The primer is aimed mainly at journalists, to help them more accurately report on claims made by medical device companies about their products, but consumers will also find it educational and useful.
Why is such a primer necessary? Because, as Joy Victory, deputy managing editor of HealthNewsReview, points out in an accompanying article, medical devices — which include a wide array of nondrug items used in medicine, such as contact lenses, blood pressure monitors, MRI scanners, knee replacements, breast implants, intrauterine devices (IUDs) and cardiac pacemakers — are all too often linked to serious safety problems after they’re already on the market.
“The reasons why often start long before the device is approved,” Victory writes. “Very little clinical evidence is required, at least compared to the amount of evidence required for new drugs. So when a device is approved, it may not be safe. And when patient complications start to trickle in, inadequate oversight means the problem isn’t quickly addressed — if at all.”
A trio of loopholes
The primer describes three key loopholes in the regulatory process that consumers need to consider:
Ninety-nine percent of devices never have to provide clinical data, thanks in part to the 2002 Medical Devices User Fee Act, which requires the FDA to use the “least burdensome route” to approval. That means most devices submit a 510(k), which has created a daisy chain of numerous modifications in which devices get tweaked and cleared for market without patient trials.
Predicate devices that were problematic and removed from the market may still be used to demonstrate “substantial equivalence” for new devices. [Companies can use a “predicate device” to argue to the FDA that their new product doesn’t need its own safety and efficacy data.] Also, devices that were already on the market when regulation began in 1979 were grandfathered; they may be used as a predicate even though they never had to demonstrate safety or efficacy. In 2011 the Institute of Medicine recommended eliminating the 510(K) pathway, saying it fails to protect patients. But since then, Congress has approved measures to allow more devices to use that pathway.
For the few devices subject to a scientific review, the quality standards are flimsy. Randomized controlled trials — the gold standard — are infrequent. Most studies are unblinded, and thus prone to bias. The FDA settles for loosely defined “reasonable assurance” that a device is safe and effective, versus its higher standard of “substantial evidence” for drugs, which require studies with comparison groups that didn’t receive the same treatment. “Thus, data that would never be sufficient to support the approval of a drug can result in the approval of a device used to treat the same condition, potentially diverting patients from effective drugs to less-effective devices,” noted Public Citizen.
What consumers can do
“The medical device marketplace needs very close scrutiny from both journalists and consumers,” Victory writes. “People are dying and getting very sick from often-expensive devices that may not even work as intended. If it’s going to get better, we have to learn why and how the system is failing us — and that’s what our new page is meant to help you with.”
What can consumers do (in addition to reading the HealthNewsReview primer) to help ensure a medical device recommended to them by their physician is safe and effective? Consumer Reports, which in 2012 published a lengthy investigation on “Dangerous Medical Implants and Devices,” has these suggestions:
Consider alternatives. Ask your doctor what will happen if you don’t get the implant. Many women who received transvaginal mesh for prolapse repair, for example, probably never even needed surgery.
Research the device. The Food and Drug Administration’s website, FDA.gov, has a wealth of information about device safety warnings, complaints, and recalls, easily accessible by typing the name of the device into the site’s search box. It’s also worth searching Google. If the results include a lot of law firms looking for clients injured by the device, that’s a sign to ask your doctor some hard questions.
Write down what you got. If your doctor doesn’t give you information about the brand name, model, and serial number (if it exists) of your device, ask for it. If you learn of a warning or safety recall, from the FDA or elsewhere, you’ll know whether yours is one of the problem models.
Stay alert — but don’t panic. If you learn that there are problems with your device, contact your doctor and ask what warning signs to watch for. Also go to the FDA website to read up on official warnings and find out whether it’s safe to keep the device in your body.