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DePuy Hip Recall: NYT Confirms High Metal-On-Metal Artificial Hip Failure Rate

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The New York Times report is gruesome:

"As surgeons here sliced through tissue surrounding a failed artificial hip in a 53-year-old man, they discovered what looked like a biological dead zone. There were matted strands of tissue stained gray and black; a large strip of muscle near the hip no longer contracted."

The Times confirms similar scenes are playing out at hospitals around the country and that researchers warned more that a decade ago that metal-on-metal (MoM) hips could shed tiny pieces of metallic shavings that posed health risks to patients.

"All orthopedic implants, regardless of their composition, shed debris as they wear. But researchers say they believe that the particles released by some all-metal hips pose a special threat because scavenger cells dispatched by the body to neutralize the debris convert it into biologically active metallic ions. In some patients, a chain reaction begins that can destroy muscle and tissue."

The Times cited a New England Journal of Medicine study that found that metal-on-metal artificial hips failed at 3 times the rate of other artificial hips. The problems have gotten so bad, the FDA ordered an in-depth study of metal-on-metal artificial hip systems. However, the FDA is leaving it up to each individual manufacturer how to conduct its study.

Metal-on-metal hips include the DePuy ASR SL Acetabular Head System, DePuy ASR Hip Resurfacing System, DePuy Pinnacle artificial hip systems, as well as certain artificial hips manufactured by Stryker, Biomet and Zimmer.

Remarkably, most medical devices recalled by the FDA in recent years because of deaths or life-threatening problems were approved under less stringent regulations that did not require human testing — meaning the devices were never tested in human patients before being implanted into hundreds of thousands of people.

Making matters worse, not only are these devices not properly tested, but the hip manufacturers pay doctors to actively promote the defective products. DePuy paid more than $80 million to doctors across the country to promote, research, and consult on DePuy’s defective hips.

Did your doctor get a kickback payment from DePuy? View the list here.

In May 2010, a State of Alaska Epidemiology Bulletin found that elevated chromium and cobalt ions were commonly detected in the blood and urine of metal-on-metal artificial hip patients, causing metallosis (formation of giant cells and fibrosis in the surrounding tissue).

[DePuy Hip Recall: Frequently Asked Questions]

In September 2010, a motion was filed to consolidate all federal court DePuy Hip product defect litigation in an MDL. That motion was granted and all DePuy metal-on-metal artificial hip lawsuits filed in federal court have been consolidated to be heard in front of Judge David A. Katz in the US District Court for the Northern District of Ohio. DePuy defective hip lawsuits filed in state courts will likely remain independent cases.

Published reports confirm that DePuy’s parent company, Johnson & Johnson, knew about the artificial hip defect for years, but failed to correct the problem or warn patients. In some cases, Johnson & Johnson replaced defective ASR hips with another defective ASR hip after patients had initial problems.

Symptoms indicating a possibly problem with an artificial hip include:

  • Serious / Chronic Pain
  • Inflammation / Swelling
  • Loosening of the Hip Implant
  • Fracture of the Bone Around the Hip Implant

In addition, the defective DePuy hips may pose a serious risk of cancer. The metal-on-metal construction of the DePuy ASR artificial hip permits grinding and allows metal particles to contaminate the surrounding tissue. These metal particles — cobalt and chromium — enter the blood stream and can be distributed to other areas of the body.

[More information on the DePuy Hip Recall]

(c) Copyright 2011 Brett A. Emison

1 Comment

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  1. deb says:
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    smith and neohew need to be added to the list,i had two metal on metal implants made by them and they both failed,so in a 2 and ahalf year span i had my hip replaced 3 times and am now disfigured,wy hip caved in and i had corrective surgery in july for it,it lasted about a month then caved in again…i had no insurance for last two surgeries,i am in soooo much debt i dont know what to do,i had many many complications throughout the whole process,All i was trying to do was get fixed so i could go on with my life and have ended up like this,a pathetic mess and the pharmaceutical company could care less,and no one will help because they are not recalled,what a colossal joke.The real ironic thing is that the first two metal on metal failed implants were one hundred percent covered because i had insurance then.