Holly Kelly Ennis
WakeUp FDA: Essure Pulled in Australia, Suspended in Europe
Worldwide controversy surrounding the Essure Sterilization device continues to grow daily. In the past few months, the device has been quietly withdrawn from the market in Finland, the Netherlands, the United Kingdom and in Canada. Although Bayer has cited "business reasons" for the withdraw, this clearly means declining sales, mostly likely due to the widespread negative coverage concerning the Essure device. Additionally, sales of the device were recently suspended for three full months in the European Union, therefore Bayer cannot legally sell Essure in the countries of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia Spain, Sweden and the United Kingdom.
The French health agency, ANSM, issued a statement urging women to avoid Essure and the Ministry of Healthcare in Ukraine has requested that Bayer recall all Essure units currently in stock with the country's health care providers. Further adding to Bayer's woes is the decision yesterday by the Australian Government's Department of Health to withdraw the device from the Australian market AND to recall all unused stock of Essure devices.The Australian Register of Therapeutic Goods noted that there will be no further implantation of Essure in Australia. The Australian Medical and Science Ltd (AMSL) notified health care professional who have performed Essure procedures in the past to provide updated information to their patients to assist in identifying any device related health issues. It also urged women to seek medical consultations if experiencing any side effects or have any concerns regarding the device.
So what is our FDA doing here in America to assist or protect women from being harmed by the Essure device? Simply stated: not enough. The FDA recently implemented a black box warning and a patient decision checklist as a "guidance" for doctors to advise their patients regarding the risks and benefits of the device. Unfortunately, few, if any doctors are providing the warning or the decision checklist and the FDA has no means to require or enforce them to do so. Accordingly, women are still being implanted with the device without adequate warnings. The FDA also required Bayer to complete another 5 year post market clinical trial. However, as of today, the clinical trial still only has one participant enrolled according to the FDA's website updated on 8/28/2017. It is unfathomable that other countries are suspending and recalling the unsafe device and it is simply business as usual in America. Shame on the FDA and on our Congress for failing to enact laws to protect its citizens from dangerous medical devices.
If you or a loved one has been injured by the Essure device or you would like more information on how to help with Congress and medical device laws, contact attorney Holly Ennis at 800-856-6405, email Holly@Ennislaw.com or visit us online at www.Ennislaw.com.