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.
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"The FDA became aware of a coding error that occurred during the upgrade of our adverse event reporting database in August of 2015," said Deborah Kotz, an FDA spokeswoman. "It affected the 'reporter occupation' field in the database and resulted in the data field not correctly specifying whether the person filing the report was a doctor or nurse."
Kotz said the FDA takes responsibility for the mistake and Bayer, the manufacturer of Essure, was not at fault.
The admission represents a quick reversal for the federal agency. On Friday, Kotz sent the I-Team an email suggesting the FDA made no mistake: the agency simply enters the exact adverse event codes that are provided by a medical device manufacturer -- in this case, Bayer.
Bayer spokesman Steven Immergut told the I-Team the company has followed all FDA rules on reporting problems with Essure.
"We have confirmed with the FDA that Bayer reported these cases correctly," Immergut wrote in an email to the I-Team.
Kotz said in the subsequent statement Tuesday that the coding error has been fixed internally and the correct information should be reflected on the public-facing database by the end of the week. She could not say whether the error was the fault of FDA staff or a private contractor hired to upgrade the adverse event reporting system.
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The FDA said the coding error also resulted in the mislabeling of problems associated with other medical devices. Despite that, Kotz said, the glitch had no impact on how regulators analyze the safety profiles of products.
Elena Mendez, a patient who had her Essure coils removed after they punctured her endometrial cavity, said it’s important to know when a doctor reports a problem because analysts might take those reports more seriously.
“They might be putting more weight toward a medical professional, whether it be a doctor, nurse, pharmacist, paramedic,” Mendez said. “Doctors know better. Medical people know better.”
After learning of the mislabeled reports of problems, Rep. Michael Fitzpatrick (R-Pa.), wrote a letter to the FDA asking for an internal investigation. In the letter, the congressman pointed out that prior to July of last year, physicians who reported problems with Essure were almost always coded as physicians.
"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."
After that review was completed, an FDA panel required Bayer to conduct more safety research and put a stronger warning about risks on the Essure packaging, but stopped short of taking Essure off the market. Since then, Fitzpatrick has introduced a bipartisan bill to halt the sale of Essure while the new safety research is conducted.
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“It’s embarrassing to us that a government agency won’t [help us] and Congress has to jump in,” Mendez said. “You’re the FDA. You should be helping us. Why does Congress have to step in and do your job?”