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Individuals with mental illness are at a very high risk of becoming victims of violence and abuse; and victims of violence and abuse are at great risk of developing a mental illness. Close scrutiny of who gets treated with ECT is needed so survivors of violence and abuse are not re-victimized by the treatment, proposed to be helpful.

On behalf of MindFreedom International, this letter is to absolutely oppose the FDA’s proposed reclassification of the device used for electroconvulsive therapy (ECT, also commonly known as electroshock) from Class III to a “low risk” designation.

while other medical devices have had to undergo the rigorous safety investigation known as PreMarket Approval (PMA), the FDA has allowed shock machines to be used for over thirty years, not only without requiring clinical safety trials, but without any scientific evidence that the devices are either safe or effective.

The International Center for the Study of Psychiatry and Psychology is calling upon the FDA to keep the Class III schedule until PMAs are performed on the devices.  In truth, we would suggest an impartial review of the evidence requires the withdrawal of ECT machines from the market.

If the device is reclassified a scientific safety investigation of these devices will never take place, and patients will not have the information they need to make an informed choice about the treatment.

Disability Rights Mississippi to the proposed ECT device reclassification, 2009.