According to a recent Bloomberg Businessweek article (Jan. 12) by Michelle Fay Cortez, Michael Carome, deputy director of Public Citizen’s Health Research Group and author of a petition to recall the Stryker Corporation’s Wingspan stent, boldly criticized the U.S. Food and Drug Administration (FDA) for not recalling the medical device due to evidence of increased possibility of stroke in certain patients when the Wingspan stent was used.
Following a review last year by an independent panel which stopped a definitive scientific trial of the device due to safety risks, Public Citizen requested FDA pull the stent from the marketplace. Carome said, “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 also said, “To allow any further implantation of this device would be highly unethical, as well as a violation of FDA laws and regulations.”
Michelle Bolek, FDA spokesperson, says the FDA plans to review an addendum to Public Citizen’s original petition and respond directly to Public Citizen. Stryker continues to advocate the use of their Wingspan stent to enlarge narrowed arteries in the brain after drug therapy to do so has proved ineffective.
Stryker Corp. is based in Kalamazoo, Michigan, and reported sales of $366.1 million from their neurovascular products during the first three quarters of 2011. Stryker purchased Boston Scientific Corporation’s neurovascular segment in 2010 and acquired the Wingspan Stent System at that time.