WASHINGTON – Experts from the U.S. Food and Drug Administration announced that on Thursday they will set a meeting to review the safety and security of Essure, the birth control product sold by Bayer, after several complaints of nearly 20.000 women using the device.
Essure was approved by the FDA in 2002. In 2013, Bayer acquired the device from Conceptus after a 1.1 billion $ deal. The implant, made of metal, is placed in the fallopian tubes, creating a barrier that prevents conception. It is the only one permanent birth control that requires no surgery.
“While there are risks with all medical devices and procedures, our highest priority is patient safety, and we sympathize greatly with any woman who has experienced problems with Essure” said a spokesman of Bayer to ABC News.
This complaints came up on social media, mostly on Twitter and Facebook in a group called “Essure Problems”, runned by Angela Lynch, who had issues in the recent past with Essure. She was 28 when she was implanted with the device. She had three children and did not want any more. In 2012 she had the device removed and underwent a hysterectomy.
Among the problems pointed out by women using Essure were depression, heavy bleeding, and allergies and other ‘unlisted symptoms’.
“Because I had just had a kid I wrote off all my symptoms as hormonal, my body trying to adjust. After two years I started losing hair. Then I started losing teeth, and over time it got to where my whole body was hurting”, said Angela Lynch to Reuters.
Although it hasn’t been yet proved the link between the symptoms and the birth control device, the FDA is looking forward to discuss it in the meeting with experts representing all parties involved. “Significant limitations must be taken into account when reviewing the data” said the FDA to ABC News.
Essure Problems is on Facebook
The group was created for women who had experienced problems with Essure, to make their stories public and get help and support from the people. One person who first answered their call was Erin Brockovich-Ellis, the famous American legal clerk and environmental activist, that helps them with an internet campaign on a website called essureprocedure.net.
Essure Problems also runs a website, filled with first hand testimonies, stories, pictures, tips, how to proceed in case of having problems with Essure, and a news section that covers the advances made following the FDA announcement. All of this information can be found on their Facebook page.
Source: ABC News.