Medical Devices First Approved in Europe Have Higher Rates of Recalls and Warnings

By Kelly Young

Edited by Susan Sadoughi, MD

Medical devices first approved in the European Union are associated with increased risk for safety alerts and recalls than those first approved in the United States, according to a study in The BMJ.

Researchers identified roughly 300 high-profile cardiovascular, neurologic, and orthopedic devices approved in the E.U. from 2005–2010, two-thirds of which were also approved in the U.S. Most received E.U. approval first.

Devices first approved in the E.U. had a higher rate of safety alerts and recalls than those first approved in the U.S. (27% vs. 14%).

The authors conclude: "Our findings suggest that products introduced earlier in their development cycle are.... more likely to increase the risk of harms, underscoring the urgent need for transparency to make truly informed decisions."