A form of birth control manufactured by Bayer called Essure has been the focus of several claims of injury, leading to class-action lawsuits and an FDA investigation. The investigation required Bayer to conduct more studies of the birth control device and stronger warnings to be placed on the devices. However, the device was not removed from the market and now the FDA has come under scrutiny for what it is calling a “coding error” regarding reports of adverse events occurring after implantation of the Essure device.
Since becoming available, doctors have reported hundreds of problems with Essure. An analysis of these issues, known as adverse event reports, shows that many were mislabeled.
Since August of last year, doctors and nurses have reported more than 300 problems with Essure. This is according to Madris Tomes, a former FDA analyst. In the data field for the occupation of the reporter, it does not say physician. It simply says “other.”
In an interview, Tomes reportedly stated, “If the FDA is relying on those physician reports to appear very obviously to be physician reports, then I would say it is concealment.”
The FDA, however, is blaming a computer glitch for the inconsistencies in its safety data.
An FDA spokesperson released a statement reporting that the agency became aware of a coding error during an upgrade to their adverse event reporting database. This coding error affected the occupation field in the database.
The FDA also reported that they were taking responsibility for the error and that the manufacturer, Bayer, was not at fault.
The admission is a reversal of previous statements by the agency. Days before accepting responsibility, the agency stated that they simply enter the data provided to them by the manufacturer.
The FDA spokesperson stated that the coding error had been fixed internally and that the correct information should display in the public database.
If you have suffered complications or injury due to the implantation of an Essure birth control device, you may be entitled to compensation. Contact the law offices of John Foy & Associates. The “Strong Arm” attorneys will help you get the compensation you deserve. Contact us today.