Re: FDA Study on Metal Ions

June 18, 2003

Hi ,

I think I was very specific when I said the conserve plus is not FDA

approved yet. That is the only device I was addressing. If you are

saying that it is an approved device, please point me to where that

is indicated - I looked at the web sites you indicated, neither of

which indicate that the conserve plus is FDA approved. Maybe you

should speak with the JRI and correct them on their representations

that the conserve plus is not yet FDA approved - since that is the

source of my information.

As far as Dr. Amstutz is concerned, he has my utmost respect -

particularly after having him personally perform my bilateral hip

resurfacing. Why you would suggest that I am having second thoughts,

or even that I would question at all any devices Dr. Amstutz felt

appropriate to us, is beyond me. I am pleased that you and other

Brits think highly of Dr. Amstutz - you should.

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

>

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