Mesh News Desk, April 7, 2016 ~ Even amid an intense debate about the validity of using a power morcellator and its potential to spread previously undiagnosed cancers, the U.S. Food and Drug Administration today okayed the marketing of the first tissue containment system to use be used with the device.
The PneumoLiner has not been proven to reduce the risk of spreading uterine sarcoma and the FDA will require the manufacturer to state just that.
It’s estimated about one in 350 women have an unidentified uterine sarcoma, sometimes being hidden in a fibroid. A morcellator shreds and removes tissues during a hysterectomy or fibroid removal, but an undiagnosed uterine sarcoma will be spread within the abdomen and pelvis worsening the patient’s chance of a long-term survival.
The PneumoLiner will contain that morcellated tissue. “But only if patients have been appropriately informed of the risks,” says William Maisel, MD with the Center for Devices and Radiological Health, the medical device division of the FDA.
The FDA continues to warn against the use of the power morcellator but has not issued a recall. Doctors and hospitals can use their own discretion on whether or not to continue using it.
Dr. Hooman Noorchashm, a cardiothoracic surgeon, whose wife, Dr. Amy Reed, is fighting cancer following a morcellation procedure, calls the approval “atrocious.” Speaking to Medscape Medical News here, he says:
“I find this a completely astonishing statement. 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. What do they expect? That gynecologists will use their patients as guinea pigs? It’s completely atrocious…. How could they let this device into the marketplace without demanding some sort of clinical study to demonstrate safety?”
Undergoing a morcellation procedure for a hysterectomy in 2013, Dr. Reed’s surgeon shredded fibroids with the morcellator. The small pieces, believed to be benign, were extracted through a tiny laproscopic incision.
One week after the morecellation, she was diagnosed with an aggressive uterine leiomyosarcoma which had now advanced to stage IV.
See the FDA announcement here.
New York Times, Op-Ed, July 15, 2015, FDA’s Medical Device Problem
Change.org Petition on the Power Morcellator
Mesh News Desk, Report Finds Doctors Still Using Power Morcellator Despite the Risks
MND August 15, 2014 Power Morcellation, the Risk of Uterine Sarcoma Dissemination