Hip Device Phaseout Followed F.D.A. Request
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Hip Device Phaseout Followed F.D.A. Data Request

Johnson & Johnson executives decided in 2009 to phase out a hip implant and sell off its inventories for use in patients just weeks after the Food and Drug Administration asked the company in a letter for added safety data about the implant, administration documents and corporate records show.

At the same time, the agency told the company that blood tests of some patients who got the all-metal hip showed a “high concentration of metal ions” that it found “concerning,” according to the F.D.A. letter obtained by The New York Times under the Freedom of Information Act.

Officials also wrote that reports from countries where the implant was then being used showed it was performing “somewhat more poorly” than data submitted by the company’s DePuy Orthopaedics unit indicated. By mid-2009, for example, data from Australia showed that the device was failing at high rates just a few years after implantation, rather than lasting 15 years as expected.

The Food and Drug Administration’s statements were contained in a so-called nonapprovable letter in which the agency confidentially notified DePuy in 2009 that it was turning down the company’s application to sell the device in the United States. The bulk of the letter focused on problems that agency reviewers found with study data submitted by DePuy to support its claim that the artificial hip was safe and effective.

In its letter, the agency also asked DePuy for added safety data if it wanted to pursue its application.

DePuy did not recall the device at issue, or a companion model that was used in this country, until August 2010, a year after it got the administration’s letter. But in September 2009, just weeks after the letter arrived, company executives started a strategy to phase out the devices while selling their remaining stocks for use in patients both here and abroad, company records show.
Read more: http://www.nytimes.com/2012/03/23/business/fda-asked-depuy-for-safety-data-just-before-hip-implants-phaseout.html?_r=1&ref=health