Ennis & Ennis, P.A
FDA To Issue Decision Regarding Essure
11/25/2015 - The Food and Drug Administration announced this week that it would render a decision regarding the Essure permanent sterilization device by the end of February. This announcement comes after intense scrutiny of the device by the media and several members of Congress. This scrutiny has been prompted due to the tireless efforts of the Essure Problems Facebook Group. Essure Problems Group Administrators and liaisons have spent countless hours educating the media and members of Congress regarding the dangers of the device. The Group has also lobbied for support of a Bill, introduced by Congressman Mike Fitzpatrick, which would remove the premarket approval granted for the device. Thousands of the Group’s 24,484 members have also reached out to their US representatives demanding support for Congressman Fitzpatrick’s Bill, The E-Free Act.
The FDA has been forced to reevaluate the Essure device after receiving thousands of complaints from women who have suffered serious injuries from the permanent birth control, resulting in significant surgeries to have the device removed. The FDA has received thousands of Adverse Event Reports filed with the FDA and Bayer has turned over more than 16,000 adverse reports it received as well. These reports include complaints of significant pain, perforation of the uterus and/or fallopian tubes, migration, severe allergic reactions and autoimmune response to the PET fibers contained in the device.
In response to these complaints, the FDA convened a meeting of the Obstetrics and Gynecology Device Panel of the Medical Devices Advisory committee on September 24, 2015. The panel heard scientific and clinical opinions as well as some limited patients’ experiences regarding the risks and benefits of Essure. The FDA also provided a public docket to comment on the device open from July 22, 2015 through October 25, 2015. The FDA received nearly 3,000 comments and is currently reviewing the views and perspectives received.
The FDA claims that, “Patient health and well-being is our first priority regarding this device and all-medical devices.” The FDA also claims that, “Presently we are reviewing information from the panel meeting, the public docket, as well as additional medical literature and adverse event reports which have been published or received since the panel meeting. In this review, we are focusing attention on the concerns identified by the public speakers and the feedback and recommendations provided by the panel. This is a high priority issue for the agency, and we are working expeditiously to conduct an evidence-based review of the available information and identify appropriate next steps. We anticipate communication our actions publicly at the end of February 2016.”
Women who were injured by the device are strongly urged to fill and an adverse event reports by following this link.http://www.fda.gov/Safety/MedWatch/HowToReport/ucm2007306.htm. Those affected are also requested to contact their US representative and demand support for the E-Free Act or that their representative contact the FDA and request that Essure’s PMA be revoked. Women seeking free legal consultations can contact Holly Ennis at Ennis & Ennis, P.A. at 1-800-856-6405 or visit us online at www.EnnisLaw.com and fill out an online form.