HEALTH AND SAFETY

» Drug, Devices, and Supplements

» Physician Accountability

» Consumer Product Safety

» Worker Safety

» Health Care Delivery

» Auto and Truck Safety

» Global Access to Medicines

» Infant Formula Marketing

 

More Information on the Wingspan Stent System

Letter to the FDA Criticizing the Decision to Keep the Wingspan Stent System on the Market

January 28, 2013

View as PDF.

Public Citizen sent a letter to the FDA today criticizing the agency’s August 2012 decision to keep a dangerous brain stent, the Wingspan Stent System, on the market after a high-quality clinical trial showed that the device causes death and stroke. The FDA acknowledged in August that the stent was dangerous for most patients, but chose to approve the device for a limited group of patients rather than ban the device outright. Public Citizen condemns the FDA for making the decision without evidence that the device would be any less dangerous for those people in the limited patient group than it is for most patients, and for failing to adequately warn doctors and patients of the deadly risks.

March 25, 2013, Response letter from FDA

Copyright © 2016 Public Citizen. Some rights reserved. Non-commercial use of text and images in which Public Citizen holds the copyright is permitted, with attribution, under the terms and conditions of a Creative Commons License. This Web site is shared by Public Citizen Inc. and Public Citizen Foundation. Learn More about the distinction between these two components of Public Citizen.


Public Citizen, Inc. and Public Citizen Foundation

 

You can support the fight for greater government and corporate accountability through a donation to either Public Citizen, Inc., or Public Citizen Foundation, Inc.

Public Citizen lobbies Congress and federal agencies to advance Public Citizen’s mission of advancing government and corporate accountability. When you make a contribution to Public Citizen, you become a member of Public Citizen, showing your support and entitling you to benefits such as Public Citizen News. Contributions to Public Citizen are not tax-deductible.

Public Citizen Foundation focuses on research, public education, and litigation in support of our mission. By law, the Foundation can engage in only very limited lobbying. Contributions to Public Citizen Foundation are tax-deductible.