STORY AT-A-GLANCE
- Europe’s medical device industry is so poorly regulated that U.S. regulators have compared it to a system where “patients are treated like guinea pigs”
- Faulty medical device implants, including artificial spine disks, breast implants, hip replacement devices, bone graft devices and insulin pumps have caused serious health problems
- Medical device implants in Europe are not regulated as strictly as medications and therefore often undergo little or no safety testing
- Medical device makers set up shop in Europe where they can get their products approved simply and cheaply
- Medical device manufactures are legally required to report problems that damage people’s health, but they often don’t and face no penalties