FDA Announces Label Changes for Essure Permanent Birth Control Implant
Essure Contraceptive Injury Lawsuits
The U.S. Food and Drug Administration recently announced a label change for Essure permanent birth control implants after receiving hundreds of adverse event reports from women who were seriously injured. Women suffered serious injuries including organ perforation after the device migrated from the insertion site, allergic or hypersensitivity reactions from the metals used in the device, and bleeding. The new warning includes information regarding the types of injuries associated with the device along with the risks of removal as reported in clinical trials and adverse event reporting through the FDA. The label must now also include a patient decision checklist for the healthcare professional to review with the patient prior to the procedure to help educate the patient about the serious risks associated with the medical device.
Hundreds or women who were implanted with the Essure permanent contraceptive device and suffered serious injuries have filed lawsuits against Bayer, the manufacturer of the device. These women claim that Bayer failed to warn them of the risk of serious injury associated with Essure. If you or someone you know received an Essure permanent contraceptive implant and suffered a serious personal injury, contact us. Our product liability attorneys have experience litigating claims against large pharmaceutical and medical device manufacturers and can provide you with a free case evaluation.