FDA approves morcellation containment system
The US Food and Drug Administration (FDA) has given the nod to a first-of-its-kind tissue containment system for use with certain laparoscopic power morcellators. Advanced Surgical Concepts Ltd., the manufacturer of the Pneumoliner, is required to warn patients and health care providers that the device has not been proven to reduce risk of spreading cancer during tissue morcellation.
The Pneumoliner consists of a containment bag and tube-line plunger to deliver the abdominal cavity. The tissue to be removed is then placed in the bag and the bag is sealed and inflated. Inflation creates a working space around the tissue and visualization during morcellation to help prevent breakage of the containment bag by the morcellator tip or other surgical instruments.
The device was tested in “worst-case” scenarios and found to be impermeable to substances similar in molecular size to tissues, cells and body fluids. Other testing showed that inflation of the bag provided adequate space for surgeons performing morcellation with good visualization, and under stress testing, it was found to withstand forces in excess of those expected to occur in actual clinical use.
The labeling for Pneumoliner underscores that the device is not to be used on tissue to be morcellated that is known or suspected to contain malignancy. It is also not intended for use on uterine tissue that contains suspected fibroids in women who are perimenopausal or postmenopausal or those who are candidates for en bloc tissue removal. It was approved through FDA’s de novo classification process, a regulatory pathway for some novel, low- to moderate-risk medical devices that are first-of-a-kind.
Commenting on the approval, William Maisel, MD, MPH, deputy director for science and chief scientist at FDA’s Center for Devices and Radiological Health said, “This new device does not change our position on the risks associated with power morcellation. We are continuing to warn against the use of power morcellators for the vast majority of women undergoing removal of the uterus or uterine fibroids.”