Patient safety pioneer Dr. Amy Reed dies at 44
The physician who helped put an end to the 18-year gap between the FDA’s approval of laparoscopic power morcellators and the safety watchdog learning that the devices can spread malignant cancers in the abdomen, Dr. Amy Reed, died yesterday of leiomyosarcoma, according to news reports. She was 44.
Power morcellators use small, rotating blades to break up large tissue masses into fragments and are commonly used to remove benign uterine fibroids in women. But if the device is used on a patient with undetected cancer, it can strew cancerous cells throughout the abdomen. Although the FDA approved morcellators in 1995, it wasn’t until 2013 when Reed exposed the risk after undergoing a hysterectomy at the Boston hospital where she worked as an anesthesiologist.
By April 2014 the FDA had issued a warning about the cancer risk and convened an advisory panel to consider the use of power morcellators in fibroid removal. The agency’s Obstetrics & Gynecology Devices committee failed to come to a clear consensus on the cancer risk from laparoscopic power morcellators, despite outraged testimony from dozens of attendees; in November of that year the FDA ordered so-called “black box” warnings for the devices. In September 2015, the Government Accountability Office said it would investigate potential safety and regulatory issues with the morcellators; legislators later called for the FDA to open a criminal probe into several deaths associated with mo...
Source: Mass Device - Category: Medical Devices Authors: Brad Perriello Tags: Women's Health Source Type: news
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