FDA’s Electroshock Hypocrisy

     In 2021 the FDA approved the marketing of an ECT Cotton Bite Block made by the MECTA Corporation, one of two manufacturers of electroshock administering devices. The FDA approval was based on the marketing of similar devices before 1976 and therefore needed no new trial evidence for safety or efficiency of the protective device.

     The FDA’s grandfathered approval of the bite block paralleled their grandfathering of the ECT device itself without any submission of scientific proof for its safety or effectiveness. As part of their approval documentation, they listed their description of the device along with its intended use.

     The description reads, in part: “During the passage of the electrical stimulus during ECT, despite the fact that the patient has been given a systemic muscle relaxant, the masseter muscles contract forcefully, necessitating the use of a bite block or mouth guard…in order to protect the teeth and tongue during an electroconvulsive therapy (ECT) treatment.” The cotton pad “allows for any damaged or compromised molars on the opp osite side of the mouth to be free from compression. In addition, incisors avoid the risk of being damaged during compression.”

     Their description also notes that the mentally ill “commonly” have poor oral hygiene, a suggestion that this is the reason for the necessity for the device, as opposed to the actual threat of 400 volts of electricity passing through the patient’s head. However, in the next section, “Intended Use,” the oral protector is said to be used “during seizures induced by electroconvulsive therapy (ECT).” What happened to the electrical stimulus of the ECT itself in the description being the actual danger?

     It returns in the following section, “Comparison of Technological Characteristics,” which justifies the FDA’s grandfathered approval. “The ECT Cotton Bite Block is substantially equivalent to its predicate device in that both bite blocks protect the compression of the back molars when the masseter muscles contract during electroconvulsive therapy.”

     That’s a lot of semantic dancing by the FDA in those three sections to hide the hypocrisy behind their approval of MECTA’s ECT mouth guard. If the electrical voltage from the device requires a mouth guard to protect a patient’s teeth from being crushed, how is the device itself safe? The FDA knows ECT is not safe, but they do nothing to curb its use.

     That’s a jarring hypocrisy from a government agency with the mission of protecting the public. 

     MECTA itself went bankrupt in 2021 because they could not be approved for product liability insurance due to the number of lawsuits against the company by those claiming brain damage and serious memory loss from their ECT sessions. MECTA CEO Adrian Kettering was quick on her feet, though, and soon started SigmaStim as another manufacturer of electroshock devices. Kettering’s new devices offer similar functions as the previous MECTA machines, but with an “updated technology” platform. 

     Kettering’s first customers? All those MECTA machine owners who would now need to update their equipment to these new standards with the purchase of the “improved” SigmaStim machine.

     Fits right in with Kettering’s sense of business ethics. In one deposition for a civil case suit against MECTA, she announced, “We are not responsible for individual patients…. that is not our responsibility from the FDA perspective or from our perspective as medical-device manufacturers.” She added, “…no effort is made to acquire adverse information caused by MECTA devices.”

     Unlike the FDA, she certainly can’t be accused of hypocrisy, can she?