Ads must state infection risk say US consumers
This article was originally published in Clinica
Executive Summary
A major US consumer organisation is calling on the Food and Drug Administration (FDA) to require makers of implantable medical devices to beef up warnings associated with their products if they advertise them directly to consumers, writes April Fulton. Consumers Union, the non-profit publisher of the popular publication Consumer Reports, filed a petition with the FDA on December 11 asking it to require that all print and electronic advertisements for implantable devices - like hip, knee and heart valve replacements and cosmetic implants - include warnings about the danger of surgical infections and the life span of the devices.