The tissue containment system recently approved by the U.S. Food and Drug Administration for use with certain laparoscopic power morcellators does not eliminate the cancer risk associated with power morcellators, cautions a report published May 17 in the Journal of the American Medical Association.
The new device, known as the PneumoLiner, is designed to isolate uterine tissue not suspected of being cancerous.
It consists of a containment bag and a tube-like plunger that positions the device in the abdominal cavity, where it gathers the tissue being removed.
The bag is sealed, inflated, and surgeons then morcellate the tissue within the bag.
Labeling for the device will caution that it should not be used during gynecologic surgery in which the tissue to be morcellated is known or suspected to be malignant.
But the PneumoLiner is not intended for use in all women, according to William Maisel of the Center for Devices and Radiological Health.
“The PneumoLiner is intended to contain morcellated tissue in the very limited patient population for whom power morcellation may be an appropriate therapeutic option—and only if patients have been appropriately informed of the risks,” he said in a statement.
Surgeons use power morcellation during minimally invasive hysterectomy or myomectomy to cut tissue into tiny portions, facilitating easy removal through small openings.
Until recently, the procedure was performed on an estimated 100,000 women annually in the U.S.
The morcellation practice has been scrutinized in recent years, however, because it may spread fragments of undetected uterine sarcomas throughout the abdominal cavity According to FDA estimates, about 1 in 350 women who undergo hysterectomy or myomectomy for fibroids has unsuspected uterine sarcoma.
Women who believe their cancer diagnosis was made worse as a result of the use of a power morcellator during their minimally invasive fibroid surgery or hysterectomy are currently filing lawsuits against the manufacturer of these devices.
Women were not told of the risk that the spinning blades of the power morcellator and these same women allege that the morcellator spread these cancerous tissues throughout their body, worsening their potential outcome.
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