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Preemption is Dumb: Reason #11,493

The Menaflex Collagen Scaffold orthopedic knee device received fast track approval from the FDA to repair and reinforce the meniscus, a C-shaped disk in the knee that acts as a cushion and helps lubricate the joint. Last week, the FDA said approving this device was a mistake. The Food and Drug Administration has taken the unusual step of admitting that it made a mistake when it approved a device used to repair damaged knees.

The “bravo to the FDA for admitting a mistake” is somewhat lessened because they can point to President Bush’s FDA for the mistake. Still, the rank-and-file FDA folks are largely the same, at least those who have not jumped on the revolving “FDA to Industry Shuttle Bus.”

Now, patients with this device are looking at surgery to have the device removed because it has been absorbed and replaced with new tissue.

This will not be the next big class-action lawsuit. This knee device to date has been implanted in approximately 50 people in this county. But what this underscores is that the FDA is not the watchdog the pharmaceutical industry claims. The “FDA approved” stamp does not mean the product is safe and could not and should not have been made safer.