Ennis & Ennis, P.A.
Essure Free Act Gains Additional Support In Congress
11/20/2015 - The fight against the highly controversial sterilization device, Essure is gaining traction as several Representatives have joined forces with Pennsylvania Congressman Mike Fitzpatrick and the formative Essure Problems Group, 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.”
Connecticut Congresswoman, Rosa DeLauro also originally agreed to co-sponsor the bill. She even sent a strongly worded letter to Dr. Stephen Ostroff, Acting Commissioner of the FDA, stating, “I am deeply disturbed by reports from women about the severe adverse health effects they have suffered due to implantation of Bayer HealthCare’s Essure System for permanent female sterilization. Essure’s benefits do not outweigh its risks, and it should be withdrawn from the market. If well-designed studies in the future indicate that the benefits outweigh the risks compared to alternative permanent or long-term contraception, the FDA can consider approving Essure at that time.” However, in typical Washington fashion, her support was withdrawn after outside pressure from powerful groups forced her hand.
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.”
This congressional support has resulted from thousands of hours of work and lobbying efforts by members of the Essure Problems Group. Headed by the Essure Problems Group Administrators and Legislative Liaison, Amanda Rusmisell, administrators and group members including Tess Schulman, Kat Fredrickson, Kimberly Hughes, Lisa Fouser, Khristi Gurganus and attorney Holly Ennis have made multiple trips to DC to meet with legislators and personally delivered copies of the bill to all 435 members of the House of Representatives. Social activist legend, Erin Brockovich also supports the fight against Essure and joined the E-Sisters this week in Washington meeting with congressional leaders.
Women who have been harmed by the Essure device are strongly urged to 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. Women who have been harmed by Essure and need legal advice can contact attorney Holly Ennis from Ennis & Ennis, P.A. at 1-800-856-6405 for a free confidential consultation or visit us online at www.Ennislaw.com and fill out an online form.