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DePuy Artificial Hip Failures Highlight "Implants Loophole"

According to the New York Times, the DePuy artificial hip implant's failure points to serious problems in the way devices are approved by the FDA, a problem it dubs the "Implants Loophole".  

The DePuy A.S.R. (Articular Surface Replacement) hip implant made by a unit of Johnson & Johnson was recently recalled due to high incidents of early failure.  The device was designed to last for at least 15 years, but has been failing in high numbers after just a couple of years.  

The problem, critics say, is that unlike the clinical trials conducted on drugs prior to their approval for use in the U.S., devices like the DePuy artificial hip, can be sold without significant testing if the company can prove it resembles an implant already approved.

In 2003, DePuy developed the A.S.R. comprised of a cup and thigh component that would remove less of a patient's thigh bone when implanted.  That version of the A.S.R was sold by DePuy outside the U.S.  

In 2005, the F.D.A. allowed DePuy to start selling another version of the A.S.R., a modified standard hip replacement that used the same cup found in the 2003 version not approved for use in the U.S. along with an approved thigh component.  Current rules do not require companies to notify the F.D.A. when they bundle together components from approved and unapproved devices.  According to, an FDA official, new iterations of device designs already used on patients typically receive scant scrutiny from the F.D.A. before being put on the market.  The F.D.A. is currently reviewing changes to this approval process.

In August 2010, DePuy recalled the A.S.R. and stated it would pay for operations to replace the device if needed and also urged patients who were experiencing pain to see their doctors.  

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