Sunday, November 27, 2011

Follow-Up for Asymptomatic Patients (directives from the FDA web site)

I can't believe these OLD  recommendations listed below  are still posted on the FDA web site.  Had I followed these directives, I would still have that toxic devise inside me.  This is the first time I have used the word "toxic" to describe the damage that resulted from this hip.  You can have a look at my post op report which I posted a few weeks ago. (just type in post op report in the search index box.)

In my opinion, this FDA regulation should be revised in light of the findings from the asymptomatic revision surgeries (of which there are likely few due to these mindless recommendations which are guiding surgeons away from appropriate testing)  and the study the "Silent soft tissue pathology is common with metal on meal hip athroplasty" which was published this year with the specific recommendation:

"We recommend that  with this implant should be closely follwed up and undergo routien metal artifact reduction screening."



These recommendations from the FDA below are causing patients to not be tested which is not consistent with the recent literature.  IN MY OPINION, EVERY SINGLE PATIENT WHO HAS THIS HIP SHOULD BE TESTED PERIODICALLY WITH BOTH THE MRI AND THE CHROMIUM AND COBALT TESTING.  Every single solitary patient who has this hip implanted should be tested periodically for the rest of their lives.

From the FDA web site:

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
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/
MetalonMetalHipImplants/ucm241667.htm
[All I can say about these uninformed recomendations is that I hope the FDA comes to thier senses and make it manditory that all patients get tested with at least 2 tests for the rest of thier lives.  While I happen to be a research oriented patient, I would never have undergone this surgery.  Preeminent surgeons and researchers in the field had strongly recomended my revision regardless of the fact that I was asymptomatic once they reviewd my test results.  They were right.  They told me if I left that hip in, in no uncertain terms, the deterioration they saw would continue until it became painful and a revision would ultimately become a necissity.   I am sure no one expected the deterioration we actually found during the revision.

It seems that the FDA continues to maintain the position " wait and see"  until the hip deterorates and the surgery becomes more complex before we suggest doing any tests.  Frankly, I find thier position outrageous.
Where is Depuy in all of this?  Why are they not making a strong recomendation to Surgeons to have all of thier patients tested?  Is this an expense issue on thier part?  Remember Depuy:  The recent study "Silent soft tissue pathology" studied 75 patients. 27 of the 75 patients had MRI detected metal debris related abnormalities of which 5 were mild, 18 moderate and 4 severe.  8 of those hips were revised with a mean time post surgery of 31 months!!!  So what this says is that 8 revisions occured with asymptomaic patients of 75 examined after 3 years.  That is a 10% revision rate in 3 years with Asymptomatic patients!

I think this testing is so important.  Look at my results, I had a hole the size of a golf ball in my ilium that required a bone graft to fix it in addition to necrotic tissue and inflamation with fluid accumulation.  It all had to be cleaned out.

I have no idea what would have happened had I did nothing.  We all agree that the surgery would have been much more complex had I waited longer. 





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