“The research has shown that these devices are not helping patients and, in fact, they are sometimes causing additional harm and even death,” Briskman said. “The Food and Drug Administration needs to review this product to determine if it is safe for consumers or if the product should be off the market.”
The Wingspan Stent System, which was approved by the FDA in 2005, is a mesh tube placed into the narrowed arteries of a previous ischemic stroke victim. This is intended to help supply blood flow to the brain. A former FDA official started a petition last December to raise awareness concerning the Wingspan System because research that shows that it was not adequately studied before approval and is dangerous.
“Many want this medical device recalled, and I think the FDA needs to explain how a device so clearly unfit for use could have been approved in the first place,” Briskman said.
The FDA’s standards for approving Humanitarian Use Devices like the Wingspan Stent System are lower than they are for other devices. Therefore, Boston Scientific did not have to prove the Wingspan’s effectiveness before the FDA approved the device, according to Public Citizen, a nonprofit watchdog group.
A post-market study by the National Institutes of Health has shown that the risks from the device outweigh the probable benefits compared with other forms of treatment.
“Doctors need to follow up on patients who have this stent system and patients should consult a qualified attorney if they have had any serious complications with this device,” Briskman said.
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