Since the FDA first approved Essure in 2002, the FDA has subsequently released several updates and additional requirements on Essure. In 2011, the FDA required updated physician labeling to warn for a contraindication related to nickel, with additional updates to both patient and physician labeling in 2012 to reflect the results of a five-year study on the drug. In 2013, the FDA required updated patient labeling to include risks of chronic pain and device migration.
In October 2016, the FDA issued a final guidance intended to alleviate some of the confusion associated with devices such as Essure and to ensure that patients receive enough information before using this device. The FDA has also stated that they will continue to monitor this device for safety.
TURN TO A TRUSTED ESSURE LAWYER
Essure’s manufacturer has been the subject of several lawsuits claiming that they knew of the potential side effects and risks of this device and failed to inform the public, leading to serious injuries and even death. In previous litigation, plaintiffs successfully received compensation to cover their medical expenses, lost wages, disability, and pain and suffering. If you or a loved one have suffered any of these consequences due to Essure, an experienced Essure lawyer could discuss your case with you, review your symptoms, discuss your legal options, and work towards recovering compensation for your injuries and losses. Consider reaching out to a dedicated Essure lawyer today to schedule your initial consultation.