FDA: nearly 16,800 concerns reported in a decade regarding hip implants.

Bloomberg News (6/22, Edney) reports that according to a report from the Food and Drug Administration, “almost 16,800 adverse events associated with metal-on-metal hip implants were reported in the US from 2000-2011.” Bloomberg notes that the FDA document found that reports of adverse events with the implants “almost quadrupled to 682 in 2008 from the year earlier, and rose again after a unit of Johnson & Johnson (JNJ) began recalling hip devices in 2010.”

Physicians criticize FDA approach on hip implants. MedPage Today (6/22, Gever) reports, “Post-marketing studies of metal-on-metal hip implants, ordered last year by the FDA, will be much less useful than they could be unless the agency changes its approach, doctors charged.” According to the story, three physicians wrote an online New England Journal of Medicine Perspective article in which they argued that the required studies by the agency have been slow to get under way and that “methodologic issues will limit the usefulness of the information that emerges from these studies.”