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Craig Kelley
Craig Kelley
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FDA on Metal-on-Metal Hips: Some Patients at Higher Risk Than Others

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The serious—sometimes life threatening—problems of metal-on-metal hip replacement devices has been a major news story ever since several of the manufacturers issued recalls of millions of devices. To date, Smith & Nephew, DePuy, and Zimmer have all recalled components of their respective hip devices or the devices in their entirety. For recipients of these metal-on-metal devices, it is understandably a worrisome and scary time.

The FDA continues to play a central role in studying the health risks of metal-on-metal hip implants, in issuing safety communications for patients and doctors and in forcing the manufacturers of these devices to conduct studies and provide information on their products. The most recent news from the FDA came just this week, when they released a new Safety Communication about Metal-on-Metal Hip Implants.

By now, many hip replacement patients are aware of the increased risks of metal-on-metal hip devices. These devices feature a metal ball and a metal cup that slide against each other while walking or running. The risk of these devices is that the rubbing between the two metal parts can release tiny metal particles into the area around the hip, which can cause complications. Those metal particles can also travel to other parts of the body, which can lead to other serious health problems. These risks do not exist when “traditional” hip implant devices are used, since those devices use a combination of ceramic, plastic and metal.

The latest safety communication has information for surgeons and doctors about when it may be appropriate to use metal-on-metal devices in spite of these risks. That is helpful for new hip replacement patients. But what about those who are already walking around with a metal-on-metal device? Well the FDA is telling us now that certain patients are at greater risk of developing complications than others:

  • Patients with bilateral implants
  • Patients with resurfacing systems with small femoral heads (44mm or smaller)
  • Female patients
  • Patients receiving high doses of corticosteroids
  • Patients with evidence of renal insufficiency
  • Patients with suppressed immune systems
  • Patients with suboptimal alignment of device components
  • Patients with suspected metal sensitivity (e.g. cobalt, chromium, nickel)
  • Patients who are severely overweight
  • Patients with high levels of physical activity.

If you fit into one of those categories, then closer-than-normal monitoring of your hip device may be something that you want to discuss with your physician. And, regardless of your specific situation, the FDA continues to offer the following advice for patients:

  • If you are not having any symptoms and your orthopaedic surgeon believes your implant is functioning appropriately, you should continue to routinely follow-up with the surgeon every 1 to 2 years.
  • If you develop new or worsening problems such as pain, swelling, numbness, noise (popping, grinding, clicking or squeaking of your hip), and/or change in your ability to walk, contact your orthopaedic surgeon right away.
  • If you experience changes in your general health, including new or worsening symptoms outside your hip, let your physician know you have a metal-on-metal hip implant.