Ennis & Ennis, P.A.
Essure Users Strongly Urged To File Comments To FDA Regarding Essure Experiences
07/26/2015 - The FDA recently announced that it would hold a meeting on September 24, 2015 to discuss the risks and benefits of the Essure System. The Obstetrics and Gynecology Device Panel is being requested to evaluate scientific data regarding the safety and effectiveness of Essure, including reports of migration and perforation, chronic pain, removal procedures, allergic reactions and unintended pregnancies. As part of this meeting, the FDA advised it is soliciting feedback from its panel members, presenters AND the public to help the agency form “recommendations and next steps about Essure.”
The FDA is opening a docket for interested persons to submit electronic or written comments regarding this meeting. This docket will close on October 25, 2015. Comments must be received by August 31, 2015 to be provided to the committee prior to the meeting. It is imperative for ALL women who have been adversely affected by the Essure System to submit their information prior to August 31, 2015 to be reviewed by the committee. This is the chance for the thousands of women whose lives have been seriously harmed by Essure to have your voice heard. Do not waste this opportunity to tell your story and to be acknowledged by the government entity that allowed this product on the market. It is up to those harmed to ensure that this vital information is portrayed to the FDA. Submit electronic comments to http://www.regulations.gov. Submit written comments to the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. The docket number is FDA-2014-N-0736 and should be included on your comments.
The FDA indicated in June that it has received only 5,093 adverse event reports regarding Essure from November 2002 through May 31, 2015. Women who have suffered an adverse event with Essure are also strongly urged to file a MAUDE report with the FDA as soon as possible. Again, it is imperative to let Bayer and the FDA know of the thousands of women who are suffering as a result of Essure. Bayer has previously dismissed the concerns of affected women as what’s to be “expected” as a result of Essure. Bayer continues to spin its rhetoric regarding Essure and the upcoming FDA meeting, stating, “Patient safety is Bayer’s top priority, given there has been a great deal of interest in the safety of Essure among some patients, we welcome this open dialogue with healthcare providers, patients, researchers, representatives from professional societies, and other members of the public to review and discuss available data regarding the benefits and risks associated with Essure.” Essure suffers need to provide as much information as possible to facilitate the “open dialogue” so welcomed by Bayer.
For more information regarding Essure, contact attorney Holly Ennis at Ennis & Ennis, P.A. for a free confidential consultation.