Essure Update June 5, 2017
Dear FDA officials,
On May 31, 2017 we became aware that Bayer will be pulling Essure from a few markets in Europe. We have confirmation of Finland and the Netherlands, but are under the impression it will be many more countries as well.
As you are aware, the governing agency in Brazil, Anvisa, chose to withdraw it from their market on Feb 17, 2017. Modern Healthcare published an article about this decision.
Currently we know of over 15,500 AE reports in the USA regarding Essure problems, with over 9,000 of them citing removal.
Bayer was ordered, by the FDA, on February 29, 2016 to conduct a 522 Postmarket study on essure.
In a media briefing, FDA official William Maisel was quoted, “So Bayer is - we expect Bayer to submit a study protocol to us within 30 days. By law they must begin their clinical trials within 15 months. And failure to do so could result in the agency taking action such as issuing a warning letter and declaring their device misbranded. We have taken those actions in the past and we will do so in the future if Bayer does not meet its requirements.” According to this statement, that would mean Bayer was required to start those clinical studies by May of 2017. It is now June 5th without any action.
“A manufacturer must submit a postmarket surveillance plan within 30 days of receipt of the 522 order (section 522(b)(1) of the Act and 21 CFR 822.8) and commence surveillance not later than 15 months after the day on which FDA issues the 522 order.” See page eight in the FDA’s guidance on May 16, 2016.
As of today, on the FDA’s own website, there is only one patient enrolled of the 2,400.
Several FOIA requests have been submitted requesting the six month report that was due on March 3, 2017. We have yet to receive any of those FOIA requests.
Finally, we are disturbed by the increasing number of women who have been implanted with the Essure device after November 15, 2016, but who were given NO information or informed consent concerning the Black Box Warning or the Patient Decision Checklist. As you are aware, this was a grave concern of ours presented to you at our last meeting. We are aware of at least 80 women who have been implanted with the device and only 3 were given a “downplayed” warning by the implanting physician, but no Patient Decision Checklist. We have also been contacted by 105 women, who were offered the Essure device but chose another alternative. Of those 105 women, only one was advised of the BBW or of the Patient Decision Checklist. Accordingly, the previous actions of the FDA regarding the ‘suggested’ Black Box Warning are not actually helping women to make an informed decision of the risks-benefits of the device. This is why a mandate would have been a better decision on the part of the FDA. Unfortunately for many women, the guidance is not only not being implemented, and they are being implanted without informed consent, but it has now further hindered their ability to pursue a personal injury claim if/when harmed.
We are asking the FDA these things.
When will OUR governing agency step in and say enough is enough? How many women have to be harmed? How many adverse event reports and/or surgeries will it take for OUR governing agency to pull this device from the market to prevent the continued harm?
What is Bayer’s current position in regards to the post market studies? We would like an update immediately.
The Essure Problems Admin Team and women harmed by Essure