Essure Problems
Essure Problems
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If Every Essure women completes and sends the following form letter to her US congressman and senators, you will see action. Please act quickly before too much time passes. I have been told by friends at the WSJ that Essure now has very good traction in the press. Congress will listen to you. Here is the form letter. Please make sure you CC a copy to Rep. Mike Fitzpatrick's office at [email protected]
Do fill in the brackets and use it:
Honorable Congressman/Senator [Enter the name of your congressman or senator here],
My name is [Enter your name here] and I am one of your constituents in the [Enter your congressional district number here] congressional district in the state of [Enter the name of your state here].
I am writing to tell you that I am a victim of a severe complication from the Essure permanent female sterilization coils manufactured by Bayer Health. Here is my story:
[Write a brief one paragraph description of what happened to you]
Following the FDA hearing of 9/24/2015, it is clear that the Essure coils were not subjected to sufficient safety testing at the time of its approval using the FDA’s PMA process. Specifically, the FDA and Bayer did not sufficiently consider the fact that these coils are made using a Nickel alloy and that a substantial number of people in the United States have allergic and hyperimmune reactions to Nickel. In addition, it was suggested that some of the Essure data provided to the FDA at the time of PMA evaluation were subject to fraud.
As your constituent, I am writing to request that you immediately communicate with the FDA leadership and demand a suspension of the PMA status for the Essure coils. At this time, given the level of harm and questionable safety profile, this is well within reasonable jurisdiction of the FDA leadership under Title 21, Section 814.46 of the Code of Federal Regulation. Such action will permit me to seek justice in civil court for the severe harm that has been to my life and family - currently my right to seek justice as an American citizen has been eliminated based on the PMA exemption precedent set by the supreme court in the case of Riegel v. Medtronic, 552 U.S. 312, 312 (2008) (holding that the federal preemption provision in § 360k potentially bars any common-law state causes of action relating to a premarket approved device’s safety or effectiveness). With regard to Essure coils, this is now a severe violation of my civil rights as an American woman.
Additionally, we demand that you immediately communicate with Congressman Mike Fitzpatrick of PA and his legislative aide, Mr. Justin Rusk, to coordinate the upcoming congressional hearing on medical device safety and women’s health in the United States.
Respectfully,
[Write your name and email and phone contact here]