FDA’s Smart Decision to Limit Use of Brain Stents

After thorough investigation, on August 8, 2012 the FDA announced that it will be restricting the use of Stryker brain stents. These stents have been used to prop open narrowed brain arteries in patients who suffer from blockages or clogging of these vital passages. However, the risks may have a greater negative impact that outweighs the possible benefits that these stents provide.

Although commonly implemented in patients who are prone to strokes, according to the U.S. Food and Drug Administration, these brain stents may drastically increase the risk of strokes in certain populations. Seems a bit counterproductive, right? Well, the FDA isn’t the only group advocating change for the brain stents. Public Citizen, an organization devoted to keeping the public safe, designated an entire petition for removing this threat from the market.

Research conducted by the group illuminated the fact that patients who used the Stryker stent products were over two times more likely to be subject to a stroke, or even fatalities, than those who only used blood-thinners for their condition. For patients hoping to reduce their chance of experiencing these serious events, staying away from the stents would seem to be a no-brainer.

Nevertheless, the FDA believes that brain stents could successfully improve the situation of some patients, and, for this reason, has left the decision-making up to the doctors.  This choice has become quite the controversy, as some claim that stents will be given to the same patients at before, continuing to endanger patients who suffer from rare, stroke-causing conditions.

To prevent this issue, the FDA suggests that the stent should only be given to patients who have a history of several strokes, and have not experienced any stroke-related symptoms in the past week. Although it may not be possible to fully regulate who receives the stents, patients and doctors must implement Stryker brain stents according to their own discretion.