- Hip and knee replacements containing cobalt (metal on metal). The cobalt makes its way into patients’ bloodstreams. Not only does it damage the tissues around the implant, it affects patients' brains and causes dementia, tremors, blindness, and other neurological problems.
- Essure, a metal contraceptive device that’s inserted into the fallopian tubes. Many thousands of women have been made seriously ill, probably for their lifetimes. There’s no fix: when trying to remove it, the device breaks apart and pieces are left in their bodies.
- A surgical mesh used to repair pelvic floor problems, such as incontinence. When used as a sort of sling around the bladder and vaginal area, the mesh shrinks, degrades, perforates nearby organs, and other horrors. Like Essure, it is nearly impossible to remove the entire mesh.
- The DaVinci robotic surgical instrument. It has caused plenty of botched
surgeries, including burns, tears, organ punctures, internal bleeding and
infection and has damaged blood vessels, bowels, bladders, vaginal cuffs, urinary tracts,
kidneys and other tissues.
Manufacturers can get these (and many others) quickly to market because of the FDA's fast-track process—known as a
510(k), which exempts products from full review if they are "substantially
equivalent" to ones already on the market. It does not require
submitting clinical data demonstrating safety and effectiveness There’s plenty of politics and money involved.
As far as I can tell, the only way to be sure a device
is safe is if it has a substantial track record and has been used on thousands
of patients without adverse effects. Older is better.
For an introduction to this blog, see I Just Say No; for a list of blog topics, click the Topics tab.
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