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Author Topic: Is the COM (ceramic on Metal) device approved in the U.S?  (Read 1077 times)

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claudia

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Is the COM (ceramic on Metal) device approved in the U.S?
« on: February 18, 2013, 04:29:54 PM »
Hello,
I have metal allergies related to my skin and I am researching the ceramic on metal implant but I cannot find any information on the FDA website regarding whether it is being tested, reviewed ?????  (in the USA)
I am active, 54 and have had two arthroscopic surgeries to clean up the hip.  Dr. Byrd in Nashville performed the last arthro  in 2008 and i was happy and mobile with about 80% mobility in that hip until 2011 when I was in an accident directly involving that hip.  From that point, it seemed to accelerate the degradation of that hip and Dr. Byrd said he cannot do another arthroscopic clean-up and it would soon be time to think about an artificial hip which I mam not interested in.  I am very interested but it seems that the stats for success with the MOM aren't very good.  My allergies to metal are really significant so that's why I am interested in Ceramic.  IF anyone has any information about whether the ceramic will be available in the US soon - I would appreciate any info.
thank you
Dr Gross, Right hip, 3/21/18

Dannywayoflife

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Re: Is the COM (ceramic on Metal) device approved in the U.S?
« Reply #1 on: February 18, 2013, 07:12:49 PM »
From what I've seen metal allergy to jewellery and a orthopaedic device are 2 very different things.

I don't think that the COM device used by McMinn is FDA approved. Speak to McMinn
Danny
Train hard fight easy
LBHR 10/11/2011 Mr Ronan Treacy Birmingham England
60mm cup 54mm head
Rbhr 54mm head 60mm cup 12/02/15 Ronan Treacy ROH Birmingham England
;)

Tin Soldier

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Re: Is the COM (ceramic on Metal) device approved in the U.S?
« Reply #2 on: February 20, 2013, 08:58:38 PM »
I think Danny has really good point about allergies to metals/skin allergies vs orthopaedic implants.  I would discuss this with one of the top HR surgeons like McMinn, others.  There are a few studies that I read awhile back that discusses this issue and I don't recall any evidence that suggested that CoCr implant would be problematic if a person had general metals allergies, which could I think could be caused by a host of different factors.  Although, piece of mind is a big thing and I understand the concern.   

I recall Pritchett telling me a year ago or so that he was involved with research on ceramic on metal.  I don't know where that's at.  You could check with his office, maybe.  I haven't checked the FDA website on HR lately, but there might some info on it there also. 

LBHR 2/22/11, RBHR 8/23/11 - Pritchett.

bosoxgordon

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Re: Is the COM (ceramic on Metal) device approved in the U.S?
« Reply #3 on: February 20, 2013, 09:46:02 PM »
In regards to the allergy question. I think it is pretty clear that the prevailing opinion of the top HSR surgeons is that the melatosis reactions were a result of improper implant positioning and therefore excessive wear. It is a particle overload issue and not an allergic reaction.

Two sources I would look to:

First, in the recent video interviews that Patricia did with Dr. Gross he explains this very issue. You can find those videos on this website to hear exactly what he said but he basically thinks it is a particle overload problem and not necessarily an allergy issue.

The second example I would point to is the testimony of one of the heros in the HSR world Vicky Marlow. I remember early in my research watching a video of her story and how she became a surface hippy. She said that she too had a metal allergy to certain jewelry but it did not affect her BHR implants.
Scott

Dr. Gross Left Uncemeted Biomet 11/13/2013

 

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