Dec. 21, 2011
Medical Device Significantly Raises Risk of Stroke or Death, Should Be Recalled
Public Citizen and a Former FDA Official Call on FDA to Withdraw Approval of Wingspan Stent System Because Benefits Do Not Outweigh Risks
*Updated to reflect name of company that currently manufacturers the Wingspan device.
WASHINGTON, D.C. – The Food and Drug Administration (FDA) should immediately withdraw its approval of a medical device that is supposed to prevent strokes in people who already have had one because a recent study found that the device actually increases the risk of subsequent strokes and death, Public Citizen and former FDA official Dr. Larry Kessler said in a petition sent today to the agency.
Additionally, the FDA should order the device’s manufacturer, Stryker Medical*, to recall all unused Wingspan Stents Systems because, when combined with aggressive medical treatment, they provide no additional benefit but cause significantly more harm than safer aggressive medical treatment alone, the petition said.
Each year in the U.S., approximately 700,000 patients experience an ischemic stroke, and 240,000 have a transient ischemic attack (which causes stroke-like symptoms). The Wingspan Stent System, approved by the FDA in 2005 as a humanitarian use device, is used to place a stent (a small wire mesh tube) in narrowed arteries that supply blood to the brain in patients who have suffered a stroke or transient ischemic attack and remain at high risk of stroke. Because the FDA’s rules for approval of a humanitarian use device (HDE) are less stringent that those for other medical devices, Boston Scientific did not have to provide evidence that the Wingspan Stent System was effective prior to its approval. In fact, the manufacturer was able to gain marketing approval based on a single, uncontrolled trial of just 45 patients that was not designed to demonstrate whether the device was more effective or even safer than medical therapy alone.
The new study, funded by the National Institutes of Health (NIH), proves that some of the key conditions upon which the Wingspan Stent System was approved as a humanitarian use device cannot be met. For example, there is no longer “a reasonable basis from which to conclude that the probable benefit to health from the use of the device outweighs the risk of injury or illness, taking into account the probable risks and benefits of currently available alternative forms of treatment [in this case, aggressive medical treatment with drugs].”
“I understand that the FDA needs to use its regulatory authority in flexible and not dogmatic ways, and granting of HDEs when data about safety and effectiveness are not complete is a legitimate exercise of regulatory authority,” Kessler – the former director of the FDA’s Center for Device Evaluation and Radiologic Health (CDRH) Office of Surveillance and Biometrics, former director of the CDRH Office of Science and Engineering Laboratories and now a professor in the University of Washington’s School of Public Health – said in a letter to Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, supporting the petition. “However, for that flexibility, the FDA must realize it has an equally important duty to move swiftly to make regulatory changes and announcements when device problems are uncovered. These compelling post-market data about the Wingspan stent provide an opportunity for the FDA to show to industry, the clinical community and most of all to patients that the agency is serious about exercising its authority by withdrawing the HDE immediately and insisting on a recall to ensure the devices on the U.S. market are both safe and effective.”
Although several studies of the Wingspan Stent System were conducted after the FDA approved it, they were not adequately designed to evaluate the effectiveness of the device compared to medical therapy alone, the petition said. However, they did demonstrate that the device comes with substantial risk of great harm.
The well-designed, NIH-funded study published in September 2011 in the New England Journal of Medicine showed a more than 2.5-fold increase in strokes or death caused by the Wingspan system. For every 11 patients treated with the Wingspan system and aggressive medical therapy, one additional patient dies or suffers a stroke within 30 days, compared to patients treated with aggressive medical therapy alone, the study found. Aggressive medical treatment included medications for high blood pressure, elevated cholesterol and diabetes, antiplatelet drugs (aspirin and clopidogrel) and management of other stroke risk factors such as smoking and being overweight.
“The message from the trial could not be clearer: The risks of this intervention substantially outweigh any potential benefit to patients,” said Dr. Michael Carome, deputy director of Public Citizen’s Health Research Group. “The device poses an imminent threat of serious harm to patients and should be pulled from the market without further delay.”
Public Citizen calls on the FDA to immediately withdraw approval of the Wingspan system’s humanitarian device exemption and to order the manufacturer to recall the device.
Public Citizen is a national, nonprofit consumer advocacy organization based in Washington, D.C. For more information, please visit www.citizen.org.