Many people assume that the medical devices recommended by their doctors are safe because they were “cleared” or “approved” by the Food and Drug Administration (FDA). Unfortunately, this is not always the case.
For years, medical devices have been deemed “FDA cleared” or “FDA approved” without a full understanding of the safety risks. This lack of due diligence has led to serious injuries and even the death of thousands of people.
At Goldwater Law Firm, our partner medical device lawyers believe that it’s vitally important for you to know the risks of the products you put into your body. Continue reading to learn more about the FDA’s clearance and approval systems and the processes that medical devices go through before becoming available for patient use.
What’s the Difference Between FDA Cleared and Approved?
If your doctor recommends a certain medical device, do you know whether it is FDA approved and if there are any potential health risks? Does your doctor?
It may surprise you to know that many doctors aren’t even fully informed about the safety of the medical devices on the market today. We assume that because a device has been approved or cleared by the FDA that it has undergone substantial testing, but this simply isn’t always the case.
When considering any medical device, it’s important to understand the difference between “FDA cleared” and “FDA approved.”
Manufacturers of complex medical devices that are implanted in your body or have the potential to cause serious injury or death typically must receive FDA approval.
In order to be FDA approved, results of clinical trials and testing must be submitted to the FDA, which will then review the results and determine whether or not the device is as safe as it claims to be.
Cleared – 510(k)
FDA approved and FDA cleared DO NOT mean the same thing. Many American products are “cleared” by the FDA, which means a manufacturer can demonstrate that their product is substantially equivalent to an already legally marketed product.
In other words, if a company can compare their product to another product that has already been FDA cleared or approved, it may forgo rigorous clinical trials or testing and be FDA cleared. To do so, companies must submit what’s known as a 510(k) to the FDA for review.
A Flawed System
The FDA’s system for approving and clearing medical devices and other products is flawed because it allows companies to rush their products to market as fast as possible before fully understanding any potential dangers for consumers.
The problem with the clearance system is that companies are sometimes able to get their products cleared by comparing them to older products that were cleared or approved at one point but are now outdated or were recalled.
It’s also important to know that the FDA doesn’t conduct any of its own tests when evaluating medical devices for FDA approval. It simply reviews the results submitted by the device manufacturer. This is an issue because large corporations are not always transparent and often put profits before the interests of their consumers.
For example, there are thousands of claims of Bayer’s Essure birth control device migrating from women’s Fallopian tubes, breaking into pieces, and perforating other organs, causing extreme harm to their bodies, according to Drugwatch. These claims allege that Bayer knew about these complications and chose to hide them.
There have been 80,000 deaths in the past decade and 1.7 million injuries relating to dangerous medical devices. Adding gas to the fire, less than 0.5 percent of medical device failures are even reported to the FDA. This means that many defective products continue to be used despite harmful defects.
Medical devices should be rigorously tested to ensure the safety of those using them, but the FDA’s approval and clearance systems do not always protect patients from the reckless and irresponsible actions of medical device manufacturers.
Before putting any medical device in your body, it’s important to do your research. With the FDA’s flawed systems and negligent companies who are only interested in making money, it is possible to suffer serious injuries and even death from a defective medical device, even if it was FDA cleared or approved.
Together with our partner medical device lawyers, we at Goldwater Law Firm are committed to seeking justice for people injured by corporate greed. If you or a loved one has suffered injuries from a defective or recalled medical device, you have legal rights.