On June 1, Angie Firmalino, one of the Essure Problems administrators, issued a call-to-action post on the group's Facebook page to encourage women to add their signatures to the letter, which requests more information from U.S. government regulators.
Firmalino's letter calls upon the agency to respond to requests filed under the Freedom of Information Act and asks for updates on the post-market safety studies outlined in the FDA's renewed safety efforts.
The letter also reminds the agency that there have been 15,500 adverse event reports filed by women in the United States. According to the letter, many women have not received the patient decision checklists required by law, which prompted action from advocates.
Read the full email:
Dear FDA officials,
Yesterday we were made aware that Bayer will be pulling Essure from a few markets in Europe. We have confirmation of Finland and Netherlands, but are under the impression it will be many more. http://www.bayer.fi/…/bucke…/news-bucket/essure-201705310916
http://www.bayer.es/…/2017_05_29_novedades_respecto_a_essur…
As you are aware, the governing agency in Brazil, Anvisa, chose to withdraw it from their market on Feb 17, 2017.
http://www.modernhealthcare.com/article/20170221/…/170229985
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 on February 29, 2016 to conduct a 522 postmarket study on essure.
https://www.fda.gov/…/News…/PressAnnouncements/ucm488313.htm
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.”
https://www.fda.gov/…/newsro…/mediatranscripts/ucm489155.pdf
According to that statement, that would mean Bayer was required to start those clinical studies by May of 2017. It is now June 1, 2017. “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 8
https://www.fda.gov/…/Devic…/GuidanceDocuments/ucm268141.pdf
As of today, on the FDA’s own website, there is only one patient enrolled of the 2,400.
https://www.accessdata.fda.gov/scri…/…/cfdocs/cfPMA/pss.cfm…
Several FOIA requests have been submitted requesting the 6 month report that was due on 3/3/17. 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.
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?
What is Bayer’s current position in regards to the post market studies? We would like an update immediately.
Sincerely,
Victims harmed by Essure
Angie Firmalino, Tannersville NY