Can everyone take one minute and do this please? At the request of Dr Hooman Noorchashm;
Amy and I ask that you and all Essure women send the following letter to the CDRH director, Jeffrey Shuren ([email protected]). Please be sure the letter is CC'd to the following individuals:
1) Congressman Mike Fitzpatrick: [email protected]
2) Mr. Justin Rusk: [email protected]
3) Dr. Peter Lurie: [email protected]
5) Mr. Jim Dickinson: [email protected]
6) Mr. Tom Burton: [email protected]
7) Mr. Karl Stark: [email protected]
Here is the letter:
Dr. Jeffrey Shuren,
You are receiving this email in your capacity as the director of the Center for Devices and Radiological Health (CDRH),
I am one of the thousands of American women harmed by the Essure sterilization coils and CDRH failure to ensure that this medical device is safe.
Here is my story of complication following placement of Essure. [Write a concise 1 paragraph description of your complication(s) folloowjg Essure placement.]
Your center's inability to properly consider the adverse consequences of nickel allergies and hypersensitivity in some patients, as well as the evidence of fraud and data tampering at the time of this device's approval, renders this PMA status invalid. These failures have very literally harmed thousands of young and otherwise healthy American women since 2002.
Your personal alignment with the medical device industry is now clearly in the public eye and represents a deadly mission-corruption at FDA's CDRH. It is, in fact, a breach of public trust.
Your continued failure to revoke Essure's PMA status, particularly after the Sept. 24, 2015, is a terrible breach of public trust - and it will lead to more harm to many more women. The Essure PMA status is now floridly violating the civil rights of thousands of American women to take their cases of harm to civil court.
We demand that you immediately revoke Essure's PMA status and step aside from your directorship at CDRH - in the interest of patient safety, medical ethics and the integrity of FDA's CDRH.