If you or a family member, loved one or friend has been damaged by electroconvulsive (electroshock) treatment, or by any electrical, electronic or magnetic brain stimulation device:
REPORT DAMAGE FROM ECT AND OTHER MEDICAL DEVICES DIRECTLY TO THE FDA
For smartphones and other mobile devices, download the following app and fill out the form:
www.fda.gov/MedicalDevices/Safety/ReportaProblem/ucm385880.htm.
For reporting online without using the app, go to:
www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home
Also report to the Citizens Commission on Human Rights (CCHR)
Contact CCHR at 1-800-869-2247, or fill out the Abuse Case Form online. All information will be kept confidential.
SPEAK OUT AGAINST PROVISIONS OF THE 21ST CENTURY CURES ACT
The 21st Century Cures Act (HR 6) is up for vote in the US Senate. Senate Majority Leader Mitch McConnell and Speaker of the House Paul Ryan intend to push the bill through after the November 8 elections.
This bill will allow drugs and medical devices to be fast-tracked through FDA approvals without any requirement for clinical trials. Amendments are being proposed to exclude psychiatric devices and drugs from this bill, while allowing passage on medical life-saving drugs.
Speak out against the provisions of the bill intended to fast-track the ECT machine and other dangerous brain devices, which have never been fully approved by the FDA, and for which no long-term safety or efficacy has ever been established. These devices must be excluded from HR 6.
In addition to your own US senators, contact:
Senate Majority Leader Mitch McConnell
DC Office: 202-224-2541
District Office in Louisville, Kentucky:502-582-6304
Website: www.mcconnell.senate.gov/public/index.cfm/contactform
(For direct contact to Senator McConnell)Speaker of the House Paul Ryan
DC Office:202-225-3031
District Office in Janesville, Wisconsin:608-752-4050
Website: https://paulryan.house.gov/contact/email.htm
(For direct contact to Congressman Ryan)
OPPOSE THE FDA’S PROPOSED RULING ON ECT
Speak out to prevent the FDA from lowering the risk classification of the electroconvulsive treatment (ECT) machine from Class III, high risk, to Class II, moderate risk. The lowered classification would place ECT machines in the same category as motorized wheelchairs and condoms, obviating the premarket approval process of clinical trials and regulatory review. You can also urge the ban of the ECT device altogether.
Contact:
Department of Health and Human Services
Assistant Secretary for Legislation Jim Esquea
200 Independence Ave.
S.W. Room 416-G
Washington, DC 20201
Phone: 202-690-7627
Fax: 202-690-7380Inspector General’s Office
Department of Health and Human Services
330 Independence Ave. SW
Washington, DC 20201
1-800-447-8477
Email: Public.Affairs@oig.hhs.govFood and Drug Administration
Division of Industry and Consumer Education for Medical Devices (DICE)
Email: DICE@fda.hhs.gov
RELATED ARTICLE
Human Rights Group Calls for Action to Stop Widespread Use of
International mental health watchdog Citizens Commission on Human Rights calls for public action to oppose a proposal by the US FDA to reclassify electroconvulsive (ECT) devices as being low risk, despite the documented health risks.
