The FDA has known for almost three decades that medical devices used to make hysterectomies and uterine fibroid removal easier could end up killing patients.
That’s what was discovered in a just-released GAO report about these devices, called power morcellators.
Along with that, the study detailed how hospitals dropped the ball when it came to sending the agency a simple report — one required by the FDA — that could have saved untold numbers of lives.
While it would be bad enough just to review the failures of this so-called “watchdog agency,” what makes the report even harder to stomach is that these devices are still in use.
In spite of all the frightening things that have come to light over the past couple years, the FDA has yet to take them off the market.
And that means you or someone you love might still be in jeopardy of becoming the next victim.
Despite the fact that power morcellators have been in use since 1991, it took a husband-and-wife team of doctors to sound the alarm about morcellators three years ago.
Surgeons told patients they would make operations easier and shorten hospital stays. But here’s what else they can do: spread a hidden cancer throughout a woman’s body by chopping up or shredding fibroids or the uterus itself.
That’s what happened to Dr. Amy Reed, an anesthesiologist at Beth Israel hospital in Boston. She had fibroid tumors and her doctor sold her on the idea of simply chopping them up using morcellation surgery. Then, the tissue could be
extracted through a tiny incision.
But Dr. Reed also had a cancer, the kind that is almost never discovered until being surgically removed.
And after the morcellation procedure, Dr. Reed found herself practically battling stage 4 cancer overnight. That’s when she and her husband, Dr. Hooman Noorchashm, went to work so that every woman out there would know about the risk of
Of course, the big question is: why didn’t the FDA get involved sooner? And how did these devices ever get approved in the first place?
According to the new GAO study, the FDA knew full well that if a woman had a hidden cancer, sending it flying around her body with a morcellator would put her life at risk. And it has known that since 1991!
But, the FDA said, the danger was considered “low,” and put the issue on the back burner, since no adverse-event reports were ever sent in.
Soon after Dr. Reed’s personal account was publicized, however, hundreds of adverse-event reports came flooding into the FDA. By September of last year, there were close to 300, with more arriving all the time.
Hospital heads contacted by Medscape said they didn’t think it was necessary to report what was happening — women who blithely went in for “simple” surgery and came out with a deadly cancer diagnosis — because the devices were not
defective. They were working exactly as they were designed to.
But that’s not all.
Because power morcellators wouldn’t have been on the market to begin with if not for the most absurd, lax and industry-friendly FDA approval process there is, called 510(k).
That’s how medical devices are approved by the agency. And it isn’t much — in fact, safety trials are not required. All a company needs to do is show that what they want to put out is “substantially the same” as something else
For power morcellators, that was a “similar” device used in orthopedic surgery, not hysterectomies! But the FDA bought it hook, line and sinker, and the first morcellator hit the market 26 years ago.
After that, it was an even easier piece of cake to get another power morcellator on the shelf…and another…and another. All in all, 25 types of morcellation devices were “approved” by the FDA, putting millions of women in
And when all is said and done, the only change made is the requirement that the boxes these devices now come in have a warning, and doctors and patients are “encouraged” to report any problems to them.
Well, thanks for nothing, FDA.
Because morcellation procedures are just as potentially deadly as they’ve ever been.
And it’s up to us to tell that to every woman we know.
“Why the FDA took 23 years to warn about morcellators: GAO report” Robert Lowes, February 10, 2017, Medscape, medscape.com