Essure Problems 

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From: Hooman Noorchashm <[email protected]>
Date: August 10, 2015 at 2:30:55 PM PDT
To: "Lurie, Peter" <[email protected]>, "[email protected]" <[email protected]>,  "[email protected]" <[email protected]>, "Long, Mary (Peper)" <[email protected]>
Cc: "[email protected]" <[email protected]>,  "[email protected]" <[email protected]>, "Levitz, Jennifer" <jennif[email protected]>,  "[email protected]" <[email protected]>, Gerard Baker <[email protected]>,  "[email protected]" <[email protected]>,  "Stark, Karl ([email protected])" <[email protected]>, "[email protected]" <[email protected]>,  "Dennis, Brady" <[email protected]>, "Jim Dickinson Mr." <[email protected]>,  "Lowes, Robert (Bob)" <[email protected]>, Alison Motluk <[email protected]>,  Vicki Brower <[email protected]>,  "[email protected]" <[email protected]>, Mary Rezac <[email protected]>,  Angie Lynch <[email protected]>,  "Mabry, Sara (Casey)" <[email protected]>,  "[email protected]" <[email protected]>,  "[email protected]" <[email protected]>, Amy Reed <[email protected]>
Subject: William Maisel and Essure sterilization coils

The FDA leadership is strongly urged to remove Dr. William Maisel, chief Scientist at the CDRH, from any and all role and transactions related to the Essure sterilization coils moving forward.

http://patch.com/maryland/laurel/fda-official-william-maisel-pleads-guilty-to-crime-keeps-job

FDA's public health mission must be served by far more stringent ethical principles and by men and women whose first and foremost priority is to secure public health.

HN
--
Hooman Noorchashm MD, PhD
Cardiac Surgeon
C: 215-593-0596

From: Hooman Noorchashm <[email protected]>
Date: August 9, 2015 at 1:40:28 PM PDT
To: "[email protected]" <[email protected]>,  "[email protected]" <[email protected]>
Cc: "[email protected]" <Melaniego[email protected]>, Angie Lynch <[email protected]>,  Amy Reed <[email protected]>, "Levitz, Jennifer" <[email protected]>,  "[email protected]" <[email protected]>, "Dennis, Brady" <[email protected]>,  "Lurie, Peter" <[email protected]>, "[email protected]" <[email protected]>,  "Stark, Karl ([email protected])" <[email protected]>,  "[email protected]" <[email protected]>, "[email protected]" <[email protected]>,  Michael Paasche-Orlow <[email protected]>
Subject: FDA Hearing on Essure

Honorable Congressman Fitzpatrick and Mr. Rusk,

As you know, the Essure female sterilization device will be the subject of a hearing on September 24, 2015.

Here is another gynecological device, like the "power morcellator" doing avoidable harm to a minority subset of unidentifiable women.

Here, again, the CDRH process for medical device approval has failed the public - of course this time the PMA process has faltered. To us this is further indication of an overall mission corruption at the FDA's CDRH - particularly pertaining to women's health.

In the interest of objectivity and to have all concerns/weaknesses on the public record, I respectfully request that you ask the FDA's CDRH leadership to assign several key members on their "expert panel" reviewing the Essure coils:

1) a PhD scientist with expertise in "mucosal immunology" 
2) a "clinical allergy specialist" 
3) a "bioethicist"

It is our very serious concern that the gynecological community does not fully appreciate the magnitude of poor outcomes imposed on an unsuspecting subset of women, whose "mucosal" immune system reacts adversely to the Nickel containing Essure coils.

Furthermore, it is insufficient for the concerns regarding the Essure sterilization coils to be reviewed by a panel of gynecologists only.

Moreover, we find it a florid ethical violation, as was the case with the "power morcellators", for FDA to compromise on women's health by accepting "majority benefit" and "patient choice" as justifications for the harm imposed on otherwise young and healthy women by a medical device.

Congressman, women's health is public health - and it defense is an absolutely critical element in the protection of families across our nation.

Yours with respect,
HN
--
Hooman Noorchashm MD, PhD
Cardiac Surgeon
C: 215-593-0596

From: Hooman Noorchashm <[email protected]>
Date: August 10, 2015 at 7:23:58 AM PDT
To: "Lurie, Peter" <[email protected]>
Cc: Michael Paasche-Orlow <[email protected]>,  "Levitz, Jennifer" <[email protected]>, "[email protected]" <[email protected]>,  "[email protected]" <[email protected]>,  "[email protected]" <[email protected]>, Angie Lynch <[email protected]>,  "[email protected]" <[email protected]>
Subject: Regarding Essure

Dr. Lurie,

Regarding the adverse biological and immunological reactions imposed on the women undergoing the Nickel based coil, Essure, please review the following papers. 


I think this list will give FDA the names of potential experts whose knowledge base will permit the agency to make a cogent and ethical decision as whether this product - responsible for debilitating so many otherwise young and healthy women - should remain on the market.

As I stated before, it will be imperative for the FDA's "expert panel" to include a "mucosal immunologist", a "clinical allergy" specialist and a "bioethicist" - not a predominant majority of GYNs, who will have an inherent conflict of interest in defending their specialty's interests and practices. 

Again, a subset of previously healthy young women are being devastated by a systemic reaction to a Nickel-based implant, approved by the FDA. 

When this Nickel based implant, Essure, is placed in contact with the potent mucosal immune system of the fallopian tubes, a severe and sustained systemic reaction ensues in a subset of these women. These lives are debilitated - many are devastated.

The magnitude of this reaction was clearly under-estimated or under-appreciated by FDA at the time of this PMA approval.

We are certain you and your colleagues can correct this error - again, in the gynecological specialty.

Yours with respect,
HN
--
Hooman Noorchashm MD, PhD
Cardiac Surgeon
C: 215-593-0596

From: [email protected]
Date: August 10, 2015 at 9:56:55 AM PDT
To: [email protected], Gerald Joseph <[email protected]>, [email protected]
Cc: Amy Reed <[email protected]>, Michael Paasche-Orlow <[email protected]>, Jennifer Levitz <[email protected]>, Jon Kamp <[email protected]>, Gerard Baker <[email protected]>, "<[email protected]>" <[email protected]>, Karl Stark <[email protected]>, Marie McCullough <[email protected]>, "<[email protected]>" <[email protected]>, "<[email protected]>" <[email protected]>, Mark Maremont <[email protected]>, Peter Lurie <[email protected]>, Denise Grady <[email protected]>, "<[email protected]>" <[email protected]>, "<[email protected]>" <[email protected]>, Sara Mabry <[email protected]>, [email protected], Melanie Goshgarian <[email protected]>, Alison Motluk <[email protected]>, Vicki Brower <[email protected]>, Harriet N Brown <[email protected]>, Robert Lowes <[email protected]>, "Jim Dickinson Mr." <[email protected]>
Subject: ACOG/ABOG public image/Essure

Drs. Lawrence, Joseph and Gilstrap,

I strongly advise you to control the impending damage to your specialty's public image as it pertains to its use of Essure sterilization coils.

The gynecological failure to protect women from the oncological hazards of power morcellators in women's health will soon be clearly exposed. Do read with care:

http://mobile.philly.com/blogs/?wss=%2Fphilly%2Fblogs%2Fhealthcare%2F&id=321270911

I can only hope that you and your colleagues will exhibit better judgement in handling the Essure disaster to many women's lives than you did in the case of morcellators.

Remember, The Essure recipients, harmed, were trusting and unsuspecting but otherwise young and healthy women whose health you are charged with. There are literally thousands of them.

Very sincerely,
HN

These emails were sent by Hooman Noorchashm MD, PhD Cardiac Surgeon, to members of the FDA, congress, the ACOG, and the media, regarding the individuals to be chosen to sit on the advisory board for the FDA's September 24th public hearing regarding Essure.