Physician-Patient Responsible for Ban on Power Morcellators, Dies

Amy J. Reed, MD, died 4 years following her surgery that used a power morcellator to remove her uterus, resulting in the spread of a hidden cancer.

She developed stage 4 leiomyosarcoma following a routine hysterectomy that was meant to take care of her fibroids. Amy J. Reed, MD, has died, 4 years following her surgery that used a power morcellator to remove her uterus.

The reason: use of a power morcellator that slices the tissue into small pieces that can then be extracted through minimally invasive surgery, which allows for faster recovery. However, what went unnoticed was that if a patient has cancer, the power morcellator accelerates the spread of cancer—this happened with Reed.

Reed’s surgery was conducted at Brigham and Women’s Hospital in Boston, within the Harvard Medical School, where she and her husband, Hooman Noorchashm, MD, hold teaching positions. A biopsy post surgery was the first diagnosis of Reed’s cancer—the morcellator had sprayed her malignant cells around her abdomen. Despite aggressive chemotherapy, radiation therapy, and immunotherapy, she suffered multiple recurrences in her abdomen, lungs, and spine.

The couple then took their case to regulatory authorities, as well as device makers, hospitals, and multiple other organizations, to raise awareness around the danger of the power morcellator. They also enlisted other women who had undergone the procedure, or their families, to join the campaign. The primary result of their effort was a study conducted and publicized by the FDA that found hidden sarcomas were more common than was previously thought—the number was 1 in 350, not 1 in 10,000. As an immediate effect, Johnson & Johnson, one of the companies that manufactured the device, suspended sales of its product.

Subsequently, the FDA banned the use of power morcellators for the removal of the uterus or fibroids in a majority of women. Additionally, the FDA asked manufacturers of these devices to include specific safety statements as black box warnings on the product label.

Aetna was the first health plan to take a stand in reaction to the FDA decision. In the summer of 2015, the company announced it would not cover use of power morcellators for myomectomy and hysterectomy procedures in most cases and that doctors would require a precertification if they do need to use the device for said procedures. UnitedHealth requires physicians to obtain prior authorization from the insurance company before using the device for hysterectomy.

Reed leaves behind her husband and 6 children.