FDA Updates Recommendations Related to Hip Implant Systems

Posted On August 19th, 2016 By CSSFIRM.COM

FDA UpdateIn April 2016, the U.S. Food and Drug Administration (FDA) updated its website with additional recommendations about soft tissue imaging and metal ion testing associated with metal-on-metal (MoM) hip implant systems including the Stryker Rejuvenate and ABGII hip implant systems.

According to the FDA, there are certain clinical situations in which orthopaedic surgeons should consider additional testing, including soft tissue imaging and metal ion testing, to assess patients that have been implanted hip stems.

Soft Tissue Imaging

The most common methods of soft tissue imaging connected with MoM hip implants include:

  • Magnetic Resonance Imaging (MRI), which offers the best visualization of soft tissue and utilizes non-ioning radiation.
  • Computed Tomography Scan (CT), which offers the best visualization of implant positioning and bony tissue
  • Ultrasound, which allows for soft tissue visualization without metal artifacts and ionizing radiation.

Metal Ion Testing

Some patients with MoM implants may have elevated metal ion levels in their bloodstream, and as a result, orthopaedic surgeons may recommend measuring metal ion levels. Obtaining accurate metal ion test results can be difficult in some patients, and not al commercial labs can precisely measure trace or ultratrace elements, although these factors have important implications for the accuracy, reproducibility, and clinical interpretation of test results.

The FDA recommends that orthopaedic surgeons should consider measuring and follow serial measurements of metal ion levels in MoM patients who develop any symptoms that may indicated that their hip implant is not functioning properly.

Stryker Hip Lawsuits

Stryker lawsuits have been consolidated into multi county litigation (MCL) in the Superior Court in Bergen County, New Jersey, and into multidistrict litigation (MDL) in the U.S. District court of Minnesota. Atlanta law firm Childers, Schlueter & Smith, LLC has filed more than 25 additional Stryker hip cases in the last six months on behalf of clients from all over the U.S.

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