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Oxford University Study
In 2008, researchers at Oxford University in England reported that at least 17 women, all of whom had undergone hip resurfacing with all-metal devices from a variety of producers, experienced abnormal soft-tissue masses in their hip joints. Based on those findings, the Oxford researchers estimated that within five years of an implant, 1 percent of all resurfacing patients could experience damage to soft tissue. -
Comparison Study performed in England
Smith & Nephew Device; In a separate study, another group of researchers in England reported adverse reactions to metallic debris in 3.4 percent of patients — 17 of 660 patients studied — who received a metal implant made by DePuy Orthopaedics. The DePuy product had been used in those patients either as a resurfacing system or for a conventional implant replacement. In that same study, an additional group of 155 patients who received the Birmingham resurfacing system sold by Smith & Nephew did not have such -
Univ. of British Columbia
A study presented by researchers at the University of British Columbia found distinctly varying levels of metallic ions in the bloodstreams of patients who received a certain model of implant made by Zimmer Holdings, depending on how it was used. The British Columbia researchers reported that patients receiving a conventional implant with a Durom socket, or “cup” as it is known, had significantly higher median blood serum levels of chromium and cobalt -
Medical Device Alert
Medical Device Alert; A British government agency, the Medicines and Healthcare Products Regulatory Agency, issued a report along with professional orthopedics groups in that country about the metal-on-metal issue. An orthopedic surgeon involved in the report, Dr. Peter Kay, said that a review of patient records suggested that 1 percent or more of resurfacing patients might experience soft-tissue damage related to metallic debris. -
Medical Device Recall Summary
Summary of Recalls; Given the ubiquity and variety of medical devices in modern healthcare, it is inevitable that a proportion will fail to perform as expected, or even cause harm. What seems unacceptable is a system of regulatory approval for devices (most of which are paid for in the UK by the NHS) that lacks even a basic level of transparency for independent evaluation.
