The E-Sisters are headed to Bayer in protest of the ridiculously unsafe Essure “permanent” birth control device. Here is the press release approved for publication. We wish them all the best at making their point to an unsympathetic Bayer.
On April 9, yet another victory was scored as the FDA issued an order restricting the sale and distribution of the Essure device. Not recalled. Not banned. Restricted. Frustrating? Yes. A step in the right direction? Most definitely. Below, you’ll find the FDA’s press release announcing the new order.
In the ongoing fight to rid the market of an incredibly harmful medical device – Bayer’s Essure “permanent” sterilization implant, Essure advocates are meeting with the FDA today for a discussion on Essure’s safety and efficacy. What follows is the official press release from the advocates. We wish them all the best and great success today!
Bayer, the manufacturer of the controversial “permanent” birth control device Essure, announced on September 18 that it is discontinuing all sales and marketing efforts of the device in all European markets. Citing “commercial reasons,” the company continued to stand by the safety and efficacy of the device despite tens of thousands of reported injuries. The Essure device will remain on the market in the U.S. For now.
The House of Representatives Subcommittee on Health is reviewing proposed legislation that could change the face of patient safety efforts nationwide. If passed, the Medical Device Safety Act will allow patients injured by a Class III medical device to take legal action against the manufacturer at the state court level. This is prohibited under current preemption protections. The balance of this post is a press release from the Essure Problems Facebook group. The E-Sisters are planning a rally in support of the Medical Device Safety Act. Information on the Act, and the rally, follows.
Despite Bayer’s strident claims to the contrary, regulators in Ireland aren’t exactly certain the German company’s Essure “permanent” birth control device is a safe option. That uncertainty prompted the National Standards Authority of Ireland (NSAI) to decline renewal of Essure’s CE marking – the commercial license that allows the device to be sold in the EU.
This post is a reprint of an email update the Essure Problems Facebook admin team sent to the FDA. Reprinted with permission.
It’s been a great week for women’s health in Europe. Just the other day, I had the pleasure of writing a piece on Bayer pulling Essure from the market in Finland. Today, thanks to a number of readers, I get the joy of writing a similar piece. It has been confirmed by Bayer that the company is withdrawing from the UK market as of September 1, 2017.
I was recently contacted by a fellow writer in reference to the letter you’re about to read. Due to my coverage of the Essure issue, he thought that our readers would like to see Dr. Novoa’s Essure letter to fellow doctors. It’s with my colleague’s permission that I share their post and Dr. Novoa’s letter.