FDA Releases New Guidance and Draft Product Labeling for Laparoscopic Power Morcellators

  • Practice Advisory PA
  • March 2020

On February 25, 2020, the U.S. Food and Drug Administration (FDA) released an updated Safety Communication on laparoscopic power morcellation. This is an update to the FDA’s 2014 Safety Communication providing guidance on the use of power morcellation for the management of leiomyomas (fibroids). The FDA now recommends performing laparoscopic power morcellation for myomectomy or hysterectomy only with a tissue containment system, legally marketed in the U.S. for use during laparoscopic power morcellation. Additionally, the FDA’s new guidance states that laparoscopic power morcellators for the removal of uterine tissue containing suspected leiomyomas should not be used in patients who are:

  • Post-menopausal or over 50 years of age, or
  • Candidates for removal of tissue (en bloc) through the vagina or via a mini-laparotomy incision.

ACOG’s current guidance on the use of morcellation for the surgical management of women with presumed symptomatic leiomyomas is Committee Opinion #770, Uterine Morcellation for Presumed Leiomyomas (March 2019).

  • ACOG agrees with the FDA that women over 50 years or postmenopausal have an increased risk of an unsuspected leiomyosarcoma when compared with women 50 years of age and younger. ACOG strongly warns against morcellation in this population. As detailed in ACOG’s Committee Opinion #770, the risk of malignancy increases with age, so for older women (50 years and older based on decision models), although the overall risk of an unsuspected leiomyosarcoma and procedure-related mortality is low, incremental mortality is greater in those women undergoing a laparoscopic approach with power morcellation because of the higher risk of an unsuspected leiomyosarcoma as women age.
  • Current data on the use of tissue containment system are limited and more research is needed. While ACOG acknowledges the FDA’s new recommendation that laparoscopic power morcellation for myomectomy or hysterectomy should only be performed with a tissue containment system (legally marketed in the U.S. for use during laparoscopic power morcellation), more information is needed. It is still unknown whether the use of a containment system prevents the spread of benign or malignant tissue. As noted in Committee Opinion #770, additional concerns include that bags may make morcellation more cumbersome, resulting in increased operative time, or could obstruct visualization of other abdominal contents, resulting in injury to those obscured organs.
  • As for all procedures, informed consent and shared decision-making are essential. Women should be informed of the risks and benefits of morcellation, including the possible risk of disseminating an occult uterine malignancy by morcellation, as well as the risk of disseminating benign uterine tissue. The process of informed consent also is expected to include informing women about the potential risks and benefits of an abdominal approach to a hysterectomy or myomectomy compared with other minimally invasive methods. See Committee Opinion #770 for potential talking points for physicians to use when counseling patients about surgery for presumed leiomyomas.

The FDA also released draft updated product labeling for laparoscopic power morcellators. Public comments on the draft product labeling can be submitted to the FDA through April 27, 2020. See the FDA’s website for additional information. ACOG currently is reviewing the draft product labeling guidance and will submit comments directly to the FDA.

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