It seems as though an explosion of medical technology has occurred in recent years. More medical devices are available to patients than ever before. The problem is that a substantial portion of them never went through clinical trials to ensure their safety and effectiveness.
This is due to a 1976 approach to approving medical devices that essentially allowed many of them to move onto the market without passing any tests. This was allowed as long as a manufacturer showed the agency that the proposed device was similar enough to a product already on the market.
The problem
This approach may have worked for the decade, or maybe two decades, after 1976. In fact, it was initially only meant to be a stopgap measure, but over the years, it became normal procedure. Now, millions of people suffer injuries and tens of thousands more die due to defective and unsafe medical devices approved under this method. Those numbers can’t go down until the FDA improves its processes.
The lack of testing and clinical trials results in flawed medical devices making it into the market and into the bodies of patients. When those devices malfunction or fail in some way, the manufacturers aren’t the ones that suffer the consequences, the patients do.
A recent study by the International Consortium of Investigative Journalists and over 50 media outlets worldwide concluded that, in the past ten years alone, around 83,000 people lost their lives and another 1.7 million suffered injuries due to medical devices approved for release into the market by the FDA.
The solution
Many believe that if the FDA removes some older medical devices from the market, manufacturers will no longer trace recent devices back to them. Those older devices do not contain the same technologies or complexities of the ones released today. To say they are similar at this point doesn’t make sense anymore. If the agency follows through on its pledge to make changes, manufacturers will once again need to put their products through the paces before pushing them onto an unsuspecting market.
In the meantime, Louisiana patients who suffer serious or fatal injuries due to defective medical devices still need to turn to the courts for relief. Perhaps the more the public calls out medical device manufacturers through the court system, the greater the chances are that the FDA will listen to those it claims to protect.
