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 morcellators.
The furor prompted Johnson & Johnson (NYSE:JNJ) to recall its morcellators in July 2014, after pulling them from the market in April of that year. J&J is now looking to settle 100s of product liability and wrongful death lawsuits brought over the Ethicon devices.
Reed is survived by her husband, Dr. Hooman Noorchashm; her children: Joseph, 15, Nadia, 14, Ava, 12, Joshua, 10, Luke, 7, and Ryan, 4; her parents, Joanne and Fred Trainer, and William and Joan Reed; her grandmother Ann Mills; 4 sisters and 3 brothers; and 11 nephews and nieces.
Reed told the Philadephia Inquirer last year of 3 women who wrote to say they refused power morcellation after reading about her; they turned out to have sarcomas that were removed intact.
“We’re not at all glad that this happened to us, but lives have been saved as a result,” Reed told the newspaper.
“Very certainly, Amy’s suffering — and how she chose to fight despite her own pain — have saved many women’s lives and shifted the contour of practice and ethics in women’s health,” Noorchashm wrote in an April 14 blog post.