The U.S. Food and Drug Administration’s failure to recall Stryker Corp. (SYK)’s Wingspan stent, used to treat narrowed arteries in the brain, is putting patients at risk, the consumer group Public Citizen said today.
The watchdog organization called on the agency to pull the stent off the market last year after an independent panel halted the first definitive trial of the device on safety risks. Patients with clogged arteries deep in their brains were more likely to have a stroke if the vessels were propped open with the Wingspan stent instead of being treated with drugs, according to the study known as Sammpris.
Leaving it on the market “represents reckless disregard for patient safety,” the Washington-based consumer group said today in an addendum to its petition. The FDA approved the device in 2005 based on a humanitarian device exemption, without evidence that it actually helped patients, said Michael Carome, deputy director of Public Citizen’s Health Research Group and author of the petition asking the agency to recall the Wingspan.
“Given the evidence of significant harm with no evidence of any benefit, there is no justification for any additional patients to be treated with this dangerous device,” Carome said in a statement. “The only way that further use of the device can effectively and definitively be prevented is to immediately remove the device from the market. To allow any further implantation of this device would be highly unethical as well as a violation of FDA laws and regulations.”
Thursday, January 12, 2012
Public Citizen Criticizes U.S. Regulators for Not Recalling Stryker Stent - Bloomberg