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DePuy Sold Hip Implant Rejected By FDA Overseas

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DePuy Orthopaedics, a unit of drug giant Johnson & Johnson, sold a version of a hip implant overseas that was rejected by the U.S. Food and Drug Administration (FDA). In 2009, the FDA-rejected DePuy ASR Hip Resurfacing System was being sold overseas as surgeons and medical device regulators, worldwide, were beginning to face issues with two DePuy ASR hip devices, according to The New York Times. The FDA’s rejection was based on safety study reviews. DePuy was selling a similar version—the ASR Acetabular System—in the United States, which was approved through the FDA’s 501(k) process. This process does not mandate human clinical trials if the device is significantly similar to approved products. The ASR Hip Resurfacing System, meant for use in a new procedure, was required to undergo human trials by the agency On the market for eight years, both devices were used in about 93,000 patient surgeries globally; one-third of these have been sold in the U.S., noted The Times. Both devices utilize the same defective construction, all-metal, or metal-on-metal, components, which are at the core of problems with these devices. The following year, DePuy issued a worldwide recall for both devices after data from the National Joint Registry of England and Wales was released that revealed that the devices were experiencing a failure rate of 12-13%. This means that an unusually high number of patients implanted with these devices needed to undergo revision surgery within five years of their original surgery, a painful and complicated procedure that involves removal of the faulty device and reimplantation with a different device. Meanwhile, The Times reports that the FDA sent Johnson & Johnson a confidential letter in August 2009 indicating that company research and clinical data used to obtain U.S. approval to sell the overseas model was insufficient to conclude the device’s safety and efficacy. The FDA told Johnson & Johnson that additional data would be required to continue with the application for approval,

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which, noted The New York Times, could take at least one year. A DePuy spokeswoman, Mindy Tinsley, confirmed it had received the FDA’s nonapproval letter, but would not provide any other information to The New York Times. Of note, not only did a review of publicly available information indicate that DePuy never discussed the FDA’s letter in financial reports or analyst presentations—when the device was still on the market—but a key research on the trials that were submitted to the agency told The Times that he was never informed of the FDA decision. The company, as far as the ASR Hip Resurfacing System is concerned, did not break any laws; overseas regulatory standards are not as strict as U.S. standards, noted The Times. Also, an FDA regulation specialist attorney told The Times that, typically, notification is not called for when the agency does not approve a device used overseas.

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