Many people have a false sense of security surrounding the safety and efficacy of medical devices. Who could blame them? We are raised believing that the government makes sure medicines and medical devices have been tested and proven safe.
Here are the facts: the FDA does not perform any testing on medical devices. It relies on the manufacturer to provide full and accurate data relating to the manufacturer's own studies regarding the safety of the device. The FDA decides whether or not to approve a medical device based on data the manufacturer provides. This has created a situation where companies that stand to profit from the sale of defective devices also act as the judges of whether or not their product is safe.
The FDA also relies on the device manufacturer to fairly report on the number of deaths and injuries associated with their products. In practice, the manufacturer decides if the event which caused a death or injury has a likelihood of being repeated, and if they decide it is unlikely to occur again they may not report the event to the FDA at all. All too often, medical device manufacturers have been caught failing to report these product accidents and hiding injury events from federal and state agencies.
The video below features attorney Jeffrey Bowersox discussing medical devices and harmful products in our markets today.
The DePuy hip replacement is another example of a dangerous device that the manufacturer continues to sell to unsuspecting patients. While DePuy has recalled two previous hip replacement devices, the DePuy ASR™ and the ASR™ XL, the Pinnacle continues to be sold even though it is causing widespread injuries to recipients.
If you have a DePuy hip replacement implanted after July 2003, or problems caused by any other medical device, please allow us to consult with you free of charge. We can help.