23 July 2018 | News
The birth control treatment is alleged to have harmed thousands of women in the past two decades.
Singapore –Bayer AG will no longer sell its controversial female contraceptive implant Essure after December 31. The birth control treatment is alleged to have harmed thousands of women in the past two decades. The company decided to pull the product off the market after the FDA threatening it with penalties if it failed to tell patients about Essure's serious health risks, including bleeding, pain and organ perforation.
The company added new warnings to Essure's labeling two years ago, including a checklist to guide doctors when counseling patients, but the agency wanted more to be done. U.S. sales have dropped 70% since the agency ordered it to conduct a postmarket study to better assess safety.
About 16K women have sued Bayer over alleged harm incurred with the device.