Month: November 2016
FDA Finalizes Essure “Black Box” Warning Label
The FDA has recommended stronger warnings about the risks of Essure, a sterilization device made by Bayer that has been linked to over 9,900 reports of problems.
FDA Blames Hospitals for Failing to Report Medical Device Safety Problems
At least 12 U.S. hospitals -- including some of the most well-known and respected facilities in the country -- have failed to report patient deaths and injuries linked to medical devices, according to the U.S. Food & Drug Administration (FDA).