Requiring a surgical implant can be a very scary experience. Many unknown factors can make you second-guess your decision to go through with it at all. However, at the urging of your doctor and the reassurances that these types of procedures are safe, you are persuaded to have the surgery. However, what if the medical device your doctor implanted isn’t as safe as you’ve been told? Many manufacturers of medical devices such as surgical mesh, hip replacements, lap bands and numerous others, do not require adequate testing for their products. This means that the device you are now relying on and have inside of you, could not only suddenly fail to work, but it could also cause you serious harm.
Like all businesses, medical device manufacturers want to make money. Therefore, if they can produce a product cheaply and then sell it at a high cost, they’re happy. Currently, the Food and Drug Administration, who regulates medical devices, does not require rigorous testing for a device to be approved for sale. For a device to be approved, it merely has to pass an investigation, known as the 510(k) clearance. This clearance requires the manufacturer to inform the FDA, 90 days in advance, of their plan to market a device. This window then allows the FDA to classify the device by comparing it to similar devices already in production. The basic theory is that if it is similar to a preexisting device, then it can be classified within the same safety standards.
This process is good for the manufacturer because it doesn’t require trials to test their devices; they merely need to show how it is similar to an already working device. As you can imagine, this saves the manufacturer a lot of time and money and can allow their devices to be put into production that much faster. The problem that this process causes doesn’t really affect the manufacturer, it affects you. If you receive one of these devices, are assured that it is up to FDA standards, but has an untested flaw, you are the one who suffers.
If you believe that you are a victim of a faulty medical device or have had to undergo multiple surgeries because of a medical device flaw, you owe it to yourself to call the Utah defective medical device lawyers at the James Esparza Law Firm. We know how scary and upsetting this can be, and we are here to help. Please call us at 800-745-4050 for a free consultation. Let us help you fight back.