RICHMOND, Va. (WRIC) — The Food and Drug Administration released a statement Tuesday saying they plan on making a decision on the controversial birth control Essure by the end of February.
In the statement, the FDA said they wanted to acknowledge those who testified at the September panel hearing and the “many others who have expressed their viewpoints and share their experiences with us.”
The statement went on to read:
Patient health and well-being is our first priority regarding this device and all medical devices.
Presently, we are reviewing information from the panel meeting, the public docket, as well as additional medical literature and adverse event reports which have been published or received since the panel meeting. In this review, we are focusing attention on the concerns identified by the public speakers and the feedback and recommendations provided by the panel (See Advisory Committee meeting summary and panel transcript).
This is a high priority issue for the Agency, and we are working expeditiously to conduct an evidence-based review of the available information and identify appropriate next steps. We anticipate communicating our actions publically at the end of February 2016.”
Essure is a tiny nickle coil marketed as permanent birth control, but thousands of women say it has left them with permanent pain.
“Within 12 months of placement I developed pain throughout my entire body,” said Kim Hudak, who had was part of the clinical trials for Essure.
At the September hearing, a panel of medical experts heard from patients, doctors and researchers. Many raised questions about the accuracy of the clinical trials conducted by Conceptus, which is now owned by Bayer.
Hudak told 8News, “The data that I have was absolutely altered; undeniably altered.”
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