Thursday, May 12, 2011

Surprising interest by the FDA in ion levels in light of thier Web site directives to Physcians!

The FDA "is aware of the public health questions regarding the safety of metal-on-metal total hip replacement systems," spokeswoman Karen Riley told Bloomberg News in an email-yesterday-. "There is not enough scientific data to specify the concentration of metal ions in a patient's body necessary to produce adverse systemic effects."

From the FDA's web site last revised on 2/11: Web site for Orthopedic surgeons re the MOM hip implants/http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/MetalonMetalHipImplants/ucm241667.htm

  • Despite the recommendations of other international regulatory agencies, the FDA currently believes there is insufficient evidence to correlate the presence of localized lesions, clinical outcomes, and/or the need for revision with specific metal ion levels for individual patients.
  • 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
  • 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
[Its about time the FDA has decided to investigate this issue with the MOM hips isn't it?  Their directive to the hip manufacurers yesterday is a really good sign that they are starting to monitor this issue much more closely.  Maybe they will change the observations on thier web site?]

No comments:

Post a Comment