Sunday, June 24, 2012

Should the FDA adopt the British regulations for patient monitoring of the MoM hips

I had addressed the "yes" side of this question in a post recently:  http://www.mydepuyhiprecall.com/2012/06/study-shows-metal-on-metal-hip-patients.html

In that document, I had argued that the British standard for monitoring asymptomatic patients was appropriate which included the need to monitor these patients for the life of the implant with both blood tests and MRIs.

The "no" side of the argument:  the British regulations were put in place without testing what they should or should not recommend.

Recently I had a chance to speak to someone who is involved in these discussions.  His point was:  I don't know what the correct monitoring procedure is for asymptomatic patients.  Why?

 Instituting mandatory testing for patients may result in the over testing you see with breast exams for example which now typically are annually.  There have been a lot of studies recently in that area recommending against doing annual breast exams due to the potential patient risk.  Consistent exposure to the radiation is problematic over time.  They now say if you continue to expose a  woman annually to radiation risk with mammograms, if she started out at 40 with no cancer, at age 50, she would have increased her chances for cancer by  continued radiation  exposure by 30%. (Some say 1% per year and some say up to 3% per year.)

My responce to that would be the hip exams should be done with MRIs not x rays.  MRIs don't have radiation exposure.  Blood tests are benign.

The other think he mentioned was that doctors not the FDA treat patients.  Well that is true however, many orthopedic surgeons DO NOT have the knowledge to deal with these issues and in my opinion require some guidance as to what they should and should not be doing with patients.  I would not go to a great surgeon and seek advise on the implications of research questions.  Surgeons are not researchers!  You wouldn't  seek a surgical opinion from a researcher would you?

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