spoke about the Essure related deaths and the numerous pregnancies.
We feel like the FDA has really been listening to us, to our group, and is taking some steps in the right direction to address the serious complications and problems with this device.
Having a large government agency paying attention to a group of women harmed by a medical device, and making arrangements to review information and allowing our voices to be heard, is huge. We plan to bring with us as many of the original clinical trial participants as we can get there, along with our supporting physicians. We need every women harmed by Essure to get to this meeting. We need every media outlet there. All are welcome. Let’s fill the room and pour into the hallways. Let your faces be seen, and let your pain serve a purpose. Not one more woman harmed by Essure.
Bound by pain, we will never stop until Essure is off the market.