Congresswomen Seek Answers From FDA Regarding Essure
Oct. 31, 2017
Last month, the Essure Problems group held a rally in support of the Medical Device Safety Act 2017. The group transitioned to a well-attended press conference presented by several of the co-sponsors of MDSA 2017. It is a bi-partisan bill currently co-sponsored by Brian Fitzpatrick, Rosa DeLauro, Louise Slaughter, and Jan Schakowsky. The bill would amend the Federal Food, Drug, and Cosmetic Act with respect to liability under State and local requirements respecting all Class III devices, including Essure. The purpose of this bill is to restore a patient’s right to litigation should he/she be harmed by a Class III medical device.
The press conference was a resounding success and the out-pouring of emotions deeply affected Congresswomen DeLauro, Slaughter and Schakowsky, who were both touched and horrified by the stories shared and promised full support for the pending legislation. A video of the hearing can be found here. https://www.facebook.com/angela.lynch.39/videos/1586322528095695/ Afterwords, Admins of the Essure Problems group, joined by Madris Tomes and attorney Holly Ennis, met separately with the three Congresswomen regarding the FDA's continued limited action concerning Essure. This inaction has been amplified by Essure being pulled around the world. After meeting with the Essure Problems Group, the Congresswomen have taken quick and decisive action writing to FDA Commissioner Scott Gottlieb requesting a meeting to discuss, "widespread safety concerns and allowing Essure to remain on the market, even while mandating Bayer to conduct an additional post-market safety study."
The Congresswomen noted, "This device is a prime example of medical device oversight shortfalls and insufficient enforcement to ensure the safety and efficacy of medical devices." The Congresswomen requested a meeting with FDA officials within a month to address their concerns regarding Essure and problems with post-market surveillance on Class III devices in general. The Congresswomen noted that studies show that despite a FDA mandate for post-market safety studies, companies lack incentive to timely enroll participants and are slow to report findings. The full letter to Commissioner Gottlieb is set forth here. https://delauro.house.gov/sites/delauro.house.gov/files/FDA-Essure-Letter-Congress.pdf
It is expected that the Congresswomen and the Essure Problems Group will continue to hold the FDA's feet to the fire to question the safety of Essure and other medical devices. To date, the FDA has been woefully slow to act and acted inadequately when taking action. Women are urged to contact the offices of the three Congresswomen, thanking them for their concerted effort to make Essure and medical devices safer. Questions regarding Essure or other medical devices can be directed to attorney Holly Ennis at Holly@Ennislaw.com.