Dr. Amy Reed’s tragic case brought to light the cancer risks posed by power morcellation. Her death hasn’t stopped lingering questions about the technology.
Power morcellators were used for 20 years to laparoscopically remove fibroids, benign tumors of the uterus, raising not a single adverse event report with the FDA. That all changed in 2013, when Dr. Amy Reed, an attending physician at Beth Israel Deaconess Medical Center, underwent a myomectomy using power morcellation at nearby Brigham & Women’s Hospital.
Reed’s fibroids were not benign, but instead a malignant form of cancer called uterine sarcoma that’s difficult to distinguish from benign tumors. Days after her procedure, Reed’s formerly treatable condition had been upstaged to a deadly cancer.
It turned out that power morcellation, a laparoscopic procedure in which surgeons use the device to mince the tumors, can seed malignant cells throughout the abdomen, drastically accelerating the cancer’s advance. Reed died last year at 44 of complications from her 2013 myomectomy, but not before she and her husband, Dr. Hooman Noorchasm, mounted a successful public health campaign to raise awareness of the risks posed by power morcellation. In 2014 the federal safety watchdog issued a black box warning for power morcellators, prompting Johnson & Johnson to pull its power morcellator from the market.
With the devices gone, a void emerged in the market – women who would have undergone a laparoscopic procedure with a morcellator now faced an open uterine resection. Organizations including the American College of Obstetricians & Gynecologists teamed with the Agency for Healthcare Research & Quality to lobby for the FDA to reconsider its 2014 guidance, arguing that patients need a laparoscopic option for tissue removal.
Meanwhile, some medtech entrepreneurs saw the risks posed by morcellators as an opportunity to create a device that would address the morcellator’s shortcomings. Eximis Surgical, a tiny Colorado-based company, set out to do just that.
Eximis came across Noorchasm’s radar after announcing that it raised $5 million from 33 investors to fund the development of its laparoscopic tissue removal system. He noticed that on their LinkedIn account, Eximis named Reed as the inspiration behind their technology. Noorchasm penned a letter to Eximis executives and published it online, asking them to remove any reference to Reed and, among other things, acknowledge that their technology is simply a resurrected version of a power morcellator.
“What they’re marketing is something that goes directly in opposition to what Amy and myself have been speaking out against,” he told Medical Design & Outsourcing. “It doesn’t matter what words you use, it doesn’t matter if you say morcellate, slice up, dice up, XCor out – if you take a tumor that has malignant potential and you mince it up, you’re exposing that patient to the risk of their cancer being upstaged.”
These featured panels at DeviceTalks Boston will explore the state of R&D at major medtech firms, as well as the latest trends when it comes to developing combination products, neuromodulation devices, robotic systems and women's health technology.
View Technology Track Featured Sessions
Register today to save. Use code TECHTRACK to save an additional 10%.