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# FDA Takes Power Morcellator Safety Steps
- URL: https://www.fdaweb.com/fda-takes-power-morcellator-safety-steps/
- Published: 2020-02-25T12:00:00.000Z
- Updated: 2026-09-14T16:04:23.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5146169

FDA says it has taken several [steps](https://www.fda.gov/news-events/press-announcements/fda-takes-new-steps-increase-safety-laparoscopic-power-morcellators-when-used-gynecologic-surgeries?ref=fdaweb.com) to make the use of laparoscopic power morcellators safer in gynecologic surgeries. The agency approved updated labeling for the PneumoLiner containment system that contains tissue to be morcellated during gynecologic surgery, issued a safety communication, and approved a new draft guidance.

The updated PneumoLiner labeling better defines the appropriate patient population for the safe and effective use of the device, including stating that the device should only be used in women who have fibroids if they are pre-menstrual and under age 50.

The [safety communication](https://www.fda.gov/medical-devices/safety-communications/update-fda-recommends-performing-contained-morcellation-women-when-laparoscopic-power-morcellation?ref=fdaweb.com) **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 and performing these procedures only in appropriately selected patients.** FDA says it continues to recommend limiting the use of laparoscopic power morcellation to certain appropriately selected women undergoing myomectomy or hysterectomy. In addition, it recommends that when morcellation is appropriate, only contained morcellation be performed.

The new [draft guidance](https://www.fda.gov/media/135425/download?ref=fdaweb.com) has recommendations for the content and format of certain labeling information for laparoscopic power morcellators that reflect the state of the science and available technology regarding morcellator use. The agency says the recommendations are being made in light of scientific information suggesting that the use of the devices contributes to the dissemination and upstaging of an occult uterine malignancy in women undergoing laparoscopic gynecologic surgery for presumed fibroids. The guidance also recommends that manufacturers incorporate into the device labeling information providing greater specificity about the risk of use as it relates to age, information on the risk of spreading malignant and benign uterine tissue, and information about the use of laparoscopic power morcellation containment systems.