Devices

Laparoscopic Power Morcellator Labeling Guidance

FDA has published a guidance, Product Labeling for Laparoscopic Power Morcellators, with recommendations on the content and format for certain labeling information for laparoscopic power morcellators (LPM). The document says the recommendations reflect the state of the science and available technology regarding the use of LPMs and are being made in light of scientific information suggesting that using the devices contributes to the dissemination and upstaging of occult uterine malignancy in women undergoing laparoscopic gynecologic surgery for presumed fibroids.

The agency says it is also recommending that manufacturers incorporate into the labeling for the devices information providing greater specificity regarding the risk of use as it relates to age, information regarding the risk of spreading malignant and benign uterine tissue, and information regarding the use of LPM containment systems.

“These labeling recommendations are intended to enhance, but not replace, the physician-patient discussion of the benefits and risks of use of LPMs that uniquely pertain to individual patients,” the guidance says. “FDA believes this effort will promote the safe and effective use of LPMs when used for gynecologic surgeries.”

An Update issued at the same time as the guidance says the agency recommends performing laparoscopic power morcellation for myomectomy or hysterectomy only with a tissue containment system legally marketed in the U.S. for use during LPM and performing these procedures only in appropriately selected patients.

The agency also issued an FDA In Brief to review the actions it took to increase the safety of LPMs used in gynecologic surgeries.

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