Semper fidelis--consumer protection for patients with implanted medical devices.

In October, after 38 months on the U.S. market and 268,000 implantations worldwide, the Medtronic Sprint Fidelis was voluntarily recalled because of its propensity to fracture. Dr. William Maisel writes that the controversy highlights the shortcomings of the regulatory system for medical devices and underscores the urgent need for legislation that will ensure adequate protection for patients.