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Deep flaws in FDA oversight of medical devices, and patient harm, exposed in lawsuits and records

A digital illustration of a cartoon figure hooked up to medical devices.
A colorful, digital illustration in pencil and watercolor shows a cartoon figure hooked up to an array of medical devices. The figure has a device in their mouth, which has caused two teeth to fall out; a glucose monitor on their arm is connected to a cellphone; a ventilator is connected to their lungs; a device is connected to their heart from the inside with battery packs on the outside; a hemodialysis machine causes blood to spurt from a vein unnoticed; and hip and knee implants are broken. (Oona Tempest/KFF Health News/TNS)
UPDATED:

KFF Health News has found that most medical devices, including many implants, are now cleared for sale by the FDA without tests for safety or effectiveness.

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