FDA’s passive reliance on self-reporting by hospitals and device manufacturers allowed harm caused by power morcellators to go unnoticed for over two decades—likely contributing to injury and deaths of hundreds of women, according to the U.S. Government Accountability Office.
The power morcellator presents a unique case study in patient harm, said Marcia Crosse, director of the health care team at GAO.
The power morcellators worked as they were intended to work: they did not fail at their intended use of morcellating large tumors. As a result, some hospitals interpreted the language of the statutory requirement to report adverse events as not applicable to the dissemination of malignant tissue. FDA has debunked this contention, saying that such cases should, in fact, have been reported.
Physicians need to start thinking of adverse events in the context of a device that functions as intended, GAO’s Crosse said in a conversation with The Cancer Letter, in which she elaborated on the findings of a GAO investigation.
Read details about the full report here.