FDA to hold 2 day meeting on metal on metal hips

[Woodstock Hippy]

I saw this in my newspaper this morning:

http://www.boston.com/business/healthcare/2012/06/26/fda-probes-safety-issues-with-metal-hip-implants/S5DL91jpgvDAntQqIcCtfN/story.html

It will be interesting to see their findings.  The article says that the implants are failing at an alarming rate.  I know that the statistics are skewed by the Johnson &Johnson failures and by some surgeons who jumped in and didn't get properly trained and had problems but I'd like to see what the FDA has to say about the implants being done right now.

The article says that the implants could fail as early as six years.  If these new hips give me six years of my running carrier back and then I need another surgery, I'm good with that.  I was advised by three orthopedic surgeons against metal on metal resurfacing, but none of them had a better alternative for me.  Complete ceramic total hip replacement was the best but I wouldn't be able to run, so in my mind I'd still be disabled.  I could be that with no surgery  and just retire and go sit on the porch.  I chose to get my athletic life back and let the chips fall where they will.  So far I have no regrets at all and I'm betting that I'll still feel this way in twenty years when I do finally hang up my running shoes!

[Pat Walter]

Thanks.  There are quite a few of us past 6 years, including me, since they started doing the BHR in 1997 overseas.

Pat

[stephen1254]

One thing I am curious about, since THR's and resurfacing's are lumped together in these studies, is whether a THR is a less precise placement of the implant? We talk about cup angles - is this an even bigger issue in a THR?

[morph]

I reckon cup angles must be equally imortant for THR's since the edge loading wear mechanism would be present and the same in both, obviously just my opinion though. Whether the THR's have been put in with the same accuracy and whether the tools exist to allow them to be put in with the same accuracy is up for debate. I think they have been seeing failures with well positioned devices.

Up until the recent warning there has been a trend in using larger MOM balls on a stem with a metal sleave/taper intersection. I know there has been questions asked to whether this sleave has been a contributing factor to the wear and high failures. Certainly it is an extra interface which can't be good.

My insurance company were rejecting claims for certain MOM devices and requested that my surgeon send a letter stating the device and size of device to be used - so they were fine with a BHR from an experienced surgeon but would have probably denied a MOM THR.

Incidentally on 25th June the Medicines and Healthcare products Regulatory Agency UK (MHRA) updated it's warning which is summarised in the table on page 6:

http://www.mhra.gov.uk/home/groups/dts-bs/documents/medicaldevicealert/con155767.pdf

No follow up tests are required for asymptomatic MOM HR. But tests are required for all large ball MOM THR's (>36mm).

[Dannywayoflife]

Morph im sure I've read somewhere that in about 50% of all cases (thr&hr) the components are not positioned correctly. I could have drempt that tho!  :)

[hernanu]

I think this can't help but be good for the long term study of HR in the US. I like that the FDA rep  explicitly said they are not going to just take the UK registry conclusions at face value, since there is so much data available worldwide.

The truth will set you free (copied from much better minds than mine)  ;D

The article itself was the usual sensationalistic tripe from an AP reporter trying to place an article. If it leads to a national registry here and some realistic assessment of the results in the US, then I can hold my nose and grin at the article.

[Tin Soldier]

Once again we have to listen to these fools who write embellished, poorly-supported articles of crap.  I guess the one truth, is that the FDA is doing additional review.  I think we can all agree to that. 

Keep in mind the ASR still has an 80% survival rating for the 6 years or so that it's been around.  I'd reference that, but I can't remember where I saw it.  80% is not awesome, but it doesn't suggest to me that there is a horrible MoM epidemic on our hands, like the journalists like to make it sound. 

With regards to the ASR, how does the FDA approve the use of the ASR as a "similar" device, assuming they said it was similar to the BHR, or maybe C+, or biomet, when some of the highly experienced surgeons that reviewed the product before it went on the market, suggested that it would have problems and it is not similar?  I guess it depends on the definition of "similar".  Hemispherical vs. almost hemispherical?  otherwise the fixation looks similar, the metallurgy is probably very similar, the surgical technique is probabaly similar,....I would love to try to spend a few days digging through the FDA file on the ASR.  All of the media BS and the attorney-driven rhetoric has essentially destroyed any ounce of truth to the ASR's life and the lawsuit continues to ruin the reputation of the other products that have excellent ratings.

Why can't the FDA analyze McMinn's dataset, or Gross' dataset, or any of the other highly-experienced surgeon's datasets and show that the product and technique provide excellent results for a long time, longer than 4 years or whatever the media thinks.  It might not have all the detailed QA/QC that is required for a bombproof FDA review, but it doesn't seem like they would come up with significantly different results from the rest of the world. 


   

[obxpelican]

As with most governmental agencies the FDA suks.   I'm sure this won't be good news from them in the end, we'll see.  Anytime I hear the "Government" and the word "help" in the same sentence I run for cover.


Chuck

[John C]

For those that have a lot of time for reading, here is a link to the FDA Executive Summary going in to the current meeting. It is important to remember that much of this information relates to MOM THRs rather than resurfacing. This was posted on the Yahoo site, so I not sure if you may need to sign in to access it.

http://f1.grp.yahoofs.com/v1/sAbqTys431X8iZw5EZoIFWbN5l_sEuDXEmJbfpzglgM4mWSX79CBJrmQbQHswW7zRGLp4HUy1LYD-1eOTfmY0lk9MGq30w/FDA%20and%20Regulatory%20Documents/2012-06-27/FDA_ExecutiveSummary.pdf

[Tin Soldier]

http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/OrthopaedicandRehabilitationDevicesPanel/UCM309302.pdf

Here is a link to the FDA site, if the yahoo connection doesn't work.  Thanks John

For the record, I am not saying that the FDA is not doing a good and appropriate job.  I was simply asking the question of how they go about making their decision.  Their process is documented and we're all allowed to review most, if not all of it, through public records.  The problem is that it would take a chunk of one's career to fully understand the decision-making process of any large agency and frankly, any large private organization.  There are a lot of checks and balances, both legal and technical,  which constrain the process to a lengthy, long-winded, and sometimes incomprehensible road.  I work for a government agency and I know all too well how a decision-making process can be so cumbersome that it easilly disegages the average person and it creates a rather long and difficult project.

I'm looking forward to reading the summary.  Should be interesting.

[David]

The FDA is one of the most incompetent, influenced and captured agencies going.  There is no independence there at all.  You can tell I am biased by passed experience.  Money talks and the truth gets lost.
Bitter Dave...

[imgetinold]

I believe in one of McMinn's videos, he discusses the results of these studies, and goes on to say that not only are THRs a large part of the negative results, but that much of the wear that produces ions is not from the cup or head, but from a different point on the implant (that does not even exist on a resufacing implant).  I cannot find that video or I would put a link.

[Woodstock Hippy]

FDA says there are few reasons to continue with metal on metal hips:

http://www.medicalnewstoday.com/articles/247294.php

This causes me to be concerned.  I'll get checked for metal ions and get xrayed every year, but later on while I'm running through the woods, I'll be feeling pretty good.

[Arrojo]

FDA says there are few reasons to continue with metal on metal hips:

http://www.medicalnewstoday.com/articles/247294.php

This causes me to be concerned.  I'll get checked for metal ions and get xrayed every year, but later on while I'm running through the woods, I'll be feeling pretty good.

But they have still approved the BHR.  If they are that opposed to MoM then why approve the BHR?  Others have said it best.  Find the best surgeon available and use an approved device.  Seems to me the FDA could have included a statement like that (beefed up for medical jargon and professionalese) as a qualifier.  A simple blanket statement does not help the public, IMO.

[bluedevilsadvocate]

It is difficult to tell from the Medical News Today article the extent to which it pertains to resurfacings.  Interesting that, according to the broad brush of the Medical News Today article, the FDA appears to be making stronger recommendations regarding MoM followup, even while the MHRA UK seems to be moving in the other direction (according to the MHRA recommendations issued just last Monday), at least for asymptomatic resurfacings (although close monitoring is still recommended for even asymptomatic ASRs).  See the chart on page 6 of 7 of the MHRA Medical Device Alert.  The MRHA's focus seems to be on symptomatic resurfacings and large-head MoM stemmed devices (THRs).

http://www.mhra.gov.uk/home/groups/dts-bs/documents/medicaldevicealert/con155767.pdf

[morph]

At the time the scaremongering press in the UK also grouped HR in with MOM THR's, even though the problems seemed to stem (no pun intended) from the large headed THR. Mainly because of the ASR recall back in ~2009 it seemed.