What Does the U.S. Food and Drug Administration’s Letter to Hip Makers Mean?
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The U.S. FDA ordered 21 manufacturers to collect information from patients.The U.S. FDA ordered 21 manufacturers to collect information from patients in a recent letter to hip manufacturers. Click here for report. The three-page letter demands blood tests and other studies within thirty days. Here is a summary of the information and questions the FDA is requiring from manufacturers:
- The harmful events observed in patients with Metal-on-Metal (MoM) total hip replacement (THR) systems.
- The levels of serum and chromium in patients prior to THR.
- The patient population's average levels of chromium and serum in the blood for a minimum of eight years after the implant (patient population is the demographics and other particulars of a particular population).
- Do the average levels of chromium and serum in the blood increase during the first eight years (or the length of time on the market)?
- Reasons for revision (alteration of a medical device) and patient population's average levels of chromium and serum in the blood at the time of the revision.
- The number of patients with pain and biological and psychological symptoms associated with the THR.
- The quantity of harmful reaction of body tissues in patients who did not have a revision.
- How differences in revisions vary over time after the initial implant?
- What demographics have higher metal ion concentrations in their blood?
- What demographics have higher risks of needing revisions?
- What causes the THRs to fail?
