Holly Kelly Ennis
Essure Problems Group Calls For FDA Action Suspending Essure
The Administrators of the Essure Problems Group wrote FDA Commissioner Scott Gottlieb today, requesting action be taken concerning Essure. The Group, along with attorney, Holly Ennis and medical data specialist Madris Tomes from Device Events, met with Commissioner Gottlieb at the FDA offices on February 7, 2018 requesting that Essure’s PMA be suspended and the product removed from the market, pending the outcome of the current clinical trials, which will not be completed until 2023. The Group made highly impactful presentations outlining the reasons why it is imperative to pull Essure in the U.S., as it has already been pulled worldwide.
In the letter, Essure Administrator Angie Firmalino noted that, “We find it imperative that you take action soon for the safety of all American women. Please take the time to look over these documents with care, as we are relying on you to make the right decision and suspend the Essure device. Since our meeting last month, 584 additional adverse events have been reported to the FDA, 534 were device removal surgeries. Migration reports alone jumped to over 4000. These women do not have the luxury of time while the device remains on the market. We look forward to your timely response and hope you make your decision based on your position to protect the American people.”
Also included in the packet sent to Commissioner Gottlieb were various documents supporting the position that Essure should be removed from the market, effectively immediately. Such documentation including letters from physicians attesting to the problems with Essure, excerpts from the September 24, 2015 FDA public hearing regarding Essure, charts prepared by Madris Tomes highlighting the adverse events reported to the FDA, medical journal articles including a Yale study which showed a higher pregnancy rate with Essure and a British Medical Journal article which concluded that patients undergoing hysteroscopic sterilization have a similar risk of unintended pregnancy but more than 10-fold risk of undergoing reoperation compared with patients undergoing laparoscopic sterilization. A MedScape Study also included showed that Essure patients were significantly more likely to undergo surgeries, hysteroscopies and resterilization procedures.
The packet provided a copy of the various presentations made to Commissioner Gottlieb including the heartfelt opening statement by Angie Firmalino and a detailed account of why Essure’s PMA should be suspended, starting as far back as improper clinical trials, altering trial participant’s records as well as significant conflicts of interests during the approval process. In short, given the powerful presentation to Commissioner Gottlieb as well as the overwhelming evidence he has been provided, it is unfathomable that he could fail to take action and suspend Essure from the market.