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FDA Says No Guarantees New Tissue Containment System Will Lessen Cancer Risks from Power Morcellation

Power morcellator, Contemporary ObGyn

Power morcellator, Contemporary ObGyn

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:

Drs. Noorchashm and Reed

Drs. Noorchashm and Reed

“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.

 

LEARN MORE:

 

New York Times, Op-Ed, July 15, 2015, FDA’s Medical Device Problem
http://www.nytimes.com/2015/07/17/opinion/the-fdas-medical-device-problem.html?smprod=nytcore-iphone&smid=nytcore-iphone-share&_r=0

 

Change.org Petition on the Power Morcellator
https://www.change.org/p/women-s-health-alert-deadly-cancers-of-the-uterus-spread-by-gynecologists-stop-morcellating-the-uterus-in-minimally-invasive-and-robot-assisted-hysterectomy

Mesh News Desk, Report Finds Doctors Still Using Power Morcellator Despite the Risks
http://meshmedicaldevicenewsdesk.com/report-finds-doctors-still-using-power-morcellator-despite-the-risks’

MND August 15, 2014 Power Morcellation, the Risk of Uterine Sarcoma Dissemination
http://meshmedicaldevicenewsdesk.com/power-morcellation-and-the-risk-of-uterine-sarcoma-dissemination

 

5 Comments

  1. Don't give up says:

    I would like to know what does the FDA do why is there an FDA are they there to just say yes ok that sounds good go for it do what you have to do but we will put a warning up in small letters to protect our ass,so all you Docs out there who believe in these new invention’s that haven’t been really approved by us as we don’t know what these things do or can do as we just say yes.
    What is going on here the citizens all over the world have to start getting involved and see what really is going on with the FDA as someone or someone’s just don’t seem to give a shit about the human life and treat the human body as experiments I got involved because of my wife and mesh but you just keep seeing article after articles about horrible things used to treat health problems go wrong but no one has the balls to just take them of the market and that will be it done gone no more fix the problem.
    I’m blown away that some have the arrogance just to believe what some pharmaceutical company tells them most likely this is the Gold Standard of a new product believe us,just to make them at the FDA feel good about them selves and get a pay cheque enough is enough smarten up FDA your there to protect the public not make sales as this is what it’s starting to look like.

  2. Dottie says:

    What happened to the meetings that were supposed to have been on the 6 and 7th in Judge Goodwin’s chambers?

  3. Kitty says:

    I was wondering if all transvaginal hysterectomys are done with this process using the morcelator

  4. Don't give up says:

    Sorry for some of my choice of words in my comment Jane but it seems that The FDA just seems not to give a crap about this I thought the Power Morcellator was taken of the market already just upsets me when I read stuff like this and people can potentially get harmed by the product.

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