Holly Kelly Ennis
June 7, 2017 FiDA highlight
Victims of Essure celebrated again today after learning that the controversial Essure Sterilization device will be discontinued in the United Kingdom as of September 1, 2017. This follows on the heels of Essure being banned by Brazil in February and recently discontinued in Finland and The Netherlands, with rumors of other countries to follow by the end of the Summer. Bayer recently confirmed it will discontinue sales in the United Kingdom set forth in the letter below:
As Bayer discontinues the sale of the Essure device or countries ban it outright, this exerts greater pressure on the FDA to take affirmative action regarding pulling the device from the market. For over three years, since the Essure Problems Administrators first shared their valid concerns regarding the device, they have heard the same tired response from the FDA, "We understand your frustration. We assure you, Essure is a high-priority issue for the Agency and we continue to take feedback like yours into consideration." Obviously, the FDA is not hearing the Group's concerns, nor is it a high priority. In fact, despite repeated pleas from the Group regarding the making the Black Box Warning mandatory to physicians, the FDA designated it as a "guidance." Accordingly, over 200 hundred women have contacted the Group since the BBW was implemented on November 15, 2016 to report that doctors failed to mention the BBW or use the Patient Decision Checklist.
The FDA responded yesterday that it, "continues to review the available information about Essure, including reports of problems submitted to the FDA." These reports now total over 15,000 with over 9,000 reports of surgical removals since 2009. How long will the FDA continue to "review" the horrific stories of ladies significantly injured by the device before it takes some definitive action and revokes the PMA for the device? The job of the FDA is to protect the health of American citizens, not line the pockets of pharmaceutical and medical device companies. FDA, it is time. Do Your Job.
Questions regarding the Essure Sterilization Device can be directed to attorney Holly Ennis at 1-800-856-6405 or visit us online at www.Ennislaw.com