Conversation with The Cancer Letter

Conversation with The Cancer Letter

Marcia Crosse: This “failure of the adverse event reporting system” should serve as a “wake up call”
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Marcia Crosse: This “failure of the adverse event reporting system” should serve as a “wake up call”

Hundreds of women were injured or have died from upstaging of unsuspected uterine cancer by power morcellation because FDA didn’t know the actual risk of cancer in fibroids, and hospitals failed to report harm, according to the U.S. Government Accountability Office.Between 1991 and 2014, FDA cleared 25 submissions for power morcellators to be marketed in the U.S. The GAO report notes that FDA had been aware of the device's potential for spreading tissue since 1991.
FDA: For Hospitals that Significantly Violated Federal Adverse Event Reporting Requirement, No Additional Action Necessary
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FDA: For Hospitals that Significantly Violated Federal Adverse Event Reporting Requirement, No Additional Action Necessary

In a 17-institution inspection sparked by reports of patient harm and death resulting from power morcellators and contaminated duodenoscopes, FDA found that nearly all hospitals surveyed either failed to report adverse events or didn't have proper reporting and documentation procedures in place.