The Food and Drug Administration has cleared for marketing a novel tissue containment system for use with certain laparoscopic power morcellators.
The PneumoLiner system is intended to be used to contain morcellated uterine tissue in a limited population of patients, including women without uterine fibroids undergoing hysterectomy and some premenopausal women with fibroids who want to maintain their fertility, according to the FDA. The agency is requiring the manufacturer to warn patients and physicians that the device has not been proven to reduce the risk of spreading cancer during surgery.
This approval – through the FDA’s de novo classification process for novel, low- and moderate-risk medical devices – comes about 2 years after the FDA first warned physicians and patients about the risk of spreading unsuspected uterine sarcomas during laparoscopic power morcellation in hysterectomy or myomectomy.
“This new device does not change our position on the risks associated with power morcellation,” Dr. William Maisel, deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health, said in an April 7 statement . “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.”
The device, which is manufactured by Advanced Surgical Concepts of Bray, Ireland, consists of a containment bag and a tube-like plunger to deliver the device into the abdominal cavity. The tissue being removed is placed in the bag and the bag is sealed and inflated. The inflation is intended to create working space around the tissue and better visualization during morcellation to prevent the morcellator tip or other surgical instruments from puncturing the bag. During laboratory testing, the containment bag was found to be impermeable to substances similar in molecular size to tissues, cells, and body fluids, according to the FDA.
Risks associated with the device include dissemination of morcellated tissue, injury to surrounding tissues or organs, infections, and a potentially longer surgical time. The FDA is requiring that the device’s label state that use of the PneumoLiner system is limited to physicians who have successfully completed the manufacturer’s validated training program.
mschneider@frontlinemedcom.com
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