FDA: Hip implant complaints increasing

Posted by Sarah Showard | Jul 16, 2012 | 0 Comments

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.

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About the Author

Sarah Showard

Sarah Showard graduated from the University of Maryland in 1985, Magna Cum Laude with a Bachelor of Arts in English-Linguistics and a Certification in Womens Studies. She then graduated from New York University School of Law in 1988. Sarah began practice initially as an insurance defense attorne...


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