Medical advances over the last few decades have allowed for some amazing things to happen. For many medical conditions that people suffer from, they used to have to be confined to a hospital bed for most of the week if they lived through it. Now, we have people who are able to use certain devices that allow them to have a mostly normal life. Wearable insulin pumps, implantable cardiac pacers, chemotherapy treatment patches, and other devices have really improved the quality of life for millions.
However, there are times when the medical devices we have come to depend on are faulty and cause much more harm than good. When that happens, you need to know where to turn. At the SMA Law Group, we will work to investigate what happened and secure the compensation you deserve.
Types Of Devices
Did you know that there is a strict approval process for medications and medical devices that make it to the market in the US? The Food and Drug Administration (FDA) must approve most medical devices before the consumer can buy them because they want to ensure that all possible safety measures have been taken. When we look at the three classes of devices, we can see many things we use on a daily basis:
- Class I devices are considered low-risk devices and include things like surgical instruments, non-motorized wheelchairs, bandages, etc.
- Class II devices are considered intermediate-risk devices and include items that serve life-saving functions but are not necessarily implanted: infusion pumps for IVs, insulin pumps, and CT scanners.
- Class III devices are considered high-risk devices because they are vital to a person’s health and can have devastating consequences if they fail. These are things that are implanted inside of a person’s body: deep-brain stimulators, pacemakers, spinal cord stimulators, heart valves, and more.
While all medical devices undergo testing of some sort, some face more scrutiny than others. Looking at the list above, it is safe to say that Class III devices are more thoroughly tested than Class I devices. In fact, Class III devices go through clinical trials just like medications.
There is no such thing as a medical device that poses no risk. We are told this when we accept treatment. However, we should be told all of the risks beforehand. If something goes wrong that is outside the parameters of what is known could occur, that is when we need to consider seeking legal assistance.
What To Do Next
If you or a loved one have been the victim of a faulty medical device, you may need to seek legal assistance. The companies behind these devices are often multi-billion dollar corporations who can pour massive amounts of money into defending themselves, so you need someone who will stand up to them. At the SMA Law Group, we do not run from a difficult situation.