Johnson & Johnson could learn a thing or two from Smith & Nephew
  • Wed, 06/06/2012 - 3:30pm

 

London medical device manufacturer Smith & Nephew, PLC recently announced that it will discontinue use of the metal liner in its R3 Acetabular System hip device, citing a high failure rate, infections, fractures and dislocations.

Studies published in medical journal The Lancet indicate that patients who received metal hip replacements are more likely to undergo revision surgery within five years. But an analysis of clinical trials showed that 1.6 percent of patients with Smith & Nephew’s replacement underwent revision surgery each year, which is above the 1 percent guideline set by Britian’s National Institute for Health and Clinical Excellence.

“We regularly review the effectiveness of our products and are not satisfied with the clinical results of this component,” said Andy Weymann, chief medical officer for Smith & Nephew.

More than 7,700 R3 Acetabular Systems have been implanted since its 2007 introduction to the market. Smith & Nephew stated that withdrawing the liner from its device will not cause any delays in surgery since patients have other nonmetal liner options.

A study published in the British Medical Journal discovered hundreds of thousands of metal hip implants may expose patients to metal poisoning, or metallosis, due to a when metal particles shed and enter the bloodstream. If these particles enter muscle or bone, patients can be affected with long-term disability and destroyed tissue.

Had Johnson & Johnson reacted quickly to the number of problems reported with its DePuy ASR Hip replacement, the company would not be facing the more than 3,000 lawsuits pending in the U.S. today. Instead, the company allegedly sold the device for three years without FDA approval, prompting an eventual recall.

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