The consumer group Public Citizen has asked for a Stryker brain stent recall as the evidence grows that it causes heightened risk of stroke and death. Public Citizen is calling for the recall because it believes that the Stryker brain stents are doing more harm than good because “combined with aggressive medical treatment, they provide no additional benefit but cause significantly more harm than safer aggressive medical treatment alone.”
Public Citizen carries with them a heavy hitter, former FDA medical device director Larry Kessler who also agrees that the FDA needs to pull these brain stents off the market and revoke their 510(k) backdoor clearance.
These Stryker brain stents are used by cardiac surgeons to open blocked arteries. Designed to prevent stroke and death, they may actually increase the risk of stroke and death. A New England Journal of Medicine study found that patients who got brain stents were found to have twice the rate of strokes and death compared to those without brain stents.
These brain stents got in through a backdoor. This stent, called the Wingspan system, cleared under the FDA’s humanitarian device exemption pathway in 2005.
Let’s forget for a second whether the 510(k) is an awful idea in general or even in this case. Should these brain stents be recalled? That is what matters now. Unless there is some incredible evidence to contradict this “twice the risk” data, let’s pull these things off the market.