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Author Topic: NYT Articles/Need for a Registry  (Read 1641 times)

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Eitan

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NYT Articles/Need for a Registry
« on: September 18, 2011, 05:14:41 PM »
I am somewhat surprised that no one has mentioned the recent series of articles in the NY Times concerning reports of high rates of failure of MOM hips.  (By my count there have been at least 4 articles in the past 2 or 3 months.  These are all essentially the same info regenerated:  ie, There has been an alarming number of reported failures of MOM hips, specifically the Dupuy ASR, and the ASR's failure numbers are almost exponentially increasing as time passes.  The articles, if I understand them correctly, are speaking more about the ASR acetabular cup when it was coupled with a MOM THR stem and less about the ASR cup when it was used in a resurfacing scenario.  As we all know, the ASR was withdrawn and in fact recalled from the market internationally.)

I do not wish to comment, per se, about these NYT articles.  I found that the information provided was woefully incomplete, and they left me with more questions than answers.  One point that was made in all the articles is that the high failure rates of this particular prosthesis were only discovered through rigorously analyzing information from Australien and British registries.  Herein, I believe, is the crux of the matter:  Why do we (ie Americans and Canadians) not have our own registry???  I would think it not terribly difficult, in this age of internet/computer access, to create and fund a national registry so that our implants can have safe and effective epidemiological follow up.  The registry could probably be funded through obligatory contributions from the prosthesis companies themselves, as they are consistently posting huge yearly profits.

Transmittal of info to the registry should be obligatory by state/federal law, and should be done on standardized computerized forms for each patient/implant, ideally with the info filled out by the operative surgeon on the day of surgery.  Data entered could look something like this:

Patient Initials:  JD
Hospital Name/Location:  Good Samaritan, LA, CA
Chart #:  123456
Patient Age:  45
Patient Sex:  Female
Surgeon's Name:  Dr Feelgood Kutumup
Date of Implant:  09/18/2011
Type of Implant:  Birmingham Hip Resurfacing
Lot/Serial #:  A3349966773
Operative Diagnosis:  Osteo-Arthrosis Left Hip
Intra-Operative Complications Noted:  None

The info could be transmitted to the registry by simply pressing the "Enter" button, or alternatively some type of bar code could be scanned and transmitted with the info attached. Once that info is transmitted to the central registry the patient is given a sticker or computer chip with essentially the same info scanned onto it.  If he/she ever presents back to any hospital for any reason with a complication from that implant (dislocation, infection, loosening, fracture etc, but especially a complication that requires further surgery), the chip or sticker can be re-scanned into the registry data base with the updated complication data.  If things continue to go well for the patient, his surgeon can re-scan his info at each follow up visit and simply check off a box on the form that states "No complications noted".

With this info a national registry could, I believe, capture useful information about the performance of specific brands of implants, specific hospital performance, and even specific surgeon performance.  At the same time, the patient's specific identifying info would remain completely confidential.

I know that the Obama administration has talked somewhere in their Obama care legislation, about the creation of a joint registry, but my understanding is that it would be voluntary, which I think would defeat the purpose. 

I would be interested to hear from other poster's on this subject.

ScubaDuck

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Re: NYT Articles/Need for a Registry
« Reply #1 on: September 20, 2011, 12:34:20 AM »
Titan-

If you search this site at all you will see at least two threads related to two of the articles in the NYT.

Dan
LHRA, Birmingham, Dr. Pritchett, 8/1/2011
RHRA, EndoTec, Dr. Pritchett, 12/6/2022
fullmetalhip.wordpress.com

Tin Soldier

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Re: NYT Articles/Need for a Registry
« Reply #2 on: September 25, 2011, 10:46:32 AM »
I agree that there should be a registry.  Although it sounds like the bad press isn't just in the US or Canada.  Australia had a show on MoM HR on "Four Corners" that recently stirred up a bunch of controversy.  I believe McMinn made some comments about the show, posted on Vicky's site or on The McMinn Centre site, can't remember. 

With the recent interest from the FDA to collect more data from each of the prosthetic manufacturers, it seems like a registry would satisfy a lot of that need.  This makes me curious about S&N and Wright and others, seems like they would be pretty frantic at trying to build their reputation. 

I think in summary, the MoM community (specifically HR) has been dealt a pretty bad blow by the whole ASR issue and it may take some time to recover from it. 
LBHR 2/22/11, RBHR 8/23/11 - Pritchett.

Eitan

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Re: NYT Articles/Need for a Registry
« Reply #3 on: September 25, 2011, 11:14:44 PM »
The ASR issue is sort of relevant in my case because I was originally going to have my surgery in around August of 2010.  When I went to see my surgeon in March of 2010 I was already aware that he was a "Dupuy" guy, and I was aware that there were vague reports of problems with the ASR resurfacing coming out of Australia.  I asked him specifically about this, and he stated that his own ASR patients were doing well, but that he was phasing out using this prosthesis as it was being taken off the market.  He was going to start using the Finsbury "soon".  Luckily for me the cortisone shot that I got in March worked until about October; I got a date for surgery in March 2011, and by this time my surgeon was quite comfortable implanting the Finsbury, so thats the prosthesis that I got.  I couldn't be happier, and I am happy that I did not end up with an ASR.

My point about the registry is this:  1)  A registry should be obligatory in both the US and Canada in order to have adequate follow up and quality assurance of implants, implanting surgeons, and hospitals.  2)  My own feeling is that neither the manufacturers, nor the FDA, nor the implanting surgeons, nor the hospitals are actually very interested in getting a registry off the ground.  3)  Probably the only way we are going to get a national registry in our respective countries is if we (patients) insist on it.

I think that if we surface hippies got together as a group and stirred up some s--t with our respective congressmen, MNA's etc we could get ourselves well on our way to having the registry that we rightly deserve. 

Lopsided

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Re: NYT Articles/Need for a Registry
« Reply #4 on: September 26, 2011, 12:00:54 AM »
It's got to be a global registry.



Proud To Be Dr. De Smet's First Uncemented Conserve Plus, Left, August 2010

Eitan

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Re: NYT Articles/Need for a Registry
« Reply #5 on: September 26, 2011, 03:20:15 PM »
I agree and disagree with Lop.  Yes a global registry would be the "ideal", but practically it's never going to happen.  I believe that the first country to get a registry was Sweden, and they were probably able to do it because they have a "one universal payer" model.  There is no way legally to mandate a "global" registry; each country has to pass its own laws, make its own decisions on this issue.  Here in the US/Canada there has been discussion for years without anyone taking any action.  If the info on the increased ASR failures (to use just one example) hadn't come out of Australia and the UK I can guarantee you that we North Americans would still be getting ASR's implanted, to our obvious detriment. 

There is no doubt in my mind that even now, here in North America, there are poorly performing prosthesis' being implanted (here I am not necessarily referring only to Resurfs, but also to THR's and TKR's), or poorly performing surgeons doing implants, or poorly performing hospitals doing implants.  Currently no one is the wiser because no regular mandated follow ups are being done, and no objective comparative data is available.  If we can send people to the moon surely we can perform proper follow up/surveillance of our implanted patients. As I said before, the push for a registry not going to come from the surgeons, the companies, or the hospitals.

Vicky

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Re: NYT Articles/Need for a Registry
« Reply #6 on: September 27, 2011, 03:33:10 PM »
The surgeons are working on putting together a U.S. hip registry, but as you guessed it, a lot of surgeons are not willing to participate.  It should be mandated IMO. 

In regards to the NYT articles, you will notice that the the one thing that most of them have in common is the author. Barry Meier, he has it out for ONLY posting ONE sided stories, and only writing HALF truths and leaving out the rest of the story.  I know first hand because his very first negative article about Women and Red Flags in the NYT about hip resurfacing, he personally called ME and interviewed me for over an hour on the phone, this was several years ago.  He asked me for the names of surgeons and two female patients, one with a femoral neck fracture, which I gave him the name of Kathy Bird and her contact info and the other was a gal named Michelle who had her resurfacing for over 12 years and was really happy with it, running and doing all sorts of activities.  Barry Meier NEVER bothered calling the positive story, he ONLY called Kathy and wrote about the negative.  The docs info I gave him, same thing, they told me they spoke to Barry and he ONLY wrote the negative and left out all of the positive side of things that the surgeons told them.  That is when I decided to tell the REST of the story and I video interviewed six of the worlds top hip surgeons. At the time I did these interviews, just between these 6 surgeons they had done over 27,000 total hip surgeries between them, out of that they had done over 13,000 hip resurfacings, just between these six surgeons.

I also wrote something here regarding the negative press out there and at first I didn't mention Barry's name, but recently changed it to just make it clear it was him I was talking about.  There is a lot more info here as well that shows the rest of the truth.  In the future, just look at who wrote the article in the NYT and if it was Barry Meier, KNOW that it is only HALF of the truth.  Hopefully in these two links you will clearly see the REST of the story.  The video interviews are excellent, please take the time to watch them, they are all shot in HD Broadcast quality video.

Vicky
« Last Edit: January 27, 2012, 10:02:24 PM by Pat Walter »

 

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