Study Reports on Trends in Hysterectomy after FDA Warnings about Power Morcellator

Chloe Meck (BIDMC Communications) 617-667-7367, cmeck@bidmc.harvard.edu

MARCH 28, 2019

 

Surgeons returned to minimally invasive procedures after abandoning potentially cancer-spreading technique

BOSTON – A new study by physician-researchers at Beth Israel Deaconess Medical Center (BIDMC) characterizes national trends in hysterectomy practice in the wake of a 2014 U.S. Food and Drug Administration warning that a tool called a power morcellator, intended to assist with minimally invasive laparoscopic hysterectomy, could spread cancer in some women. After ending the use of power morcellation, surgeons initially returned to more invasive abdominal hysterectomies in the year following the federal warning, BIDMC researchers reported in the journal Obstetrics & Gynecology. However, the team observed an overall increase in the proportion of minimally-invasive hysterectomies performed since 2012, as surgeons found alternatives to power morcellation.

“Since the FDA safety warning about electric power morcellation in 2014, there has been an explosion of literature on safe, contained alternatives,” said lead author Elisa M. Jorgensen, MD, of BIDMC. “Our study found that the gynecologic community has continued to advance minimally invasive hysterectomy even after largely ending the use of power morcellation.”

Patients who undergo minimally invasive hysterectomy have shorter hospital stays, quicker recovery times and fewer complications overall than patients who have uterine tissue removed via abdominal incision. The electric power morcellator was developed to enable minimally invasive procedures by mincing bulky tissues into smaller pieces for removal via laparoscopy.

In April 2014, however, the FDA issued a warning advising surgeons performing laparoscopic hysterectomies to discontinue use of power morcellation, after physicians from prominent hospitals voiced concerns that the device could spread cancer in women with existing but undetected uterine malignancies – affecting an estimated 1 out 350 women undergoing hysterectomy.

Jorgensen, a minimally invasive gynecology surgery fellow at BIDMC, and colleagues used records from the American College of Surgeons National Surgical Quality Improvement Program to identify nearly 180,000 hysterectomies performed between 2012 and 2016. The team then analyzed trends across four modes of hysterectomy surgery before, within one year of, and more than one year after the FDA warning.

In the first quarter of 2012, prior to the FDA warning, surgeons opted for minimally invasive laparoscopic hysterectomies more than any other mode of procedure, performing them about 34 percent of the time, while abdominal hysterectomies accounted for about 30 percent of hysterectomies. Minimally invasive vaginal and laparoscopic-assisted vaginal hysterectomies comprised the remaining 36 percent of surgeries.

Around the time of the 2014 FDA safety advisory, the proportion of abdominal hysterectomies increased by a little more than one percent per quarter, while the proportion of minimally invasive procedures decreased slightly. However, within a year of the FDA communication, the proportion of minimally invasive procedures had rebounded and continued to climb, accounting for nearly half of all hysterectomies by the study’s end in the fourth quarter of 2016. The proportion of abdominal procedures continued to fall by nearly one percent per quarter to a low of 23.7 percent by the end of 2016.

“Previous studies reported an increase in abdominal hysterectomy in response to the FDA safety communication, and our results are consistent within the initial six-month period after the first concerns about power morcellation were reported,” said Jorgensen. “However, by looking at data through 2016, we found a complete reversal of the previously reported effect. In fact, minimally invasive hysterectomy was at its peak incidence at the end of our five-year study period.”

In addition to Jorgensen and senior author Christopher Awtrey, MD, additional co-authors included Anna M. Modest, Hye-Chun Hur, and Michele R. Hacker, all of the Department of Obstetrics and Gynecology at BIDMC.

The work was supported by Harvard Catalyst, Harvard Clinical and Translational Science Center (National Center for Advancing Translational Sciences, National Institutes of Health Award UL1 TR001102) and financial contributions from Harvard University and its affiliated academic health care centers.

Michele R. Hacker received money paid to her institution from the Breast Cancer Research Foundation, Society for Family Planning, and the Charles Koch Foundation. She has also received funds from the National Institutes of Health and Affiliates Risk Management Services, Inc. The authors did not report any potential conflicts of interest.

About Beth Israel Deaconess Medical Center

Beth Israel Deaconess Medical Center is a patient care, teaching and research affiliate of Harvard Medical School and consistently ranks as a national leader among independent hospitals in National Institutes of Health funding.

BIDMC is in the community with Beth Israel Deaconess Hospital-Milton, Beth Israel Deaconess Hospital-Needham, Beth Israel Deaconess Hospital-Plymouth, Anna Jaques Hospital, Cambridge Health Alliance, Lawrence General Hospital, Signature Healthcare, Beth Israel Deaconess HealthCare, Community Care Alliance and Atrius Health. BIDMC is also clinically affiliated with the Joslin Diabetes Center and Hebrew Rehabilitation Center and is a research partner of Dana-Farber/Harvard Cancer Center and the Jackson Laboratory. BIDMC is the official hospital of the Boston Red Sox. For more information, visit www.bidmc.org.