Woman’s abdominal implant erupts from her leg; experts call for FDA reforms

Suspicious deaths, perforated sheep veins went unreported before device hit market.

See full article...

 

[ChicagoCurmudgeon]

This is a pretty nasty violation of FDA regulations. The requirement to report problems is pretty strict about serious injury or death.

"Manufacturers: Manufacturers are required to report to the FDA when they learn that any of their devices may have caused or contributed to a death or serious injury. Manufacturers must also report to the FDA when they become aware that their device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur."

I did some work on medical device as an attorney. In most states the attorney would be permitted to break the duty of confidentiality to disclose the problem. I would have if the threat of doing so did not prompt the client to make the disclosure themself.

(edited to fix the second link)

 

[ChicagoCurmudgeon]

No person will answer for this, ever. Cook Medical will be fined 1% of the profit made on it. Politicians will blame the other party.

I think you are missing out counting the injury and wrongful death lawsuits. The kind of information coming out is not only the stuff of losing the case but having punitive damages stacked on top of them.

 

[ChicagoCurmudgeon]

I get that double blind randomized trials with a control group are the gold standard statistically. But I'm struggling to figure out how you would do that while retrieving an devices that had been implanted. Perform surgery on half the participants, but don't actually implant the device?

In this case, I think the control group is the general public?

It depends. Where it unethical to leave people untreated the control group is treated with the industry standard of care. For example, cancer patients are not left untreated.