Ennis & Ennis, P.A.
Congressmen Push FDA To Revoke Pre-Market Approval Status For Essure
10/14/2015 - Following a full day FDA hearing on September 24, 2015 about the controversial Essure sterilization device, many people were left with a sense of outrage regarding the cavalier attitude of the FDA and Bayer concerning the thousands of adverse injuries caused by the device. One such individual was Justin Rusk, Legislative Director for Pennsylvania Congressman Mike Fitzpatrick. Mr. Rusk met with several of the injured women who voiced the concerns of thousands of women whose severe adverse injuries are not being addressed by Bayer nor the FDA. Mr. Rusk relayed these concerns to Congressman Fitzpatrick who is introducing legislation to revoke the pre-market approval granted to Essure.
During the week of October 20, 2015, Congressman Fitzpatrick will introduce the E-Free Act in the House of Representatives. The bill seeks to revoke the pre-market approval (PMA) status originally granted to Conceptus in 2002. Bayer acquired Conceptus in 2013. The bill, if passed, directs 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 appears to be joining forces and should support the bill. In a strongly worded letter to Dr. Stephen Ostroff, Acting Commissioner of the FDA, Ms. DeLauro stated that, “ 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.” DeLauro also noted that, “There were three postapproval studies ordered regarding Essure, two in 2002 and one in 2004. Yet there is strong reason to believe that data presented to FDA did not include the full breath of side effects reported by women…Given this background, it appears that Conceptus, Essure’s prior manufacturer, systematically grossly underreported symptoms experienced by patients treated with the device.” DeLauro concluded her letter to the FDA Commissioner by strongly stating, “Essure’s benefits do not outweigh its risks, and it should be withdrawn from the market.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.”