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There's no testify to reinforcement the safety or effectiveness of nearly 8 percent of all components Euphemistic pre-owned in hip-replacement surgeries in England and Wales, a new learn finds in Dec 2013. The University of Oxford researchers said the accepted regulatory process "seems to be entirely inadequate" and called for a reborn system for introducing new devices m. The team's con of data revealed that more than 10000 of the nearly 137000 components utilized in primary hip replacements in England and Wales in 2011 had no durable 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 weekly BMJ. In a monthly dope release, researcher Sion Glyn-Jones and colleagues said their findings are of great concern, "particularly in merry of the widespread publicity local up to date safety problems with matter to some resurfacing and other large-diameter metal-on-metal joint replacements".
The researchers said their results indubitably underestimate the actual extent of the problem. "This library shows that the need still exists for an improved and more rigorous make advances to regulation of devices to avoid devices with no available validation 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 quarterly editorial. Doctors who use unfledged devices that "have dwarf or no evidence of prestige over existing products need to be educated about the implications of their choices," Kesselheim and Avorn said fertility. "They should also assure that their patients discern about the benefits and risks of the new - but often unproved - medical devices they are receiving".
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