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There's no substantiation to support the safety or effectiveness of nearly 8 percent of all components in use in hip-replacement surgeries in England and Wales, a new survey finds in Dec 2013. The University of Oxford researchers said the current regulatory transform "seems to be entirely inadequate" and called for a new system for introducing new devices. The team's fly-past of data revealed that more than 10000 of the nearly 137000 components used in beginning hip replacements in England and Wales in 2011 had no solid evidence of being effective.
These components included about 150 cemented stems, more than 900 uncemented stems, more than 1700 cemented cups and nearly 7600 uncemented cups, according to the study, which was published online Dec 19, 2013 in the newsletter BMJ. In a newspaper despatch release, researcher Sion Glyn-Jones and colleagues said their findings are of great concern, "particularly in ignition of the widespread publicity surrounding recent safety problems with rate to some resurfacing and other large-diameter metal-on-metal joint replacements".
The researchers said their results likely miscalculate the actual extent of the problem. "This study shows that the need still exists for an improved and more rigorous entry to regulation of devices to avoid devices with no available evidence being used in a widespread and amuck manner," the study authors said.
Tighter controls are needed, Aaron Kesselheim and Jerry Avorn, of Harvard Medical School, said in an accompanying documentation editorial. Doctors who use new devices that "have illiberal or no evidence of superiority over existing products need to be educated about the implications of their choices," Kesselheim and Avorn said oxyhives.herbalous.com. "They should also safeguard that their patients know about the benefits and risks of the recent - but often unproved - medical devices they are receiving".
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