It is now September, 2016. It has been one year since the FDA held it's public hearing on Essure. It has been six months since the FDA announced its decisions regarding the new requirments on Essure, yet no final actions have been taken regarding the black box warning. Emails to the FDA from Essure Problems admins have gone un answered. We need patients harmed by Essure to email the FDA and demand answers! Here is a template email to use. Feel free to personalize this template.
Members of the FDA,
Following an emotionally charged 12 hour hearing on September 24, 2015 concerning the dangers of Essure, the FDA promised these concerns would be given high priority within the agency. It claimed that, “Patient health and well-being is our first priority … Essure is a high priority for the agency and we are working expeditiously to conduct an evidence-based review of the available information and identify appropriate next steps.” FIVE months later, the FDA ruled it was requiring Bayer to add a black box warning and Patient Decision Checklist to the product packaging/labeling to assist women in understanding the risk of this device. Although we can not stress enough the importance of removing the device from the market, the FDA has been recalcitrant in its refusal to do so. Accordingly, to fulfill the FDA obligation to protect the public, and not pharmaceutical companies, we believe it absolutely imperative that certain warnings be added to the proposed black box, effective immediately.
More than SIX months have elapsed since the FDA mandated that Bayer add the requisite warnings and Patient Checklist, however, this has yet to be accomplished. On July 8, 2016 the Essure Problems Group contacted the FDA regarding specific warnings it felt were essential for the black box warning and Patient Checklist and inquiring about the status of the warning. This letter was neither acknowledged by nor responded to by the FDA. The Group reached out again on July 27, 2016 and again, any requests for information were ignored.
Each day that passes without the enactment of the black box warning and patient checklist, innocent women are being implanted with the Essure device, without adequate information of the risks and dangers associated with the device. Hundreds of physicians still remain uninformed of the risks of Essure and therefore are not conveying these risks to the women they implant. It is imperative that the black box warning and Patient Decision Checklist be finalized and implemented immediately to adequately inform each and every woman considering the Essure device. It is unconscionable that the FDA continues to drag its feet regarding this essential action. Please do your jobs that you were entrusted to perform.
Here are a few FDA officials to contact: