15 Years Ago, Engineer Whistleblower Raised Alarm for Metal-on-Metal Hip ImplantsMar 21, 2012 | Parker Waichman LLP
An unidentified biomedical engineer is claiming that he or she, along with their colleagues, raised serious concerns about the safety of metal-on-metal hip implants years before their safety issues became widely publicized. According to a report in the U.K.'s Daily News, the whistleblower was working at a firm - also unnamed - contracted to develop of the first metal-on-metal hip implant devices that made it to market. Roughl7 15 years ago, they were concerned enough about the safety of the all-metal hip implant to warn the firm.
The metal-on-metal hip implant whistleblower says they and their colleagues felt the device contained a design flaw that would allow toxic metal debris to shed from the implant, and endanger tissue, organs and other bodily systems.
"An averagely bright teenager knows that running metal against metal will cause friction, and sooner or later friction causes wear," the whistleblower writes.
Unfortunately no one listened. Instead, the company developing the unnamed metal-on-metal hip implant insisted the doctor that came up with the design of the device knew better than the engineers.
It is this reliance on surgeon consultants - who receive thousands of dollars from device companies each year for their input and endorsements - for the metal-on-metal hip implant debacle, the whistleblower asserts.
"'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."'
Now, a decade and a half after this whistleblower raised concerns about metal-on-metal hip implants, the devices are causing health problems and failing in large numbers of patients, just as was feared. Last May, the U.S. Food & Drug Administration (FDA) directed 21 companies, including DePuy and Wright Medical, which 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. Authors of a study published last week in the Lancet have called on doctors to stop using all-metal hip implants because of their high failure rate. 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.