See this report in the NYTIMES
http://www.nytimes.com/2011/05/11/business/11hip.html?_r=1&hp
I just read this article. I am very upset. The main reason I find this so upsetting is that as we all knew this was being discussed, I was told it was known to be occurring in -2% of the patients. The article seems to say 12-15%, what is the truth and when was it known?
This is an important subject for all members to discuss and explore. Our own informal poll so to speak.
I had my BHR installed March 25th, so far so good, but I am now nervous about my decision.
Hmm interesting but I wouldn't be too concerned by this. Colbolt and chrome alloys have been used in arthroplasty for a long time. Mr Mcminn used John Charnleys work on metal alloys as a start point. From what I have read on the subject it strikes me that the real problem is that the HR devices are quite sensitive to the angle of inclination of the cup. If this is set at the incorrect angle it seems that excessive wear will occur. I'm sure that I read that that was the finding of the recent Oxford study on the subject. (I could be dreaming there though! I am a scatter brain!)
i wonder if this will make surgeons shy about doing MOM implants in the future. I hope we dont see a return to ceramic/metal THR as the main option for younger patients.
QuoteAlong with the DePuy division of Johnson & Johnson, other major producers of hip implants include Zimmer, Stryker, Biomet and Wright Medical.
Nowhere does the article mention THR vs. HR, and for some reason they did not include Smith & Nephew in the list of manufacturers. Is it possible that this order only applies to MOM THR devices?
Is this continued fallout from the ASR recall? The lawsuits will go on for years. The FDA maybe obliged to be seen to do something.
The article does say 'it was up to each manufacturer to determine how to conduct its studies' and 'including taking blood samples to determine the levels of metallic ion.' So it seems that the FDA does not want to pull any devices, they just want to make sure that ion levels are correct.
In an interview with Dr. De Smet (which I think is on this site somewhere), he said that he foresaw increasing adverse opinion of resurfacing.
So I think there will be plenty more wise gurus around in the future, bolstered by cases of failed resurfacing by inexperienced surgeons.
I certainly would not have wanted the alternatives to resurfacing, plastic liners, femur amputated, etc.
The article does seem a bit disconcerting. However, making the decision to get resurfacing was a commitment, and so long as my device is good, I will be happy about it.
Just great. Now that I have made the decision and scheduled my surgery, this comes out.
I still believe my research tells me that a resurfacing now is better than a continual downward spiral in quality of life until a THR would be necessary. And it seems that many people on this site have followed up with metal ion tests and been fine.
The article is vague (and poorly written) but the data raises questions.
I hope for a spirited discussion on this site. I hope for more information in the next two months leading up to my surgery.
Dan
I think anything that gets us more knowledgeable about this is good. I did as much research as is possible, went with a surgeon that had done many procedures, but in the end the question was about quality of life. I will keep monitoring my metal ion levels and will contribute to any studies available if asked.
I will also keep enjoying life and if this surgery, which has been great so far, leads to some complications, will deal with them later; hopefully that won't be the case, and statistically, even it the statistics are 85-90% I am still in good shape.
See the link at FDA at www.fda.gov/medicaldevices/productsandmedicalprocedures/implantsandprosthetics/metalonmetalhipimplants
This site covers both metal on metal THR's and hip resurfacings.
The FDA wrote 145 orders to 21 manufacturers regarding the study.
Nice find Stevel
"The FDA is continuing to gather and review all available information about currently marketed metal-on-metal hip systems, including information related to adverse events that may be associated with increase levels of cobalt and chromium in the bloodstream. To that end, on May 6, 2011 the FDA issued orders for postmarket surveillance studies to manufacturers of metal-on-metal hip systems. The FDA sent 145 orders to 21 manufacturers. Manufacturers will be required to submit a research protocol to the FDA that addresses specific safety issues related to these devices. Data from the studies conducted will enable the agency to better understand these devices and their safety profiles."
I wish that there was more information about the specific orders and manufacturers. Manufacturers need to submit a research protocol. This research could take years before any results are developed. In the meantime I think I'll just be really happy with what I have.
I would expect that my doctor would request the blood work and I am glad that they will be using the data in a bigger study. We will all have to wait and see what the research protocols are and then where we all fit in to research. This is going to be a long long process.
I am focused on my recovery, enjoying riding my bike and getting fit again
Phill
Please don't forget that there are NOW the Austalian and UK national registries with that type of revision rates, etc. I will post the most recent data shortly. The BHR by Smith & Nephew has a 96% retention rate world wide. I will give more specifics when I get time to review the information. The information in the National Registries is not OPINION, it is fact. http://www.surfacehippy.info/nationalregistries.php (http://www.surfacehippy.info/nationalregistries.php) The BHR meeting I was at had information from the 2010 National Registries. I will get it posted shortly.
Please don't panic because the FDA wants devices tested and checked. The BHR has the best record of all the hip resurfacing devices. Again, that is not opinon, but based on medical studies and the National Registries. I seldom state an opinion rather that a statment based on National Registry information or published medical studies.
I will post more shortly. Stay calm and if you have plans for a hip resurfacing with one of the top surgeons, you should not panic and cancel your surgery. Remember, if you don't get a Hip Resurfacing, your next choice would be a MOM metal on metal THR of the same composition or you will end up with a small ball THR with a ton of restrictions.
Pat
This is the kind of negative support insurance companies like to use to charge you a little more for "questionable" treatments. I don't define "questionable" as 85% success, or as Pat says for the BHR, 96%. There is not a lot of question there that HR works and it works for most of us.
I think I need to understand the FDA's procedures and thresholds a little more, because it doesn't seem like there is enough negative data to say that HR is a problem, to the contrary, it seems like there is so much positive anecdotal and maybe even empirical data presenting the benefits of HR (I know I am looking at an HR website) that there wouldn't be much of a question.
I'll add to Pat's options, if you don't do HR and you don't do THR, you could take narcotics the rest of your life and stumble on the sidewalk, run from picnic tables, stop taking hikes with the family, put the bike away FOREVER,... I think everyone here agrees that 10 years or 15 years of having your life back is well worth the limited risk of having a failure. If you have a failure, you always have the option of THR and in some cases you might be able to do HR again.
I agree with you Pat. The most comprehensive body of facts and statistics on resurfacing is contained in the Registries. As a double-hip BHR man (at 3.3 and 1.5 years), I find the Australian Registry's information gives me no cause for concern at all.
Neil
Sorry, but I find all the numbers mumbo-jumbo to be a big fat smoke screen. Dudes are always making a case for one side or the other, ad nauseum. I kind of tuned out when they said the sun was bad for you. Or eating a hamburger is bad for you.
As far as I'm concerned, I'm walking around on a new hip with a new life and, although there's surgical pain still (2 weeks out), I don't have that incessant deep gnawing knife sticking into my hip joint. I'll keep Betty Birmingham and leave the beaners and number-crunchers to have at it.
Kate
Way to go Kate
Cheers - Phill :D
The ASR recall and MOM debate was in full swing by the time I was meeting with a surgeon to discuss my options in January this year. I still chose to go with a MOM prosthesis after reviewing all of the information I could find. When I went in to meet with him that first time I knew nothing about what he might suggest or what I should do and he brought my attention to the media attention and issues with ASR and why he still favours the MOM prosthesis, particularly BHR and BMHR (both with pretty low failure rates). After my own independent research, I agreed that this was the best option for me as did many others on this discussion board.
It kind of looks like the FDA is in cover yourself mode at the moment since these devices were approved by them. Everything these days seems to need a label (as Kate and others have mentioned) and really it comes down to what risk you are prepared to take. As Tin Soldier suggested, is 10-15 years quality of life worth it - I say yes and I wouldn't call my path to recovery one of the easy ones around. Don't let this discourage you - I'm a bilateral with long term damage and ROM issues. If I had of done this 10 years ago, I might have been as quick in recovery as some of these other guys but I waited and spent that 10 years not sitting at picnic tables (except for the end seat) and without many other activities that others were enjoying. I didn't want to do it anymore and even the slower recovery time is worth the ultimate goals.
Like Kate, the pain is now gone. I'm not yet sitting at picnic tables, nor am I even walking without crutches but I know what its going to be like when I do heal and that is worth the extremely low risk of metallosis. Nothing good in life comes without risk.
If you look at this video http://www.youtube.com/watch?v=3I1IeXJ1gMw (http://www.youtube.com/watch?v=3I1IeXJ1gMw) from three years ago, Dr. De Smet talks about the backlash and the catastrophe in the US and inexperienced surgeons.
Kate and Lori - Amen!!!!! A very smart man said "Everything that can be counted does not necessarily count; everything that counts cannot necessarily be counted." No one knows what we lost because of this disease. While the science is still out, I am glad I am not sitting on the sideline in pain waiting. They are in the process of learning more about MOM. Maybe one day they will cure this debilitating disease. Until then I will join you at the picnic table.
I agree, the article is rather vague. I'm not at all alarmed. I think there is enough data and history on MOM devices that proves that they are the way to go if put in place properly. Sounds like the FDA is responding to the negative press. On the other hand maybe there are too many surgeons doing HR who should not be doing it because of inexperience or inability. I don't know, just my .02.
Quote from: Tin Soldier on May 11, 2011, 04:30:04 PM
I'll add to Pat's options, if you don't do HR and you don't do THR, you could take narcotics the rest of your life and stumble on the sidewalk, run from picnic tables, stop taking hikes with the family, put the bike away FOREVER,...
Tin,
Great quote! How true. All those things were me before HR.
By the way, I sat at a picnic table one week ago. First attempt since HR. NO PROBLEM! Swung my legs over the bench and sat right down. Who's the MAN, picnic table?!! 8)
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
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
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.
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.
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.
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?
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
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.
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?
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.
Quote from: muzza on May 16, 2011, 08:12:11 AM
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 (http://www.mcminncentre.co.uk/response-abc-corners-program.html)
Well worth a read.
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.
I wonder if general body PH has an effect on ions wearing off a MOM joint. Maybe more acidic = more ions?
Quote from: Lori Cee on May 28, 2011, 07:18:34 AM
Quote from: muzza on May 16, 2011, 08:12:11 AM
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 (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.
Quote from: summergirl on June 01, 2011, 09:23:54 PM
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.
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
Wow Pat!
I just read that post and wondered, WT#? Thanks for watching out for us and GOOD JOB! ;D
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.
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/
Quote from: Lori Cee on May 28, 2011, 07:18:34 AM
Quote from: muzza on May 16, 2011, 08:12:11 AM
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 (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.