An unnamed whistleblower who says they are a biomedical engineer has made the stunning claim that, a decade and a half ago, he or she raised serious concerns about the dangers posed by metal-on-metal hip implants. According to a column authored by the whistleblower in the U.K.’s Daily Mail, the individual worked with the company contracted to develop and manufacture one of the first all-metal hip resurfacing devices to come on the market.
According to the Daily Mail column, the whistleblower and other colleagues were vociferous in their criticism of metal-on-metal hip implants when they were in development roughly 15 years ago. At the time, the new all-metal hip implants were being hailed as providing better mobility than older — but safer and longer-lasting models made from other materials. The whistleblower implied their criticisms of the devices appeared obvious, writing that an “averagely bright teenager knows that running metal against metal will cause friction, and sooner or later friction causes wear.” It was feared that the debris shed by metal-on-metal hip implants could cause untold damage to highly delicate tissues and organs, the vascular system and lungs, the whistleblower writes.
According to the whistleblower, they and their colleagues pointed out this basic design flaw to the company where they were working 15 years ago. But their concerns were brushed off, and they were told the surgeon who’d come up with metal-on-metal design beingknew better.
In the Daily Mail column, the whistleblower asserts that allowing surgeons to have so much say in the design process contributed to the metal-on-metal hip implant debacle:
“‘Designed by surgeons for surgeons’ seems to be a slogan that every medical device company wants to trumpet on their new products, without stopping to consider just how ludicrous this is.
Certainly surgeons may spot a need for a medical advance or even come up with a rough concept of how this may work.
But unless they happen to also have an engineering or design degree alongside their medical and surgical skills, allowing them to act as if they are design experts is — as we can see now — a dangerous path to take.”
The whistleblower claims that every major medical device design introduced in the past 10 years has involved extensive surgeon input. And the column points out that medical device companies pay these surgeons thousands of dollars per year in royalties for their input, and the surgeons’ endorsements of the products they help develop. According to the whistleblower, this arrangement puts patient health at risk. The author calls for surgeons to return to being surgeons, and for device development to be returned to the “experts who have had years of training in design and engineering to actually create, test and produce the device.”
Unfortunately, this whistleblower’s fears have proven true for metal-on-metal hip implants. Last May, the U.S. Food & Drug Administration (FDA) directed 21 companies that market all-metal hip replacement devices to conduct post-market studies of their products to determine if they were shedding dangerous amounts of metallic debris in patients. In the U.K., the Medicines and Healthcare Products Regulatory Agency (MHRA) announced that blood tests should be conducted yearly to check cobalt and chromium blood levels in some all-metal hip implant recipients, those with bearings of 36 mm or above, as well as MRIs for any patient who does exhibit high metal ion levels. The British Hip Society advised that larger metal hip implants to be used in total hip replacement surgery at all.
Late last month, the British Medical Journal revealed that metal-on-metal hip implant manufacturers were aware of mounting evidence linking metal-on-metal hip replacement devices to serious, long-term health consequences, but for years failed to warn the public about these dangers. Last week, The Lancet published a study conducted by University of Bristol researchers who found that people with metal-on-metal hip implants were twice as likely to experience early failure of their device compared to those fitted with other types of implants. The authors of the study asserted the devices should no longer be used.
Already, two metal hip implants devices, DePuy Orthopaedic’s ASR XL Acetabular Hip Implant and the ASR Hip Resurfacing System, have been recalled because they were failing prematurely in high numbers of patients. Both the ASR devices, and an all-metal version of DePuy’s Pinnacle hip implant have been named in product liability lawsuits by patients who claim the implants failed early due to the shedding of metal debris. Lawsuits involving all-metal hip implants made by Wright Medical Technology and Biomet have also been filed in the U.S.