A study has found that a stent approved by the U.S. Food and Drug Administration intended to prevent strokes in high-risk patients actually increased the occurrence of strokes after it was placed. Accordingly, testing of the stent was immediately stopped to avoid the risk of further harm caused by the potentially defective product.
According to the New York Times, the stent was approved for limited use by the FDA in 2005 for placement in the brain to hold open blocked arteries. The goal was to prevent disabling and fatal strokes in patients with significantly increased risks of suffering them because of atherosclerosis, or blocked arteries, similar to how stents are used to prevent heart attacks.
Patients receiving the stents in the study recently had a stroke or similar event – a transient ischemic attack – and also had a brain artery that was 70 to 99 percent blocked. Before the stent was placed, their risk of having another stroke within one year was about 23 percent, even with careful management of their risk factors.
Contrary to expectation, the study found that patients with the stents actually had twice the rate of stroke or death after the device was placed than those without stents. More than 14 percent of the patients who received stents had a stroke within the first month, while less than 6 percent of the patients who did not receive stents had strokes within the same time frame.
The dismal results of this study call into question the FDA’s procedure for approving medical devices like these stents because they put patients at such high risk for serious harm and furthercomplications from strokes. As the gatekeepers for medical devices entering the market, the FDA must help ensure that dangerous medical devices and defective products do not reach consumers.