Since the FDA issued warnings against using power morcellation for hysterectomies and myomectomies, the rate of minimally invasive laparascopic hysterectomy has fallen by 4.1% and majorly invasive abdominal hysterectomies have increased by 1.7%. Because there are repercussions from doing more invasive surgeries, two groups of gynecologists in the January 2016 Green Journal have published articles exploring this very topic.
First, a 45-member review group led by Dr. Parker of UCLA and the Leiomyoma Morcellation Review Group stick their necks out for power morcellators. They critique the FDA’s methods of reviewing the literature, noting that their search criteria did not include studies in which no leiomyosarcoma were found. The FDA reported that 1 in 458 women having surgery for presumed fibroids actually have the malignant and feared leiomyosarcoma. This task force re-calculated the FDA data and found that, in light of new information, the estimate should be 1 in 1,550. They site other studies that show rates as low as 1 in 4,360, which is about 0.02%. The authors remind readers that there are benefits to minimally invasive surgeries: fewer perioperative deaths, embolisms, wound infections, shorter hospital stays, and faster return to work and family. To quote the authors conclusion, “Respecting women who have leiomyosarcoma, we conclude that the FDA directive was based on a misleading analysis.” They believe each woman should have the freedom to choose whether or not she would like to select power morcellation as a part of her surgery.
The second article on this topic comes from Kaiser Permanente. Their gynecologic oncology group amassed a huge database of over 34,700 hysterectomies performed for fibroids from 2006 to 2013. They set out to answer two questions. First, what is the incidence of occult (previously undetected) uterine sarcoma among women undergoing hysterectomy for suspected benign leiomyomas? They found that more than half, about 57%, of uterine sarcomas were known before the hysterectomy surgery. Women with uterine sarcoma were more likely to be over 50 years of age and were about half-and-half pre and post menopausal. Doctors were more likely to detect a uterine sarcoma before surgery if it was a high-grade endometrial stromal sarcoma than if it was a leiomyosarcoma or low grade endometrial stromal sarcoma. Overall, the researchers found that the incidence of occult uterine sarcoma was 1 in 278 and of occult leiomyosarcoma was 1 in 429 hysterectomies. To note, this estimate is very close to the original FDA estimate.
The second question was: is morcellation associated with length of survival for women with leiomyosarcoma? The 3 year disease-free survival was the same, whether the women had power morcellation, non-power morcellation (i.e. the surgeon used a scalpel instead of a power morcellator), or no morcellation. The same was true for overall survival; morcellation or not, the results were the same after 3 years. The authors did find one significant survival outcome. Death 1 year after surgery was higher for power & non-power morcellation combined versus no morcellation. They also found more abdominal recurrences for leiomyosarcoma with morcellation than without. However, if you count all types of recurrence, morcellation and no morcellation had similar risks of recurrence. The authors caution that they had relatively low power because of the small number of sarcomas, and that they most likely overestimate the incidence of leiomyosarcoma. Nevertheless, their analysis provides an important and heretofore unavailable look at the outcomes from different types of surgeries for known and occult sarcomas at the time of hysterectomy.
As is evident from these two different looks at power morcellation and fibroids, the debate rages on. We will have to stay tuned to see where it ends up.