Re: FDA Study on Metal Ions

[Guest guest]

>

>Reply-To: surfacehippy

>To: surfacehippy

>Subject: FDA Study on Metal Ions

>Date: Mon, 16 Jun 2003 22:26:08 -0000

>, so how did your procedure and hospital experience go? I am going to

>have both hips resurfaced in August and am curious about many things. When

>did you start rehab? When did you walk with full weight? Can you drive

>yet? What about sleeping on your side, any incisional pain? What about

>the " 90 degree rule " ? Any information you feel like sharing would be

>appreciated. Thanks, Dianne

>My bilateral resurafce was on 5/8/03 using the conserve plus. I was

>asked, and have agreed, to participate in an official FDA study

>regarding the release of cobalt or cromium ions into the blood and/or

>urine stream. Apparantly the FDA wants to get beyond speculation as

>well and a formal study is now underway. I will be doing my first

>post-op blood and urine donations at the end of August, and then

>annually coinciding with my annual check-up of my resurface. The

>tests and study are being doen at the Joint Replacement Institute-

>Orthopedic Hospital of Los Angeles. I'll keep everyone posted.

>

>Joe

>

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[Guest guest]

I have had great news today from Dr De Smet. He got my xrays today nad says I

am okay for a resurf as the bones look okay,so far as he can tell from xrays.

I may be looking at having both done, because he can see the OA in both. Just

waiting to hear back from him as to whether he recommends having both doen.

Does anyone here have experience with having both done at the same time, and

would you recommend it?

See ya in Belgium, June!

Sharry

FDA Study on Metal Ions

>Date: Mon, 16 Jun 2003 22:26:08 -0000

>, so how did your procedure and hospital experience go? I am going to

>have both hips resurfaced in August and am curious about many things. When

>did you start rehab? When did you walk with full weight? Can you drive

>yet? What about sleeping on your side, any incisional pain? What about

>the " 90 degree rule " ? Any information you feel like sharing would be

>appreciated. Thanks, Dianne

>My bilateral resurafce was on 5/8/03 using the conserve plus. I was

>asked, and have agreed, to participate in an official FDA study

>regarding the release of cobalt or cromium ions into the blood and/or

>urine stream. Apparantly the FDA wants to get beyond speculation as

>well and a formal study is now underway. I will be doing my first

>post-op blood and urine donations at the end of August, and then

>annually coinciding with my annual check-up of my resurface. The

>tests and study are being doen at the Joint Replacement Institute-

>Orthopedic Hospital of Los Angeles. I'll keep everyone posted.

>

>Joe

>

_________________________________________________________________

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[Guest guest]

Hi Sharry

I had both hips done at the same time with the conserve plus in Los

Angeles, California. My experience was wonderful. I am very glad

that I did both hips at the same time. I do highly recommend though

that you keep yourself in reasonable shape up to the point of

surgery - I was doing the life cycle and swimming laps, and some

weight training to keep the biceps and triceps strong. From speaking

with others who also had bilaterals done, the better shape you are in

the better the recovery. I can also tell you that when I asked Dr.

Amstutz if I could have both hips done at the same time, he didn't

hesitate to tell me yes.

Joe

> I have had great news today from Dr De Smet. He got my xrays today

nad says I am okay for a resurf as the bones look okay,so far as he

can tell from xrays. I may be looking at having both done, because

he can see the OA in both. Just waiting to hear back from him as to

whether he recommends having both doen. Does anyone here have

experience with having both done at the same time, and would you

recommend it?

> See ya in Belgium, June!

> Sharry

> FDA Study on Metal Ions

> >Date: Mon, 16 Jun 2003 22:26:08 -0000

> >, so how did your procedure and hospital experience go? I

am going to

> >have both hips resurfaced in August and am curious about many

things. When

> >did you start rehab? When did you walk with full weight? Can

you drive

> >yet? What about sleeping on your side, any incisional pain?

What about

> >the " 90 degree rule " ? Any information you feel like sharing

would be

> >appreciated. Thanks, Dianne

> >My bilateral resurafce was on 5/8/03 using the conserve plus. I

was

> >asked, and have agreed, to participate in an official FDA study

> >regarding the release of cobalt or cromium ions into the blood

and/or

> >urine stream. Apparantly the FDA wants to get beyond

speculation as

> >well and a formal study is now underway. I will be doing my

first

> >post-op blood and urine donations at the end of August, and then

> >annually coinciding with my annual check-up of my resurface. The

> >tests and study are being doen at the Joint Replacement

Institute-

> >Orthopedic Hospital of Los Angeles. I'll keep everyone posted.

> >

> >Joe

> >

>

> _________________________________________________________________

> The new MSN 8: smart spam protection and 2 months FREE*

> http://join.msn.com/?page=features/junkmail

>

>

>

[Guest guest]

Sharry,

I had both hips done simultaneously by Dr DeSmet last year July 2. I am so glad

that I did it that way. One surgery and recovery- the only way to go.

I was able to walk without crutches in less than 8 weeks and I can run and play

singles tennis.

I had a great experience with those wonderful people in Belgium and so will you!

Best wishes,

Saeed

Madison, WI

[Guest guest]

Metal on metal THR's have been around (and approved??) for some

time. Same articulating interface. Why does the FDA have to focus

again on this area?

Don W

> My bilateral resurafce was on 5/8/03 using the conserve plus. I

was

> asked, and have agreed, to participate in an official FDA study

> regarding the release of cobalt or cromium ions into the blood

and/or

> urine stream. Apparantly the FDA wants to get beyond speculation

as

> well and a formal study is now underway. I will be doing my first

> post-op blood and urine donations at the end of August, and then

> annually coinciding with my annual check-up of my resurface. The

> tests and study are being doen at the Joint Replacement Institute-

> Orthopedic Hospital of Los Angeles. I'll keep everyone posted.

>

> Joe

[Guest guest]

Dear Saeed

Thanks for answering me! Can you tell me how long you were in hosptital for

both and what the extra cost was, as opposed to getting just one done? (also,

because it makes a difference in recovery time, can you tell me how old you are

- I'm 59, so I think it'll take longer than some, and I've had to lead a

gawdawful sedentary life this past 3 years due to the pain.).

Sharry

Re: FDA Study on Metal Ions

Sharry,

I had both hips done simultaneously by Dr DeSmet last year July 2. I am so

glad that I did it that way. One surgery and recovery- the only way to go.

I was able to walk without crutches in less than 8 weeks and I can run and

play singles tennis.

I had a great experience with those wonderful people in Belgium and so will

you!

Best wishes,

Saeed

Madison, WI

[Guest guest]

The Swedes have done it. The Brits have done it. A group of 8 (I think)

European countries are doing it. So why not the FDA. Some doctors / hospitals

in the US and other countries have already correlated MOM data. It just seems a

waste of resources and time.

Really speaking all countries should get together and just do it once. It would

be in everyone's interest.

It just requires the will of the people. Each country would collect their own

data.

Something for the next G8 summit perhaps!

Rog

Re: FDA Study on Metal Ions

Metal on metal THR's have been around (and approved??) for some

time. Same articulating interface. Why does the FDA have to focus

again on this area?

Don W

> My bilateral resurafce was on 5/8/03 using the conserve plus. I

was

> asked, and have agreed, to participate in an official FDA study

> regarding the release of cobalt or cromium ions into the blood

and/or

> urine stream. Apparantly the FDA wants to get beyond speculation

as

> well and a formal study is now underway. I will be doing my first

> post-op blood and urine donations at the end of August, and then

> annually coinciding with my annual check-up of my resurface. The

> tests and study are being doen at the Joint Replacement Institute-

> Orthopedic Hospital of Los Angeles. I'll keep everyone posted.

>

> Joe

[Guest guest]

In a message dated 6/17/2003 2:32:52 PM Pacific Daylight Time, jjg@...

writes:

> Preo-op I was sure I was going to need a bi-lat. McMinn, said that

> while the left side was obviously heading for a resurfacing someday, he

> said it probably wasn't ready yet. He pointed out that I was basically

> one-footed, and that plus the really weird way I was limping but tremendous

> stress on the left side. He said that lots of people end up getting relief

> from all sorts of joint pain (knees & ankles) as well as referred pains, so

> just wait and see.

>

I think trusting the good doctor's advice is a good idea, but once again,

there are no rules on this one.

Just before my left BHR, my right hip was pain-free. As I got out of bed for

the first time after surgery, the pain started in the left one and never went

away until I had it resurfed 18 months later. It was almost as if it said to

me: " Now it's my turn. "

Isn't nature wonderful?

Des Tuck

[Guest guest]

Biomet uses a MOM articulating THR combo. So does J & J (I believe).

So are these still yet to be approved? Or can't the articulating

data be extrapolated to the resurf configuration for some reason?

(Not sure what it means to " correlate the data " ).

Cheers,

Don W

> > My bilateral resurafce was on 5/8/03 using the conserve plus.

I

> was

> > asked, and have agreed, to participate in an official FDA study

> > regarding the release of cobalt or cromium ions into the blood

> and/or

> > urine stream. Apparantly the FDA wants to get beyond

speculation

> as

> > well and a formal study is now underway. I will be doing my

first

> > post-op blood and urine donations at the end of August, and

then

> > annually coinciding with my annual check-up of my resurface.

The

> > tests and study are being doen at the Joint Replacement

Institute-

> > Orthopedic Hospital of Los Angeles. I'll keep everyone posted.

> >

> > Joe

>

>

>

[Guest guest]

Don

Correlate means

1.. To put or bring into causal, complementary, parallel, or reciprocal

relation.

2.. To establish or demonstrate as having a correlation: correlated drug abuse

and crime.

This means to collect information; for example Number of patients with MOM hips,

associate this with the ion levels in the blood and associate this with the age

of the person associating this with how many years post operation etc,etc etc.

I have read on the internet that 2 separate doctor/surgeon lead surveys in the

USA are historical fact and found no proof of cancer being more evident than the

rest of the population. As usual with the sue happy culture an escape route is

added at the end of the report to state that further research needs to be done.

Sweden have evaluated 115,000 patients with various hip types (plastic,metal,

ceramic) and still more research is needed. How many patients are needed for

this? For how many years? Surely somebody will recognise the futility of

separate bodies going over the same ground time and time again. Probably not!

Re: FDA Study on Metal Ions

Biomet uses a MOM articulating THR combo. So does J & J (I believe).

So are these still yet to be approved? Or can't the articulating

data be extrapolated to the resurf configuration for some reason?

(Not sure what it means to " correlate the data " ).

Cheers,

Don W

> > My bilateral resurafce was on 5/8/03 using the conserve plus.

I

> was

> > asked, and have agreed, to participate in an official FDA study

> > regarding the release of cobalt or cromium ions into the blood

> and/or

> > urine stream. Apparantly the FDA wants to get beyond

speculation

> as

> > well and a formal study is now underway. I will be doing my

first

> > post-op blood and urine donations at the end of August, and

then

> > annually coinciding with my annual check-up of my resurface.

The

> > tests and study are being doen at the Joint Replacement

Institute-

> > Orthopedic Hospital of Los Angeles. I'll keep everyone posted.

> >

> > Joe

>

>

>

[Guest guest]

Understand the definition but.... do you (or anyone) know of _any_

MOM devices (resurfs or THR's)that have been approved by the FDA? Or

maybe I am thinking since the resurfs have a larger surface area they

produce more ions and are therefor subject to more screwtiny. Truth?

Cheers,

Don W

> > > My bilateral resurafce was on 5/8/03 using the conserve

plus.

> I

> > was

> > > asked, and have agreed, to participate in an official FDA

study

> > > regarding the release of cobalt or cromium ions into the

blood

> > and/or

> > > urine stream. Apparantly the FDA wants to get beyond

> speculation

> > as

> > > well and a formal study is now underway. I will be doing

my

> first

> > > post-op blood and urine donations at the end of August, and

> then

> > > annually coinciding with my annual check-up of my

resurface.

> The

> > > tests and study are being doen at the Joint Replacement

> Institute-

> > > Orthopedic Hospital of Los Angeles. I'll keep everyone

posted.

> > >

> > > Joe

> >

> >

> >

[Guest guest]

Not neccessarily so! A 120lb woman in stilleto heels standing on your foot

(small contact area) vs. a 180lb man doing the same (large contact area) - I

know if I could choose to be stood on by the man. Abrasion is related to

force/unit area. Another way of putting it is to put a mark on a piece of steel

you would need to use another piece of steel with a sharp point. If you used a

1/4 " round bar with a rounded nose and the same force you would not mark it all.

So the point removed metal whereas the larger contact area didn't. Same thing

applies to your hips - the larger the contact the less ions given off.

Rog

Re: FDA Study on Metal Ions

Understand the definition but.... do you (or anyone) know of _any_

MOM devices (resurfs or THR's)that have been approved by the FDA? Or

maybe I am thinking since the resurfs have a larger surface area they

produce more ions and are therefor subject to more screwtiny. Truth?

Cheers,

Don W

> > > My bilateral resurafce was on 5/8/03 using the conserve

plus.

> I

> > was

> > > asked, and have agreed, to participate in an official FDA

study

> > > regarding the release of cobalt or cromium ions into the

blood

> > and/or

> > > urine stream. Apparantly the FDA wants to get beyond

> speculation

> > as

> > > well and a formal study is now underway. I will be doing

my

> first

> > > post-op blood and urine donations at the end of August, and

> then

> > > annually coinciding with my annual check-up of my

resurface.

> The

> > > tests and study are being doen at the Joint Replacement

> Institute-

> > > Orthopedic Hospital of Los Angeles. I'll keep everyone

posted.

> > >

> > > Joe

> >

> >

> >

[Guest guest]

Hi Joe

Thanks for sharing your experience. I'm afraid that I am not in great

shape, having led a pretty sedentary life because of the chronic hip pain. My

surgery is in late August, and I am seeing a physiotherapist tomorrow to see

about exercises for upper body (to handle the crutuches better) which won't

hurt, and she has told me already that there are some hip exercises she can give

me which could help to do now, which may help post-surgery recovery. It only

gives me 2 months, but I only learned of hip resurf a month ago, and just

recently got my date eith Dr De Smet. I used to be a regular jock, but really

got discouraged and basicly gave up when I couldn't even swim anymore without a

lot of pain. I am stil debating about a bilateral vs getting just one done, as

Dr De Smet's latest email seems to be saying that my left hip may recover, once

the right one is done. Anyone else have this happen? I've had to ask for

clarification, becase his English is not always completely understandable..

Sharry

From: joey94568

To: surfacehippy

Sent: Monday, June 16, 2003 6:11 PM

Subject: Re: FDA Study on Metal Ions

Hi Sharry

I had both hips done at the same time with the conserve plus in Los

Angeles, California. My experience was wonderful. I am very glad

that I did both hips at the same time. I do highly recommend though

that you keep yourself in reasonable shape up to the point of

surgery - I was doing the life cycle and swimming laps, and some

weight training to keep the biceps and triceps strong. From speaking

with others who also had bilaterals done, the better shape you are in

the better the recovery. I can also tell you that when I asked Dr.

Amstutz if I could have both hips done at the same time, he didn't

hesitate to tell me yes.

Joe

> I have had great news today from Dr De Smet. He got my xrays today

nad says I am okay for a resurf as the bones look okay,so far as he

can tell from xrays. I may be looking at having both done, because

he can see the OA in both. Just waiting to hear back from him as to

whether he recommends having both doen. Does anyone here have

experience with having both done at the same time, and would you

recommend it?

> See ya in Belgium, June!

> Sharry

> FDA Study on Metal Ions

> >Date: Mon, 16 Jun 2003 22:26:08 -0000

> >, so how did your procedure and hospital experience go? I

am going to

> >have both hips resurfaced in August and am curious about many

things. When

> >did you start rehab? When did you walk with full weight? Can

you drive

> >yet? What about sleeping on your side, any incisional pain?

What about

> >the " 90 degree rule " ? Any information you feel like sharing

would be

> >appreciated. Thanks, Dianne

> >My bilateral resurafce was on 5/8/03 using the conserve plus. I

was

> >asked, and have agreed, to participate in an official FDA study

> >regarding the release of cobalt or cromium ions into the blood

and/or

> >urine stream. Apparantly the FDA wants to get beyond

speculation as

> >well and a formal study is now underway. I will be doing my

first

> >post-op blood and urine donations at the end of August, and then

> >annually coinciding with my annual check-up of my resurface. The

> >tests and study are being doen at the Joint Replacement

Institute-

> >Orthopedic Hospital of Los Angeles. I'll keep everyone posted.

> >

> >Joe

> >

>

> _________________________________________________________________

> The new MSN 8: smart spam protection and 2 months FREE*

> http://join.msn.com/?page=features/junkmail

>

>

>

[Guest guest]

Hi Don,

MoM has been approved by whom? I know that the conserve plus is not

approved in the U.S. - at least not by the FDA. It is now considered

in the investigative stages and I have been told that approval of the

conserve plus is looking good. I also know that MoM was attempted

about 20 years ago in the U.S., but that it was discontinued in the

U.S. because of poor wear characteristics; and that about 10 years

ago MoM was reintroduced because of advances in machining technology

and advances in metal alloys. I know that MoM has been used in

European countries for quite some time now - but I guess it's up to

the individual as to their confidence in those providers that may

hold a different position than that of the U.S. FDA and U.S. medical

providers.

As the old saying goes, to each their own - and good luck to all.

Joe

> > My bilateral resurafce was on 5/8/03 using the conserve plus. I

> was

> > asked, and have agreed, to participate in an official FDA study

> > regarding the release of cobalt or cromium ions into the blood

> and/or

> > urine stream. Apparantly the FDA wants to get beyond speculation

> as

> > well and a formal study is now underway. I will be doing my

first

> > post-op blood and urine donations at the end of August, and then

> > annually coinciding with my annual check-up of my resurface. The

> > tests and study are being doen at the Joint Replacement Institute-

> > Orthopedic Hospital of Los Angeles. I'll keep everyone posted.

> >

> > Joe

[Guest guest]

Hi Sharry, I had a left BHR in May of '02 by Dr De Smet. My right

hip was also hurting quite a bit at the time but not nearly as much

as the left one. Within a month after the LBHR, my right hip got

dramatically better and has been pretty good for the last 13

months. On the x-ray,there still is some cartilege left on my right

hip and who knows how long it will last. I think my pelvis was so

tilted preop that the right hip was not seating properly in the

socket. After the surgery on the left, the tilt was corrected and

the right hip was seated better. At least that's my theory. I

would take Dr De Smet's advice based on his opinion of your x-rays.

That's what I did and it has worked out very well so far. I really

think that my right hip will eventually need a BHR and when the

pain/x-rays indicate the need, I will immediately be scheduling with

Dr De Smet. He is such an incredible surgeon/person. I could go on

and on about that. I just emailed him yesterday and got a response

within hours as usual. I also am looking forward to another trip to

Gent. If the right hip doesn't give out in the next couple of

years, I'm going back anyway just to visit. My wife and I had such

a great time there last year even with the few days in the hospital.

take care,

> > I have had great news today from Dr De Smet. He got my xrays

today

> nad says I am okay for a resurf as the bones look okay,so far as

he

> can tell from xrays. I may be looking at having both done,

because

> he can see the OA in both. Just waiting to hear back from him as

to

> whether he recommends having both doen. Does anyone here have

> experience with having both done at the same time, and would you

> recommend it?

> > See ya in Belgium, June!

> > Sharry

> > FDA Study on Metal Ions

> > >Date: Mon, 16 Jun 2003 22:26:08 -0000

> > >, so how did your procedure and hospital experience

go? I

> am going to

> > >have both hips resurfaced in August and am curious about

many

> things. When

> > >did you start rehab? When did you walk with full weight?

Can

> you drive

> > >yet? What about sleeping on your side, any incisional

pain?

> What about

> > >the " 90 degree rule " ? Any information you feel like

sharing

> would be

> > >appreciated. Thanks, Dianne

> > >My bilateral resurafce was on 5/8/03 using the conserve

plus. I

> was

> > >asked, and have agreed, to participate in an official FDA

study

> > >regarding the release of cobalt or cromium ions into the

blood

> and/or

> > >urine stream. Apparantly the FDA wants to get beyond

> speculation as

> > >well and a formal study is now underway. I will be doing

my

> first

> > >post-op blood and urine donations at the end of August, and

then

> > >annually coinciding with my annual check-up of my

resurface. The

> > >tests and study are being doen at the Joint Replacement

> Institute-

> > >Orthopedic Hospital of Los Angeles. I'll keep everyone

posted.

> > >

> > >Joe

> > >

> >

> >

_________________________________________________________________

> > The new MSN 8: smart spam protection and 2 months FREE*

> > http://join.msn.com/?page=features/junkmail

> >

> >

> >

[Guest guest]

Bill,

I'm curious about what you said about your pelvis being tilted. Did yours

reposition right away or was it after some PT? The reason I ask is that

mine is very much tilted (about 1 " difference in iliac crests) and I'm

hoping I can expect it to even out. I'm having both of mine done in August

and can't wait to walk without feeling the awkward strain on my lower back

and sacrum. Tell me more, please!

>

>Reply-To: surfacehippy

>To: surfacehippy

>Subject: Re: FDA Study on Metal Ions

>Date: Tue, 17 Jun 2003 21:06:29 -0000

>

>Hi Sharry, I had a left BHR in May of '02 by Dr De Smet. My right

>hip was also hurting quite a bit at the time but not nearly as much

>as the left one. Within a month after the LBHR, my right hip got

>dramatically better and has been pretty good for the last 13

>months. On the x-ray,there still is some cartilege left on my right

>hip and who knows how long it will last. I think my pelvis was so

>tilted preop that the right hip was not seating properly in the

>socket. After the surgery on the left, the tilt was corrected and

>the right hip was seated better. At least that's my theory. I

>would take Dr De Smet's advice based on his opinion of your x-rays.

>That's what I did and it has worked out very well so far. I really

>think that my right hip will eventually need a BHR and when the

>pain/x-rays indicate the need, I will immediately be scheduling with

>Dr De Smet. He is such an incredible surgeon/person. I could go on

>and on about that. I just emailed him yesterday and got a response

>within hours as usual. I also am looking forward to another trip to

>Gent. If the right hip doesn't give out in the next couple of

>years, I'm going back anyway just to visit. My wife and I had such

>a great time there last year even with the few days in the hospital.

>

>take care,

>

>

>

>

>

> > > I have had great news today from Dr De Smet. He got my xrays

>today

> > nad says I am okay for a resurf as the bones look okay,so far as

>he

> > can tell from xrays. I may be looking at having both done,

>because

> > he can see the OA in both. Just waiting to hear back from him as

>to

> > whether he recommends having both doen. Does anyone here have

> > experience with having both done at the same time, and would you

> > recommend it?

> > > See ya in Belgium, June!

> > > Sharry

> > > FDA Study on Metal Ions

> > > >Date: Mon, 16 Jun 2003 22:26:08 -0000

> > > >, so how did your procedure and hospital experience

>go? I

> > am going to

> > > >have both hips resurfaced in August and am curious about

>many

> > things. When

> > > >did you start rehab? When did you walk with full weight?

>Can

> > you drive

> > > >yet? What about sleeping on your side, any incisional

>pain?

> > What about

> > > >the " 90 degree rule " ? Any information you feel like

>sharing

> > would be

> > > >appreciated. Thanks, Dianne

> > > >My bilateral resurafce was on 5/8/03 using the conserve

>plus. I

> > was

> > > >asked, and have agreed, to participate in an official FDA

>study

> > > >regarding the release of cobalt or cromium ions into the

>blood

> > and/or

> > > >urine stream. Apparantly the FDA wants to get beyond

> > speculation as

> > > >well and a formal study is now underway. I will be doing

>my

> > first

> > > >post-op blood and urine donations at the end of August, and

>then

> > > >annually coinciding with my annual check-up of my

>resurface. The

> > > >tests and study are being doen at the Joint Replacement

> > Institute-

> > > >Orthopedic Hospital of Los Angeles. I'll keep everyone

>posted.

> > > >

> > > >Joe

> > > >

> > >

> > >

>_________________________________________________________________

> > > The new MSN 8: smart spam protection and 2 months FREE*

> > > http://join.msn.com/?page=features/junkmail

> > >

> > >

> > >

[Guest guest]

Mee too. Preo-op I was sure I was going to need a bi-lat. McMinn, said that

while the left side was obviously heading for a resurfacing someday, he

said it probably wasn't ready yet. He pointed out that I was basically

one-footed, and that plus the really weird way I was limping but tremendous

stress on the left side. He said that lots of people end up getting relief

from all sorts of joint pain (knees & ankles) as well as referred pains, so

just wait and see.

He was right, the pain went away and I have only had a touch of it now and

the, usually when I've over done it. YMMV (You Mileage May Vary), but I'd

trust the good doctor's advice on this one.

Cheers,

Jeff, who used to be a wamblin' man

rBHR Aug. 1, 2001

Mr. McMinn

>Hi Sharry, I had a left BHR in May of '02 by Dr De Smet. My right

>hip was also hurting quite a bit at the time but not nearly as much

>as the left one. Within a month after the LBHR, my right hip got

>dramatically better and has been pretty good for the last 13

>months. On the x-ray,there still is some cartilege left on my right

>hip and who knows how long it will last. I think my pelvis was so

>tilted preop that the right hip was not seating properly in the

>socket. After the surgery on the left, the tilt was corrected and

>the right hip was seated better. At least that's my theory. I

>would take Dr De Smet's advice based on his opinion of your x-rays.

>That's what I did and it has worked out very well so far. I really

>think that my right hip will eventually need a BHR and when the

>pain/x-rays indicate the need, I will immediately be scheduling with

>Dr De Smet. He is such an incredible surgeon/person. I could go on

>and on about that. I just emailed him yesterday and got a response

>within hours as usual. I also am looking forward to another trip to

>Gent. If the right hip doesn't give out in the next couple of

>years, I'm going back anyway just to visit. My wife and I had such

>a great time there last year even with the few days in the hospital.

>

>take care,

>

>

>

>

>

>> > I have had great news today from Dr De Smet. He got my xrays

>today

>> nad says I am okay for a resurf as the bones look okay,so far as

>he

>> can tell from xrays. I may be looking at having both done,

>because

>> he can see the OA in both. Just waiting to hear back from him as

>to

>> whether he recommends having both doen. Does anyone here have

>> experience with having both done at the same time, and would you

>> recommend it?

>> > See ya in Belgium, June!

>> > Sharry

>> > FDA Study on Metal Ions

>> > >Date: Mon, 16 Jun 2003 22:26:08 -0000

>> > >, so how did your procedure and hospital experience

>go? I

>> am going to

>> > >have both hips resurfaced in August and am curious about

>many

>> things. When

>> > >did you start rehab? When did you walk with full weight?

>Can

>> you drive

>> > >yet? What about sleeping on your side, any incisional

>pain?

>> What about

>> > >the " 90 degree rule " ? Any information you feel like

>sharing

>> would be

>> > >appreciated. Thanks, Dianne

>> > >My bilateral resurafce was on 5/8/03 using the conserve

>plus. I

>> was

>> > >asked, and have agreed, to participate in an official FDA

>study

>> > >regarding the release of cobalt or cromium ions into the

>blood

>> and/or

>> > >urine stream. Apparantly the FDA wants to get beyond

>> speculation as

>> > >well and a formal study is now underway. I will be doing

>my

>> first

>> > >post-op blood and urine donations at the end of August, and

>then

>> > >annually coinciding with my annual check-up of my

>resurface. The

>> > >tests and study are being doen at the Joint Replacement

>> Institute-

>> > >Orthopedic Hospital of Los Angeles. I'll keep everyone

>posted.

>> > >

>> > >Joe

>> > >

>> >

>> >

>_________________________________________________________________

>> > The new MSN 8: smart spam protection and 2 months FREE*

>> > http://join.msn.com/?page=features/junkmail

>> >

>> >

>> >

[Guest guest]

Hi

It was so nice to hear about your experience and situation, so much like

mine. I'm afraid I'm even more confused now because I just got an email from Dr

De Smet, saying:

" The right side is really bad. On the left side you see the inner aspect of

the acetabulum has no cartilage anymore. This is the protocol of your xrays.

That does not tell anything about what problems you are having with the left

hip. If you feel alright with the hip, nothing should be done at this moment. "

So my dilemma persists because:

My right hip is so bad that it is very difficult to really judge how bad the

pain is in my left hip. As I was saying before, I wasn't having any trouble at

all with it until about one month ago, when I started noticing that it would

'collapse' under me, rather like my right hip did (and still does) back about 3

years ago when the pain started getting really excruciating. And the other

peculair thing, which I wonder is another indication of more problems to come,

is that the muscles all along the front of my left thigh are starting to give me

a lot of pain (not constant, more like they go rigid and catch me unawares also,

like the hip joint 'collapsing' does) - again similar to what the right hip

started with.. Has anyone else had this muscle cramp problem, a clue to worse

things coming on very quickly?

Sharry

FDA Study on Metal Ions

> > >Date: Mon, 16 Jun 2003 22:26:08 -0000

> > >, so how did your procedure and hospital experience

go? I

> am going to

> > >have both hips resurfaced in August and am curious about

many

> things. When

> > >did you start rehab? When did you walk with full weight?

Can

> you drive

> > >yet? What about sleeping on your side, any incisional

pain?

> What about

> > >the " 90 degree rule " ? Any information you feel like

sharing

> would be

> > >appreciated. Thanks, Dianne

> > >My bilateral resurafce was on 5/8/03 using the conserve

plus. I

> was

> > >asked, and have agreed, to participate in an official FDA

study

> > >regarding the release of cobalt or cromium ions into the

blood

> and/or

> > >urine stream. Apparantly the FDA wants to get beyond

> speculation as

> > >well and a formal study is now underway. I will be doing

my

> first

> > >post-op blood and urine donations at the end of August, and

then

> > >annually coinciding with my annual check-up of my

resurface. The

> > >tests and study are being doen at the Joint Replacement

> Institute-

> > >Orthopedic Hospital of Los Angeles. I'll keep everyone

posted.

> > >

> > >Joe

> > >

> >

> >

_________________________________________________________________

> > The new MSN 8: smart spam protection and 2 months FREE*

> > http://join.msn.com/?page=features/junkmail

> >

> >

> >

[Guest guest]

Yup, the 120# women walking up an airplane aisle did at one time

punch holes thru the flooring. The aisles had to be reinforced. But

at one time (if I remember corectly??) I did run into a reference

that claimed larger balls led to larger production of ions (MOM)

That said, I would like to believe that you are correct. So if you

have a reference.... I would appreciate.

But the major question is, Biomet and J & J(?) do supply metal to

metal THR's for use in the USA. They must be FDA approved since the

patient getting these does not sign off a trial waiver form. So why

are these ok and not the resurf's approach. What is so different

that needs blood monitoring and a reapproval??

Don W

> > > > My bilateral resurafce was on 5/8/03 using the conserve

> plus.

> > I

> > > was

> > > > asked, and have agreed, to participate in an official

FDA

> study

> > > > regarding the release of cobalt or cromium ions into

the

> blood

> > > and/or

> > > > urine stream. Apparantly the FDA wants to get beyond

> > speculation

> > > as

> > > > well and a formal study is now underway. I will be

doing

> my

> > first

> > > > post-op blood and urine donations at the end of August,

and

> > then

> > > > annually coinciding with my annual check-up of my

> resurface.

> > The

> > > > tests and study are being doen at the Joint Replacement

> > Institute-

> > > > Orthopedic Hospital of Los Angeles. I'll keep everyone

> posted.

> > > >

> > > > Joe

> > >

> > >

> > >

[Guest guest]

MoM THR has been approved by the FDA. About 3 years ago. There are several

manufacturers with MoM hips: , Centerpulse, Biomet, and DePuy (J & J)

are ones I know of.

Even the jumbo MoM THR has been approved. It uses the same shell as the

Conserve Plus. In fact calls the jumbo head the " Conserve THR " . I

recently noticed started a new website just for this,

http://www.wmt.com/bigfemoralhead/default.asp

There are some metal studies going on. I think people may be jumping to

conclusions to say that these are " FDA studies " , and that they're related to

MoM THR or MoM resurf regulatory status. I don't know who is funding them,

but the one for which they drew my blood at JRI most recently was for a

study that was not just looking at metal concentrations but was looking at

T-cells and other indicators of possible allergic reaction to metals. This

is a very rare occurance, but they also need to define what the natural

levels of these things are and they are trying to understand the process by

which it happens.

The metal concentrations themselves may be part of the routine documentation

to show there is not a significant difference between the C+ and the Jumbo

THR ion levels, for example. It seems logical that the concentrations would

be nearly the same since the devices are very much alike, but sometimes, as

they say, the devil is in the details.

-

> Re: FDA Study on Metal Ions

>

>

> Hi Don,

>

> MoM has been approved by whom? I know that the conserve plus is not

> approved in the U.S. - at least not by the FDA. It is now considered

> in the investigative stages and I have been told that approval of the

> conserve plus is looking good. I also know that MoM was attempted

> about 20 years ago in the U.S., but that it was discontinued in the

> U.S. because of poor wear characteristics; and that about 10 years

> ago MoM was reintroduced because of advances in machining technology

> and advances in metal alloys. I know that MoM has been used in

> European countries for quite some time now - but I guess it's up to

> the individual as to their confidence in those providers that may

> hold a different position than that of the U.S. FDA and U.S. medical

> providers.

>

> As the old saying goes, to each their own - and good luck to all.

>

> Joe

>

>

>

> > > My bilateral resurafce was on 5/8/03 using the conserve plus. I

> > was

> > > asked, and have agreed, to participate in an official FDA study

> > > regarding the release of cobalt or cromium ions into the blood

> > and/or

> > > urine stream. Apparantly the FDA wants to get beyond speculation

> > as

> > > well and a formal study is now underway. I will be doing my

> first

> > > post-op blood and urine donations at the end of August, and then

> > > annually coinciding with my annual check-up of my resurface. The

> > > tests and study are being doen at the Joint Replacement Institute-

> > > Orthopedic Hospital of Los Angeles. I'll keep everyone posted.

> > >

> > > Joe

>

>

>

>

[Guest guest]

,

I appreciate your feedback and the information you have provided.

However, please note that the conserve plus is not FDA approved. The

conserve is approved, but not the conserve plus. The JRI did

indicate to me that the conserve can possibly be used with another

prosthetic which then is in essence similar to the conserve plus -

the benefit of this is that the two prosthetics are considered

indpendent of each other and FDA approved.

As to other MoM prosthetics which you indicate have been FDA approved

as early as three years ago, that I wouldn't know about - since my

bilateral resurfacing was with the conserve plus, which was where my

attention was solely focused.

Regarding the metal ion study, you may be right, it may not have been

an FDA study - I'll have to pull the paperwork I signed and read it

again. Regardless, JRI did indicate that the study was for the

purpose of detecting whether or not cromium and/or cobalt ions are

being released, though the testing may encompass other elements of

importance as well.

Joe

> > > > My bilateral resurafce was on 5/8/03 using the conserve

plus. I

> > > was

> > > > asked, and have agreed, to participate in an official FDA

study

> > > > regarding the release of cobalt or cromium ions into the blood

> > > and/or

> > > > urine stream. Apparantly the FDA wants to get beyond

speculation

> > > as

> > > > well and a formal study is now underway. I will be doing my

> > first

> > > > post-op blood and urine donations at the end of August, and

then

> > > > annually coinciding with my annual check-up of my resurface.

The

> > > > tests and study are being doen at the Joint Replacement

Institute-

> > > > Orthopedic Hospital of Los Angeles. I'll keep everyone

posted.

> > > >

> > > > Joe

> >

> >

> >

> >

[Guest guest]

Hi Joe,

Please read http://www.activejoints.com/mom.html

It will tell you which MOM devices are approved by the FDA in the US. These are

THR devices but similar to resurfacing bits in the joint area so Don was in the

right ball park .

Please read http://www.healthandage.com/Home/99!gid1=3626!gm=15 It's one of many

on the internet,this ones about a Baltimore hospital offering such a device.

Dr Harlan Amstutz who has been working on such devices and is one of a few

outside the UK to be awarded a Fellow of the Royal Academy of Orthopaedic

Surgeons. It shows how much us Brits think of his work. I'd be happy with one

of his devices, wouldn't you ? Have you changed your mind ?

Rog

Re: FDA Study on Metal Ions

Hi Don,

MoM has been approved by whom? I know that the conserve plus is not

approved in the U.S. - at least not by the FDA. It is now considered

in the investigative stages and I have been told that approval of the

conserve plus is looking good. I also know that MoM was attempted

about 20 years ago in the U.S., but that it was discontinued in the

U.S. because of poor wear characteristics; and that about 10 years

ago MoM was reintroduced because of advances in machining technology

and advances in metal alloys. I know that MoM has been used in

European countries for quite some time now - but I guess it's up to

the individual as to their confidence in those providers that may

hold a different position than that of the U.S. FDA and U.S. medical

providers.

As the old saying goes, to each their own - and good luck to all.

Joe

> > My bilateral resurafce was on 5/8/03 using the conserve plus. I

> was

> > asked, and have agreed, to participate in an official FDA study

> > regarding the release of cobalt or cromium ions into the blood

> and/or

> > urine stream. Apparantly the FDA wants to get beyond speculation

> as

> > well and a formal study is now underway. I will be doing my

first

> > post-op blood and urine donations at the end of August, and then

> > annually coinciding with my annual check-up of my resurface. The

> > tests and study are being doen at the Joint Replacement Institute-

> > Orthopedic Hospital of Los Angeles. I'll keep everyone posted.

> >

> > Joe

[Guest guest]

Went to your reference (thanks!) and extracted the following 3

paragraphs:

#1

New technology now facilitates very precise metal on metal bearings

with extremely low wear, and there is evidence that larger ball sizes

with a metal on metal bearing combination produce less wear than

smaller balls. This is the opposite result of what we found with

metal and polyethylene (plastic) combinations ref 7.

#2

And in the FAQ's:

Frequently Asked Questions:

Do Big Heads wear more or less than smaller heads?

Several studies have been done which have shown that head size

diameter does not adversely affect the rate of wear. In fact,

there's theoretically less wear with larger heads.

#3

Re superfinishing:

In addition to smooth rotation, this superfinishing also allows for

optimum fluid lubrication of components which in turn reduces wear.

.....

So thanks... it is _poly_ that with larger heads that produces more

wear.

Regarding metal to metal wear, this requires a lubricating film

between the surfaces for it to work properly. The very low tolerance

is to provide wicking or capillary action. If the head is scratched

during surgery (from Biomet SOP (hmmm)), the head is disgarded.

(Talk about the need for close tolerances). From the video I've

seen of Amstutz's approach, he does not (as far as I could see)

conserve the capsule. If the capsule is conserved synovial fluid

lubricates the surfaces instead of body fluid, making for a less

wearing interface. So there must be some sort of fluid gear shift as

the pseudo capsule grows back.

Anyway, I'm glad that decided to call their product BFH

(Big Femoral Head) instead of BFD (Big Femoral Diameter).

Cheers,

Don W

PS. Again, thanks for the link.

****

> > > > My bilateral resurafce was on 5/8/03 using the conserve

plus. I

> > > was

> > > > asked, and have agreed, to participate in an official FDA

study

> > > > regarding the release of cobalt or cromium ions into the blood

> > > and/or

> > > > urine stream. Apparantly the FDA wants to get beyond

speculation

> > > as

> > > > well and a formal study is now underway. I will be doing my

> > first

> > > > post-op blood and urine donations at the end of August, and

then

> > > > annually coinciding with my annual check-up of my resurface.

The

> > > > tests and study are being doen at the Joint Replacement

Institute-

> > > > Orthopedic Hospital of Los Angeles. I'll keep everyone

posted.

> > > >

> > > > Joe

> >

> >

> >

> >

[Guest guest]

Mike, All things being equal, I think it is more difficult to

lubricate a large surface than a small one. What I think happens is

that the pressure from the ball to the socket is such as to allow a

thin film of " lubricant " to separate the ball from the socket. Then

as the joint moves the ball either rolls or slides in the socket.

The lubricant is needed moreso when the ball is sliding. If there

were a ding in the ball (say a peak/valley) it would defeat the even

flow of lubricant. To compensate for the difficulty in lubricating a

larger surface, precision machining is needed to insure the eveness

of flow. So reducing pounds per square to reduce wear is not the

primary consideration. (I think somewhere I ran across a paper on

start up effects in metal on metal devices).

Don W

> As far I know, Medical Technologies has the only large

diameter MOM

> THR that is already approved by the FDA.

>

> http://www.wmt.com/bigfemoralhead/default.asp

>

> There are several other MOM THRs

> but the larger diameter MOM is comparable to resurfacing in

function,

> durability and resistance to dislocation. Larger diameter devices

appear to

> exhibit more synovial fluid lubrication and less over all wear too.

>

> Compared to older MOM devices that exhibited excessive wear and

metal debris

> production, the newer precision machining capabilities of

manufacturers have

> produced much smaller tolerances between moving parts that allows

more

> lubrication through this microscopic film of synovial fluid. Also

the

> dispersal of contact over the larger area results in minimal wear.

>

> This is truly impressive technology and larger diameter does NOT

mean more

> IONS, it means less. That holds true for resurfacing too. Of course

if IONS

> are a concern, there are ceramic/ceramic THR hips available too.

> also has a newly approved Ceramic hip.

>

> http://www.wmt.com/ceramic/default.asp

>

> That option may make a lot of sense for patients with multiple

allergies,

> sensitivities

> to metal (jewelry, dental fillings, Etc.), asthma, people who

obsess about

> cancer and other risk intolerant individuals.

>

> Resurfacers seem to be relatively risk tolerant anyway since, at

least in

> the US,

> the device has not been given FDA approval for general use yet and

it has

> the shortest track record of all the devices in use throughout the

world

> except perhaps for Ceramic.

>

> One statement I saw on this discussion group said that

resurfacing " should "

> last longer than THRs of various technologies. I would like to

think this is

> going to be true, especially with my own, but I think this is a

pretty brash

> and possibly irresponsible statement to be making, especially when

so many

> people are basing important life effecting decisions on what they

may read

> here.

>

> THRs do have a longer track record and though I agree, resurfacing

seems to

> be the way to go for anyone who expects to live long and actively,

there are

> plenty of surgeons urging caution and restraint regarding the

procedure.

> Once again, I hope everyone is talking to two or three good

surgeons and

> getting a variety of opinions and lots of information on the

various options

> available.

>

> Mike

[Guest guest]

Now, I'm going to have to confess my past as a mechanic. If you've ever

looked at the most stressed part of any internal combustion engine, the

crankshaft. This is the part that takes the direct impact form the

" explosion " of hot gases in the combustion chamber. You will find that the

bearing surface between the piston rod and the bearing surface on the

crankshaft is large and flat. It is lubricated by a thin film of machine oil

and does an admirable job of resisting wear, sometimes for hundreds of

thousands of miles.

I see strong parallels between the repeated shocks of walking and running on

the hip joint and the pulses of power in an engine and the larger surface

area seems absolutely appropriate to me. Another rather fun example of thin

film lubrication happens when you put a glass of ice water on a smooth table

and it glides across the surface for a bit on a film of water.

You're right of course, the key is the evenness of the surface and the

quality of the lubricant.... So buy a good quality hip, change your oil, and

take your chondroitin sulphate / gluscosamine!

Mike