The Food and Drug Administration or FDA is the government agency responsible for making sure that the food and drugs sold to us and that ultimately go into our bodies are safe. They conduct their own independent testing on thousands of new food and drug products everywhere. What the FDA does not test, however, is the tech that goes into our bodies. Specifically, the FDA does not test the medical device implant technology that is becoming more and more a part of our lives — and our bodies.
The Dark Side of the Medical Implant Industry
The medical implant industry is worth several billion dollars. One huge part of that industry are hip and joint replacement systems. As our population continues to live longer, our joints increasingly seem to be the first part of our bodies that give out. Naturally, we then look to have those joints replaced. And there are millions of Americans walking around today who wouldn’t otherwise be able to thanks to the incredible technological and medical breakthroughs of the past few decades.
There is, however, a dark side to this technology. As the implant industry has grown, regulation of that industry has not kept pace. Currently, there is no formal review process for new medical implant technologies. All testing is done in-house, by the companies manufacturing and/or marketing the technologies themselves. In some cases, in order to introduce a highly desirable and profitable product to the market, they will overlook certain flaws; they might even ignore evidence that their newest product could be dangerous to a certain proportion of recipients. Most cynically, they might simply write off those dangers — and the lawsuits they provoke — as the cost of doing business in a competitive market.
Lawsuits Act As Only Brake on Rush to Market for Metal-on-metal Implants and Other Devices
Metal-on-metal hip implants are a prime example of what happens when capitalism outweighs caution. These devices were the gold standard of hip implant technology for a few decades before people began to notice that, at least for some of them, they were suffering from condition far worse than hip pain thanks to defects and design flaws in the implant systems. In the worst cases, the metal in the metal-on-metal implants was leeching into their bloodstream and damages delicate tissue and organs. Many unfortunate patients were severely injured by the hip implants; some even died.
Many of the world’s largest medical device manufacturers are now in the midst of multi-billion lawsuits over the injuries they caused unsuspecting recipients of their technologies. No doubt many of those recipients simply assumed that the FDA or some other independent body had reviewed the efficacy and safety of the devices that would be installed into their bodies. They would be wrong. Only after thousands of Americans, along with people all over the world, began to report severe health complications due to metal-on-metal implant systems did the FDA step in and issue a recall.
Unfortunately, the FDA’s principal role in this industry is retrospective. Once there is a major problem with some product or technology, the FDA will step in and issue a recall. But for those thousands of unfortunate people who have been harmed by the implants already, their only recourse is through the lawsuits that have become increasingly prevalent. Litigation has become our de facto form of regulation; fear of lawsuits appears to be the only brake on the implant industry’s rush to bring new and potentially hazardous products to market.
