When Kathleen Yaremchuk, Chair of the department of otorhinolaryngology (ear, nose and throat) at Henry Ford Hospital in Detroit, began getting calls about mysterious cases of respiratory distress, she launched a study to figure out what was going on.
All these patients, it turned out, had a small device implanted in the top of their spines to relieve pain. The object, used to hold a protein that stimulates bone growth, was cleared for sale by the Food and Drug Administration in 2003 without clinical testing in humans.
When Yaremchuk and her colleagues reviewed the records of all 260 patients implanted with the device at Henry Ford Hospital between 2004 and 2009, they found that a significant number developed airway obstruction, trouble swallowing and respiratory failure, in some cases leading to death.
The neck implant is just one of the products associated over the past decade with 1.7 million injuries and more than 80,000 deaths.
A searing global investigation last year by the International Consortium of Investigative Journalists places much of the blame on significant failings in the FDA’s oversight. The agency’s laissez faire attitude has resulted in artificial hips that cause cobalt poisoning (which can damage the heart and brain); surgical mesh that cuts through flesh and organs, causing infections and haemorrhage; and defibrillators that repeatedly shock patients beyond human endurance.
Safety problems have led to recalls of devices implanted in hundreds of thousands of people. And the devices can be difficult or impossible to remove if they go bad
No wonder many patient advocates cheered when the FDA announced in November that it planned to make “transformative” changes in the way more than 80% of medical devices are cleared for sale in the United States. But the promised transformation is mere window dressing. Two key loopholes still exist, allowing most products to be approved for sale without clinical trials in humans.
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Source: The Washington Post, 4 January 2019