FDA Reports Nearly 17,000 Adverse Events From Metal Hip Implants (press release)
Bernstein Liebhard LLP, a New York law firm nationally recognized for its consumer protection and mass tort practices, reports that there have been nearly 17,000 adverse events related to metal hip implants reported to the U.S. Food and Drug Administration (“FDA”) from 2000-2011.* Specifically, a June 21, 2012 Bloomberg News article analyzing the adverse events reported to the FDA during that time period highlighted the following:
The reports almost quadrupled to 682 in 2008 from the year earlier, and rose again after DePuy, a subsidiary of Johnson & Johnson, issued a worldwide recall of the ASR hip implants in August 2010
In 2011, the FDA received 12,137 adverse event reports associated with metal hip implants, compared with 6,332 associated with other types of hip implants, such as ceramic and plastic
In 2011, the DePuy ASR hip implants accounted for 74 percent of the incident reports received by the FDA
Revision surgery is the most commonly reported adverse event, which requires patients to undergo a second surgery in order to remove the defective hip replacement system; and
To date, the FDA re...
