You received a new medical device as part of a treatment. It seems promising—you're part of the first wave of patients to receive the new device, and new technology is always more effective—right?
But do you really know how safe that medical device is? Did you know that most medical devices haven't been tested much, or even at all, before they are used on patients? If you've been given a new medical device, you are essentially an experiment for the product.
A medical device, unlike a prescription medication, is a medical product that works mechanically or physically for your body. Often, these products are implanted and operate in your body, such as hip implants, surgical mesh, and heart defibrillators. But after a while, the medical devices might start failing or causing problems that make you feel worse than you did before you had the medical device.
Here are just a few medical devices that have resulted in major product injuries:
While a medication must go through Food and Drug Administration (FDA) testing, a medical device does not. It's scary to realize how little testing a medical device goes through before it can go on the market and be used on patients. To have their product put on the market, manufacturers usually only have to fill out some paperwork and pay the FDA a fee of about $4,000.
Only one of three FDA medical device classifications requires proof of clinical testing, and that's Class III. Class III includes the most risky medical devices, and it typically includes those that are implanted and support or sustain life. But even though Class III devices require testing, it's still not comforting—manufacturers can bypass the testing stage if the product is considered "substantially equivalent" to another product already on the market.
That's not all. Medical devices typically don't have serial numbers. This means that if your medical device is defective and the manufacturer issues a recall, it's more difficult to alert you. Plus, it takes years to reclassify a device as a Class III risky product and get it tested. Thousands of patients could suffer during that time, and even then, testing wouldn't be as rigorous as it is for prescription medications.
Even though medical devices can always pose a possible danger, there are a couple steps you can take to help you make the best decisions when it comes to your health:
At Edgar Snyder & Associates, we have experience going up against the manufacturers that market unsafe medical devices. We think it's unfair that you were supposed to receive a tested, safe medical device, and instead, you suffered more injuries. Our attorneys have the resources to investigate your medical records, gather evidence, and use our 30 years of experience to build your case. We're here to work for you while you focus on your health.
If you, or someone you love, are suffering from an unsafe medical device, you may have a case. Contact Edgar Snyder & Associates today for a no obligation, free legal consultation. And when we say there's never a fee unless we get money for you, we mean it.
Call 1-866-943-3427, or fill out the form at the top right of this webpage for your free legal consultation. There's no time to waste—call and learn your legal rights today.