Letter to the FDA Criticizing the Decision to Keep the Wingspan Stent System on the Market
January 28, 2013
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Public Citizen sent a letter to the FDA today criticizing the agency’s August 2012 decision to keep a dangerous brain stent, the Wingspan Stent System, on the market after a high-quality clinical trial showed that the device causes death and stroke. The FDA acknowledged in August that the stent was dangerous for most patients, but chose to approve the device for a limited group of patients rather than ban the device outright. Public Citizen condemns the FDA for making the decision without evidence that the device would be any less dangerous for those people in the limited patient group than it is for most patients, and for failing to adequately warn doctors and patients of the deadly risks.
March 25, 2013, Response letter from FDA