Rep. Mike Fitzpatrick sent a letter to the Food and Drug Administration regarding dramatic changes in the reporting of adverse events caused by the medical device Essure.
The letter reads, in part:
“Information has been brought to my attention that shows a dramatic change in how Adverse Event Reports relating to the permanent sterilization device Essure were submitted to the FDA coinciding with the agency’s announcement that it was reviewing the safety of the device.
As you know, when a manufacturer submits an Adverse Event Report to the FDA one of the data fields to be filled is ‘Reporter Occupation.’ Examples of how that field can be coded by the manufacturer include ‘Physician,’ ‘Health Professional,’ ‘Nurse,’’“Pharmacist,’ ‘Paramedic,’ ‘Risk Manager,’ and ‘Other.’
“As it relates to Essure, from January 2002 through June 2015, the manufacturer of the device submitted nearly 600 Adverse Event Reports in which the ‘Reporter Occupation’ field was coded as ‘Physician.’ This corresponds to the narrative information included in the report in which it clearly states the information in the report came from a medical doctor, a Gynecologist/ Obstetrician, a physician, or other similar term.
“However, this coding changed dramatically in July 2015. I find this extremely concerning given the fact that on July 17, 2015, the FDA announced it was reviewing the safety and effectiveness of the Essure device.
“After the FDA’s public announcement, Adverse Event Reports received by the agency from the manufacturer of Essure no longer coded reports from medical doctors as Physician reports. Instead, almost every report received from a physician between August 2015 and February 2016 listed the Reporter Occupation field as ‘Other.’ This is a clear change from how the manufacturer coded prior to FDA’s announcement despite the same keywords, like medical doctor or Ob/Gyn, being found in the narrative portion of the reports. A similar change was noted in reports received from nurses.”
