Thursday, July 14, 2011

The FDA Surveillance Program

As you all know, the FDA has directed the companies who are selling hip replacements to being collecting data on the issues associated with the hips.  More information is contained on earlier posts.  I found the following information interesting on  a post today from Dr. David Lipschitz who is a geriatrician.  Here are the excerpts from his post:

The FDA encourages every patient with a metal-on-metal implant to contact their orthopedic surgeon, and whether symptomatic or not, the patient should agree to participate in the surveillance program. Then as much information as possible can be obtained and everything can be done to assure patient safety and the best possible quality of life.

The FDA surveillance program will include an analysis of every adverse effect from all types of metal implants, the reason why revision surgery is needed, and the incidence of pain and difficulty walking in those patients who do not have revision surgery. The FDA also suggests measuring patients’ chromium and cobalt levels before receiving a metal-on-metal implant and at frequent intervals for the first eight years after the surgery.

[I had never seen the details of the monitoring program before.   This is a great step and every patient with a hip should agree to be a part of that surveillance program.  Ask your surgeon on your next visit if they are participating in that program.  If there are no reports of issues, the frequency of issues will never surface!]

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