A new study found that high-risk medical devices were approved without much proof of their safety and efficacy.
Reuters reported that the Yale study also found that once the device is on the market, there is little follow-though to see how the device is working.
"… in many European countries they have much better capacity to follow devices once they are in practice,” senior author Dr. Joseph S. Ross of the Yale University School of Medicine told the news outlet. "They allow devices on the market quicker in the U.K., but follow the devices so they can observe them in practice.”
Although Ross said he doesn't want to scare the public, he thinks the findings should be taken seriously.
According to Reuters, "Of the 28 such devices granted initial marketing approval by FDA during the study period, 15 were new stents for the heart or elsewhere in the body. Ten were later recalled from the market."
