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