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FDA Publishes Warning on Metal-on-Metal Hip Replacements

FDA Publishes Warning on Metal-on-Metal Hip Replacements

January 17, 2013 — According to a Safety Communication from the U.S. Food and Drug Administration (FDA), metal-on-metal hip implants can shed toxic particles of metal and cause soft tissue damage — conveying “unique risks in addition to the risks of all hip implants,” according to the warning. The FDA has outlined specific recommendations for surgeons to reduce the risk of complications and warn patients about the risk. However, the FDA has stopped short of recommending routine blood tests, unless the patient has problems with the implant.

The FDA has also proposed strict new requirements that would force all five manufacturer of metal-on-metal hip implants to submit a new, Pre-Market Approval (PMA) application every time a new device is introduced to the market. Currently, manufacturers avoid conducting safety studies by submitting 510(k) applications, which allows approval of new devices that are “substantially equivalent” to an approved device.

Unfortunately, in recent years, researchers have published studies finding that the 5-year failure-rate of a metal-on-metal hip implant is significantly higher than plastic or ceramic designs. Some experts have called on the FDA to ban metal-on-metal hip implants because they do not provide additional benefits over other designs, but have higher risks.

One of of the most serious risks is that toxic particles of cobalt and chromium can shed into a patient’s body as the metal “ball and socket” grind together. The FDA recommended that surgeons discuss this risk with their patient before implanting the devices. According to the FDA Safety Communication:

“Metal release will cause some tiny metal particles to wear off of the device around the implant, which may cause damage to bone and/or soft tissue surrounding the implant and joint.”

The FDA also warned that complications are most likely to occur in the following patients:

  • 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.

Do I have a Metal Hip Implant Lawsuit?

The Schmidt Firm, PLLC is currently accepting metal hip implant induced injury cases in all 50 states. If you or somebody you know has been injured by a metal-on-metal hip replacement, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.

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