Patients should be asking their doctors undergoing surgery when implants are placed whether there is FDA apprroval? All surgeons use products that are not cleared but the reason must be well understood. Technology that has proven outcomes should be the goal. I still find many patients that do not know what was put in their back by the previous surgeon. I try to use models and detailed information when preparing patients for surgery. I never ever suggest better then70 to 80 percent outcome for improvement.