On October 9th, 2015 Congresswoman Rosa DeLauro sent THIS letter to the FDA regarding Essure:
On October 21st, 2015, Rosa co signed this letter that went out to all congressmen and women.
Congressman Fitzpatrick is introducing the E-Free act to congress tomorrow, Nov. 4, 2015. The act demands that the FDA revoke PMA of a medical device known as Essure. Essure acquired PMA based on minimal and potentially fraudulent clinical trials. PMA removes our rights to hold the company accountable for the harm it has caused TENS of THOUSANDS of women.
This bill WAS a bipartisan act, originally co-sponsored by Congresswoman Rosa DeLauro. Due to the recent pressure she’s been facing by others, Rosa has backed out.
These women are now a victim of political bias and organizations that falsely claim they protect women's health. I am saddened that anyone would see the e-free act as anything other than restoring our civil rights as people, as women. Essure is being propped up by the FDA under a law that congress enforces. This is not a political party or organization issue, this IS a women's health crisis where 24,000 women seek the same justice through the same channels that are promised to us as US citizens.
Thousands are harmed. The device is not curing an incurable disease. It is avoidable. The PMA was incomplete and potentially fraudulent. Riegel vs. Medtronic is violating the civil rights of thousands of women because this PMA is invalid.
Where in America have we accepted the sacrifice of a minority subset of unsuspecting people for the benefit of the majority or for the sake of choice and convenience?
Shame on Rosa and any other political party or organization that claim to protect women's health and women's rights only to turn their back on 24,000 women who's civil rights were taken from them.