Houston Personal Injury Lawyer Explains How Manufacturers Abuse the FDA’s 510(k) Process

If you have been the victim of a failed hip or knee replacement, you may have wondered how a defective device was allowed for your surgery. It may seem impossible to believe, but critical prosthetic devices like hip replacements or knee replacements can come to the market with little or no testing through the FDA’s 510(k) process.

So what’s wrong with the FDA’s 510(k) process? Well, it may not be so much of a problem with the FDA as it is a problem with manufacturers. For new medical devices entering the market, they must be approved for sale through the FDA. The FDA has a process called 510(k), which is in place to allow products that are significantly similar to products released before May 28, 1976 to come to market without testing. This is in place because one could argue it is foolish to demand money be spent on testing for products that are so similar to tried and true products already on the market.

Though, as always, manufacturers have exploited the 510(k) process and brought defective products to the market. The FDA claims that products must be “substantially equivalent” to those already on the market. However, many new hip and knee replacement devices differ in technology, material, and even function from the products they are supposed to be “substantially equivalent” to.  

As experienced hip replacement and knee replacement attorneys, we have watched the recall process and failure rates vigilantly. It is obvious that manufacturers are bringing products to the market that are dangerous and unproven. If you have been the victim of a hip or knee replacement failure, please give the attorneys at Vujasinovic & Beckcom a call at (877)724-7800 for a free consultation.