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Whistleblower Claims to Have Made Metal-On-Metal Hip Implant Warning 15 Years Ago

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A whistleblower has come forward with shocking claims that he/she made metal-on-metal hip implant warnings as far back as 15 years ago. The “unnamed biomedical engineer” is a medical device designer who worked with a firm that developed and manufactured one of the first hip resurfacing devices.

Along with a number of colleagues, the engineers and designers vocally censured the then-new all-metal design. According to The Daily Mail’s anonymous source, “an averagely bright teenager knows that running metal against metal will cause friction, and sooner or later friction causes wear.” The wear, said the source, leads to debris which cannot be filtered out of the body and can lead to damage. This damage is now being discussed by the Medicines and Healthcare Products Regulatory Agency, said The Daily Mail. Studies have also linked the all-metal devices to increased risks for bladder cancer and the devices are suffering from higher early failure rates versus other types of hip devices.

The unnamed biomedical engineer notes that engineers and designers were working on a prototype developed by a surgeon. When some in the group advised their company of the basic design flaw, they were told that the surgeon was more knowledgeable that they. The surgeon who developed the idea was collaborating with the company to produce and endorse the all-metal replacement system.

The engineer told The Daily Mail that the practice of touting surgeon-created designs is a huge part of a growing problem. Biomedical engineer and design experts, who, it seems, have long complained of the basic design flaw in metal-on-metal hip devices, would never have allowed the device to be put on the market. Allowing surgeons, who do not have expertise in design and engineering, to create devices is foolhardy and points to larger industry issues. Surgeons may aptly see a need for medical advances and can develop a rough concept; however, without engineering and design skills and expertise, faulty designs are making it to market and, in the case of all-metal hip devices, changing the lives of untold numbers of patients in terrible ways, said The Daily Mail’s source.

Industry has grown heavily reliant on endorsements, regardless of design appropriateness. A surgeon endorsement of a new device could result in profits of 2,000-3,000% over costs, said the whistleblower. One surgeon boasted of earning “well over £100,000” (roughly, $160K) annually, in device royalties alone. Consider financial benefits when surgeons form companies to purchase devices directly, often outside the country, and at discounted prices, only to sell them back to hospitals at inflated costs, said The Daily Mail.

“In any other profession this would be seen, at the very least, as a conflict of interest,” the source said, explaining: “No one is saying that surgeons or, indeed, any doctor should not be allowed to come up with ideas for improving patient care. Of course, they are the ones at the front line, who see the need for a new device or a better product. But then they should step away, leave the design to experts who have had years of training in design and engineering to actually create, test and produce the device…. I’m not saying this because I want to protect my profession. I’m saying it because I genuinely believe it is unsafe to allow untrained people so much power and responsibility in producing devices that can have a huge impact on people’s health.”

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