FDA’s Failure to Recall Stryker Wingspan “Reckless”: Public Citizen

A consumer watchdog group says that the FDA is acting recklessly by failing to heed requests to recall the Stryker Wingspan, a brain stent that is supposed to prevent strokes. 

Public Citizen urged federal regulators to pull the stent from the market last month, highlighting that clinical trials have shown that the device increases the risk of strokes and deaths instead of preventing them. However, the group says that the FDA and Stryker have made comments publicly since the petition was filed that indicate they have no intention on issuing a Wingspan stent recall.

FDA officials and Stryker raised Public Citizen’s ire by suggesting that the subjects of a study that found an increased risk of strokes associated with the Wingspan were not comparable to patients for whom the Wingspan was actually intended to treat.

The Stryker Wingspan is a small mesh tube implanted in narrowed arteries to the brain to prevent strokes in people who have already suffered one. The stent was approved as a humanitarian use device (HDE), which allowed Boston Scientific, the original designer, to get it approved with only one uncontrolled trial of 45 patients, Public Citizen stated.

In April, the U.S. National Institute of Neurological Disorders and Stroke (NINDS) ordered a halt to further clinical trials of the Wingspan after almost 15% of the patients implanted with the Wingspan suffered strokes or died in the first month. The trial included 451 patients, half of whom were treated with the Wingspan and a drug regimen of Plavix and aspirin, and the other half treated with just drugs alone. Only 6% of those given just the drugs suffered strokes or death.

An independent monitoring board stopped the trials, saying it was unethical to continue. The findings were published in September in the New England Journal of Medicine.

“Due to the FDA’s unconscionable decision to delay withdrawal of the agency’s approval of the Wingspan Stent System HDE, the continued use of this device exposes patients to an unacceptable risk of serious harm, including death,” said Michael Carome, deputy director of Public Citizen’s Health Research Group. “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.”