Occasionally, the potential harm of a medical device far outweighs any benefits patients here in Ohio or elsewhere receive from it. In these cases, the Food and Drug Administration can ban such devices, but it does not use this power very often. When it does use this option, what happens?
First, a medical device will usually only face a ban if the information and evidence available shows that it causes a substantial and/or unreasonable risk to those who use it. In addition, if patients are deceived into believing in the supposed benefits of a product and those benefits do not exist, the FDA could ban it. In many cases, a simple change of labeling could resolve an issue, but when that option will not work, the product could be banned.
A substantial amount of investigation goes into making the decision to ban a product. The FDA reviews medical literature, the history of adverse events connected with a product, and the risks and benefits of a particular product when compared to others already on the market. The agency will then work with medical professionals and experts to ascertain the efficacy of the medical device in question. The agency does not have to have proof of actual injuries in order to use this power, but only needs to show the potential harm is substantial.
Some would say the Food and Drug Administration fails to use this power as often as it should. People here in Ohio and elsewhere have suffered significant harm, including death, from a variety of medical devices over the years and many wonder why the products even remain on the market. In some cases, any action by the agency would be too late to save individuals from serious injury or death. Under those circumstances, it would be up to the victim, or the victim’s surviving loved ones, to take action against the appropriate parties to pursue financial restitution for the harm suffered.
