Medical devices comprise a $156 billion industry in the United States. One in every ten Americans has a device inside his or her body. Although many of these devices can help people, there are substantial risks involved. The Internal Consortium of Investigative Journalists found that, in the last decade, 80,000 people have died, and 1.7 million people have been injured as a result of their medical devices.
What is most alarming is that many of these medical devices are not tested in clinical trials before they are used on patients. Congress gave the FDA authority to approve medical devices in 1970. When the FDA approves a device, the device is considered “FDA-cleared,” but very few people understand what that phrase means.
The FDA created the 501(k) pathway to approval so as not to stifle innovation in the medical device industry. That means companies do not have to test their devices if the device they create is “substantially similar to one that had come before.” Thanks to that loophole, 80% of medical devices are cleared without being tested. One device can be substantially similar to the one that came before it, which was substantially similar to the one that came before it, and on and on. So, this “similarity” can actually be based on something created decades ago and have virtually no resemblance to the current device.
If your doctor tells you that you need a medical device, he or she probably has your best interests at heart. But do your research and be your own advocate—medical devices should alleviate your pain, not increase it.