I've written about this before. If you get a medical device implanted in you and it doesn't work, how do you give it back and get a new one? Hmmm... That's right up there with trying to uncook overcooked food.
Some geniuses (and I use the term loosely) commissioned a report to review the process by which medical devices are approved and regulated. They are now amazed to find out the process needs complete review because it does not look at safety and effectiveness of the devices.
How can a process approve and regulate something if they don't look at safety and effectiveness? And if they are so smart in the first place, why did they have to review the process in the first place? Let me guess, they thought they were perfect and couldn't be wrong and requested the review to prove they were right.
I think my point (and I always need a point) is that if the system is flawed and approving items which are not safe and/or effective, perhaps they should reconsider how they are doing it? If I have a medical device in me, I want to be very sure it is safe and effective. Perhaps the industry should not be about money but about the patients.