Cement Hip Replacement Warnings Ignored For Years
Orthopedic surgeons, medical device manufacturers and the medical community at large seem to have ignored warnings issued by a British patient watchdog in 2009, which indicated that surgical cement used in some hip replacement surgeries may cause fatal complications.
Earlier this week, a report published in the British Medical Journal, highlighted the risk of death from Bone Cement Implantation Syndrome (BCIS), which may have killed at least 40 hip patients in the U.K. between 2005 and 2012.
Surgical cement is particularly of concern when used in patients undergoing hip hemiarthroplasty for fractured femur necks, as opposed to total hip replacements. Researchers indicated that the number of problems associated with the cement hip replacements continues to increase.
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In March 2009, the now-defunct National Patient Safety Agency (NPSA) issued a warning that intraoperative deaths were occurring after the use of bone cement during hip arthroplasty. The NPSA rapid response report indicated that at the time at least 26 deaths had already been linked to BCIS, and called orthopedic surgeons to take actions to mitigate the risks.
The report called on surgeons to consider patients with pre-existing cardiopulmonary dysfunction as those most likely at risk of BCIS and to “maintain particular vigilance during instrumentation and fixation of the implant.” It also called for incidents of peri-operative harm or patient death to be reported to the NPSA and the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA).
Researchers in the recent study published this month suggest that the warning did little good . They report at least 62 severe patient injuries or deaths have now been linked to BCIS.
“Three-quarters of the deaths in this study have occurred since that alert, suggesting incomplete implementation or effectiveness of those mitigation measures,” the researchers concluded. “The fact that deaths have continued clearly shows that the implementation of mitigation measures set out in the alert was suboptimal, or that their effectiveness is suboptimal, or both.”
On June 1, 2012, the key parts of the NPSA were folded into the U.K.’s National Health Service (NHS) commissioning board, and researchers say it is unclear how much the NPSA’s reports and warnings affected patient care in that country.
They did not have any information on how frequently patients had been severely injured or died due to BCIS in the United States or other countries.
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.
BCIS occurs when the insertion of the surgical cement appears to cause fat and bone marrow contents to be released in the bloodstream. This can lead to a sudden pulmonary embolism, which can cause respiratory problems and cardiac arrest minutes after the cement is applied.
Researchers reported that 80% of the 41 known deaths in the U.K. happened on the operating table. They estimated that BCIS occurs once for every 2,900 hip replacement procedures for fractured neck of femur. No one cement or implant has been linked to BCIS.
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