Medical Devices

Out of joint: The story of the ASR

BMJ 2011; 342 doi: http://dx.doi.org/10.1136/bmj.d2905 (Published 15 May 2011)
Cite this as: BMJ 2011;342:d2905
  1. Deborah Cohen, investigations editor
  1. 1BMJ, London WC1H 9JR, UK
  1. dcohen{at}bmj.com

Why did it take so long to recall from the market a hip implant after it became apparent that it was causing pain and disability in patients. In an investigation for the BMJ, Deborah Cohen describes how companies dictate the fate of their own devices and exert an unduly strong hold over surgeons

It is one of the biggest disasters in orthopaedic history, according to one senior surgeon. On 24 August 2010, DePuy, a subsidiary of American giant Johnson and Johnson, recalled its ASR (articular surface replacement) hip prostheses from the market. The recall followed years of denial by the company that the ASR implants had caused pain and disability in patients. In a statement to the BMJ, DePuy claim that “given the available information, we believe we made the appropriate decision to recall at the appropriate time.”

Pathologically, the failing prosthesis had several effects. Metal debris from wear of the implant led to a reaction that destroyed the soft tissues surrounding the joint, leaving some patients with long term disability. Ions of cobalt and chromium—the metals from which the implant was made—were also released into the blood and cerebral spinal fluid in some patients.1

The long term effects are uncertain. But the US Food and Drug Administration recommends that patients should be monitored for systemic effects, particularly cardiovascular, neurological, renal, and thyroid signs and symptoms.1

With more than 93 000 ASR implants sold and ongoing litigation in many countries, the situation may prove costly for DePuy. And if lessons are not learnt from this latest episode in the chequered history of hip implant failures, it may also prove costly for the reputations of the regulators and the orthopaedic community.

The ASR is not the first hip implant to be recalled—there have been many others. One …

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