Surgical Cement for Hip Replacements Linked to Deaths: Study
The findings of a new study suggest that some surgical cement used in partial hip replacements may increase the risk of death, raising serious concerns about the safety of cement use following hip fractures.
In a report published this week in the British Medical Journal, the former chief medical officer of England and other researchers warn about the risk of “bone cement implantation syndrome” (BCIS) among patients undergoing hip hemiarthroplasty for fractured femur necks.
First seen in 2009, BCIS can strike in minutes after cement insertion, and has been linked to the death of dozens of patients.
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The insertion of the cement appears to cause fat and bone marrow contents to be released into the bloodstream, according to the study, potentially resulting in a sudden pulmonary embolism, which can cause respiratory problems and cardiac arrest. No one single product or group of products were specifically identified.
In 2009, the National Patient Safety Agency (NPSA), which no longer exists, issued an alert about the problem, but some experts say the alert was mostly ignored or overlooked.
The researchers, which included Sir Liam Donaldson, former chief medical officer of the Imperial College of London, looked at data from the U.K.’s National Reporting and Learning System (NRLS) from 2005 to 2012, and found 62 cases that describe severe acute patient deterioration linked to cement use in hip replacements.
Of those cases, at least 41 patients died, 14 were resuscitated after suffering cardiac arrest and 7 were resuscitated from periarrest.
In 55 of the cases, or 89%, bone cement syndrome onset occurred in minutes. According to the study, 80% of the deaths happened on the operating table during the hip replacement procedure with cement. Victims were between the ages of 66 and 100 years old.
The study’s findings indicate that incidents of BCIS occur once for every 2,900 hip replacement procedures for fractured neck of femur. About 22,000 people underwent such a procedure in 2012 in the U.K. alone, the researchers estimate.
The report does not include another 39 suspected cases of BCIS because the researchers could not be certain that the procedures were specifically linked to hip replacement for fractured neck of femur, which is different from total hip replacement. However, all involved severe injury or death during hip replacement procedures.
The incidents of BCIS seem to be occurring more frequently, according to the study, with a steady increase in the number of incidents reported since 2005.
“The patient safety incident reports detailed in this paper are compelling, representing eyewitness accounts of instances in which bone cement seems to have caused death or severe harm,” the researchers noted in their conclusions. “Patient safety incident reports tend to be undervalued, mainly because there is under-reporting, but this is only likely to underestimate the extent of a problem, not to overstate it.”
In the United States, these complaints are commonly referred to as adverse event reports, and experts say that they typically only account for about 1% to 10% of all incidents that actually occur.
“This study suggests that the risk is one death or severe harm per 2900 cases, although this conclusion is limited by under-reporting,” the researchers concluded. “Although rare, BCIS contributes to the total mortality associated with cemented hip hemiarthroplasty surgery.”
Hip hemiarthroplasty involves the replacement of one half of the joint with an artificial surface, leaving the other part in the natural state. This partial hip replacement procedure is most commonly performed following a hip fracture involving the neck of the femur.
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