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FDA Issues Safety Communication about Metal-on-Metal Hip Implants


On January 17, 2013 the FDA issued a safety communication to surgeons and patients about the "unique risks" connected with metal-on-metal hip implants. The DePuy ASR hip replacement and some DePuy Pinnacle hip replacements are metal-on-metal implants. These implants are the subject of approximately 10,000 lawsuits in U.S. state and federal courts. Our Ohio DePuy hip implant lawyers are representing plaintiffs in several of these cases.

In the communication, the FDA acknowledged that metal released from metal-on-metal implants can cause an "adverse reaction to metal debris," which may lead to pain, failure of the implant, and a need for surgery to replace it. The FDA also acknowledged that the metal debris can cause illness in other areas of the body as it travels through the bloodstream. But the FDA concluded that it does not have enough data to state what concentration of metal ions in a patient's blood or tissue is necessary to produce adverse systemic effects.

The communication had these recommendations for patients with metal-on-metal hip implants:

  • Patients who develop pain, swelling, numbness, noise (popping, grinding, clicking or squeaking) in the hip, or changes in their ability to walk should contact their orthopedic surgeons immediately.
  • Patients who experience any changes in their general health, such as symptoms outside the hip area, should inform their doctors that they have a metal-on-metal hip.
  • Patients without symptoms whose surgeons believe their implants are functioning properly should routinely follow up with their surgeons every one to two years.

The communication had these recommendations for orthopedic surgeons following up on patients with metal-on-metal implants:

  • Surgeons should thoroughly evaluate a patient with a metal-on-metal hip who experiences symptoms in the hip area such as pain, swelling, noise in the joint, or difficulty walking more than three months after surgery.
  • Symptomatic patients should be evaluated at least every six months.
  • Patients without symptoms should be evaluated every one to two years. The evaluation should include a physical exam and routine radiographs.
  • Surgeons should be aware that certain patients with metal-on-metal implants should be followed more closely because they have a greater risk for adverse reactions. Some patients in this category include:
    • Patients with implants in both hips.
    • Women.
    • Patients with suppressed immune systems or who are receiving high doses of corticosteroids.
    • Patients with renal (kidney) insufficiency.
    • Patients who are severely overweight.
    • Patients who are highly physically active.

In addition, the FDA has instructed manufacturers of metal-on-metal hip implants to conduct studies that will provide doctors and patients with additional information about the safety of these implants. You can read the entire communication on the FDA's website.

If you have a DePuy hip implant and are experiencing any of the above-described symptoms, you may be entitled to compensation. The Ohio DePuy hip implant lawyers at Rourke and Blumenthal LLC, LLP will be happy to evaluate your case. Call 614-220-9200 to speak with one of our experienced attorneys. We promise that an attorney will respond to you within 24 hours. You will never be turned away by a paralegal or secretary.

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