The FDA issued a warning in late 2014 about the use of power morcellators to treat uterine fibroids.
Eight months later, the debate about the safety of power morcellation continues to rage in the gynecologic oncology community.
Here is an overview of the procedure, a summary of the FDA’s guidance and a glimpse into its early impact.
Question: What is power morcellation?
Answer: During power morcellation, a tiny instrument with a rapidly rotating blade grinds up uterine fibroids — or benign tumors within the uterus — and allows for their removal via a laparoscope.
Q: Why is the procedure performed?
A: It allows for a smaller incision, quicker recovery period, fewer side effects and lower rate of morbidity than more invasive open surgeries. Open surgeries include myomectomy — in which fibroids are removed but healthy tissue of the uterus is left intact — and hysterectomy, which involves the surgical removal of all or part of the uterus.
Q: Why did the FDA issue its warning?
A: The agency’s “immediately in effect” guidance — issued in November 2014 — warns against the use of morcellators in hysterectomies or myomectomies in the majority of women due to the potential that they can spread undetected uterine sarcomas.
Q: What are the FDA’s specific recommendations?
A: The FDA recommended manufacturers of laparoscopic power morcellators include a boxed warning to acknowledge the risk that undetected leiomyosarcomas or other malignancies within uterine tissue can be disseminated throughout a woman’s pelvic and abdominal cavities during morcellation, increasing risks for morbidity and mortality.
The guidance also recommends two contraindications be included on product labeling.
One recommendation is to contraindicate laparoscopic power morcellators for women who are peri- or postmenopausal, as well as those who are candidates for en bloc tissue removal through the vagina or mini-laparotomy incision. Most of the estimated 50,000 to 100,000 women who undergo laparoscopic procedures for hysterectomy each year in the United States meet these criteria.
The guidance also recommends contraindication of the devices during gynecologic surgery in which the tissue to be morcellated is either suspected or known to be cancerous.
Q: How big is the risk that power morcellators will spread undetected malignancies?
A: Based on quantitative analysis of available data, the FDA estimated that approximately 1 in 352 women who undergo hysterectomy or myomectomy for presumed benign fibroids has an unsuspected uterine cancer, and that 1 in 498 has an unsuspected leiomyosarcoma. However, the Society of Gynecologic Oncology issued a statement suggesting the FDA based its recommendation on studies included in a retrospective case series with “low-quality evidence.”
“The FDA would not approve a device using such low-quality retrospective data,” the statement read. “It is concerning that the FDA would now consider banning a device with a similar low level of evidence.”
Q: What has other research shown?
A: A team of researchers led by Jason D. Wright, MD, division chief of gynecologic oncology at Columbia University Medical Center, conducted a study that evaluated more than 36,000 women who underwent minimally invasive hysterectomy between 2006 and 2012. Their findings, published in JAMA, showed the risk of occult malignancy was 1 in 368.
Jason D. Wright
However, a meta-analysis performed by Elizabeth A. Pritts, MD, an obstetrician–gynecologist at and medical director of Wisconsin Fertility Clinic in Middleton, Wisc., and colleagues suggested the risks are not as high as the FDA indicated.
The analysis by Pritts and colleagues included 133 studies with evaluable data. Their findings indicated an occult leiomyosarcoma would be found in 0.12 of every 1,000 surgeries, whereas the FDA statistics indicate an occult leiomyosarcoma would be found in 2.01 of every 1,000 surgeries.
A subsequent study by Wright and colleagues, published in JAMA Oncology, assessed pathologic outcomes among patients who underwent myomectomy with electric power morcellation. They found that the prevalence of cancer and pre-cancer abnormalities was 1 in 1,073 women, indicating the risk for cancer is “much lower” among women who undergo myomectomy than hysterectomy, Wright and colleagues wrote.
Q: How does age contribute to patients’ risk?
A: In the myomectomy study conducted by Wright and colleagues, older age was the strongest risk factor for cancer.
In another study published in The Oncologist, Andrew S. Brohl, MD, of the department of hematology and medical oncology at Icahn School of Medicine at Mount Sinai, and colleagues sought to determine the incidence of unexpected uterine sarcoma in women who underwent surgery for suspected benign leiomyoma. They determined the risk for unexpected uterine sarcoma increased with age. Women aged younger than 30 years demonstrated the lowest risk (<1 in 500), whereas women aged 75 to 79 years demonstrated the highest risk (1 in 98).
Q: What has changed since the FDA issued its guidance about power morcellation?
A: Soon after the FDA’s announcement, Johnson & Johnson, a leading manufacturer of laparoscopic power morcellators, pulled its products off the market. Several large institutions — including Brigham and Women’s Hospital and Cleveland Clinic — stopped performing laparoscopic power morcellation. Multiple insurance companies also have stopped covering routine use of power morcellators.
The debate also has prompted conversations about whether steps can be taken to make the procedure safer, ensuring it remains accessible to patients who understand their potential risks and provide informed consent. These efforts could include pre-operative imaging or biopsy, as well as the use of containment bags, which allow fibroids to be morcellated inside a bag in the abdominal region to prevent the potential spread of tissue.
Brohl AS, et al. Oncologist. 2015;doi:10.1634/theoncologist.2014-0361.
Pritts EA, et al. J Minim Invasive Gynecol. 2015;22:26-33.
Wright JD, et al. JAMA Oncol. 2015;doi:10.1001/jamaoncol.2014.206.
Wright JD, et al. JAMA. 2014;312:1253-1255.