Essure Problems 

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Hello. Today we are sharing with you an email that many Essure victims received from our FDA. You see, many of us have multiple FOIA requests in to the FDA asking for clinical data regarding Essure. The number one request was the post approval requirement five year follow up study. Our requests have been in for well over a year.

Recently we arranged a phone conference with Tegan Millspaw, and this was the post we put on our Facebook page:

"I am happy to announce that the admins have secured a conference call with Tegan Millspaw. Tegan is an investigator on the United States Senate Committee. She can be seen speaking here around minute 21... http://www.c-span.org/video/?304952-5/freedom-information-act-legislative-outlook- The call is scheduled for Wednesday September 17th at 2:30 Eastern time. Please comment if there is anything you would like us to be sure and bring up and we will keep you posted after the call. "

 

Tegan is speaking about FOIA issues in that clip.

Shortly after us posting that, we all got this email:

 

Good day!  I am following-up with you regarding your Freedom of Information (FOI) requests for Essure records.  You submitted a request a while ago for records and currently, we (CDRH) have a massive backlog, unfortunately delaying our response to you.  I sincerely apologize for any inconvenience, as we received several requests for these records. 

I have attached a response letter to you and in an effort to provide some of these records more timely, I have completed reviews of the Adverse Event Reports and Post-Approval Study records and have affirmatively released them on our website in the CDRH Electronic Reading Room:

http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHFOIAElectronicReadingRoom/default.htm

I want to encourage you to visit the web link above to review the records that are currently posted. 

There is also an Essure Permanent Birth Control webpage with additional information regarding this medical device:

http://www.fda.gov/medicaldevices/productsandmedicalprocedures/implantsandprosthetics/ucm371014.htm

Please contact me with any specific questions or comments.

Thanks so much in advance and have a great day!

Jill R. Hammond, MPH

Commander, U. S. Public Health Service

Senior Regulatory Research Officer

Division of Information Disclosure (DID)

Office of Communication and Education (OCE)

Center for Devices and Radiological Health (CDRH)

Food and Drug Administration (FDA)

Phone: (301)-796-6895/Email: [email protected]

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FDA FOIA Webpage

 

 

Ironic? I think not. However, if you click on the link provided, and try to view some of the clinical trial evidence, you will see the majority of it is redacted, blacked out. There is NO information there. We are left in the dark, yet again. Why would the FDA scramble and throw this together knowing they are giving us nothing?