FDA orders study of all MOM hips

[Jeremy76761]

Hi All,

Just a sideline. Does anyone  know if there is work underway to make THRs or mini-hips conducive to running? HRs clearly work as people are doing everything with them. But, how long before the alternatives work for running as well?  Maybe Pat as some idea. No crystal balls, of course.

Also, I don't think that NYT article is alarming. The FDA has a responsibility to examine data. Probabably no major difficulties access the MOM HRs will come of it.  If there are restrictions on HRs, it might make it harder to access the best surgeons, which would translate into a longer wait. That's the most likely scenerio, if there are any changes at all. Just a thought.

Jeremy

[DakotaDocMartin]

Personally... I'm not at all worried about my decision to have the BHR surgery.  I spent a lot of time reading here on SurfaceHippy and elsewhere for the past two years and I'm still confident I made the right decision.  The BHR is as good as it gets with the current technology.

I only wish I had the surgery a couple of years ago.  ;D

[hipnhop]

I've heard that some people with MOMTHRs are running and engaging in other high level sport activities.  I've read stories about a few people completing marathons and reaching PRs with THRs. (check out this 55 year old dude who started running marathons after THR):

http://www.mhrrc.org/kopacs_corner/information/200302_hip_runner.html

I think the risk for revision is greater and should be a major factor of consideration.  

Who knows what the future has in store. I just know I'm not waiting. Gotta go and walk the dog (something I couldn't do 5 months ago). In another three months I'll be racing him down the street.

[Jeremy76761]

That's amazing with that guy running so much for 10 years with a THR. As he said in the article, weighing 150lbs helped. It shows what is possible, even without the stats, and also how good some of these devices have become.

[muzza]

A one hour documentary on the very popular program "Four Corners" just screened here in Australia. It dealt with the De Puy recall and the whole matter of metal on metal hip implants and metalosis. Quite alarmist in the way it covered the subject. Did a complete demolition job on a retired Adelaide surgeon who was involved in the design of the ASR. His reputation largely destroyed. Focused quite a lot of attention on the findings and opinions of the Newcastle research group and on the opinions of surgeons who were anti metal on metal. Nothing from the likes of Mr McMinn or Dr Gross to give the other side of the story. Nevertheless, some very informative case-studies of people with the ASRs who had problems with cobalt /chromium levels.

[danebuxbaum]

This is a question for Pat, or anyone out there who is really up on this metal ions thing.
Would you recommend getting the blood test that measures metal ion levels in the bloodstream without any obvious symptoms  - what ever those can be - as SOP?
If so, where should your blood be sent as I have heard that many labs don't even know how to look for this stuff.
Also, at what period post op should this be considered? Finally, can anyone let me know what the very first physical symptoms of metal ion overload are?

[toby]

Muzza,
Interestingly, I've just moments ago seen a very similar one hour UK documentary- 'Despatches'. It  didn't uncover anything new but also looked at all the issues you mentioned but a with a UK focus. It highlighted the problems Tony Nargol (eminent British surgeon) experienced with the ASR THR and HR devices. Yet Nargol had no such problems with the BHR and warned Depuy, who ignored his findings when he preseNted them at the AAOS conference and instead placed the blame on surgeon error! Also, the programme focused critically on DePuy's handling of the situation and the ethical issues in the US re- those surgeons who have been on the DePuy pay roll for ASR's development and promoted use of the device. Programme also focused on a male US dancer suing DePuy and Dr Shmalzried a result of his matalosis and revision surgery.
In response to danebuxbaum's question-the UK guidance from the MHRA (FDA equivalent) is that all UK patients with a MOM hip should have annual blood test for Cobalt and Chromium levels.
Regards
Toby

[Tin Soldier]

The FDA webpage on HR for the surgeons, states that you should not worry about getting a blood test unless you have other symptoms.

http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/MetalonMetalHipImplants/ucm241667.htm

I think a standard total metals analysis of blood using ICP mass spectromy is what you would want.  It looks like the FDA does not have a standard test method, though.  For soil and groundwater samples EPA has method numbers which specifically state how and what you collect, how long you digest the sample with what type of solvent, and then lots of detail on the type of equipment you use to do the analysis, followed with a healthy dose of QA/QC.  I don't know much about medical labs, but I suspect the test method for Chromium, Cobalt, or any heavy metal is probably going to be pretty similar to a method used for environmental analysis.

I think the big question would be what material do I test, blood, serum, synovial fluid? and also what is the form of the metal in that material?    Elevated levels in blood might not mean much if the exposure duration is not very long.  Assuming there is a 6 month to 1 year wear-in period, you may have elevated metals in your blood stream for that period of time, that might not cause any impact to the system.  I saw a study with some blood metals data that showed an increase at the beginning followed by a decrease back to more "background" levels.  I'd reference it if I could find it.  I think the study concluded that just because you have elevated metals in your blood, does not mean you are automatically looking at a failed HR. 

I wonder how the metals dissolve and become ionic in the blood stream.  Mechanical wear of a metal alloy doesn't create individual ions of metal, it creates very small particles of that alloy.  In this case a tightly bound CrCoMb molecule.  Actually I don't know the chemical formula for these alloys, there may be some other trace metals in there.  If you have a minute particle of this alloy in you bloodstream, it may be totally stable and benign, but it would still show up on a blood test. Maybe synovial fluid is slightly acidic? 

I guess in summary, with all this arm-waving is that the metals issue is pretty complicated and I'd like to read up on more.   

[23109VC]

I thought about the metal debris issue before surgery...butnwhat is the alternative?  As far as I kmow, there weren't any alternatives if you want hip resurfacing?

In the last Coiple of months my quality of life has improved so dramatically I'll take the risk.  I hope I don't have a problem....but if I do I guess I'll have to consider a revision.  That would suck...I will pray my MOM HR lasts a long long time...I hope all of us get a lifetime out of our devices. 

I can't worry about stuff I can't change.  My implant is in... And boy does it feel great.  Being pain free is wonderful.

Haven't they been using MOM for a long time?  The early BHR devices are MOM and many of those have lasted 10+ years right?

[Tin Soldier]

Those guys in England back in the 70s had MoM hips before poly became popular.  I don't know if there was any solid data out of it, but it sounded like there were good results for much longer than 10 years.  I think I read about that in one of Pritchett's papers. 

What did the recent McMinn presentation have to say?  I think Pat just posetd that recently.  Results of a ten-year study for BHR, or something like that?   

BTW - totally agree on the fact that you don't have much of a choice when it comes to OA and a painful hip/leg. 

[Lori Cee]

A one hour documentary on the very popular program "Four Corners" just screened here in Australia. It dealt with the De Puy recall and the whole matter of metal on metal hip implants and metalosis. Quite alarmist in the way it covered the subject. Did a complete demolition job on a retired Adelaide surgeon who was involved in the design of the ASR. His reputation largely destroyed. Focused quite a lot of attention on the findings and opinions of the Newcastle research group and on the opinions of surgeons who were anti metal on metal. Nothing from the likes of Mr McMinn or Dr Gross to give the other side of the story. Nevertheless, some very informative case-studies of people with the ASRs who had problems with cobalt /chromium levels.

McMinn responds here: http://www.mcminncentre.co.uk/response-abc-corners-program.html
Well worth a read. 

[cwmoto]

Fine, lets have a unbiased study [if that's possible]. I am more worried about fluoride in drinking water, trans fats in processed foods , genetically modified  food- [no long term studies], and the studies that link colon and prostrate cancer to bovine milk protein consumption.

[cwmoto]

I wonder if general body PH has an effect on ions wearing off a MOM  joint. Maybe more acidic = more ions?

[moe]

A one hour documentary on the very popular program "Four Corners" just screened here in Australia. It dealt with the De Puy recall and the whole matter of metal on metal hip implants and metalosis. Quite alarmist in the way it covered the subject. Did a complete demolition job on a retired Adelaide surgeon who was involved in the design of the ASR. His reputation largely destroyed. Focused quite a lot of attention on the findings and opinions of the Newcastle research group and on the opinions of surgeons who were anti metal on metal. Nothing from the likes of Mr McMinn or Dr Gross to give the other side of the story. Nevertheless, some very informative case-studies of people with the ASRs who had problems with cobalt /chromium levels.

McMinn responds here: http://www.mcminncentre.co.uk/response-abc-corners-program.html
Well worth a read. 

Thanks for the link Lori, everyone should read this. I did a lot of research a couple of years ago on the McMinn site, as he points out at the Northern Lights debate the problems with the ASR were well known in advance to his team.

[Lopsided]

FDA has its own flaws, including those companies who made hip replacements considering how such defective hip replacement systems had been out to the market and make the real people as alternative guinea pigs.

"Make crime pay. Become a lawyer."
recall on hip replacement | recall on hip replacements

Not quite sure what you are trying to sell, and even less sure about your grammar.

[Pat Walter]

The previous post was removed since it was an ad for a website against hip resurfacing and suing hip device companies.  I don't allow ads on the discussion group.

Pat

[newdog]

Wow Pat!

I just read that post and wondered, WT#? Thanks for watching out for us and GOOD JOB!   ;D

[gary2010]

Jeremy,
I have a friend who is a pro wrestling/MMA coach and has a THR one side, that was 4 years ago, he doesn't seem to care what he does with his legs, though he doesn't run "never liked running anyway". THR isn't the end of the world, though I'm pleased I got a resurfacing.
G.

[synthetic]

Interesting Video on Metal on Metal THR and Resurfacings on Australian Television:

For the program see: http://www.abc.net.au/4corners/special_eds/20110516/hips/

[muzza]

A one hour documentary on the very popular program "Four Corners" just screened here in Australia. It dealt with the De Puy recall and the whole matter of metal on metal hip implants and metalosis. Quite alarmist in the way it covered the subject. Did a complete demolition job on a retired Adelaide surgeon who was involved in the design of the ASR. His reputation largely destroyed. Focused quite a lot of attention on the findings and opinions of the Newcastle research group and on the opinions of surgeons who were anti metal on metal. Nothing from the likes of Mr McMinn or Dr Gross to give the other side of the story. Nevertheless, some very informative case-studies of people with the ASRs who had problems with cobalt /chromium levels.

McMinn responds here: http://www.mcminncentre.co.uk/response-abc-corners-program.html
Well worth a read.  

Mr McMinn's response is very good indeed and very reassuring. Australia's Four Corners is a good program but often sensationalist. A few weeks ago it exposed the horrific slaughtering practices in Indonesia of Australian live export cattle. The outraged response by the general public was so huge that the very next day our Federal Governernment was forced to immediately ban the export of live cattle to certain Indonesian slaughterhouses; and many politicians are calling for a complete ban on all live export. I can't ever remember such swift and decisive  action by politicians and a government. All because of a one hour Four Corners program. Sometimes Four Corners gets it right; sometimes not so right as with the hip device program.  

PS. Just as I completed typing the above, I heard on the radio that the Australian Federal Government has banned all live cattle exports to Indonesia.