New York Times EDITORIAL
Published: February 10, 2013 FiDA Highlight
All-metal
hip replacements have failed at a high rate and harmed many patients in recent
years. Now there is evidence that a major manufacturer was aware of a serious
problem with one of its models yet failed to alert patients or doctors and
continued to market it aggressively.
The all-metal hips, in which a ball and a cup
component are both made of metal, were thought to be superior in some respects
to traditional hip replacements made of plastic and metal. Some 500,000 people in this
country received all-metal devices over the past decade. They were not adequately tested
because of regulatory loopholes the Food and Drug
Administration is now moving to close, and began
failing not long after implantation.
Thousands of patients have had to replace them in
painful operations; hundreds more have suffered internal damage. Court
documents now show that a major manufacturer, the DePuy Orthopaedics division
of Johnson & Johnson,
buried the bad news about a model known as the Articular Surface Replacement,
the most failure-prone of the implants. The implants were recalled in 2010, but
the documents show that as early as 2008 DePuy
executives were told by a number of surgeons, including its own consultants,
that the device appeared flawed. That was never disclosed to doctors
who were putting the device into patients, nor were other unfavorable internal
studies. By the time of the recall, the device had been implanted in about
93,000 patients around the world.
Surgeons have largely stopped using the
device; even so, the
company is facing more than 10,000 lawsuits in this country related to
past implantations. Though the company says the evidence will ultimately show
that it acted appropriately, it clearly has a lot of explaining t
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