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FDA Issues Updated Warning on Metal-on-Metal Hip Implant Safety Risks

January 17, 2013 – The U.S. Food & Drug Administration (FDA) issued a press release today informing the public and medical communities of new safety recommendations for metal-on-metal artificial hip implants. The updated warning is based on the administration’s cumulative assessment of the risks associated with metal-on-metal hip devices, and focuses on a commonly-reported complication known as metallosis. This side effect occurs when metal is released into the recipient’s bloodstream due to parts of the implant rubbing together, and can result in severe inflammation, scarring around the implant site, and metal poisoning.

Free Metal-on-Metal Hip Implant Lawsuit Evaluation: If you or a loved one suffered a severe injury after being implanted with a metal-on-metal prosthetic hip device, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer of the artificial hip and we can help.

What’s the problem?

In metal-on-metal prosthetic hip devices, the ball and cup slide against each other when the recipient runs or walks. During this process, tiny metal fragments can be released into the bloodstream by the implant components, which can lead to a condition known as metallosis. Additional complications of metal-on-metal hip implants have been reported to include:

  • severe pain
  • bone and soft tissue damage
  • implant loosening
  • device failure
  • the need for additional revision surgeries (which may or may not be successful in correcting the problem)

In some cases, metal ions released by the devices’ wear and tear may travel to other parts of the body, where they can cause a broad range of health complications and illnesses.

At this time, the FDA still does not have enough scientific data to accurately determine the amount of metal that can build up in the bloodstream due to prosthetic hips, or the amount necessary to produce the side effects listed above. Additionally, complications resulting from metallosis seem to be specific to individual patients, with different people having different reactions to the metal ions in their bloodstream.

For a more comprehensive understanding of the risks associated with metal-on-metal hip implants, the FDA is recommending healthcare professionals follow the reporting procedures established by their facilities. Reports of side effects related to metal hip devices should include incidences of pain, malposition, adverse local tissue reaction, metallosis, hypersensitivity (allergy), loosening, and dislocation. Healthcare professionals are encouraged to report such complications to the FDA’s MedWatch Safety Information and Adverse Event Reporting System.

Do I Have a Metal-on-Metal Hip Implant Lawsuit?

The Medical Device Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in metal-on-metal hip implant lawsuits. We are handling individual litigation nationwide and currently accepting new metal-on-metal hip injury cases in all 50 states.

Free Metal-on-Metal Hip Implant Lawsuit Evaluation: If you or a loved one suffered a severe injury after being implanted with a metal-on-metal prosthetic hip device, you should contact our law firm immediately. You may be entitled to compensation by filing a metal-on-metal hip implant suit and we can help.

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