When you go to the doctor to receive medical treatment, you anticipate that you’ll be treated safely. After all, medical professionals take an oath that they will do no harm. Yet, all too often mistakes are made that put innocent patients like you in harm’s way. Sometimes those errors are caused by doctors and nurses, but other times the medical equipment used by these professionals is to blame.
This is troubling given the amount of time, money and effort that goes into developing new medical devices. And one would think that stringent standards implemented by the FDA would ensure that only truly safe equipment would reach the market and the public. Yet, far too often dangerous medical devices slip into hospitals and treatment centers, resulting in injuries and death.
Don’t medical device recalls keep patients safe?
Not in all instances. Although it’s true that some recalls mandate that medical devices be removed from use, the public has oversimplified the term “recall.” The truth is that a recall can be made without forcing dangerous medical equipment to be removed from use.
In fact, between 2019 and 2023, 338 Class 1 recalls were made for medical devices, but only 174 of those recalls required removal of the devices in question from use. The other 164 recalls were “correctional” in nature, meaning that modification to the device’s instructions or use were deemed sufficient, or the devices needed repaired prior to further use.
But time and again these dangerous devices that are left on the market have been found to cause significant harm to patients. For example, Abbott’s MitraClip, which is a cardiac device aimed at preventing backwards flow of blood through the heart’s mitrial valve, has been recalled three times.
Despite one of those recalls indicating that the device can result in serious injury and death, the product has never been removed from the market. Abbott has claimed that those who use the device are aware of the risks associated with it, and that modified instructions and recommended doctor training have alleviated the need for the recalls. Yet, multiple deaths have been linked to removal of the delivery system from the clip itself.
Why aren’t dangerous medical devices removed from the market?
When considering whether to remove a device from the market, the FDA weighs several factors, including the frequency and the severity of harm caused by the defective product, the effectiveness of any suggested corrective action, the benefits afforded to patients by keeping the device in question available to them, and the overall risk of continued use of the device. So, with the MitraClip, the FDA found that the benefits of the equipment outweighed the risk of removing it from the market. Therefore, simply because a product has remained on the market and in use does not mean that it’s safe.
Beware the dangers of medical devices
The list of defective medical devices is staggering. For example, Medtronic’s cranial mapping software was recalled after it was discovered that it was susceptible to errors in gauging biopsy depths, meaning that it could cause doctors to remove healthy brain tissue while missing a suspected tumor altogether. It’s issues like these that can leave you or a loved one seriously injured or even dead.
What should you do if you or a loved one has been harmed by a defective medical device?
If you suspect that a medical device has caused your or a loved one’s injuries, then now is the time to consider legal action. The company responsible for your harm needs to be held accountable, but that can only happen if you act. So, be prepared to pursue your case with convincing evidence and strong legal arguments, which is something that your attorney can help you navigate in hopes of securing a fair and just outcome.
