Patients trust that when their doctors recommend a particular medical device, it is safe for them to use. Unfortunately, that isn't always the case. Many people end up suffering serious injuries or even death due to faulty medical devices.
If you've heard of a spinal-cord stimulator, you may wonder if it is safe to use. While many people report that it is safe and effective, many other patients have suffered shocks, burns and even nerve damage. Over 500 people have died from using these devices. If you or a loved one here in Oregon suffers an injury due to a spinal-cord stimulator, here is what you need to know.
What do the statistics say?
Though many physicians tout spinal-cord stimulators as a safe alternative to opioids for pain reduction, there are others who say the risks outweigh the benefits. It is one of the fastest-growing products in the medical device marketplace. Surgeons implant over 60,000 of them into patients each year.
These stimulators are responsible for the third-highest number of medical device injuries. Over 80,000 people since 2008 experienced an injury from a spinal-cord stimulator. Though hip implants have a higher number of injuries, they are also much more widely used. Spinal-cord stimulators have a very high injury rate by comparison.
How did this happen?
The medical device industry is a $400 billion business. Sometimes companies push devices through FDA testing and receive approval without proper vetting, according to some experts. Some even accuse the FDA of being quick to approve new technology, but slow to recall or correct any problems.
For their part, the FDA says that it is working to generate better safety standards for patients. They report that they are using more accurate data in order to achieve this end. Higher-risk devices, like spinal-cord stimulators, should undergo more rigorous testing. However, the FDA stands by its process for approving new medical devices, saying that they stop many dangerous devices from ever reaching the market.
History plays a role
Laws have been in place for decades that seek to protect consumers from dangerous medical devices. When they were originally created, many devices were approved because they were similar to existing products, and therefore did not undergo the same testing as other devices. Advocates say that the laws should have changed over the years to address that potential flaw, but haven't been. Furthermore, many spinal-cord stimulators received FDA approval because they were similar to devices that were already available.
Sadly, all of this means that many people suffered debilitating injuries because of a medical device that may not have undergone proper testing. It is a story that happens to far too many people. If you or someone you know received an injury from a defective medical device like a spinal-cord stimulator, you do not have to face it alone.