Approval of untested ‘safety’ device promotes use of risky procedure
One of the most frightening pieces of medical equipment around may be set to make a big comeback.
And you or a woman you love could be right in harm’s way.
For ages now I’ve been warning you about the risks of laparoscopic power morcellators. They’re used to chop up uterine fibroids and even to perform hysterectomies.
But they also can fling undetected cancer cells all over your body, and are considered so dangerous that some docs won’t use them any more.
Now the FDA has approved a new “containment system” that in theory will make problems with power morcellators a thing of the past.
The only problem is… no one really knows if that’s true. Not the FDA, and especially not the women who may be given a song and dance about how easy and “safe” morcellation has now become.
Dr. Amy Reed is one of those living the morcellation nightmare firsthand.
Three years ago that procedure was used to remove her uterine fibroids. And it left her with stage IV cancer.
That’s when Dr. Reed and her husband, cardiothoracic surgeon Dr. Hooman Noorchashm, started on a crusade to warn others about the danger.
And fighting device manufacturers, doctors and even the FDA hasn’t been easy.
Two years ago, Dr. Noorchashm wrote a letter to members of a Senate committee saying that continuing to use morcellation is a result of a failure of education, ethics and responsibility at the “very highest levels” of the healthcare industry.
Well, it looks like things have totally failed once again.
A few months ago, the FDA approved a device called the PneumoLiner containment system to be used during morcellation procedures.
And here’s where, as Dr. Noorchashm puts it, we’ve entered the “Twilight Zone.”
No testing was required to see if the PneumoLiner actually works to prevent the spread of cancerous tissue, said the doctor, and that’s despite “the agency’s full knowledge” of the dangers of morcellation.
He also points out that in the FDA’s press release, issued when the device was approved this spring, the agency makes it very clear (yes, it actually says “we want to be clear”) that the device has “not been proven to reduce the risk of cancer spread during surgery.”
So, why is this device even on the market?
I think it’s quite clear that the only reason this untested baggie system was approved is to allow women to be deceived into thinking that morcellation has somehow been “fixed” and is now safe.
In other words, a giant kowtow to an industry that’s putting untold numbers of lives in danger.
Sure, there’s a boxed warning saying that the device “has not been clinically demonstrated to reduce the risk” of morcellation. But how many times do you think a surgical patient, drugged and on a table is going to see the box a surgical device came in?
The FDA also says that the potential risks with the PneumoLiner “should be shared with patients.” But that’s totally voluntary. Doctors can share it, or not. It’s up to them.
And, as I warned you years ago, doctors often try to convince women to go along with morcellation, saying it’s much faster and easier and has a quicker recovery time than a standard operation does. And now, some may even say it’s safe.
But remember, there’s no evidence to prove that’s true.
Morcellation procedures are still as risky as ever. And that’s the only thing that’s perfectly clear.
Sources:
“How the FDA may be repeating its morcellator mistakes on another device” Hooman Noorchashm, M.D., Ph.D., Amy J. Reed, M.D., Ph.D., August 10, 2016, philly.com
