#FDA Blames Computer Glitch for Hundreds of Errors Found in Essure Adverse Event Reports
Since it hit the market, doctors have reported hundreds of problems with a form of birth control called Essure. But a new analysis of those alleged problems, known as adverse event reports, shows many have been mislabeled.
Physicians and nurses have reported more than 300 problems with Essure since August of last year, according to Madris Tomes, a former Food and Drug Administration analyst. In most cases, the data field for the reporter’s occupation doesn’t say "physician." It says "other."
"If the FDA is relying on those physician reports to appear very obviously to be physician reports, then I would say it is concealment," Tomes said in an interview with the I-Team.
The FDA blamed a computer glitch for the inconsistencies in its safety data in a statement Tuesday
Also read: "Patient Advocacy Group Calls On Congress To Investigate FDA’s Role In Essure Approval"; http://sco.lt/4neB1d