April 3, 2014
Public Citizen to FDA: Take Enforcement Against Companies Manufacturing and Distributing Misbranded Medical Devices
Stryker and Boston Scientific Published False, Misleading Information, Misbranding Wingspan Stent System
WASHINGTON, D.C. – The U.S. Food and Drug Administration (FDA) should take immediate action against two medical device companies, Stryker Neurovascular and Boston Scientific, for publishing false and misleading information on their websites that misbrands Wingspan Stent System devices, Public Citizen said in a letter today.
The Wingspan Stent System is a medical device used to open narrowed arteries in the brains of patients with narrowing blood vessels who have experience repeated strokes. Boston Scientific, which obtained initial FDA approval in 2005 to market the device as a humanitarian use device, currently manufactures it for sale and distribution by Stryker.
The device is described as safe and effective on Stryker’s website; however, the website contains an inaccurate disclaimer and omits a critically important report that found dangers for patients using the device.
The disclaimer on Stryker’s website fails to include restrictions on use of the device that were imposed by the FDA in August 2012. The restrictions narrowed the scope of patients eligible to have the device implanted in their brains. By such omission, Stryker provides a falsely broader indication for the Wingspan Stent System than is currently authorized by the FDA, Public Citizen told the agency.
Additionally, the Stryker website lists published reports regarding research pertinent to the Wingspan Stent System; however, it omits the critically important results of the Stenting and Aggressive Medical Management for Preventing Stroke in Intracranial Stenosis (SAMMPRIS) Study. This study is the only large, prospective, randomized, well-controlled clinical trial conducted to date involving the device, and it demonstrates a greater than two-fold increase in the rate of stroke or death in subjects receiving the stent combined with aggressive medical management — which included drugs for treating high blood pressure, lowering cholesterol levels and preventing blood clots — compared to patients who received only aggressive medical management.
Public Citizen also describes false and misleading statements by Boston Scientific on its website.
“Under federal law, a medical device that is distributed with false or misleading information in its labeling is considered misbranded,” said Dr. Michael Carome, director of Public Citizen’s Health Research Group. “By posting only favorable studies and failing to include a complete and accurate disclaimer on its website regarding uses of the Wingspan Stent System, Stryker’s webpage labeling for the device seems to fit the statutory definition of misbranding. The FDA needs to step in and enforce the law.”
Because of the results of the SAMMPRIS study, Public Citizen in December 2011 petitioned the FDA to remove the Wingspan Stent System from the market. Instead, the FDA restricted its use.
“Given the serious, life-threatening safety risks associated with the Wingspan Stent System and the lack of sound evidence demonstrating effectiveness, it is imperative that the FDA takes immediate action to ensure that complete and accurate information is disseminated by Stryker and Boston Scientific to health care providers, patients and the public,” said Carome.
The letter also urges the FDA to update its website because the current professional labeling for the Wingspan Stent System is not available.