Buyer Beware: Medical Devices Do Have Side Effects

by 
Jennie Shulkin – Override Cofounder

The Allure of Medical Devices

Everyone knows that medications have side effects. TV ads and our doctors make sure we are aware. Unlike medications, one of the allures of medical devices is that they are often advertised as having “no side effects.” 

As someone with a complex chronic pain syndrome for over a decade, and who works in the chronic pain space as the founder of Override Health, you can imagine that I have tested my fair share of medical devices. I always have my eyes and ears open for new and promising innovations – for myself and for my Override patients.

They Can Have Side Effects

But I have found that many of these medical devices are much more dangerous than advertised. One medical device left me with permanent and non-stop tinnitus (ear ringing) in my left ear; customer service checked in on me for a couple days and then stopped calling. Another medical device left my feet numb and tingling for hours after use; I did not continue using the device to find out if continued use would’ve led to permanent numbness and tingling. 

Occasionally, people find out through medical device usage that they are electrically sensitive and experience various side effects related to it. Other device users might be experiencing side effects but not realize a relation to the device if it isn’t obvious.

Many medical devices are well-intentioned but simply haven’t been tested sufficiently. A company once sent me a device that had a sticker on it saying: “Not tested yet on humans.” I wasn’t sure I wanted to be the first, so that one is still hanging out under my bed untouched.

One Particular “Miracle” Device 

In April, I opened an Instagram device for a headache device (I won’t name the name). I clicked on the website and was immediately impressed. It boasted that over 90% of users experience instant relief. It was extremely reasonably priced at $30 with a 90 day moneyback guarantee. The reviews were outstanding – things like: “Don’t question it. Just buy it” and “It works. It works. It works.” 

I dug into the science a little bit and was impressed that this device was not even electrically powered, as most are. It didn’t require batteries or the cable connected to the wall. The mechanism involved creating pressure through air suction in the ear canal to relieve pressure in the head.

It looked like a miracle device. Why didn’t every headache sufferer in the world have one of these?, I thought.

Validating the Reputation of the Device

Out of curiosity, I looked up the product on https://www.amazon.com/. I sometimes do that to get a better sense of customer reviews and confirm legitimacy, as I tend to trust Amazon more than I do the direct websites. (I know that the trustworthiness of Amazon reviews is also debated.) 

To my surprise, the product was on Amazon and only received about 3.5 stars. Not great. I scrolled down to the one-star reviews because I was interested in potential side effects and disaster reviews. 

19% of the reviews were one star reviews. That’s essentially 1in 5 users who say that the device is either worthless… or worse. 

Some of the reviews simply said that it was a gimmick, a waste of money, or completely unhelpful. But even scarier, I started to read review after review that said that this device that uses pressure inside of the ear actually DAMAGED EARDRUMS. 

If it’s shocking to you, you better believe that it was to the injured consumers as well. Many of them used capital letters just like that to express their horror as to their DAMAGED EARDRUMS. They thought they were getting headache relief and then they ended up with a worse problem.

I don’t doubt that this product helps people. I do not believe that the positive reviews are bogus. But can you imagine if you were the 1 in the 1 in 5 users that gets a damaged eardrum from trying the device that was touted as an affordable, safe, miracle medical device?

The Future of Medical Devices 

I remain optimistic about the latest advances in the pain industry, and medical devices are a big part of that. I believe that the vast majority of the people focused on pain innovation do it because they are mission driven and believe that their product or service will help people. 

Good intentions, however, do not cancel out harm done to real people. And not everything is as safe as it may be advertised as. 

The unfortunate reality is that every new medical device has to be tested first on someone (many people) before it can be deemed safe or FDA approved. To have new innovation, we have to get through a testing and tweaking process, which involves risk to early users or adopters. 

So that’s part of the process. But let’s at least do it with our eyes wide open.

My Advice

 Evaluate devices just as you would evaluate pills or proposed surgeries or procedures. 

And start slow. If something weird happens, consider calling customer support or your doctor and discontinuing use. 

Don’t just push through, assuming no side effects are possible.

A Quick Plug for Virtual Care like Override

One of the things I love about Override Health’s virtual pain management services is the safety of what we do. 

Our physicians do prescribe medication (although not opioids), so of course there can be side effects of these medications. Outside of that, though, our providers (including our physical therapists) work with patients virtually, which means we don’t inject them, do surgery on them, adjust them like chiropractors or osteopaths, attempt to release trigger points, or anything else that might be painful during or afterwards – especially when done poorly.

Especially our highly sensitive patients, who flare easily, do not have to subject themselves to the risk of touch or procedures gone wrong. Our patients feel safe because they are receiving care from the comfort of home where they are in control, rather than on an exam table having something done to them by someone else. 

Every patient of course needs to decide what course of treatment they trust, feel safe with, and think will lead to the best results for them.

Posted on 
May 10, 2024

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