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Report Questions Timing of DePuy ASR Hip Implant Phase-Out | 24-7-news.com cialis online

Report Questions Timing of DePuy ASR Hip Implant Phase-Out

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Although DePuy Orthopaedics has long claimed it phased out its controversial ASR hip implant devices over declining sales, a breaking The New York Times report says the device maker chose to phase out the ASR only following a U.S. Food and Drug Administration (FDA) request.

The agency sent a so-called “Nonapprovable Letter” to DePuy, a division of Johnson & Johnson, citing the “high concentration of metal ions” in the blood tests of some patients implanted with its metal-on-metal hip implant, said The Times. The Times obtained the FDA letter under the Freedom of Information Act. At the same time, reports were being received that indicated the implant was performing “somewhat more poorly” than data submitted by DePuy, The Times wrote, citing the FDA letter. As a matter-of-fact, said The Times, Australian data revealed that by mid-2009, the device was failing prematurely and at high rates.

The nonapprovable letter was sent confidentially to DePuy in 2009 and indicated it was rejecting DePuy’s application to sell the all-metal device in the U.S. The letter, in large part, dealt with issues that FDA reviewers had with DePuy’s study data, said The Times, and asked DePuy for additional safety data in order for the application to be pursued.

At that time, DePuy was already marketing another version of the device, the ASR XL Acetabular Hip Implant, in the U.S.Neither device was recalled until August 2010, a full year after the FDA letter.

In the meantime, said The Times, in September 2009, DePuy officials implemented a strategy to phase out both devices, although remaining stock continued to be used in patients worldwide, according to DePuy records.

The recalled DePuy ASR XL Acetabular System and ASR Hip Resurfacing System are both metal-on-metal implants, originally believed to offer improvements over prior metal-on-plastic devices. For some time now, health professionals have been concerned with metal-on-metal grinding that would cause shards to shed into patients’ bodies leading to inflammation and joint, nerve, and tissue damage. Experts are concerned that the metal debris could poison organs, increase cancer risks, and even impact the developing fetus.

The number of patients implanted with DePuy’s ASR hip implants in between September 2009 and the August 2010 recall is not known; however, over an eight yearpeirod, 93,000 patients worldwide—about one-third in the U.S. alone—received the faulty ASR, said The Times.

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