FDA Approves Controversial Morcellation Device

The U.S. Food and Drug Administration has approved a controversial uterine tissue container bag for use during laparoscopic power morcellation. However, Advanced Surgical Concepts, the maker of the PneumoLiner, must market the device with a warning that it has not been proven to reduce the risk of spreading cancerous tissue.

Patient safety advocates have raised concerns over the use of power morcellation in gynecological procedures like a hysterectomy where the procedure is used to cut the uterus or uterine fibroids into small pieces so they can be extracted. The PnemoLiner is designed to be inserted into the abdomen where it can collect uterine tissue during the procedure.

Studies have found that when power morcellation is used during fibroid surgery it can spread cancer throughout the abdomen in the case of one in 350 patients with unsuspected uterine cancer. By approving the device, opponents fear the FDA may not be doing their part to let patients know about the risks associated with power morcellation.

Hooman Noorchashm, MD, who has advocated to ban power morcellation ever since his wife’s cancer spread after having the procedure, says, “Despite all the demonstrated catastrophe this device has caused, they've gone ahead and approved a device — this federal agency is admitting now that the cancer risk of this device is unknown — and yet they're OK with unleashing it into the marketplace."

The FDA, however, says its approval does not change their stance on power morcellation.

"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," said William Maisel, MD, MPH, of the FDA's Center for Devices and Radiological Health.

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