Whenever a medical device makes headlines for causing harm to patients, one of the first questions people ask is “how did this ever get approved?” While it’s true that the Food and Drug Administration (FDA) performs well-documented tests for drug approval, many have questioned their scrutiny of implanted medical devices. A recent podcast of the NPR program Fresh Air sat down with the author of new new book titled “The Danger Within Us” to shed some light on how potentially dangerous medical devices fly under the FDA’s radar.
The book’s author, Jeanne Lenzer, worked as a physician’s associate in emergency rooms prior to her career change to investigative medical journalism. The move was triggered when a treatment she and others used for chest pain was found to actually be causing deadly heart rhythms. Lenzer has since devoted her career to informing the public of potentially dangerous medical devices like artificial joints, surgical mesh, and cardiac stents.
Lenzer asserts that unlike drugs, medical devices undergo far less inspection before being approved for consumers, many times without receiving clinical trials. According to Lenzer, once the devices reach the market, no one is tracking the numbers or rates of harm to patients. And even though the FDA maintains a database where doctors and hospitals are able to report deaths and other adverse effects, they have no record of the total number of people implanted with those devices.
“Walmart tracks how many heads of lettuce they have on a shelf at any given time, and they know exactly how many heads of lettuce they have to replace,” said Lenzer. They can track those a lot better than we’re tracking medical devices implanted in people.”
In her interview, Lenzer relates several stories that provide an eye-opening look into how little oversight and accountability some dangerous medical devices receive. One of these stories involves a patient implanted with a vagus nerve stimulator as a means of treating his epilepsy. Instead of providing relief from seizures, the device malfunctioned, and began stopping the patient’s heart at exactly three-minute intervals until the device was disabled.
While investigating this story on behalf of the British Medical Journal, Lenzer reached out to the manufacturer and the FDA in order to obtain studies showing that the device was safe. Both the company and the FDA produced the same five studies – all of which lacked data on patient deaths.
“I went back to the company and said, do you have unpublished data about deaths? I need to know about deaths. That’s why this device was approved conditionally. And they said, ‘we never collected data on deaths.’”
Lenzer goes on to discuss the harm caused by other devices, such as pelvic mesh.
“Pelvic mesh – again, a seemingly simple device. It’s just mesh after all – surgical mesh. And yet it has grated through tissues like a cheese grater through cheese and caused what’s called fistulas – holes between the rectum and the vagina and causing serious pain, infections, hemorrhage. There are all kinds of problems with medical devices that people might want to think about first.”
The full interview collected in the podcast is just over 30 minutes long, and is well worth giving a listen at the link below.
https://www.npr.org/2018/01/17/578562873/are-implanted-medical-devices-creating-a-danger-within-us
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