FDA Review of MOM Hips

[Boomer]

There is an article in today's Wall Street Journal on page B3 regarding proposals from the FDA to require human clinical evidence to gain approval for marketing metal on metal hip joints. The article contains the usual negative language about metal on metal failure rates. I have been reading the WSJ every day for thirty years. They usually provide better research and validation. No mention of the Australian studies on hip resurfacing or any differentiation between hip replacement and resurfacing. I hope some of the AAOS folks respond to offset the alarm this article will generate.

Boomer

[Dannywayoflife]

I don't understand how they can bad mouth something that in the hands of a top surgeon has the best track record of them all!

[Marco Polo]

Boomer:

I just read the article and I agree with you.  I generally feel that the WSJ's reporting is fairly thorough and balanced.  However, in this case they report the FDA's decision to require device makers to supply data on their safety and intimate (by omission of important details) that the Lancet article raises concerns about the safety of Metal on metal devices generally, as opposed to the more specific (and rebuttable) concerns it raises relative to certain patient groups.  The end result is to cast a shadow on these devices, with no attempt whatever to dig into the underlying facts.

Very disappointing.

Marco

[Pat Walter]

Somewhere, somehow - someone just wants hip resurfacing to quietly dissapear into the unknown!  Someone has a negative agenda and I wish someone else had a positive agenda just as forceful about the truthful information about hip resurfacing.

It is amazing what the media can do when it wants to.  Very scary when you think about the power they have.

We will all keep telling our positive stories and hope people will stop by to read them, the positive videos and positive national registry information.

Pat

[imgetinold]

I do not subscribe, and therefore cannot read the article online.

I wonder if there are enough of us hippies, both here and on Vicky's site, to make enough noise for the WSJ to hear us?

[halfdone]

In case of interest to anyone

https://www.federalregister.gov/articles/2013/01/18/2013-01006/effective-date-of-requirement-for-premarket-approval-for-two-class-iii-preamendments-devices

also, current FDA safety guidance on MOM

http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm335775.htm

[hernanu]

In case of interest to anyone

https://www.federalregister.gov/articles/2013/01/18/2013-01006/effective-date-of-requirement-for-premarket-approval-for-two-class-iii-preamendments-devices

also, current FDA safety guidance on MOM

http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm335775.htm

Pretty interesting. It maintains the status quo of MOM HRs (and THRs) as grade III devices (need pre approval), no change in that.

What I did like is that they included the Australian registry information, not just the UK info. More of the same, I think - they are not predicating against MOM devices, just asking surgeons to consider the different alternatives. I did like that they spelled out the cumulative revision rates as being pretty low.

Thanks, halfdone.