As the U.S. Food and Drug Administration prepares to examine how safe metal-on-metal hip implants are, the agency released a report saying it received more than 16,800 reports of adverse events associated with the devices from 2000-2011.
Complaints increased after Johnson & Johnson began recalling its ASR hip implants in 2010, according to Bloomberg News.
- More than 6,000 lawsuits have been filed against Johnson & Johnson related to the hip implants, which represents 74 percent – or 9,006 of the 12,137 complaints the FDA received in 2011.
- The company recalled the 37,000 ASR hip implants sold in the U.S. (93,000 worldwide), saying 12 percent would fail within five years.
The FDA held a two-day expert advisory panel meeting to discuss the risks and benefits of metal-on-metal hip replacements on June 27-28.
Meantime, three doctors say in a New England Journal of Medicine article that the FDA’s approach to assessing the safety of metal-on-metal hip implants limits the “usefulness” of research collected in studies conducted after a product goes on the market. The doctors say post-marketing studies required by the FDA are lagging and the FDA’s requirements put too much power into the manufacturers’ hands as to how data is collected.