Medical devices are big, big business to the medical industry. Replacing hips, knees and shoulders, robotic surgery, vaginal mesh, and the implanting of sterilization devices, have become increasingly more common over the years. But these procedures often do not have the desired income of bringing better health to the patient: Artificial metal hips can cause cobalt poisoning, which affects memory and the general nervous system. Vaginal mesh can become embedded in the tissues of the vagina, causing inflammation and illness, and tissues from the mesh can migrate to other parts of the body when attempts are made to remove it. Essure devices have cause a myriad of health problems to hundreds of thousands of women all over the world.
My guess is that medical devices comprise a high percentage of all iatrogenic illness or impairment. Iatrogenic illness is medically-induced illness.
‘The Bleeding Edge’ Netflix Documentary, 2018, reveals much about the dubious pre-market testing regulations of the FDA on medical devices, and the risk which people take in having new devices implanted into their bodies.
Many people, who might previously have unwittingly agreed to try ‘innovative technology’ without any evidence of its safety, could be spared an expensive and agonizing outcome because of ‘The Bleeding Edge’ and its participants’ stories.
Note: The testing of medical devices by the FDA is not as stringent as for the testing of drugs, (though much could be said about the drug issue, too) and if your new product existed prior to 1976, or is similar to an earlier, approved prototype, even though that prototype has been withdrawn from the market, then your new product will be automatically approved. This process of approval is known as 510{K}.
The Bleeding Edge movie has already had an impact on the medical industry: Soon after its premiere very recently, Bayer agreed to withdraw the medical device known as Essure from the US market by the end of 2018. A group of Essure victims had met with the FDA Commissioner Gottlieb in February 2018, but the only effect this had had was that doctors had to warn their patients about the risks of Essure implants. So – that Bayer at last have agreed to stop selling Essure by the end of this year is a real triumph for the Essure campaigners and for the makers of the Netflix documentary.
Damaged Essure victims have fought a long battle to have Essure banned in America. Thousands of women have had devastating consequences to their health and marriages after the implanting of the sterilization device called Essure. Yet their complaints have been ignored for many years by the FDA, who have stuck by their product.
The movie gives more than a hint at just why it is so difficult to get the FDA to remove faulty products from the marketplace, yet it is so easy to get them approved without proper investigation to begin with: The current FDA Commissioner, chosen by Trump, is Commissioner Gottlieb. This man is well known in the medical industry. He served in the FDA from 2003 to 2007, and his company, ‘New Enterprise Associates’ funded the development of the Essure sterilization device.
Gottlieb’s first action after gaining power of the FDA was to elect a new lead attorney, and this new attorney happens to be the same lawyer who represented Bayer against patients harmed by medical devices.
The movie points out that many of the FDA executives come from medical industry and return to medical industry after serving a few years on the FDA. They return to industry, and the market place, after being schooled in the way of least resistance in getting their new products approved by the FDA.
Quote from the movie: “Thank God it’s Gottlieb” said one investment analyst, when Trump announced his choice of Gottlieb to run the FDA.