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Author Topic: Article in NY Times 3/4/2010  (Read 3740 times)

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kwarendorf

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Article in NY Times 3/4/2010
« on: March 04, 2010, 11:33:29 AM »
An interesting article appeared in today's paper. Here it is, both link and text.

Concerns Over ‘Metal on Metal’ Hip Implants
By BARRY MEIER

Note by Patricia Walter:  I am sorry, but I removed the complete article posted below because you are not allowed to copy and post a complete article written by another author without permission because it has a  copyright.  I can't do that on my website either because it is not legal. Since I own and moderate Hip talk, you are not allowed to do that on Hip Talk either.  This is not my rule - it is the law.  Please do a search about copyright material.
« Last Edit: August 29, 2014, 11:25:55 PM by Pat Walter »

halfdone

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Re: Article in NY Times 3/4/2010
« Reply #1 on: March 04, 2010, 01:07:56 PM »
Thanks for posting.
Very interesting to see an article like this appearing on the front page of the NYT business section.
It is bound to be an issue that potential MOM implant candidates now consider more seriously, even though the findings remain open to further investigation, analysis and interpretation.
As someone who is comfortable with my existing MOM prosthesis, and needing the other side done fairly soon, my initial takeaway is not to reconsider the device (in my case a BHR) but to pay even more attention to choice of surgeon (my original surgeon has retired.)
I will be interested to read further comments from patients and professionals on the subject.

Pat Walter

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Re: Article in NY Times 3/4/2010
« Reply #2 on: March 04, 2010, 01:44:04 PM »
If you read the complete article you will see some important points.  Here is a quote

Quote
The limited studies conducted so far estimate that 1 to 3 percent of implant recipients could be affected by the problem. Given the large number of people who have received metal devices, that could mean thousands of patients in the United States.

Note that this is based on "limited studies"  and it is an "estimate that 1 to 3 percent" problems that "could be affected" are occuring.  This is pretty iffy.  When it comes to limited and estimates - they are not concrete numbers. The national registries based on actual date report less than 1 percent problems 
Quote
One hip device company, Smith & Nephew, which markets an implant called the Birmingham hip resurfacing system, said that data from an implant registry in Australia showed that fewer than 1 percent of patients using that product had reactions to metal.

I just wanted to make sure people read the whole article and saw the actual data presented on the  the National Registry which does not show up until the middle of the second page.  It is often a problem with so many studies that they are based on only a few, usually less experienced, surgeons that have not done a large amount of patients.

The article does explain that acetabular cups which are not placed at the proper angle can cause high metal ions.  That does not have a thing to do with the MOM hip device - but with the surgeon's skill.

I just wanted to comment on the article.  You do have to read all the way to the second page to read the more positive information it presents.  So many of the articles are meant to scare people and make a procedure that are not in the main stream appear dangerous.  We know there can be high metal ions produced by misplaced cups and we know that there are a few people that are allergic to the cobalt/chrome of the device - but these cases are in the minority.  I have not changed my mind about hip resurfacing.  It is still my choice over an old fashioned THR and the choice I suggest to people needing a hip replacement.

Pat
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kwarendorf

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Re: Article in NY Times 3/4/2010
« Reply #3 on: March 04, 2010, 02:53:55 PM »
I agree with Pat. The Times is just trying to sell papers. Even at 1%-3%, I would have made the choice to have the MOM resurfacing.

"Given the large number of people who have received metal devices, that could mean thousands of patients in the United States."

At 3%, 50,000 MOM sugeries would result in 1,500 problem cases. At 1% 150,000 procedures would result in 1,500 problems. It would also result in 48,500 & 148,500 problem free cases :)

PS Sorry about posting the full text :)
« Last Edit: March 04, 2010, 02:57:46 PM by kwarendorf »

obxpelican

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Re: Article in NY Times 3/4/2010
« Reply #4 on: March 04, 2010, 04:18:13 PM »
I think if everyone digs deeper with the stats that most doctors who are experienced have a  < 1% problem with metal debris.

I am going to zip an email out to Lee at Dr. Gross's office to see what percentage he's had with the biomet.

Of course if the device is not loading probably anyone can have issues but in properly implanted devices I would bet the percentage is < 1/2 % or more.

This once again points us all to find the most experienced surgeon if you want an HR.


Chuck
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kld

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Re: Article in NY Times 3/4/2010
« Reply #5 on: March 04, 2010, 08:52:10 PM »
My surgeon (Dr Boettner) was upfront with me about this possible complication, and I still chose to go through with the resurfacing.  I think that you have to weigh the possible benefits with the odds of having a problem.  I considered waiting until there was more data out there about the long term outcomes, but ultimately it felt like that would have been years of my life not hiking and biking through the mountains and it was really a quality of life issue.  Of course, I'm also keeping my fingers crossed that I don't have to confront these possible complications.

Nina P

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Re: Article in NY Times 3/4/2010
« Reply #6 on: March 04, 2010, 10:44:32 PM »
Hi, Pat and others--I was also concerned when I read this article.  I had surgery with Dr. Edwin Su just over a year ago.  I still have some "soft tissue" pain in the hip area. It's nowhere near the pain I had before surgery, but I am still disappointed that I have any residual pain.  All of my xrays have been excellent, so I am assuming the placement is fine.  I have seen another doctor and just had a CT scan to see if anything can be determined and am waiting for the results.  I am wondering if it is prudent to have a blood test from time to time to see if there is any of this metal disbursement that the article talks about.  I also have had shoulder pain on the same side as my hip resurfacing for the past 6 months and have not been able to "fix" that with either cortisone shot or physical therapy.  Could be a coincidence, but this article has me thinking...

Pat Walter

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Re: Article in NY Times 3/4/2010
« Reply #7 on: March 05, 2010, 03:44:25 AM »
Hi Nina

Why don't you ask Dr. Su about having a metal ion test?

I have not heard about anyone that had an allergy to cobalt or high metal ions that had problems with other joints in their bodies.  Of course, I am not a doctor, and don't know everyone's stories.  Only those people post.  Normally allergies and high ions cause a lot of pain around the joint. Again, that is only what I have read.

I think you should talk more with Dr. Su or his office about your questions.  They will give you better answers.

I think the article was very one sided in trying to make MOM devices sound very bad.  The actual problems are less than 1% according to the national registries.  I would concentrate more on the facts that the negative outlook the article posted. 

Some people have just taken a very long time to heal.  You did not say how long your hip was bad.  Sometimes if you limped and had a bad hip for years, it takes a long time to get your body back to normal.

Keep us posted.

Pat
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stevel

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Re: Article in NY Times 3/4/2010
« Reply #8 on: March 05, 2010, 05:05:24 PM »
Vicky Marlow had her hip tested for metal ions at 3 1/2 years post-op and the levels were very low at 2.1 parts per billion (chromium) and 1.0 parts per billion (cobalt).  The testing and payment for testing was coordinated by Dr. Su.  The results are available at "Vicky's metal ions and reasons for excess metal" on her website.  She also mentions the Cory Faulk's metal ion levels are very low, and he has been pounding his hip by doing triathlons and marathons over the same time period.  Cory has probably loaded his hip through more cycles in 3 1/2 years than the rest of us would do in a lifetime.The results suggest that the metal ions are very low for a properly placed device.  This emphasizes the need to go to an experienced surgeon.  If you are an athlete rather than a couch potato, I would go to just a handfull of "experienced" surgeons.  I would also only select the BHR device because of its most successfull results since 1997 compared to other devices with a shorter duration of use.  Some of the other devices have been pulled from the market e.g "Durom" and "ASR."  Doing anything less is risky and stupid. 
Steve
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DonC

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Re: Article in NY Times 3/4/2010
« Reply #9 on: March 05, 2010, 06:55:41 PM »
The topic of 'edge loading' is an interesting one. No question that a properly placed device is most critical. However, I can't help but think that some exercizes would increase the risk of edge loading by putting the hip at an extreme angle. For example, there would be a much different loading/angle on the hip joint when walking up stairs or doing deep knee bends than there would be when you are simply walking in a straight line. So I would imagine there are things a person could do that would increase 'edge loading' no matter how well placed the device. This is my own speculation and I could be completely wrong but it does seem like a reasonable possibility. The examples of both Vicky Marlow and Cory Faulk's success is encouraging. Personally, I'm staying away from high impact exercizes like running as well as deep knee bends.  For now, I'm very happy to be walking pain free again after 12 weeks post op. and I can only hope that Dr. Gross did everything correctly.

obxpelican

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Re: Article in NY Times 3/4/2010
« Reply #10 on: March 05, 2010, 07:36:21 PM »
Metal ions are an issue, but no more an issue than dislocations and infections.

2 cases, even 3 that are low in metal ions is not statistically sound logic, with any HR surgery too many times it's how the device was implanted that can cause metal ion issues and yes, tissue damage from it.  Any athlete with a device improperly implanted can have issues a few weeks post-op.

Often surgeons if they have a patient with a device implated at a wrong angle will test for ions, if the ions are not an issue, or a problem, and the patient is not having problems many times the patient just uses his device as it was implanted.

What is really encouraging are that so many people do not have any issues.

Don't worry, just keep walking pain free, statistically you have a great chance of walking without pain and a small chance of issues, at least that is why the numbers bear out now.

Think positive, don't just keep thinking about what might happen.


Chuck
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Nina P

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Re: Article in NY Times 3/4/2010
« Reply #11 on: March 06, 2010, 01:19:56 AM »
Thanks, Pat and everyone else who wrote about this issue.  I spoke to another doctor who did not do the hip surgery with whom I did a CT scan. He said the CT scan did not reveal anything in particular.  I plan to contact Dr. Su's office and ask about testing, but the responses that I read here are making me feel better.  I'll keep you posted on any further diagnoses, etc.
Nina

obxpelican

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Re: Article in NY Times 3/4/2010
« Reply #12 on: March 10, 2010, 12:10:31 AM »
Everyone,

As I mentioned earlier I said I was going to zip an email to Lee (Dr. Gross's surgical assistant) and I got his response and his report is very positive, she did not give me permission to post, I asked her and am awaiting her response.

I'll quote one part of his response "I have used over 3000 metal bearings in primary total hip and hip resurfacing as well as revision surgery. I have revised 2 for adverse wear 7 years after implantation."


Chuck
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Pat Walter

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Dr. Gross Responds to NY Article about Adverse Wear in MOM Bearings
« Reply #13 on: March 10, 2010, 12:18:19 AM »
The controversy regarding adverse wear in metal-metal bearings

Thomas P. Gross , MD 3/5/2010

I have used over 3000 metal bearings in primary total hip and hip resurfacing as well as revision surgery. I have revised 2 for adverse wear 7 years after implantation. I know that most other high volume hip resurfacing surgeons have a similar experience. The revisions were straightforward and the patient enjoyed the same rapid and complete recovery as if she had a primary hip  replacement.
Currently less than 5% of my practice involves revision surgery. However, I have revised over 100 metal plastic replacements for excess wear. Furthermore significant wear related damage to the tissues is seen in virtually all metal plastic hip replacement or knee replacement revised for other causes.

A surgical group that has seen a surprisingly large number of wear‐related failures of metal  bearing implants has coined the term “seudotumor”when an inflammatory soft tissue mass is seen around the hip of a metal bearing implant. However, this inflammatory soft tissue reaction to metal wear debris is not much different than the inflammatory reaction that we have seen with plastic wear debris for many years.

All artificial bearing implants give off wear particles. The question is, which type of wear debris is best tolerated by the body? During the last 20 years of joint replacement polyethylene osteolysis (bone destruction caused by plastic wear debris) has been a major problem. But anyone who has revised total joints is also aware that polyethelene debris also is always associated with large amounts of soft tissue reaction around the joint. Polyethelene has been improved, and metal bearings have been developed. Both give off much less wear debris than the old polyethelene implants. The question is which results in less wear related damage? At this point we do not yet have the answer. Adverse wear reaction is a serious problem, but fortunately it is very rare.

Lets put this into perspective. The most common reason resulting in revision of total hip replacements in the US is hip instability (recurrent dislocation). 20% of all hip revisions are done for this reason. This is far more common than adverse wear reaction. Hip instability is a very disabling condition that occurs in 3‐5 % of hip replacements. The rate of instability for large head metal bearings is less than ½%. Larger bearings are the solution for this problem. Large head metal bearings (resurfacing and total hip) are currently the only ones that allow reconstructingthe hip in a biomechanically normal fashion to avoid instability. Proponents of plastic and ceramic bearings realize this and have made their bearings thinner recently to allow larger heads to be inserted (32‐36mm). This has made them more stable, but 32‐36mm does not yet approximate normal femoral head sizes in the average female (48mm) and average male (52mm) patients. These larger head (32‐36mm) implants for plastic and ceramic bearings have only been in use for a few years and it is not yet clear if these bearings will break at a higher rate because they are thinner. I would not recommend impact sports on thin plastic and ceramic bearings. Anatomic sizing that matches the patient’ own size is only possible with large metal head designs. These are stable and can tolerate repetitive full impact without breaking. Wear rates are not significantly increased by running.

In the last few years we have learned that these rare cases of adverse wear in metal bearings are related to three factors: steep acetabular inclination greater than 55 degrees, small component sizes, certain component designs with an extremely shallow arc of coverage. At this point it is still only a very tiny percentage of patients with cup inclination angles above 55 degrees that have had wear problems. If a patient with an inclination angle above 55 degrees develops symptoms years after surgery, I would first check metal levels and an MRI. If the levels were high or a soft tissue mass developed I would recommend revision. So far this has happened twice in my practice.
More important, however, is prevention of this adverse wear complication. Since this information about cup inclination has become available several years ago we developed and tested a protocol  for measuring the inclination by XR during the operation. The paper reporting this technique will be published in CORR this year. Using this technique in every case, I now have had no cupsimplanted with inclination greater than 55 degrees since 10/ 2007. We expect that this technique will completely eliminate this rare cause of failure in metal bearing hip implants: adverse wear reaction.
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obxpelican

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Re: Article in NY Times 3/4/2010
« Reply #14 on: March 10, 2010, 12:19:29 AM »
Hey Pat,

Good news spreads fast!!!   :)


Chuck
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Pat Walter

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Re: Article in NY Times 3/4/2010
« Reply #15 on: March 10, 2010, 12:37:21 AM »
Chuck

Thanks for taking time to write to Lee about the NY Times Article.  She said a lot of patients have been contacting them and were very concerned about the article.  It is great when patients can tell a doctor about their concerns and get an educated response to their questions.

Thanks again.

Pat
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Bionic

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Re: Article in NY Times 3/4/2010
« Reply #16 on: March 10, 2010, 03:17:09 PM »
Perhaps we should ask Dr. Gross to submit this response to the NY Times as a letter to the editor?
Right uncemented Biomet Recap/Magnum
Feb. 11, 2009 with Dr. Thomas Gross and Lee Webb

stevel

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Re: Article in NY Times 3/4/2010
« Reply #17 on: March 10, 2010, 09:45:29 PM »
Check out the latest NY Times article "With warning, a hip device is withdrawn" by Barry Meier concerning the ASR THR at www.nytimes.com/2010/03/10/business/10device.html.
Steve
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RBHR 60mm/54mm Dr Su 11/1/19 age 66

Pat Walter

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Re: Article in NY Times 3/4/2010
« Reply #18 on: March 10, 2010, 11:33:28 PM »
Hi Steve

Althought the ASR has been withdrawn from the market, there are many patients with sucessful ASRs which they received from the very experinced hip resurfacing surgeons.  As I understand the situation, the cup is not as deep as other cups from different manufacturers and must be placed at the proper angle for the hip device to perform properly.

I am not saying the ASR is good or bad since I am not an experinced surgeon and have no way of knowing. The only point I want to make for people that have the ASR and new people reading this post is - patients with ASRs that were implanted by the top experinced resurfacing surgeons should have no problems.  Doctors like Dr. Bose used half BHRs and half ASRs in his practice. He has not had any revisions of his ASRs and he has done hundreds of small Indian women.  Several of the other top surgeons have placed a large amount of ASRs and have none or very few revisions. 

I don't want people with ASRs laying awake at night worrying.  I think the one recommendation that I have made - hundreds and hundreds of times -  to use the most experienced hip resurfacing surgeons applies in this situation. Few people in the US have gone to the less experinced surgeons for ASRs since few used them.  So hopefully we won't read too many stories about revisions of ASR cups on the discussion groups.

Pat 
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stevel

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Re: Article in NY Times 3/4/2010
« Reply #19 on: March 11, 2010, 12:15:13 AM »
Hi Pat,

The withdrawal pertains to the ASR Total Hip Replacement (THR) device, because of failures reported in the US.
In regards to the ASR Total Hip Resurfacing device, I don't know about any problems.
Particularly since experienced surgeons such as Dr. Schmalzried, Dr. Ball and Dr. Bose have been installing them.
« Last Edit: March 11, 2010, 12:19:07 AM by stevel »
Steve
LBHR 60mm/54mm Dr Su 9/29/08 age 55
RBHR 60mm/54mm Dr Su 11/1/19 age 66

 

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