Description
This guidancecontains recommendations concerning the content and format for certain labeling information for laparoscopic power morcellators (LPMs). The recommendations in this guidance reflect the state of the science and available technology regarding use of LPMs and are being made in light of scientific information that suggests that the use of these devices contributes to the dissemination and upstaging of an occult uterine malignancy in women undergoing laparoscopic gynecologic surgery for presumed fibroids. FDA is also recommending that manufacturers incorporate into the labeling for these 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. FDA believes this effort will promote the safe and effective use of LPMs when used for gynecologic surgeries.
Scope & Applicability
Product Classes
3Devices excluded from the scope of this guidance due to different principles of operation.
Systems intended to isolate and contain tissue that is considered benign during morcellation.
Guidance concerns content and format for certain labeling information for laparoscopic power morcellators (LPMs).; The primary device class addressed in the guidance for gynecologic surgery.
Stakeholders
1Entity responsible for submitting NDINs
Regulatory Context
Attributes
2A patient state that serves as a contraindication for LPM use with suspected fibroids.
Refers to an increase in the extent or severity of the disease due to tumor spread.
Identified Hazards
Hazards
2The primary safety concern associated with the use of LPMs.
Spread of unsuspected cancerous tissue beyond the uterus when LPMs are used.
Related CFR Sections (1)
- 21CFR884.4050§ 884.4050 Gynecologic laparoscopic power morcellation containment system.
(a) Identification. A gynecologic laparoscopic power morcellation containment system is a prescription device consisting of an instrument port and tissue containment method that creates a working space allowing for direct visualization during a power morcellation procedure following a laparoscopic pRead full regulation →