Larry Kessler, a former FDA official is joining the consumer watchdog group Public Citizen, in asking the federal government to withdraw a Stryker medical device associated with increased rates of stroke and death.
The public safety advocates Public Citizen says a recent medical study funded by the National Institutes of Health found a 2.5-fold increase in stroke or death with the Wingspan stent system.
This medical device is designed to prevent stroke by improving blood flow to the brain. The group asks the FDA to remove the device from the market in a petition filed this week and co-signed by a former executive from the agency's device division. According to Professor Larry Kessler, "I can see no reason why this device should continue to be available" he states in a letter accompanying the petition. Kessler spent many years in FDA's device division.
The FDA approved the device in 2005 as part of the controversial 510(K) process and under a special program that grants speedy approval to devices for rare diseases and conditions. Stryker Corp., recently acquired the stent from its original manufacturer, Boston Scientific.
Wingspan consists of a small, mesh metal tube or stent that is placed in the affective brain blood vessel, promoting blood flow through the arteries to the brain. The device was approved for patients who have had one stroke and are at risk for additional strokes.
A study published in September 2011 New England Journal of Medicine found that patients treated with the device were more likely to suffer a second stroke or die within 30 days, compared to patients treated with a combination of blood-thinning medications.
Public Citizen's petition argues that the FDA should remove the device from the market, and suggests it should not have been approved in the first place. Under the FDA's so-called Humanitarian Device Exemption program, medical implants can be cleared based on preliminary evidence, so long as there is a "reasonable basis" to conclude that the device's benefits outweigh its risks.
Using this program, Public Citizen's Dr. Sidney Wolfe writes that Boston Scientific "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."
Shezad Malik is an Internal Medicine and Cardiology specialist, a Texas Medical Doctor (retired) and Defective Medical Device and Dangerous Drug Attorney. Dr. Shezad Malik Law Firm has offices based in Fort Worth and Dallas and represents people who have suffered catastrophic and serious personal injuries including wrongful death, caused by the negligence or recklessness of others.