Are Implanted Medical Devices Creating a 'Danger Within Us'?

Medical journalist Jeanne Lenzer warns of potential dangers for people with implanted medical devices, which she says are cleared with far less scrutiny than drugs, and go to market without clinical trials, reports National Public Radio . "One of the problems with devices is that nobody's really tracking the numbers of harm — or the rates of harm," Lenzer says. She cites as one instance the vagus nerve stimulator (VNS) for controlling epileptic seizures, for which the Food and Drug Administration (FDA) gave conditional approval due to concerns about deaths. "The idea of conditional approval is that once the company proves it's safe after it's on the market, then its approval is complete," Lenzer says. She notes the five studies the device maker provided her did not record how many people died, if they died, or when they died, while her request for them to release mortality data from the Social Security Death Index on behalf of the British Medical Journal was denied. "When I brought all this to the FDA, the FDA said, it's safe," Lenzer recalls. "And I said, how can you say it's safe when we don't have death data? And their answer ... is we never asked the company to count the number of deaths." One person with a VNS device suffered heart stoppage because of the implant, and an FDA database recording adverse device events listed similar incidents and significant deaths. "Only about 1 percent of all serious adverse events make it into the FDA's adverse event database," Lenzer says. She also suggests the FDA does a poor job of regulating these devices because they are heavily influenced by the industries they regulate.