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.
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.
""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 researchers said. "Physicians who adopt new technologies that have little or no evidence of superiority over existing products need to be educated about the implications of their choices. They should also ensure that their patients know about the benefits and risks of the new – but often unproved – medical devices that they are receiving."