On February 29, 2016, the FDA recommended labeling changes including a black box warning and a checklist for doctors to discuss the potential risks of Essure to patients. The boxed warning will explain the injuries that may result from Essure, including their insertion and removal procedures. The "patient check list" will allow doctors to discuss the risks and reported injuries from Essure and help the patient make an informed decision. Additionally, the FDA recommends that the checklist is signed by the patient prior to receiving Essure.
If you or a loved one suffered tubal/uterus puncturing, bleeding, or other injuries from Essure, please call our experienced products liability attorneys at (888) 606-5297 for a free consultation about your Essure lawsuit.