A new study suggests that doctors have sharply curtailed their use of uterine morcellation in the wake of warnings from the U.S. Food & Drug Administration (FDA). However, the decline has not resulted in an increased rate of hysterectomy complications, as some had feared.
Uterine morcellation involves the use of a device called a power morcellator to carve up uterine tissue and fibroids during minimally-invasive hysterectomies and myomectomies. The morcellated tissue can then be removed via a small abdominal incision.
In April 2014, the FDA discouraged doctors from using the devices in gynecological procedures, due to their potential to spread and upstage undetected uterine cancers. This following November, the agency warned that power morcellators should not be used on a majority of hysterectomy and myomectomy patients because of this risk. Among other things, the FDA pointed out that screening for uterine malignancies prior to surgery is unreliable, and noted that a woman’s odds of long-term survival are greatly reduced if these cancers are allowed to spread beyond the uterus.
It would appear now that the FDA warnings have had their desired effect. According to a study published this week in the Journal of the American Medical Association, 13.5% of minimally invasive hysterectomies involved power morcellators in the fourth quarter of 2013. However, by the first quarter of 2015, the percentage had dropped to 2.8. The findings were based on an analysis of medical records from 200,000 women who underwent hysterectomies at 500 U.S. hospitals.
Overall, rates of hysterectomy complications did not change. In fact, complication rates for abdominal hysterectomies actually declined, while rates for minimally invasive hysterectomy and vaginal procedures were stable.
“The FDA warnings might result in a lower prevalence of cancer among women who underwent morcellation due to greater scrutiny on patient selection,” the authors of the study wrote. “However, the high rate of abnormal pathology after the warnings highlights the difficulty in the preoperative detection of uterine pathology. Continued caution is needed to limit the inadvertent morcellation of uterine pathology.”
In recent years, morcellator manufacturers have faced dozens of lawsuits over the potential for the devices to spread and upstage uterine cancers. While Johnson & Johnson’s Ethicon, Inc. unit has settled the majority of lawsuits involving its power morcellators, other manufacturers continue to face uterine cancer claims.