Power Morcellator: A Boon or Curse ? Dr. Amy Reed, a staunch opponent of power morcellator loses battle to uterine cancer.

Amy Reed, MD, PhD, an anesthesiologist died because of uterine leiomyosarcoma on Wednesday, May 24 at age of 44.

She underwent a laproscopic hysterectomy in October 2013 for fibroid, but her undiagnosed, occult uterine leiomyosarcoma was upstaged because of dispersion in abdominal cavity by the use of power morcellator. Since then, the power morcellator is the focal point of a four-year debate that has divided the surgical field.

The surgery took place at the Harvard-affiliated Brigham and Women’s Hospital in Boston where both Reed and her husband Noorchashm worked.

She came to know about the diagnosis only after the histopathology reports came in after the surgery. To date, there isn’t a reliable method to determine whether or not a uterine tumor is malignant before it has been removed and fully examined. The estimated incidence of leiomyosarcoma is 0.64 per 100,000 women.

The couple immediately knew they were in trouble and it was just a race against time. 

She turned her calamity into advocacy against the use of power morcellator and have fought an uphill battle to ban morcellation.  

Introduced to the United States in 1993 and approved by the FDA in 1995, the device gained rapid popularity among gynecologists particularly for the removal of fibroids and in hysterectomies.

It is estimated that Power Morcellator is used in about 600,000 minimally invasive hysterectomies and myomectomies annually.

Traditional cancer therapies were all ineffective as the morcellation has already advanced the cancer to stage IV. She fought an epic battle against the deadly disease along with a campaign to ban morcellation. She and her husband wrote numerous emails to FDA, along with device makers and hospitals and legislators. They also waged the war on social media and other traditional medias.

It is because of her efforts that FDA revisited the literature and made an announcement on April 17, 2014 “Importantly, based on an FDA analysis of currently available data, it is estimated that 1 in 350 women undergoing hysterectomy or myomectomy for the treatment of fibroids is found to have an unsuspected uterine sarcoma, a type of uterine cancer that includes leiomyosarcoma.”

“If laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s likelihood of long-term survival.”

“For this reason, and because there is no reliable method for predicting whether a woman with fibroids may have a uterine sarcoma, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids.”

Soon, after this FDA newsletter, Johnson & Johnson pulled its device off the market.

Morcellator use dropped after this, but was not completely banned. By September 2016, the FDA received 285 additional reports of cancer spread by morcellation.

Many gynecologist surgeons however, continue to use the morcellator. In 2014, ACOG issued a position statement on Power Morcellation quoting that while it supports FDA commitment to women’s health, but believe that power morcellation has a role in gynecologic surgery. A careful selection of cases and evaluation of woman’s risk for leiomyosarcoma plus informed consent can protect women against the negative outcome. 

Following the ongoing controversy, on April 7, 2016, FDA granted permission to an Irish company to market the “PneumoLiner,” a first-of-its-kind containment system indicated for isolating and containing uterine tissue during a minimally invasive hysterectomy or myomectomy.

However, FDA requires the manufacturer to warn patients and health care providers that the containment system has not been proven to reduce the risk of spreading cancer during power morcellation.

FDA recommendation can be accessed here.

ACOG full statement can be accessed here.

Drs. Noorchashm and Reed make a joint presentation at a symposium focused on FDA law and law enforcement at Widener University Law School.