The FDA announced that in the future it would be looking more closely at a range of medical devices and products — along with the materials they’re made from — that have caused the most trouble for consumers in recent years. The agency singled out breast implants, metal-on-metal hip replacement systems, and the components of birth control implant system Essure. Most strikingly, the announcement targeted not just the final products manufactured by medical device companies, but the materials they used to make the products.
The 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.
After an initial golden age of promise, the medical implant industry has suffered a sharp backlash in recent years. Numerous implant systems and technologies have either failed to perform as promised or done more harm than good — some have even killed people. As recipients of these faulty devices have gone to the press or to court, the reputation of the medical implant industry has been dragged through the mud and then some.
Recently, Zimmer’s M/L taper hip with Kinectiv and Versys head has been the subject of product liability and personal injury litigation. Like similar hip implant systems from Wright, Johnson & Johnson, and Stryker, the Zimmer system has allegedly caused metallosis in some patients. So far, more than twenty lawsuits have been filed against the manufacturer.