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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 Women's Studies. She then graduated from New York University School of Law in 1988. Sarah began practice initially as an insurance defense attorney, and has been representing plaintiffs since 1990. Sarah has a son, Benjamin, who recently graduated from The Gregory School and will attend ASU in the fall, with future plans to attend law school and eventually join Showard Law Firm. In her spare time Sarah enjoys horseback riding and spending time in Sonoita with her husband Peter.

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