Following recent FDA restrictions, declining sales, bad press, and mounting legal claims, Bayer announced that it will discontinue sale of Essure permanent birth control at the end of 2018. https://www.bayer.us/en/newsroom/press-releases/article/?id=123229 Bayer had previously pulled the device from all other markets.
Bayer’s announcement follows the FDA order in April 2018 to restrict the sale and distribution of the Essure device to ensure that all women considering use of the permanent contraception device are provided with adequate risk information so that they can make informed decisions. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm604098.htm The FDA required Bayer to add additional warnings for Essure due to concerns about the safety of Essure, and about whether Bayer was adequately warning woman about the risks and dangers of Essure. This followed prior action by the FDA to require additional testing and warnings that the FDA found to be insufficient
Scores of woman nationwide have made claims against Bayer for bleeding, pain and organ damage caused by Essure permanent birth control. At last count, more than 16,000 woman in the United States have made legal claims against Bayer relating to Essure. https://www.bloomberg.com/news/articles/2018-07-25/bayer-essure-suits-skyrocketed-as-fda-pushed-stronger-warnings
Although Bayer claims that its halt of sales of Essure is purely a business decision, and not related to the safety of Essure, the announcement coincided with the release of the Netflix Documentary Bleeding Edge, highlighting the danger of medical decisions including Essure. https://www.marieclaire.com/health-fitness/a22518890/netflix-the-bleeding-edge-essure/
If you would like additional information, or if you or a family member has been damaged by Essure permanent birth control, call the Greensboro Law Center at (336) 478-6000 for a free consultation. We are already representing women like you.Contact Us Today