When a new medical device is approved by the U.S. Food and Drug Administration, the medical community and patients alike often have high hopes that the product will significantly improve the quality of life for many folks in Illinois and throughout the entire U.S.
But when further research reveals that a device may not be as safe or effective as initially thought, the medical community must be aware of any changes in restrictions and regulations. A hospital’s failure to inform surgeons about new restrictions on medical devices and ignoring warnings about medical products can cause harm to patients. Patients could suffer injuries or a wrongful death when a medical device is not used as recommended.
This week, the FDA announced that it is adding restrictions on a device that is commonly used to treat patients who suffer from clogged brain arteries. Stryker’s Wingspan stent has been linked to increasing patients’ risks of suffering strokes or fatal injuries.
It is extremely important that Joliet doctors take these new restrictions into consideration when treating patients who suffer from clogged brain arteries. The FDA recommends that the devices, which have been approved since 2005, only be used to treat patients who have not been able to benefit from any other type of treatment. Basically, Stryker’s Wingspan stents should only be used by doctors as a last resort.
Recent studies have shown that the stents, which are supposed to help blood flow through brain arteries, can increase a patient’s risk of suffering a stroke or death. Patients who are treated with blood-thinning medications have a lower risk of stroke or death, researchers say. One safety group requested that the device be pulled from the market, but the FDA still believes that some patients may benefit from using the stent.
Although the FDA is restricting how it allows Stryker to sell and label its device, doctors will still be able to use the devices in patients as freely as they wish. For the safety of patients, it is imperative that doctors do carefully take into consideration the FDA’s new restrictions.
Source: USA Today, “FDA restricts use of Stryker brain stent,” Aug. 8, 2012