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 May of 2019, two of our BISA representatives Maria Gmitro and Julie Lykins joined the Medical Device Problems advocates and traveled to Washington, DC to lobby for medical device safety.
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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.


Take Action

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

Support people considering or affected by a medical device.
Explore the Medical Device Problems Webpage
Follow the Medical Device Problems Facebook Page 

Join the Medical Device Problem Facebook Group 

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)

4. Lobby Your Members of Congress

Visit Medical Device Problems to learn how to lobby your members of congress from Amanda Rusmisell, the Legislative Liaison and Administrator of Essure Problems and Secretary of ASHES Nonprofit