Yesterday the FDA announced it would restrict the sale and distribution of Essure to protect women and ensure that patients receive risk information. However, the welcome regulatory action goes much further.
Following a meeting with the Essure Problems Administrators, attorney Holly Ennis and data specialist, Madris Tomes, FDA Commissioner Scott Gottlieb writes a response which has many Essure victims seeing red.
It has been nearly a month since Essure Problems Administrators, Madris Tomes and attorney Holly Ennis met with FDA Commissioner Scott Gottlieb to discuss remedial actions concerning Essure. There has been no acknowledgment or word from the FDA following this meeting and the Essure Problems Group wants answers. and action.
Advocates from the Essure Problems Group, including administrators, attorneys and a data specialist, met with FDA Commissioner Scott Gottlieb yesterday to discuss the ongoing problems with the controversial sterilization device Essure and to persuade the FDA to suspend Essure's PMA pending the outcome of the current clinical trials set for completion in 2023.
A new French study comparing the outcomes of women undergoing the Essure Sterilization procedure versus laparoscopic sterilization has once again ignited the heated debate regarding the safety of the highly controversial Essure device.
Despite repeated requests by multiple Congresswomen and Administrators from the Essure Problems Facebook Group, FDA Commissioner Scott Gottlieb, refuses to allow any women affected by the device to attend meetings with the Congresswomen to discuss the safety of the device.
Bayer faces scrutiny regarding it post-market clinical trial on Essure due to conflicts of interest by several of its participating physicians. Three US Congresswomen seek a meeting with the FDA to discuss Essure and post-market studies regarding Class III medical devices.