ECT DEVICE PRODUCER FLOUTS FDA REGULATIONS
Thanks to documents released from a Freedom of Information Act (FOIA) request, Food and Drug Administration (FDA) inspection reports are now available showing that MECTA, a Lake Oswego, Oregon-based electroconvulsive therapy (ECT) device manufacturer, failed to report that their device may have caused or contributed to serious injury or death. Additionally, in fliers, the company didn’t mention that their machines are classed as “high-risk” by the US Food and Drug Administration (FDA).
The FOIA request was submitted on behalf of the Citizens Commission on Human Rights.
ECT, a highly controversial procedure, involves shooting up to 460 volts of electricity through the brain—up to 33 times the amount employed by some types of electric shock torture devices. According to the FDA, ECT can cause cognitive impairment, memory impairment, prolonged seizures, dental trauma, manic symptoms, pulmonary (relating to the lungs) complications and death. The procedure, when administered involuntarily, was described “in the guise of rehabilitation” in a 2013 report published by the United Nations High Commissioner for Human Rights Committee Against Torture. One third of ECT patients experience permanent memory loss and many suffer a steep drop in IQ.
In 2001, MECTA employed fliers using the words “safe and effective,” while not disclosing their machines are categorized as a Class III machine by the FDA, the highest risk category available. (In more recent brochures, MECTA uses the phrase “extensive regulatory agency approvals,” although its devices never received an FDA Premarket Approval). Further, MECTA did not submit Medical Device Reports (MDRs) of many adverse events, though these are mandated by FDA regulations.
In 2007, MECTA was found to have ignored Medical Device Reports highlighting memory loss and other severe adverse events sent to them by the FDA. MECTA’s president, Robin Nicol, dismissed a number of these.
“Ms. Nicol stated the firm did not believe in the validity of complaints,” reads the FDA report.
MECTA further ignored a woman’s death from ECT, filing no MDR on the incident. Nicol claimed it was the first adverse event the firm has received in spite of other MDRs forwarded to them by the FDA and outstanding lawsuits against the company.
ECT devices have never gone through standard clinical trials to establish safety and efficacy, though the FDA gave device manufacturers a 32-month time frame to do so in September of 1979. Thirty-seven years later, this has never been done. Nevertheless, in December 2015, the FDA issued a proposed order to down-classify the risk category for the device, a move followed by a wave of public outcry.
“ECT devices have never gone through standard clinical trials to establish safety and efficacy, though the FDA gave device manufacturers a 32-month time frame to do so in September of 1979.”
Constitutional attorney Jonathan Emord filed a Citizen Petition with the FDA to prevent this reclassification. According to the petition:
- The FDA received more than 3,000 comments, most of which (79%) opposed reclassifying ECT devices to Class II.
- The comments related hundreds of stories of permanent memory loss, deaths of loved ones and the debilitating effects of ECT.
- There were 92 group submissions representing 6,462 individuals against reclassification and 462 in favor.
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