It would seem reasonable to assume that any medical device recommended for implantation in a human body would have FDA approval for safety and efficacy – right?
That’s what most consumers in the U.S. believe.
Sadly – it’s not the case.
The vast majority of medical devices are approved by the FDA but have undergone little if any clinical testing.
You might want to read that last sentence again.
Hard to believe – isn’t it?
In just the last ten years alone, medical devices have caused almost two-million injuries and more than 80,000 deaths.
As the New York Times reports:
“There have been metal hips that released poisonous debris into the body, implantable defibrillators that shock people at random (causing indescribable terror) and artificial heart valves with questionable shelf lives. In operating rooms, there have been staplers that misfire; temperature control machines that spray bacteria into open chest cavities; and robotic surgeons that slap, burn and, in some cases, maim patients.”
And that account covers just a small number of the instances of harm.
Virtually every case of medical device failure or malfunction is the result of shaky regulatory “approvals,” poor post-market surveillance, and slow regulatory responses to obviously dangerous products.
What might the FDA do to rectify this deadly problem? Here are some suggestions:
- Significantly tighten the approval process. Require that every single device be tested extensively for safety and efficacy.
- Improve reporting on these devices after they are made available to consumers to help ensure problems are spotted early.
- Break up the party at FDA. For too long – staff at the FDA have either come from the ranks of device makers or been hired by manufacturers after stints at the FDA. Ethical standards need to be raised so that those with a vested interest in these products aren’t foxes watching the proverbial hen house.
If you or a loved one has been harmed by a medical device or drug, call a qualified Connecticut product liability lawyer. A knowledgeable product liability attorney can help to ensure that your rights are protected.
RisCassi & Davis has handled hundreds of product liability cases over our more than 60 years serving the people of Connecticut.
What’s more, our Connecticut product liability lawyers have received local and national recognition for our handling of these cases.
We have a great team of legal experts dedicated to protecting consumers in Connecticut. Please contact us if we can help you.
The consultation is free, and there is no obligation of any kind.