• Hundreds of Errors Found in FDA Essure Reports
  • May 27, 2016
  • Law Firm: Law Offices of Peter G. Angelos A Professional Corporation - Baltimore Office
  • Over the past ten years, hundreds of adverse event reports have been filed with the FDA detailing complications that occurred after receiving the Essure birth control implant. The most common complications reported have related to severe pain in the pelvis, hemorrhaging and migration of the device within the uterus. According to reports, these complications have required additional operations to repair damage, and in many instances to remove the device. Patients and physicians have also reported that complications from Essure have led to ectopic and unintended pregnancies, which can be fatal under certain conditions.

    A recent NBC investigation suggests that many FDA adverse event reports related to Essure were mislabeled due to a coding error. Because of this error, hundreds of reports submitted by doctors and nurses were wrongfully classified as being submitted by an individual with an occupation of “other”. Critics of Essure stress that correctly labeling the occupation of an event reporter is important, as an adverse event report that is submitted by a physician with medical expertise may carry more weight when influencing an FDA decision, than that reported by an outside party.

    A statement by FDA spokeswoman Deborah Kotz suggests that the FDA became aware of the coding error in the adverse event reporting system in August, 2015. According to Kotz, “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.” The FDA maintains that the error has since been corrected.

    Congressional Representative Michael Fitzpatrick, an opponent of Essure, has requested that an internal investigation be conducted regarding the coding issue. The Congressman alleges that the adverse event coding changed substantially in July, 2015—the same month in which the FDA announced it was reviewing the safety and effectiveness of the Essure device.