Study: Hip implant regulatory review 'entirely inadequate'

December 24, 2013 by Arezu Sarvestani

Researchers warn that some 8% of hip implants on the market are not supported by any readily available clinical evidence of their efficacy or safety.

Study: Hip implant regulatory review 'entirely inadequate'

A group of U.K. researchers is calling for a major shift in regulation of orthopedic hip implants, warning that a significant number of the devices get on the market without providing much evidence of their safety or efficacy.

University of Oxford researchers called existing hip implant regulation "entirely inadequate," pointing to the ongoing controversy over failure rates in metal hip implants as evidence of the need for an overhaul.

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The team examined data from the National Joint Registry of England & Wales, looking at use of devices that were dubbed "unclassified" or "pre-entry" by the Orthopaedic Data Evaluation Panel, a group that rates implants based on their levels of evidence.

"Unclassified" implants have no evidence submitted by their manufacturers and "pre-entry" implants have less than 3 years of evidence. Both types are on the market and available for use.

The researchers reported that of the more than 136,500 components used in hip implants in 2011 about 7.6% were used "without readily identifiable evidence of clinical effectiveness." Their figures are likely an underestimation of the true pervasiveness of under-studied devices, they noted.