FDA orders study of all MOM hips

[Ernie]

See this report in the NYTIMES 

http://www.nytimes.com/2011/05/11/business/11hip.html?_r=1&hp

[joedb123]

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.

[Dannywayoflife]

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!)

[hipnhop]

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.

[FlbrkMike]

Along 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?

[Lopsided]

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.

[ScubaDuck]

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

[hernanu]

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.

[stevel]

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.

[FlbrkMike]

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.

[phillwad]

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

[Pat Walter]

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  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

[Tin Soldier]

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.   

[muzza]

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

[katekosar]

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

[phillwad]

Way to go Kate

Cheers - Phill

[Lori Cee]

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. 

[Lopsided]

If you look at this video 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.

[hipnhop]

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.

[newdog]

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.

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?!!