The FDA knew of the risk. It’s yet another medical device scandal from the FDA.
A new report from the Government Accountability Office (GAO) details how the FDA tragically underestimated the risk of a device used to remove uterine tumors called fibroids.
The device, called a power morcellator, was approved in 1991; by 2013, it was being used on at least 50,000 women a year. The device consists of a spinning blade used to shred fibroids so they can be removed through tiny incisions in “minimally invasive” surgery.
But for women with fibroids and undiagnosed cancers, the morcellator can spray malignant cells from the uterus into the abdomen and pelvis, spreading the cancer and making it significantly more deadly.
The GAO report notes that, when the FDA approved the device, the agency was aware of this danger but thought the risk was “low.” Hospitals and doctors did not submit adverse event reports to the FDA until 2013, when a high-profile case of morcellator-spread cancer was reported in Boston. After the bad PR, adverse event reports began pouring into the FDA: by 2016, there were 285, and some women had died.
How many thousands of other women were affected or killed by this device between 1991 and 2013? We may never know.
Since becoming aware of the increased danger, the FDA, rather than pull approval for the dangerous device, merely issued a warning about using the morcellator to remove uterine fibroids, with guidance to industry suggesting a similar warning on the box of the device.
New reports have described this scandal as evidence of a weak, passive adverse event reporting system—one that relies too much on doctors and hospitals to report such events to the FDA. As we saw in 2015 with our coverage of endoscopes spreading drug-resistant infections, the problem goes much deeper. The FDA apparently doesn’t want you to have access to natural medicines that are demonstrably safe—but has no problem approving drugs and devices that kill people, so long as they are profitable for industry.
Other articles in this week’s Pulse of Natural Health:
Fake Organics Flooding US Market
Use of Psychotropics Has Doubled
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This morcellator should raise red flags. A spinning blade used internally to break down cancerous tissue? It’s going to spread the cancer.
They wouldn’t use it if they suspected cancer, this happened in someone that had cancer but it was undiagnosed. For most women, this would be a great option for minimally invasive surgery.
obviously not….
The FDA, CDC, EPA, and all the rest of our agencies suck. Their best interests are the corporations or should I say they are the corporations. End them all.
Terminate the FDA (and also about 3 dozen other useless alphabet agencies) and remove the law the prevents the pharmaceuticals and device manufactures from being sued. That is pure cronyism on the part of congress. Threats of law suits used to keep these businesses in line forcing them to make sure what they are producing actually works (and with no side effects).
the FDA has never approved the use of vaccines in the pregnant – to date all vaccines given to pregnant women lack FDA approval; after speaking with the FDA extensively finally they admitted the tests are not something they want an answer to …. this sort of lack of science and ethics is exactly why we do not vaccinate — the science (minus conflict of interest) is totally undone.
I know a woman who had cancer released from one, finite point to racing throughout her body by this device. I hope she is alive and well in spite of the horrible injustice done to her! She had a team that had her on track. She was walking for five miles a day, still teaching part time and on a ketogenic diet. Her gynecologist apologized-wow, after doing this to her! Doctors seldom question the FDA, pharma drugs & devices, yet they escew diet, hormones, vitamins-those things which our bodies need to live. You cannot leave MDs out of this equation.
Roto Rootering cancerous tissue inside a woman’s abdomen. What could go wrong silly????