Medical Device Safety
The Bleeding Edge documentary on Netflix examines the the $400 billion medical device industry and the profit-driven mind-set that rushes implanted devices into the marketplace with proper clinical trials.
The medical device industry's troubling lack of regulation is discussed on HBO's Last Week Tonight with John Oliver.
We need your help to advocate for safe medical devices.
In the US, the current approval process and loopholes for medical devices are harming patients. These failing devices, sometimes never even tested in humans, are causing healthcare and insurance rates to rise. The current statistics are not a true representation of the problem because less than 10% of adverse events are reported and doctors are currently not required to report adverse events. The FDA recently released six million hidden reports, which included over 350,000 reports related to breast implants. Breast implants are also considered to be a Class III medical device.The FDA has now stopped the use of alternative summary reporting. The Medical Device Guardians Act (HR2915) will mandate doctors to report adverse events to the FDA. The Medical Device Safety Act (HR2669) would amend the Food, Drug and Cosmetic Act to restore patient rights, hold manufacturers accountable and require safer medical devices.
To learn more about these issues, watch the documentary The Bleeding Edge on Netflix and HBO's Last Week Tonight with John Oliver: Medical Devices on YouTube.
Read below to learn how YOU can get involved.
1. File a Report
File a report of a problem with a medical device with the FDA's MedWatch program or call 1-800-332-1088.
MedWatch Voluntary Reporting Form:
2. Join Medical Device Problems
3. Sign and Share Petitions
Sign and share both of the following petitions. An email will automatically be sent to all of your representatives asking for their support.
Petition for The Medical Device Safety Act (H.R. 2996)
Petition for The Medical Device Guardians Act (H.R. 2915)