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FDA Approves Morcellation Device, With a Warning

Tissue containment system doesn't reduce cancer-spreading risk, agency says.

Published: April 8, 2016

REMAINS RISKY Tissue containment doesn't eliminate morcellation's hazards.

A tissue containment system that isolates uterine tissue during laparoscopic power morcellation has received the FDA's approval for U.S. sales, but the approval comes with a caveat.

The PneumoLiner, manufactured by the Irish firm Advanced Surgical Concepts, must be marketed with the warning that it has not been proven to reduce the risk of spreading cancerous tissue.

Recent studies have raised concerns that power morcellation during fibroid surgery may scatter cancer throughout the abdomen in the 1 out of 350 patients who have unsuspected uterine sarcomas, leading the agencies and patient safety advocates to advise extreme caution.

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

For critics of morcellation, and of the FDA's response to its potential complications, this warning isn't enough.

"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," says Hooman Noorchashm, MD, who has called for a ban on the procedure after his anesthesiologist wife allegedly suffered its cancer-spreading effects.

David Bernard


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