I recently watched this documentary called, "The Bleeding Edge". It was about faulty medical devices and how these devices were able to land on the market. One interesting example it showed was hip replacements.
Currently, one of the options for hip replacements is to use cobalt. It was advertised to be the most effective and longest-lasting material to use. The person who has advocating to educate surgeons to NOT use cobalt was a surgeon himself; he got a cobalt hip replacement and suffered neurological consequences. He was starting to have Alzheimer's/Dementia-like symptoms and had a severe mental relapse.
He later discovered that the cobalt used for his hip replacement was seeping into his blood and he had 100x the normal amount of cobalt in his blood. His health improved after removing the cobalt hip.
He did studies on his own patients (he was an orthopedic surgeon) and did scans of the brains of his patients and saw that patients with cobalt hips had scans that are similar to Alzheimer's patients.
It was interesting to learn that the FDA regulates both drugs and medical devices but the latter has been much more profitable and often times much more dangerous.
I found the relevant paper on neuropsychiatric symptoms from cobalt joint replacements (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5259873/). It seems like not only was the cobalt leeching out into the patient's blood, but so was the chromium. As a knitter and spinner, I've always been warned off using chromium dyes for yarn dyeing (even though they give much brighter colors) because they are so toxic in comparison to alum-fixed dyes. Although the sample size in the above study is very small (the researchers only got post-revision chromium and cobalt measurements for two patients), in both those patients the chromium levels remained high even after revision. Clearly the FDA ought to reconsider their approval of these replacements.
ReplyDeleteIt's really scary to think that these sorts of devices are being approved without the full extent of their effects being known but then again, it would be difficult to realize what the effects might be, especially if they take years to fully develop. This article published earlier this year (https://www.drugwatch.com/news/2017/12/12/new-fda-medical-device-approval-process-will-lower-bar/) states that a newer approval process (they say it's like a more streamlined version of the 510k process) will allow for the FDA to make devices available even while they are gathering data on unintended side effects. While it does look like this website is a rather alarmist one, I can't help but think about what that might mean, especially since the documentary stated that over 70 million Americans have had devices implanted over the last ten years. There have been multiple lawsuits over the last few years about medical devices (the first one that comes to my mind is pelvic mesh), so it makes me wonder why they would want to streamline the process even further.
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