John Oliver talks the scary world of medical devices on Last Week Tonight

Medical devices can change lives for the better, but incautious people can pay a serious price. John Oliver tries to warn us on Last Week Tonight.

For many of us, medicine is a horrifying subject. We’re not talking a simple matter of over-the-counter painkillers or even a standard dental filling, but instead the nitty-gritty terror of fractured bones and blood clots. So, unless you’re a doctor, nurse, or other medical professional, fixing broken human bodies is frankly awful. Now, thanks to the latest episode of Last Week Tonight with host John Oliver, we know of another avenue where it can get even worse.

Ironically, the issue under consideration stems from an attempt to help others: medical devices. These include all manner of implants and upgrades to the human body, from joint replacements, to some kinds of birth control, to various meshes.

Medical devices are a huge industry, totaling some $156 billion dollars. Furthermore, an estimated 32 million Americans have some sort of medical device implanted within their body. Chances are good that you’re carrying one of your own.

Of course, medical devices can change lives for the positive. But, they can also go very wrong. Think of all the TV lawyer commercials focusing on lawsuits for failed hernia mesh, duodenoscopes, and so on. Yeah, they’re kind of sleazy, but the fact that those commercials and class action lawsuits exist point to a real issue.

However, these medical devices can go horribly wrong. An estimated 80,000 deaths and 1.7 million injuries are linked to medical device malfunctions within just the past decade. What’s even worse is the prospect that many medical devices undergo next to no testing, Approval processes for their use can amount to little more than a rubber-stamped okay.

First, we’ve need to understand how these devices are approved in the first place. Surely, they’ve got to go through a rigorous process to actually make their place in a human body. Right? Well, this is Last Week Tonight, so rest assured that the reality is much, much more disappointing than you may hope it would be.

The FDA does have some authority to approve medical devices. But that doesn’t mean all medical devices are okayed by the FDA. Manufacturers like to throw around the phrase “FDA cleared”, but that’s not really good enough. For some to be “FDA cleared” means only that it’s passed a pretty low bar. It doesn’t mean a device, you know, actually works.

Most products are cleared through a 510(K) pathway. That means a device that is “substantially similar” to a predecessor gets to bypass much of the inspection points. Nowadays, around 80% of FDA “cleared” medical devices move on via this pathway. Also, there are no real limits to devices that are cleared via their similarity to earlier devices, which also passed because of their own similarity to earlier devices, which were also approved because they were similar to… you get the idea.

Consider metal hip replacements, which degraded because their parts were grinding metal upon metal. The effects on patients’ bodies were horrifying. The company at the heart of this, DePuy Synthes, was too busy trying to push the marketing on its metal hips. It seems as if they were less concerned about the real human suffering caused by its product.

At least hip replacements can be removed. That’s not the case for surgical mesh, which is implanted. That means human tissue grows around it, sealing the mesh in place and making it incredibly difficult to remove. Vaginal mesh – yep, this is definitely “opossum” territory – is an especially bad example of this. People with vaginas have some real horror stories about the ongoing pain associated with faulty vaginal mesh.

Some things might be getting better. Recently, the FDA has ordered manufacturers to stop selling vaginal mesh. Metal-on-metal hip replacements are also now required to be tested on humans.

Manufacturers are required to do their own testing. Yet, clinical trials are a tricky thing to rate, especially when you’re talking about comfort. If you’ve ever tried to communicate your level of pain with a doctor via a smiley face chart, then you understand the difficulty. These studies are also rife with opportunities to mark less-than-optimal experiences – with pain and discomfort included – as somehow “excellent”.

Oliver says that somewhere around half of medical device malfunctions go unreported to the FDA. Even when they do speak up, there’s no guarantee that patients will be taken seriously. Take the issue of breast implants. Women have long argued that breast implants can become painful and injurious. Facebook groups centered on the issue began to proliferate. Yet, it was only mere months ago that the FDA held public hearings on the problem.

Plenty of this circles back around to the 510(K) loophole. Yet manufacturers are resistant to the idea of working harder in order to pass more stringent regulations. We can’t say we’re surprised.

Until more substantial reforms are passed, patients must be their own advocates. They must do their own research, because manufacturers can be staggeringly corrupt. Even well-intentioned doctors can be missing vital information.

If you needed a bit of extra reinforcement, Jane Krakowski is here with a TV lawyer-style infomercial with the horrifying news – “your best source of information may be f–ing Facebook”. Unfortunately, we are not yet living in a utopia where physicians are fully informed and the desire to actually help people rules the process. Until then, get educated, avoid meshes if you can, and try to make sure that your medical device can be removed if all goes horribly wrong. At least then, you won’t be left yelling “opossum” at your own doctor as they deliver the bad news.