Congressman pens Essure letter to FDA
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Essure victims have found a new ally in their fight to get the device removed from the market. Pennsylvania Congressman Michael Fitzpatrick has made it his mission to get the FDA to look closer into the defective medical device, particularly after some suspicious errors were found in adverse event reports.
When a doctor discovers a problem with a medical device, he or she reports it to the FDA using codes provided by the maker of the device. These codes can give regulators insight into the kinds of problems that are frequently occurring in patients around the country. But when the codes are not reliable, they fail to do the job they’re designed to: alert the FDA to potential dangers.
That’s the story with Essure, a permanent birth control device that’s caused thousands of women pain and suffering. It was recently discovered that many of the Essure adverse event reports submitted by physicians failed to include the reporter’s occupation, due to an error in the coding. This meant that countless problems reported were not associated with actual doctors – and likely taken less seriously because of this.
While errors are bound to happen from time to time, some believe there may be a more sinister explanation behind the mistake. Congressman Fitzpatrick penned a letter to the FDA addressing his concerns. In the letter, he pointed out an odd coincidence:
“This coding changed dramatically in July of 2015,” Fitzpatrick wrote. “I find this extremely concerning, given the fact that on July 17th, 2015, the FDA announced it was reviewing the safety and effectiveness of the Essure device.”
Thousands of Essure users have experienced chronic pain, allergic reactions, and even punctured tissue. Many of the women affected have filed lawsuits against the maker of Essure, Bayer.