Even with an FDA advisory and more careful patient selection by surgeons, some women who underwent morcellation still developed cancer, researcher tells MedPage Today.
Use of power morcellators in gynecologic procedures decreased significantly following an FDA warning but the cancer risk thought to be associated with the devices' use did not, a review of a national database showed.
Among women undergoing minimally invasive hysterectomy, use of power morcellators declined from a peak of almost 14% in late 2013, before the FDA warning, to less than 3% by early 2015. However, the rate of uterine cancer in women treated with morcellators actually increased from 0.28% before the FDA advisory to 0.53% afterward, although the difference did not reach statistical significance.
The rate of abdominal hysterectomy increased over the same time period, whereas the rate of minimally invasive procedures decreased. Nonetheless, the overall complication rate associated with hysterectomy did not change, Jason Wright, MD, of Columbia University in New York City, and coauthors reported in the Aug. 23/30 issue of the Journal of the American Medical Association.
"The striking thing about this study is that even with all the media attention and the uptake of guidance and the scrutiny -- and certainly, physicians are being more careful about who they choose to perform this procedure in -- some women who underwent morcellation still developed" cancer, Wright toldMedPage Today.
"I don't think there is any patient that you can say with certainty that there is no cancer risk," he added. "However, prior studies have shown us that younger women generally have a lower risk of cancer, and that's probably the group of women that is safest to consider morcellation in."
Without discounting the cancer risk, gynecologic oncologist Barbara Goff, MD, of the University of Washington in Seattle, called for a more balanced discussion of the potential harms and benefits of morcellation.
"From my perspective, I think it's always been a one-sided equation," said Goff, who was president of the Society of Gynecologic Oncology (SGO) when the morcellation controversy emerged during 2013 and 2014. "All we've done is talk about cancer. We're not talking about all of the other things that can happen. I think people have been very short-sighted in what they're looking at and not looking at the whole global picture for these patients."
Noting the increased rate of more invasive abdominal hysterectomies during the study period, she added, "Informed consent means that we not only talk about the cancer risk but that we also talk about risk of surgical site infection, the higher risk of wound complications, the higher risk of deep-vein thrombosis and pulmonary embolism. You can die from some of those things too."
The findings by Wright and colleagues reopened a discussion that has made headlines, off and on, since late 2013. In December of that year, the SGO published a position statement advising caution in the use of morcellation to treat uterine fibroids. Several case reports had documented that the procedure unleashed cells from unrecognized leiomyosarcoma, which evolved into advanced uterine cancer. An editorial published inThe Lancet Oncology in early 2014 noted that the cancer risk associated with morcellation had been recognized for at least two decades.
The FDA subsequently issued an advisory, discouraging use of power morcellators in association with hysterectomy or myomectomy procedures. An FDA advisory committee reviewed the evidence linking morcellation and cancer but came to no conclusions. Then, in July 2014, Wright and colleagues published the first comprehensive data on the issue, which showed a cancer risk of 1 in 368, derived from a review of 200,000 cases.
In November 2014, the FDA issued an updated advisory, specifically "warning against the use of laparoscopic power morcellators in the majority of women undergoing myomectomy or hysterectomy for treatment of fibroids." A black box warning followed.
A decision-tree analysis published in early 2015 lent support to Goff's view that more balance is needed in the discussion. The data showed that laparoscopic hysterectomy with morcellation was associated with fewer overall deaths, fewer surgical complications, and increased quality of life as compared with abdominal hysterectomy.
The updated review by Wright and colleagues examined morcellation use, associated uterine cancer rate, and other factors before and after the FDA warnings. Using the Perspective database, investigators identified 203,520 women who underwent hysterectomy from 2013 to the first quarter of 2015.
The results showed that:
- The proportion of minimally invasive procedures decreased from 59.7% to 56.2% (P<0.001)
- The proportion of abdominal procedures increased from 27.1% to 31.8% (P=0.004)
- Power morcellator use decreased from 13.7% of minimally invasive procedures to 2.8% (P<0.001)
- The total complication rate did not change (8.3% versus 8.4%)
- Complications associated with abdominal hysterectomy declined slightly but significantly (18.4% versus 17.6%, P<0.001)
- The prevalence of uterine and other gynecologic cancers did not change significantly among women undergoing morcellation
Unswayed by the slight decrease in complications with abdominal procedures, Goff offered a straightforward interpretation of the new data.
"If you know there's cancer, don't morcellate the uterus," she said. "If you think there's cancer, don't morcellate the uterus. If you think that it's benign, go the extra mile to make sure it's not cancer. Once you're pretty sure there is no cancer there, I think it is a patient's right to choose between a higher complication rate versus a very, very low rate of morcellating cancer."