WHO'S WATCHING THE FDA?

Lucas,

A medical device that is implanted inside your body should be at least as safe as a pill you ingest, right?

But the Food and Drug Administration's (FDA) standards for allowing new medical devices on the market are significantly lower than its standards for approving drugs.

Medical devices can save lives. But each year, thousands of patients suffer severe, painful, life-threatening complications caused by untested implanted and high-risk devices.

Tell Congress: End the absurd double standard. High-risk medical devices, including those that are permanently implanted, should be at least as safe as pharmaceuticals.

Also, real stories can help us advocate for stronger medical device standards. If you or someone you know has suffered because of an implanted medical device, follow this link to share your story today .

Many devices allowed on the market by the FDA have caused great alarm because of their unreasonable safety risks. For example, medical studies show that many women who received certain types of implantable surgical mesh during surgery for pelvic organ prolapse suffered serious infections, severe chronic pain and other life-altering complications. (1)

Other examples include: the Wingspan Stent used to prevent strokes but shown to actually double the risk of death and stroke (2) and metal-on-metal hip implants that can release metal debris in patients' bodies and damage muscles and other soft tissue. (3)

These are just a few examples of medical devices that fell through the cracks of our nation's regulatory system, injuring or killing thousands of patients.

The time for scrutinizing these devices is BEFORE they're cleared or approved by the FDA, not after they've already been implanted in hundreds of thousands of patients.

Please tell your members of Congress that the device approval process should be strengthened to protect the public.

Thanks for all you do,

Rick Claypool
Public Citizen's Online Action Team
action@citizen.org