I wrote earlier today about Johnson & Johnson’s continuing quality problems including troubles in its DePuy Orthopaedics division over DePuy’s metal-on-metal hips. Now, in breaking news, the FDA has ordered Johnson & Johnson, DePuy and other artificial hip makers to undergo further study of these metal-on-metal hip implants that have been linked to high failure rates and severe health problems.
Other manufacturers include Biomet, Inc., Stryker Corp. and Zimmer Holdings Inc.
One of the major issues to be studied is the effect on patients of metal-on-metal grinding that may release toxic metal debris into the patient’s tissue. These metal-on-metal hips are made from metals including cobalt and chromium.
Cobalt and chromium ions are commonly detected in the blood and urine of MoMHA patients as a result of wear at the bearing surfaces over time. The accumulation of metal ions in the areas surrounding the prosthetic join can cause metallosis, indicated by the formation of giant cells and fibrosis in surrounding tissue. — May 2010 State of Alaska Epidemiology Bulletin
I wrote back in September 2010 that these toxic metals could enter a patient’s blood stream and be distributed to other areas of the body. Elevated cobalt and chromium levels can cause serious side effects and health problems, including cancer.
FDA officials believe the concerns are significant enough to warrant a broad review of risks and dangers of the artificial hip implants. However, the FDA is leaving it up to each individual manufacturer how to conduct its study. Manufacturers have 30 days to file a proposed study plan.
[More on the DePuy Hip Recall]
- Hip Makers Told to Study More Data [Barry Meier at NYT]
- FDA Asks J&J, Hip Makers for Data on Metal in Blood [Bloomberg]
- What You Need to Know About Johnson & Johnson’s DePuy Artificial Hip Recall
- DePuy Artificial Hip Recall: Is There A Cancer Risk?
- DePuy Hip Recall: Problems With DePuy’s Pinnacle Hip Replacements As Well
(c) Copyright 2011 Brett A. Emison
Brett Emison is currently a partner at Langdon & Emison, a firm dedicated to helping injured victims across the country from their primary office near Kansas City. Mainly focusing on catastrophic injury and death cases as well as complex mass tort and dangerous drug cases, Mr. Emison often deals with automotive defects, automobile crashes, railroad crossing accidents (train accidents), trucking accidents, dangerous and defective drugs, defective medical devices.