Re: Will surfacehippy be sponsored by a manufacturer??

[Guest guest]

> G'day All,

> I wanted to pose this question due to recent postings by a

> manufacturer who presented the case for their product, in response

to

> some questions raised by members of this group. Now I can't

question

> the valididity of the arguement presented, as scientific fact and

> testing is not my forte'. Hence I will not argue whose product is

> better for whatever reason.!

Skip,

I would like to point out that the posting you refer to did not

disparge the BHR device itself. It simply pointed out the facts

about the Corin device that ARE being disparged on the BHR site. I

see nothing wrong with any of the post. In fact it refered people to

various web sites where they can do their own research. What is

wrong with facts???? I find it helpful to have someone with actual

knowledge of the manufacturing process who is willing to answer

questions. The post made no bones about where it comes from so that

anyone reading it can take that into account. I would have found it

unethical if the post had been presented as coming from an ordinary

person presenting what they found in research. It's hard enough to

get facts with all the different OPINIONS presented as fact and some

people aren't inclined to search beyond this site. For the umteenth

time I will say...People should be able to read all they want about

all the devices and then make up their own minds about what they

think is best or which device they can actually get. In the end I

say each person should get a resurfacing if they qualify wherever

they can and with whichever device they can get. There isn't that

much difference...As said, the most important variables going

into this surgery are the person's bones and the surgeon doing the

operation.

Trudy

and now I am really going to stop gettiing myself into trouble by

shutting my mouth on the subject!! BYE

[Guest guest]

G'day Trudy,

As you may have noticed I questioned the need for manufacturer

inputed fact when a simple reference to manufacturer web site would

have surficed and from there we the consumer could make a judgement.

Also Trudy I have not named any one of the manufacturers, i just hope

they can devote their energies to the benefit of all rather than

slinging off at each other.

OOOOrrrooo Skip

> > G'day All,

> > I wanted to pose this question due to recent postings by a

> > manufacturer who presented the case for their product, in

response

> to

> > some questions raised by members of this group. Now I can't

> question

> > the valididity of the arguement presented, as scientific fact and

> > testing is not my forte'. Hence I will not argue whose product is

> > better for whatever reason.!

>

> Skip,

> I would like to point out that the posting you refer to did not

> disparge the BHR device itself. It simply pointed out the facts

> about the Corin device that ARE being disparged on the BHR site.

I

> see nothing wrong with any of the post. In fact it refered people

to

> various web sites where they can do their own research. What is

> wrong with facts???? I find it helpful to have someone with actual

> knowledge of the manufacturing process who is willing to answer

> questions. The post made no bones about where it comes from so

that

> anyone reading it can take that into account. I would have found

it

> unethical if the post had been presented as coming from an ordinary

> person presenting what they found in research. It's hard enough to

> get facts with all the different OPINIONS presented as fact and

some

> people aren't inclined to search beyond this site. For the umteenth

> time I will say...People should be able to read all they want about

> all the devices and then make up their own minds about what they

> think is best or which device they can actually get. In the end I

> say each person should get a resurfacing if they qualify wherever

> they can and with whichever device they can get. There isn't that

> much difference...As said, the most important variables going

> into this surgery are the person's bones and the surgeon doing the

> operation.

> Trudy

> and now I am really going to stop gettiing myself into trouble by

> shutting my mouth on the subject!! BYE

[Guest guest]

> The point I would like to address is, I think the manufacturers would

> be better advised putting their time and effort into having their

> product approved by FDA and to convince insurance companies of the

> worthiness of their product and the benefit and cost savings this

> will present to the community in related health care costs. If the

> manufacturer has been keeping a watch on this site they would have

> noticed the continued effort by members of this group to receive the

> hip technology at great personal cost both finacially and

> emotionally.

From my point of view I think they are doing all they can with respect to

the FDA issue. Its just that the FDA is being rather hard-nosed of late,

this is noted in the American business press with respect to drug approvals.

The incidents recently with the French ceramic hip manufacturer and the

Sulzer hip shell problems do not make things any easier for them or the

manufacturers. To the credit of Corin they are investing the money for the

clinical trial to gain US FDA approval, while Midland Medical Technology

appears complacent about the US market.

Corin has been very cooperative with my requests for information. I have

tried to present all manufacturers an opportunity to explain the advantages

of their product in the implant questionnaires on the surfachippy " Files "

section. To date, only Corin has responded directly to my requests for

that. representatives do monitor what goes on here and elsewhere on

the internet, and they were very responsive when there was confusion

regarding their C+ device and the FDA at the end of May. The situation was

resolved exactly as promised.

Finally, I will point out that there has been independent research that

confirms what Mr. Dunbar was saying. The wear rate is more dependent on the

manufacturing tolerances than the heat treatment. I've been busy of late,

when I get a chance I'll look up the article -- I ran across it while

researching for the " Metal Defense Protocol " paper.

-

[Guest guest]

> G'day Trudy,

> As you may have noticed I questioned the need for manufacturer

> inputed fact when a simple reference to manufacturer web site would

> have surficed and from there we the consumer could make a judgement.

The messages that and Iain responded to made specific arguments

about the BHR versus the Corin device. The best way to respond to

those arguments is to answer them directly.

> Also Trudy I have not named any one of the manufacturers, i just hope

> they can devote their energies to the benefit of all rather than

> slinging off at each other.

I don't see the problem with manufacturer's representatives posting

here as long as they clearly identify their affiliation, and they're

providing real information, not marketing BS. By that standard, both

's and Iain's posts were appropriate.

We're all grownups here. We can weigh the information and make our own

decisions.

Jim

(not affiliated with any medical device manufacturer!)

[Guest guest]

> G'day Trudy,

> As you may have noticed I questioned the need for manufacturer

> inputed fact when a simple reference to manufacturer web site would

> have surficed and from there we the consumer could make a judgement.

Skip,

In this particular case there was a specific question that urgently

needed answering. I don't believe it is answered on their web site.

Not all the manufacturers websites have a long sales pitch on their

device as does the BHR. So no, it wouldn't have sufficed.

Trudy

[Guest guest]

Trudy,

In that particular case would it not be advisable for the maufacturer

to update its web site then?

Skip

> > G'day Trudy,

> > As you may have noticed I questioned the need for manufacturer

> > inputed fact when a simple reference to manufacturer web site

would

> > have surficed and from there we the consumer could make a

judgement.

>

> Skip,

> In this particular case there was a specific question that urgently

> needed answering. I don't believe it is answered on their web

site.

> Not all the manufacturers websites have a long sales pitch on their

> device as does the BHR. So no, it wouldn't have sufficed.

> Trudy

[Guest guest]

>

> Finally, I will point out that there has been independent research that

> confirms what Mr. Dunbar was saying. The wear rate is more dependent on

the

> manufacturing tolerances than the heat treatment. I've been busy of late,

> when I get a chance I'll look up the article -- I ran across it while

> researching for the " Metal Defense Protocol " paper.

The article is " Wear and Lubrication of Metal-on-Metal Hip Implants " ,

F W Chan et al., Clinical Orthopedics and Related Research, Dec 1999, 10-24.

Quoting from page 21, " Certainly, with similar ranges in clearance and

surface roughness values, no statistical difference between the high C

wrought and high C cast implants was identified. " My understanding is that

all three manufacturers are using ASTM-F75 high carbon Cobalt Chrome for

their devices. Elsewhere in this article they show a strong correlation

between surface roughness and wear, and between diametrical clearance and

wear.

There are a number of interesting points made which are pretty convincing

that even considering the worst of the devices tested, this generation of

metal-on-metal bearings is much better than the past generation. The

self-healing properties of metal are confirmed in that the wear rate

decreases significantly after the first 0.5-1.0 million cycles of initial

wear-in/polishing for all pairs tested.

-

The PubMed abstract for this article is copied below:

Clin Orthop 1999 Dec;(369):10-24

The Otto Aufranc Award. Wear and lubrication of metal-on-metal hip implants.

Chan FW, Bobyn JD, Medley JB, Krygier JJ, Tanzer M.

Department of Biomedical Engineering, McGill University, Montreal, Quebec,

Canada.

The implication of polyethylene wear particles as the dominant cause of

periprosthetic osteolysis has created a resurgence of interest in

metal-on-metal implants for total hip arthroplasty because of their

potential for improved wear performance. Twenty-two cobalt chromium

molybdenum metal-on-metal implants were custom-manufactured and tested in a

hip simulator. Accelerated wear occurred within the first million cycles

followed by a marked decrease in wear rate to low steady-state values. The

volumetric wear at 3 million cycles was very small, ranging from 0.15 to

2.56 mm3 for all implants tested. Larger head-cup clearance and increased

surface roughness were associated with increased wear. Independent effects

on wear of material processing (wrought, cast) and carbon content were not

identified. Implant wear decreased with increasing lambda ratio, a parameter

used to relate lubricant film thickness to surface roughness, suggesting

some degree of fluid film lubrication during testing. This study provided

important insight into the design and engineering parameters that affect the

wear behavior of metal-on-metal hip implants and indicated that high quality

manufacturing can reproducibly lead to very low wear.

PMID: 10611857 [PubMed - indexed for MEDLINE]

[Guest guest]

HI Skippy

As I understand it the FDA have been dragging their feet because of the lack

of patient feedback - NOT because of manufacturers information. Outside of the

USA patient feedback info is available (NHS's NICE in the UK) and MOM

resurfacing is approved and available in both the public and private sectors.

Personally (I have had my operations and continue to go to my annual assessments

and to fill in the postal questionnaires) I think the more views the merrier and

look forward to all who wish to make comment no matter who.

Rog

Will surfacehippy be sponsored by a manufacturer??

G'day All,

I wanted to pose this question due to recent postings by a

manufacturer who presented the case for their product, in response to

some questions raised by members of this group. Now I can't question

the valididity of the arguement presented, as scientific fact and

testing is not my forte'. Hence I will not argue whose product is

better for whatever reason.

The point I would like to address is, I think the manufacturers would

be better advised putting their time and effort into having their

product approved by FDA and to convince insurance companies of the

worthiness of their product and the benefit and cost savings this

will present to the community in related health care costs. If the

manufacturer has been keeping a watch on this site they would have

noticed the continued effort by members of this group to receive the

hip technology at great personal cost both finacially and

emotionally.

Furthermore most members of this group have always referred questions

by new members and others of technology to manufacturers web sites

and helpdesks. Occassionally someone will chip in with their 2cents

worth but always qualify that by the IMHO type statement.

In closing I would just like to point out that I am not a paid

employee of any hip resurfacing Manufacturer and I best get BTW.

Just thought I would throw in my 2cents worth!

OOOrrooo Skip