Medical devices cause a lot of harm to patients. I have written about the problems with power morcellators that spread cancer and with endoscopes, which were designed in such a way that they could not be properly cleaned and as a result transmitted deadly bacterial disease. Unfortunately, these are but a few of the medical devices that were marketed in this country without proper testing and which ended up harming or killing patients. Two new stories discuss the loopholes in the FDA’s current approval process and the Trump administration plans to expand those loopholes.
A story from the New York Times discusses how an orthopedic surgeon, who knows far more than any of us lay people, specifically requested a hip prosthesis for himself that ended up being defective. When they finally took the defective hip out of him, it looked like his hip socket was full of dirty motor oil. Cobalt had leaked from inside the prosthesis and created a condition called “metallosis,” which damaged not only the hip joint and surrounding structures but the doctor’s brain and heart as well.
The FDA is supposed to approve medical devices as safe before they are used in patients but, according to the Times story, most high-risk medical devices have undergone no clinical testing at all. This is where the loopholes come in. In 1976 when the FDA assumed responsibility for medical devices, it decided to just “grandfather in” all of the existing devices being sold in the United States. Since that time, a device manufacturer can avoid testing by simply certifying that a new device is “substantially equivalent” to an existing device which was either previously approved or one of the grandfathered devices. Manufacturers can also avoid the testing process by certifying that they have made only a minor modification to a previously approved device. Very few medical devices are not approved through one of these two loopholes. Even this “Wild West” environment is apparently too much regulation for our friends in the Trump administration, who never met a consumer protection that they didn’t hate.
The Wall Street Journal recently ran an article describing the changes the FDA wants to make to get devices to market sooner and leave the testing for safety to some later date. The problem, of course, is that testing may show problems after many defective devices have been permanently placed in patients. According to respected physicians and researchers, the FDA’s track record on post-approval testing is already a poor one. Tests are either not undertaken or not completed and, even when they are completed, the data is not available to the physicians who are ordering the devices for their patients.
While it may do no good, write your member of Congress and your Senators and ask them to protect patients. The Wild West may have been a romantic place but it is not where I would like to go to get a medical device implanted.
