[flarets]

"Unlike drugs, implants don’t need to go through clinical trials in most cases."

The artical says "surgical innovations" which probably means instruments and procedures. Also "some implants" are exempt from showing efficacy in clinical trials under HDE for cases in which the patient would have died anyway (e.g. pacemakers).

All medical devices of Class 2 and 3 must go through clinical trials to prove safety and efficacy as part of the FDA IDE. Spinal implants would certainly be Class 3.

Edit: clarification

[tjoff]

> Also "some implants" are exempt from showing efficacy in clinical trials under HDE for cases in which the patient would have died anyway (e.g. pacemakers).

How about if the implant kills the patient?

There was a local story today about a pacemaker where the electrode had failed and he was defibrilated 47 times during 3 hours before the battery ran out.

[flarets]

It depends if the implant does more good than if it wasn't implanted. All regulated devices require post market monitoring by the company and reporting to the FDA. If the data shows harm is being done to patients the FDA can issue a recall.

[tjoff]

That seems like a very slow process. Another story today that implants has caused 83 000 deaths.

I assume/hope they have saved much more lives than that but regardless the types of failures seems to indicate that a lot more could be demanded of these products.

http://www.tellerreport.com/news/---83-000-deaths-in-unsafe-...