FDA Examining Safety of Morcellators for Hysterectomy and Myomectomy

Late last week, the FDA issued a safety communication on laparoscopic power morcellation in hysterectomy and myomectomy. In their own words, the FDA said: “If laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s likelihood of long-term survival. For this reason, and because there is no reliable method for predicting whether a woman with fibroids may have a uterine sarcoma, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids.”

If every available alternative treatment for symptomatic uterine fibroids is considered and laparoscopic power morcellation is deemed the best treatment option, the FDA reminds physicians to do the following:

- Ensure that patients are aware that if unexpected cancerous tissue is encountered, that their prognosis will be worsened significantly.
- Know that some physicians and institutions are using a specimen “bag” during morcellation to attempt to contain uterine tissue and minimize the risk of spread in the abdomen and pelvis.

The FDA has instructed manufacturers of power morcellators used for fibroid removal to review their product labeling and will continue to monitor the risk of inadvertent cancer spread in women with uterine fibroids who have undergone laparoscopic power morcellation.

Meanwhile, ACOG is evaluating all available evidence to provide ob/gyns and other clinicians with the best guidance for use of laparoscopic power morcellation in women with uterine fibroids.