-- Robert Preidt
FRIDAY, Dec. 20, 2013 (HealthDay News) -- There's no evidence to
support the safety or effectiveness of nearly 8 percent of all
components used in hip-replacement surgeries in England and Wales,
a new study finds.
The University of Oxford researchers said the current regulatory
process "seems to be entirely inadequate" and called for a new
system for introducing new devices.
The team's review of data revealed that more than 10,000 of the
nearly 137,000 components used in primary hip replacements in
England and Wales in 2011 had no solid evidence of being
These components included about 150 cemented stems, more than
900 uncemented stems, more than 1,700 cemented cups and nearly
7,600 uncemented cups, according to the study, which was published
online Dec. 19 in the journal
In a journal news release, researcher Sion Glyn-Jones and
colleagues said their findings are of great concern, "particularly
in light of the widespread publicity surrounding recent safety
problems with regard to some resurfacing and other large-diameter
metal-on-metal joint replacements."
The researchers said their results likely underestimate the
actual extent of the problem.
"This study shows that the need still exists for an improved and more rigorous approach to regulation of devices to avoid devices with no available evidence being used in a widespread and uncontrolled manner," the study authors said.
Tighter controls are needed, Aaron Kesselheim and Jerry Avorn,
of Harvard Medical School, said in an accompanying journal
Doctors who use new devices that "have little or no evidence of
superiority over existing products need to be educated about the
implications of their choices," Kesselheim and Avorn said. "They
should also ensure that their patients know about the benefits and
risks of the new -- but often unproved -- medical devices they are
The U.S. National Institute of Arthritis and Musculoskeletal and
Skin Diseases has more about
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