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 (When Surgical Innovation Kills).

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

More on this award-winning series here.

An interview with Amy Reed, formerly an anesthesiologist at Beth Israel Deaconess Medical Center, and Hooman Noorchashm, formerly a cardiothoracic surgeon at Brigham & Women's Hospital.Debate Over Brigham's Containment Bag StudyFDA's other option is to mandate creation of a post-market surveillance study combining power morcellators with a containment system or bag, which would be used to prevent the dissemination of any tissue, benign or malignant.
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.
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.