At a recent two-day advisory panel meeting, surgeons and patients criticized the FDA for not taking a more proactive approach regarding metal-on-metal implant failures.
FDA Gets an Earful Over Metal-on-Metal Implants
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Secondary#foodanddrugadministration#metalonmetalhipimplants#interbodycages#arthroprosthetic
Over the past several years, the Food and Drug Administration (FDA) has acknowledged safety concerns surrounding metal-on-metal systems. The purpose of this advisory panel meeting was to provide a forum for patients and physicians who have concerns to present them to the FDA. While much of the data provided during the meeting was regarding metal-on-metal systems, the meeting was meant to cover “the science of how patients respond to implanted metal regardless of the specific device.”
Stephen Tower, M.D., an orthopedic surgeon in Anchorage, Alaska, spoke before the advisory committee and provided some of the most damning evidence about metal-on-metal implants.
Dr. Tower, incidentally, is both an orthopedic surgeon and a metal-on-metal hip implant recipient. His patient studies painted a grim picture of the negative effects of any hip/knee/shoulder with a chrome-cobalt implant.
Dr. Tower criticized the FDA, stating, “You guys allowed industry to pull metal-on-metal hips silently off the market and those metal-on-metal hip patients that are not recalled are now coming into my office, seriously neurologically ill and in heart failure and it is a public health travesty.” Dr. Tower continued, “The FDA, in my experience with orthopedic implants, is more interested in the health of the arthroprosthetic industry than it is in the health of the patient.”
Dr. Tower stressed that the threat is not limited to metal-on-metal implants. He testified, “This is not a metal-on-metal problem. We are seeing this with many popular hip designs that are still commonly implanted.”
OTW spoke to Dr. Tower about his personal experience with cobalt poisoning and research in the area. He noted that one of his largest concerns is that chrome-cobalt has been our go-to for joint replacement and that there will be a tendency that people in the industry don’t want to believe that it is a problem. He fears that because of the way the system works, the default is not to believe it. Dr. Tower fears the FDA is “captured by the industry” and reluctant to make any finding that would be disadvantageous to the industry.
Dr. Tower told OTW that more research needs to be done in this area, but that he doesn’t have the funding to do it. He added, “I’m certainly not going to be able to get anyone to fund it.”
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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