How Medical Devices Do Harm

In 2013, a Harvard-affiliated physician, Amy Reed, needed to have her symptomatic fibroids removed. Armed with the best surgeons and standards of care Harvard could offer, she agreed to undergo a widely used surgical procedure called power morcellation—involving a device with spinning blades to pulverize the uterus for extraction—not knowing it would contribute to the dissemination of her undetected uterine cancer.

Reed and her husband, Hooman Noorchashm, knew her days were numbered, learning that she wasn’t the only woman to experience adverse outcomes. Disappointed and outraged by the recalcitrance of the gynecological establishment, they fought to save other women from the same fate.

The Cancer Letter’s award-winning series, led by reporter Matthew Ong, tracked each development, provided policy analyses and examined the root causes of harm—triggering congressional investigations and federal action—and contributed to the evolution of an entire medical field’s approach to minimally invasive surgery and surgical innovation.

Reed died from complications related to sarcomatosis on May 24, 2017, less than four years after she underwent morcellation.


Challoner: We Recommended FDA Replace 510(k) ClearanceThe Cancer Letter asked David Challoner, emeritus vice president for health affairs at the University of Florida, to discuss the intricacies and effects of the FDA's 510(k) medical device approval process, and the parties that influence it.
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.