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News Center
Many Medical Implants Have Never Been Safety Tested
First Breast Implants came under scrutiny, then hip replacements, and now a shocking new research from Consumer Reports declares that many medical devices are not tested for safety at all.
Car manufacturers spend millions testing their vehicles for every imaginable accident, drinking water and food must meet certain standards, and even cell phones have had research as to the ramifications of their microwave radiation. So, it seems incredible that a device that is actually implanted inside the body, the ramifications of which are complicated and beyond the understanding of the average patient, can be brought to market by its manufacturer after a simple process of some paper work and a filing fee.
The report, which is available online at www.ConsumerReports.org accuses the regulatory system of being broken, leaving trusting patients and busy healthcare professionals at the mercy of the suppliers who appear to be happy using patient's bodies as their laboratory and sole testing procedure.
Nearly one in five Americans has some kind of medical implant, and that figure looks set to climb with more advanced prosthetics becoming available, along with the increasing affordability and popularity of cosmetic procedures. With that in mind, a panel from the Institute of Medicine recommended that the FDA totally revamp its regulating system for medical implants, saying that the current process provides no guarantee of patient safety, even after they have received an implant.
Unfortunately, Congress has taken the opposite approach and is currently in the process of approving legislation that would not only leave the present, yet inadequate system in place, but pave the way for manufacturers to bring devices to market even faster.
Availability of information, research and reviews into the devices available, combined with the fact that most patients will trust their physician to make the right choices for them, leave patients in the dark; the average consumer probably does more research and has more information about their car, laptop or sunglasses than they do about a potentially life threatening breast implant or hip replacement product that might cost tens of thousands of dollars.
