Wednesday, March 16, 2011

Hip revision and monitoring recommendations from the FDA site: Poppycock!

I was made aware of these recomendations by one of my consults a few days ago.  Last nite as I was reading these and  I concluded that these recommendations are preposterous!
I am one of these asymptomatic patients and speaking from only my experience,   anyone who has this  depuy hip should get two basic tests:
·         MRI with the appropriate MAVRICK or MARS protocol to enable high resolution of the soft tissue and bone associated with the implant  AND
·         Cobalt and Ion Toxicity test to view your levels.

Why?  Simple. Corrective action can be taken on two fronts if there are problems brewing below the surface while the  patient is asymptomatic:
(1)    You can stop the bone and tissue damage from progressing by removing the hip even if you have no pain
(2)   You can lower the cobalt and chromium levels in your blood at least (not sure about the organs) and given no one knows the long term effects of these metal levles on the organs, it can’t be a bad thing to lower them.  The levels will go down when the implant is removed so my consults tell me.

All of this has to be weighed of course against the risk of surgery with your medical team but for goodness sakes, you can’t just buy into an argument that states, no symptoms=no problems.
 Once I was tested (in an asymptomatic state) I found four things: (1) very high ion levels of both chromium and cobalt, (2) bone damage (aka ostyeolysis), (3) soft tissue damage and (4) a potential systemic link between my thyroid issue and the lead in this metal.    Bone and tissue damage will continue to occur unless the implant is removed. So advised one of my consults.
While each of these individually may not be enough to merit revision surgery, what happens when you are asymptomatic and you have all of these things?
While the FDA seems to recommend that asymptomatic patients should be followed up with a “careful exam”, I don’t see what merit can be found in doing that.  There is no harm in having the appropriate MRI done and certainly no harm in getting a baseline on your ion toxicity levels. The risks are likely higher if you simply do nothing.  Am I missing something here?
I have been writing this blog now for almost 4 months and I have never commented on anything being so preposterous as the recommendations below from the FDA.  Good Grief.  Is it better to be walking around with bone damage, soft tissue damage, high levels of metal ions and potential systemic toxicity and not know because a patient is asymptomatic and didn’t bother to get tested?  If the FDA is reading this site, please advise what kind of thinking lead to this conclusion.  If I am missing something, I would be happy to retract this!
Copied from the FDA site verbatium:
Device Revisions
  • At this time, there is insufficient scientific data to provide a rigorous science-based recommendation for a threshold value of metal ion levels in the blood that would serve as a trigger for intervention or revision.
[Comment by Connie:  I agree with the above statement but when the levels are taken into account with a complex of issues such as soft tissue damage, and osteolysis, this statement is highly suspect.  The big picture needs to be investigated symptomatic or not.  If I had all of these problems in an asymptomatic state, how many other people have these same issues going on?  I will send a note to Depuy about this.
Follow-Up for Asymptomatic Patients (From the FDA site verbatium)

Clinical Evaluation

  • Follow-up of asymptomatic metal-on-metal (MoM) patients should occur periodically.
  • Patients, including the following, are at risk for increased device wear and/or adverse reactions to metal debris and should be monitored closely:
    • Female patients
    • Patients with increased activity
    • Patients with malpositioned components
    • Patients with bilateral implants
    • Patients with evidence of renal insufficiency
  • Patient follow-up visits should include:
    • Careful exam which includes a functional assessment
    • Physical examination for asymptomatic local swelling or masses
    • Careful review of systems for general health changes and evidence of systemic effects (particularly as pertains to the cardiovascular, neurological, and thyroid systems)
  • At this time, the utility of routine screening of asymptomatic patients using diagnostic soft tissue imaging and/or blood metal ion testing has not been established. Moreover, findings of lesions on soft tissue imaging, or of elevated blood metal ions, in the absence of symptoms, though reported in a limited number of research studies for some MoM hip implant patients, are difficult to interpret because:
    • The exact incidence or prevalence of asymptomatic lesions and their natural history is not known
    • The correlation between elevated blood metal ions and development of future local or systemic system adverse reactions is not well established

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