Ennis & Ennis, P.A.
Representative Tom Cole Joins The E-Free Fight
02/16/2016 - The fight against the highly controversial sterilization device, Essure is gaining traction as Oklahoma Congressman, Tom Cole has joined the E-Free fight. The Act, sponsored by Pennsylvania Congressman Mike Fitzpatrick seeks to have the device removed from the market. Representatives Marsha Blackburn (Tennessee), Chris Smith (New Jersey) Gregorio Sablan (Northern Mariana Islands) and Lou Barletta (Pennsylvania) have all requested to co-sponsor the legislation.
The bill seeks to revoke the pre-market approval (PMA) status originally granted to Conceptus in 2002. Bayer acquired Conceptus in 2013. If passed the legislation would require the Commissioner of Food And Drugs to issue an order withdrawing approval for the Essure System. The Act, entitled the “E-Free Act” states: “Not later than 60 days after the date of enactment of this Act, the Commissioner of Food And Drugs shall issue an order under section 515(e) of the Federal Food Drug and Cosmetic Act (21 U.S.C. 360 e (e)) withdrawing approval for Essure System.”
The bill presents a new and unconventional method to force the FDA to act. However, the FDA has been completely recalcitrant in its failure to address the injuries of thousands of women harmed by this device. Congressman Fitzpatrick noted the necessity of this bold move and stated, “The failures of Essure are well documented and wide ranging. Yet, in the face of all these facts, this device remains on the market; certified with the FDA’s stamp of approval. That’s unacceptable to me and unacceptable to the tens of thousand of ‘Essure Sisters’ who are living with the device’s effects. If the FDA or manufacturers aren’t willing to act in the best interest of these women, Congress must.”
Representative Cole serves on the prestigious House Appropriations Committee. He is Chairman of the Subcommittee on Labor, Health and Human Services, Education and Related Services. Congressman Cole could play a pivotal role in appropriating funding for the FDA. Representative Cole also serves on the Budget Committee and the Rule Committee, so he may be quite influential regarding the E-Free Act.
This congressional support has resulted from thousands of hours of work and lobbying efforts by members of the Essure Problems Group. The Group returned again to DC on February 1-3 to garner support for the E-Free Act. Members also met with key Senators to discuss the harmful ramifications of the 21st Century Cures Act. The group educated Senators to the dangers of the Act and how the Act will ease and facilitate dangerous devices like Essure in getting to the marketplace.
Women who have been harmed by the Essure device MUST contact their Congressmen and request support for the passage of the bill. The women are counting on the members of Congress to take the necessary action to require the FDA to do what is right. The tenacity of the Essure women is historic and they will not stop until the PMA for Essure is revoked.