The FDA confidentially notified the company that it wouldn’t approve a version of its subsidiary DePuy Orthopaedics’ ASR Hip Replacement because the metal-on-metal design had showed significant failure among patients during studies.
The company continued to market the device without disclosing the nonapprovable letter, but the company was within its rights to do so. The company decided to phase out the device in 2009, after it spent eight years on the market, but maintain it was a business decision.
By contrast, the e-mail correspondences from 2009 indicate Johnson & Johnson had results showing the ASR implants could have higher failure rates than the control group, even among the surgeons they hand-picked to position the implants correctly, according to the report.
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