FDA computer glitch mislabeled information in Essure adverse event reports

Essure FDA computer glitch mislabeled information in Essure adverse event reportsThe Food and Drug Administration (FDA) relies on physicians, patients and caregivers to report adverse events caused by medications or medical devices. These reports can help identify public health issues and can lead to products being recalled or withdrawn from the market, or being labeled with a black box warning. While adverse event reports from all parties are welcome, those from medical professionals can provide more crucial data that can be helpful for regulators when conducting a safety review of a drug or medical device.

But an investigation by the NBC New York I-Team has found that many adverse event reports involving the controversial Essure permanent birth control device were mislabeled, listing medical professionals as “other” instead of “physician” in the report’s occupation data field.

“If the FDA is relying on those physician reports to appear very obviously to be physician reports, then I would say it is concealment,” said Mardis Tomes, a former FDA analyst, in an interview with the I-Team. When questioned about the issue, the FDA said the inconsistencies with the safety data were simply a coding error that occurred when the FDA updated its database in August 2015.

That means reports filed by medical professionals after that date were not tagged as being filed by a physician. This is an issue, critics say, because during that time the FDA was conducting a safety review of adverse event reports involving Essure. Those reports included side effects such as chronic pain, infections,  allergic reactions and autoimmune disorders. There were also cases of device migration and perforation of the fallopian tubes or uterine wall.

In February, the agency fell short of banning the device and instead recommended that a black box warning be placed on the label. Bayer, manufacturer of Essure, was ordered to collect safety data to better gauge risks.

Could the FDA’s computer glitch involving Essure adverse event reports have prevented a possible removal of Essure from the market? No one knows for sure. But Elena Mendez, a woman who had her Essure device removed after it punctured her endometrial cavity, says that she believes physician reports might hold more value with regulators than patient reports.

“They might be putting more weight toward a medical professional whether it be a doctor, nurse, pharmacist, paramedic,” she told the I-Team. “Doctors know better. Medical people know better.”

Source: NBC New York