Newly released court records show that Johnson & Johnson, the maker of the recalled hip implant, has downplayed the device's early failure rate to the public.
The device, the Articular Surface Replacement, or A.S.R., was recalled in mid-2010, and the report estimated that the device would fail within five years in nearly 40 percent of patients who received it. The company's analysis also shows that the implant is likely to fail prematurely over the next few years in thousands more patients in addition to those who have had painful and costly surgeries to replace it.
About 93,000 patients have received an A.S.R., with about one-third in the United States.
Over 10,000 lawsuits are expected against the company, as these court documents become public. The first of the trials is expected to begin Friday in California.
The A.S.R is a hip implant in which a device's cup and ball component are both made of metal. Surgeons have abandoned using such devices because their parts grind together, releasing metallic debris that causes damage to bones and tissues. The device was recalled after data from the National Joint Registry of England and Wales showed that it was failing prematurely at a higher rate than competing implants.
Johnson & Johnson challenged the findings in the data in 2011, but other medical organizations have made similar findings in the failure rate of the implant.
Most hip implants are made from metal and plastic, and last for 15 years before they need to be replaced.
It was also made public by an engineer at the company that officials were aware in 2008 that A.S.R. was releasing high levels of metallic ions, particularly in woman.
Based on the number of patients who have received the implant, it is estimated that 37 percent of patients might need to have it replaced within five years of receiving it.
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Source: The New York Times, "Maker Aware of 40% Failure in Hip Implant," Jan. 23,2013.