You know you’re taking a risk if you’re skydiving or bull riding. But did you know there are serious risks associated with many medical devices? Maybe your diabetes leads to a recommendation for an insulin pump. Or perhaps years of constant hip pain led you to a surgeon’s office to discuss a hip replacement. Or maybe your doctor recommends a spinal-cord stimulator to minimize your debilitating back pain. Device manufacturers, and doctors, make bold claims on the benefits of medical devices. But it turns out that many devices involve serious health risks. How safe are medical devices? And what is the government doing to keep patients safe?
How safe are medical devices?
Less safe than you probably think.
An investigation by the International Consortium of Investigative Journalists (ICIJ), in conjunction with over 50 media partners around the world, found that in the past 10 years, there were more than 1.7 million injuries from medical devices of all types. Additionally, there were almost 83,000 deaths.
What types of devices cause the most harm?
The ICIJ investigation found that between 2008 – 2017, these 6 devices caused thousands of injuries:
How does the FDA keep patients safe from medical devices?
You’re not alone if you’re wondering how dangerous devices remain on the market. Why isn’t the US Food and Drug Administration (FDA) making sure medical devices are safe? Sadly, the ICIJ investigation found that many of the FDA’s practices put patients at risk. Importantly, and shockingly, the FDA often pushes devices through an abbreviated approval process, regularly approving most medical devices with little clinical testing. Additionally, until very recently, the FDA kept records of device failures from the public. How and why? Read on…
A little bit of history regarding FDA device approval.
In response to tens of thousands of women developing life-threatening infections from an intrauterine device, Congress passed the Medical Device Amendments in 1976 to make sure medical devices were safe and effective.
The FDA, charged with carrying out this new law, created three classes of medical devices. (For information on the 3 classes, visit this FDA webpage.) In theory, products in the high-risk category must undergo the most rigorous clinical testing standards. However, that usually doesn’t happen. Instead, the vast majority of devices go through a less stringent review process that provides an easy approval for devices deemed “substantially equivalent” to products already approved for use.
Unfortunately, this process for quick approval of equivalent devices should have been phased out as Congress originally intended. But, instead, it’s a standard way for thousands of devices to quickly and easily enter the marketplace. For example, a particular hip replacement device was recalled because metal shavings from the devices made patients sick. But surgeons implanted tens of thousands of these particular devices before the FDA recalled the device. Additionally, the FDA approved some spinal cord stimulators without new clinical studies, basing their approval on results from studies of earlier spinal stimulators. (Read below to learn more about the dangers of spinal cord stimulators.)
Seemingly lax oversight of artificial intelligence devices
Although artificial intelligence (AI) is the fastest-growing frontier in medicine, it seems to be growing without appropriate oversight. The FDA approved over 160 medical AI devices/products in recent years “based on widely divergent amounts of clinical data”. Furthermore, the FDA did not require manufacturers to publicly document their testing on patients of different genders, races, and geographies, leaving doctors unsure about the effectiveness and quality of AI devices.
How else is the FDA failing the public?
In addition to problematic quick approvals, the ICIJ investigation also found the FDA doesn’t respond adequately when dangerous products are identified. For instance, the FDA responds slowly when they should be forcing companies to correct dangerous, sometimes life-threatening, products. Furthermore, the FDA rarely pulls devices from the market, even when major problems emerge.
FDA record-sharing failures.
Ever year the FDA receives hundreds of thousands of reports regarding medical devices associated with suspected device-associated deaths, serious injuries, and malfunctions. But, this information wasn’t always available to the public. In fact, more than 20 years of data relating to medical device issues was not released. Consequently, some device manufacturers kept safety issues a secret. Fortunately, the FDA just released information on approximately 6 million adverse event reports (injuries and/or malfunctions) dating back to 1999. These incidents are now included in the federal database Manufacturer and User Facility Device Experience, or MAUDE.
What’s MAUDE? It’s a database of medical device reports submitted to the FDA by mandatory reporters (manufacturers, importers and device user facilities) and voluntary reporters (health care professionals, patients and consumers). Another bit of good news? The FDA has plans to upgrade the MAUDE database to make the information more user-friendly.
What’s the FDA say about allegations of shortcomings?
According to an AP article, the FDA “acknowledges its data has limitations, including mistakes, omissions and under-reporting that can make it difficult to determine whether a device directly caused an injury or death. But it rejects any suggestion of failed oversight.”
The government can and does impose fines.
In some cases, the government imposes fines on device companies for bribing doctors, illegally promoting products for unapproved uses and paying for studies that proclaim the safety and effectiveness of their products.
For instance, in 2016, Olympus Corp. of the Americas (the largest US distributor of endoscopes and related medical equipment) agreed to pay $623.2 million “to resolve criminal charges and civil claims relating to a scheme to pay kickbacks to doctors and hospitals”. And, Olympus also “agreed to make various improvements to its compliance program.”
What about the medical device companies?
Unsurprisingly, medical device companies invest countless resources to develop safe, effective products. But, at the same time, device companies also spend millions and millions to influence regulators, hospitals and doctors.
How much money do medical device companies pay to doctors and hospitals?
In 2017, the 10 largest medical device companies paid almost $600 million to US doctors and hospitals for consulting fees, research, travel and entertainment fees. Why should this concern you? Because you want your doctor to recommend a device for you because it will improve your health and well-being, not because it will improve your doctor’s bank balance.
Furthermore, these companies spend millions to influence the US government. For instance, lobbying records show that since 2017 the top 4 spinal-cord stimulator manufacturers spent over $22 million to try to influence legislation that would benefit their businesses (which also includes other devices).
Fortunately, in the US, drug and device manufacturers must report their payments to doctors and hospitals. You can look up your doctor and/or hospital on the ProPublica Dollar for Docs site.
Spinal cord stimulators – one example of a device that’s caused thousands of injuries.
These stimulators, implanted in patients’ backs, use electrical current to block pain signals. The use of these devices has increased dramatically over the years as the device manufacturers, and doctors, praise the ability of these devices to safely treat a wide range of painful conditions. In fact, spinal cord stimulators are one of the fastest-growing products in the medical device industry, with roughly 60,000 units implanted each year.
However, these devices are more dangerous than many patients know, according to an AP investigation. These stimulators account for the 3rd highest number of medical device injuries reported to the FDA, with over 80,000 incidents reported since 2008.
What types of injuries?
The FDA data shows reports of shocks, burns, and spinal-cord nerve damage ranging from muscle weakness to paralysis. Furthermore, the FDA data includes over 500 reports of death for patients with spinal cord stimulators, but scant details make it impossible to determine if the stimulator itself or the surgery to implant the device caused the deaths.
A few more examples of unsafe medical devices.
Kaiser Health News conducted their own investigation regarding medical device safety and found interesting, albeit frightening, information on blood glucose meters, dental implants, surgical staplers, breast implants and more.
How can you learn if your medical device is safe?
First and foremost, don’t say yes to a device without giving it serious consideration, unless you or a loved one are facing a life-or-death situation. Because there is potential for serious harm, talk to your doctor, get a second opinion, and do some research of your own.
I suggest you ask your doctors the following questions:
- Are there any steps you can take to avoid the device? Will a change in diet or exercise lead to ample improvements? Will physical therapy help? Other medical procedures?
- Can the device be removed if a problem develops?
- How long has the recommended device been on the market? Importantly, don’t assume that new means better. “New” does mean less time in use, which can lead to outcome results that are not as robust as those for an older device. And don’t assume that all devices in a particular category are equally safe and/or effective.
- Have there been clinical trials for this specific device? What do the results show?
- How many surgeries have you performed using this specific device? What were the outcomes for these patients?
Additionally, do some independent research:
- Search the FDA’s Manufacturer and User Facility Device Experience (MAUDE) to determine if there have been incidents of harm caused by any device you are considering.
- Additionally, research online to learn about:
- Any history of complications experienced by other patients – search for the type, brand, and model of the recommended device, along with “complications” or “problems”.
- Clinical trial studies – Because there are far too many studies for doctors to keep track of, it’s always a good idea to do your own research, even if you ask your doctor as well.
- Use the ProPublica Dollar for Docs site to determine if your doctor and/or hospital receives payments from the device company. If so, ask your doctor about the payments and any potential influence the money has on his/her recommendation.
- Search for and join a Facebook group for patients who have experience with the device you are considering. You can receive helpful information from these peer-to-peer networks, proven to be a beneficial source of information. For more information on this topic, read my blog post: Can You Trust Advice from Other Patients?