Olympus America, Inc. is going forward with its efforts to overhaul the power morcellator with its new, “contained-tissue extraction system,” but the U.S. Food and Drug Administration (FDA) remains unconvinced regarding the device’s safety.
The FDA is requiring that the redesigned device – which is combined with a bag intended to prevent cancer cells from escaping during morcellation – carry a warning stating that it has not been clinically proven to reduce the risk of spreading uterine cancer, and that morcellation is not a suitable treatment in most cases. Olympus recently announced that the company plans to launch a clinical study of 140 hysterectomy patients to show that the system is safe and effective, but some have charged that the study is too small to accurately assess oncological safety.
Other companies have developed similar bags to use in contained morcellation, but the systems have not been widely used because they posed technical issues. Olympus says that in laboratory tests, its bag did not exhibit leakage of cells or bodily fluids, and endured the tugging that is anticipated to occur during use. The company said it would consider the upcoming clinical trial a success if no more than one bag out of 140 ruptures during the testing, which has not yet begun.
What is Morcellation?
Power morcellators are minimally invasive tools used to remove common uterine growths known as fibroids during gynecological procedures like hysterectomies. The devices can cut the sometimes large, cumbersome growths into smaller pieces that can be removed from the body through small incisions.
But deadly cancers can appear as benign tumors and there is no conclusive way to diagnose uterine cancer before morcellation, so when the tissue is ground up the undetected uterine cancer cells can be spread throughout the abdomen, leading to rapid upstaging of the disease. As a result, power morcellation has come under growing scrutiny and prompted numerous lawsuits.