A medical device, according to the U.S. Food and Drug Administration (FDA), is any instrument, machine, implant or apparatus which has been designed for use in diagnosing, curing, treating or preventing a specific disease or medical condition.
Before a newly-developed medical device can make it to the U.S. market and be used in hospitals or doctor's offices, manufacturers must first go through the FDA's 510(k) process for review. Once a device is approved and goes to market, many manufacturers consider their work is done, but that is not necessarily true.
While this process may act as a public safety measure, it is generally after these devices get on the market when problems begin to arise. Dangerous devices can be left on the market, not recalled by manufacturers. Even in instances when a recall is issued, it may be only after countless people have been injured or killed as a result of the defective device.
One of the problems, according to a study reported in the Journal of the American Medical Association, is the lack of information provided to the public as to the safety and effectiveness of med,ical devices.
If you or a loved one has been injured by a medical device, whether it was implanted or used during the treatment process, it is important you seek legal representation at once.
Our experienced attorneys have a deep passion for standing up for the rights of patients and their families. If you would like to request a free, no-obligation case review, please use our contact form and we will get back with you promptly!