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.
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.
While obviously a hip replacement can’t “kill” the way a heart-attack can, a defective device can set off a sequence of events and conditions that can lead to serious harm or even death. And it happens far more often than we think, particularly because the manufacturers of these devices do not want anyone to know how often it happens.