#FDAStopTheShockDevice: Sign the MindFreedom International Petition here:https://www.change.org/p/fda-stop-fda-from-down-classifying-the-shock-device-to-a-class-ii-device-stop-shock-treatment
Join 900+ Supporters saying #FDAStopTheShockDevice
Do Not Be FooledIt is important to understand that the psychiatric industry - the trade organization for the psychiatrists, the American Psychiatric Association--have their own campaign supporting the use of shock treatment on people that they assign as "depressed", "bipolar", "treatment-resistant", or "require rapid response".
They are threatened by the truth. This statement is from the American Psychiatric Association to its members in its push to support shock treatment:
"A similar reclassification proposal by the FDA in 2010 met significant resistance from anti-psychiatry groups and did not pass. That is why it is so important for psychiatrists to take the lead in expressing their views in regard to the role that ECT plays in clinical practice and in the treatment of major depressive disorder."The American Psychiatric Association tells its membership blatant lies: specifically they are arguing that the Shock Device is currently listed as "Class III (high risk)" and that what the FDA is proposing is to move them to Class II (low risk)".
Class III means that the device has never been tested for safety or efficacy (and is usually high risk).
Because the shock device existed prior to the FDA, it was grandfathered in as a Class III device.
There is a move at the FDA to either have all Class III devices moved to Class I (general controls) or Class II (special controls) devices--or-- taken off the market.
The American Psychiatric Association's claim to its membership that Class II is "low risk" is an outright lie.
Class II means that there are special controls put on a medical device to try to mitigate risk.
In the current case of the shock device, what the FDA is trying to do is say that by labeling the device with its known risks and brain and body damaging consequences, the risk is mitigated. This of course, is ludicrous.
Putting a label on a device will not mitigate the real risks of shock treatment.
The risks of shock treatment consist of one whole section of the proposed rule. Yet, there is not one specific known benefit that the FDA lists in the proposed rule, just a consistent "unknown" benefit. Concerning risk, Section V (FDA, 2015, p. 81227) is as follows:
"After considering the available information from the reports and recommendations of the advisory committees (panels) for the classification of these devices, FDA has evaluated the risks to health associated with the use of ECT devices and determined that the following risks to health are associated with its use:
- Adverse reaction to anesthetic agents/neuromuscular blocking agents. The muscle relaxing and sedating (or sleep inducing) drugs that are a part of the procedure may hamper the patient’s ability to breathe spontaneously.
- Adverse skin reactions. The patient contacting materials of the device may cause an adverse immunological or allergic reaction in a patient.
- Cardiovascular complications. The therapeutic convulsions may be accompanied by arrhythmias (irregular heartbeat) or ischemia/infarction (i.e., heart attack). Hypertension (high blood pressure) as well as hypotension (low blood pressure) may be associated with ECT treatment. ECT treatment may also result in stroke (impairment of blood flow to the brain or bleeding in the brain).
- Cognition and memory impairment. ECT treatment may result in memory impairment, specifically immediate post-treatment disorientation, anterograde memory impairment and retrograde personal (autobiographical) memory impairment.
- Death. Death may result from various complications of ECT such as reactions to anesthesia, cardiovascular complications, pulmonary complications, or stroke.
- Dental/oral trauma. Dental fractures, dislocations, lacerations, and prosthetic damage may occur as a result of strong muscle contractions during treatment.
- Device malfunction. Faulty hardware, software or accessories (electrodes) or improper use may cause electrical hazards, such as the risk of excessive dose administration, prolonged seizures, and skin burns.
- Manic symptoms. ECT treatment may result in the development of hypomanic or manic symptoms.
- Pain/discomfort. The patient may experience mild to moderate pain following the motor seizure induced by ECT treatment.
- Physical trauma. Inadequate supportive drug treatment may allow the patient to be injured from unconscious violent movements during convulsions.
- Prolonged or tardive seizures. ECT treatment may result in prolonged or delayed seizures, and status epilepticus (continuous unremittent seizure) may ensue if prolonged seizures are not properly treated.
- Pulmonary complications. ECT treatment may result in prolonged apnea (no breathing) or inhalation of foreign material, such as regurgitated stomach contents.
- Skin burns. Excessive electrical current or improperly designed electrodes may cause the patient’s skin under the electrodes to be burned.
- Worsening of psychiatric symptoms. ECT treatment may be ineffective and therefore may result in worsening psychiatric symptoms."
Again, there is not one specific known benefit that the FDA lists in the proposed rule.What Psychiatric Survivors and Allies Are Doing
People who are psychiatric survivors, particularly people who are survivors of shock treatment, allies, and MindFreedom International members have held 9 national teleconferences since the FDA released the proposed rule, December 29, 2015.
We have created a petition stating that the FDA should not down-classify the shock device for any reason. We are also demanding that the FDA hold hearings about this proposed rule to down-classify the shock device. If this rule is put in place the use of shock treatment to soar.
What You Can DoPlease join the 900+ supporters who are calling on the FDA to do the right thing and not down-classify the shock device, and listen to those who have been damaged by those who subjected them to shock treatment.
Sign the petition here: https://www.change.org/p/fda-stop-fda-from-down-classifying-the-shock-device-to-a-class-ii-device-stop-shock-treatment
Thousands Are Having Shock Treatment For Breakfast. #FDAStopTheShockDevice
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