Tags: faulty | hip | replacements

Recalled Implants Sold Overseas

Wednesday, 15 February 2012 03:30 PM

Johnson & Johnson recalled faulty hip implants in the U.S., but continued to sell them overseas, according to news reports.
The company sold a related implant model overseas after the U.S. Food and Drug Administration rejected the devices in the United States, as a result of a regulatory loophole.
The sales abroad, first reported by The New York Times, involved implant models recalled in August 2010 amid reports of high rates of failure in patients. In August 2009 the FDA had rejected the implant in a confidential letter that Johnson & Johnson never made public.
It's not illegal to sell medical products overseas that have been rejected in the U.S. and there is no suggestion that Johnson & Johnson broke the law.
Regulatory standards in other countries, like those in Europe, for approving the sale of medical devices are typically lower than in the U.S. A spokeswoman for a British regulatory agency, the Medicines and Healthcare Products Regulatory Agency, told The Times that companies like Johnson & Johnson were not required to notify it when the F.D.A. refused to approve a product that was used in patients there.
A spokeswoman for DePuy orthopedic division of Johnson & Johnson confirmed that the company had received the agency’s so-called nonapproval letter, The Times reported. But the spokeswoman declined to release the letter or to respond to questions about when, or if, DePuy disclosed the ruling to doctors, patients, investors or regulators abroad.

© HealthDay

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Hip replacements recalled in the U.S. were sold overseas, according to new reports.
Wednesday, 15 February 2012 03:30 PM
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