DECEMBER 23, 2011 ~ The consumer group Public Citizen frequently calls for the recall of dangerous drugs or medical devices including a petition last August calling for the recall of synthetic surgical mesh from the market because of the complication rate and a failure to show a benefit over risk (here). Now in a highly unusual move, former FDA medical device director, Larry Kessler, is joining Public Citizen in asking the Food and Drug Administration (FDA) to recall the Stryker Wingspan brain stenting system. Kessler and Public Citizen claim the device should not be used under the humanitarian device exemption (HDE) that it was approved under because of a concern it can be contributing to fatalities among users.
The Public Citizen petition was filed Wednesday, December 21 (here). It asks the FDA to pulls the stents from the market and revoke Stryker’s 510(k) clearance which put the stents on the market without clinical trials for safety and efficacy. Kessler says the stents have an enormous downside of an elevated risk of strokes and death without enough of a benefit to justify them continuing on the market.
Stents serve to open up narrowed arteries that deliver blood to the brain.
Mass Device reports the Wingspan system was cleared by the FDA in 2005 under a humanitarian device exemption (HDE) however since then, a New England Journal of Medicine study reported the death rate from stroke rose 12.2 percent in the group of patients without stents and 20 percent for the patients receiving the stent medical device.
The Kalamazoo, Michigan-based Stryker (which bought Boston Scientific Neurovascular), recently defended itself against the results from a National Institutes of Health SAMMPRIS study by saying the NIH didn’t use the device as intended.
Kessler writes in a letter (here) , “With the conclusion of the recent SAMMPRIS trial showing that Wingspan has a much higher complication rate than modern medical management, it is imperative that the FDA take swift and decisive action. I have looked at the FDA website and tried to find out whether the Agency has even warned clinicians using a Medical Device Safety Communication. I cannot locate such a notice and would ask the FDA to explain why they have been so silent in the face of this significant trial showing clear concerns about this regulated medical device. I can see no reason why this device should continue to be available. “
Boston Scientific got the Wingspan cleared for marketing after a single trial of 45 patients, according to Public Citizen. The device is cleared for use on no more than 4,000 patients a year and for those who are high-risk for suffering a second stroke.
Public Citizen presented research showing that aggressive medical treatment involving blood thinners and lifestyle changes reduces the risk of stroke and death better than receiving medication and the Wingspan stent. Those results were published in the New England Journal of Medicine in September.
Kessler is now the Professor and Chair in the Department of Health Services at the University of Washington’s School of Public Health in Seattle. #