RE: What could be the root of the shortage?

[Guest guest]

At 11:35 PM 5/25/2002 +0000, you wrote:

>is it that all the surgeons are out at the same

>time?

I suspect they are not all out. The only ones we have heard from are the

couple that have used their entire allotment. My best guess anyway....

[Guest guest]

Hi. I just had resurfacing 5/21. My surgeon, Kennedy in Sarasota, Fl.

said he received a fax on 5/22 telling him to immediately suspend all

resurfacing...cancel surgeries he had scheduled...and that the apparatus would

receive FDA approval in 3 months...he's cleared for Corian June 1 but isn't

doing any surgeries until Sept. anyway because he'll be on vacation in Maine,

lucky guy! He says it might be because there are no negatives now and they

don't want any before FDA approval...I slid right in under the wire.

ann Gronbach wrote: At 11:35 PM 5/25/2002

+0000, you wrote:

>is it that all the surgeons are out at the same

>time?

I suspect they are not all out. The only ones we have heard from are the

couple that have used their entire allotment. My best guess anyway....

[Guest guest]

In a message dated 5/27/02 9:07:12 AM Eastern Daylight Time,

jim@... writes:

> Has anyone else heard about followup being the problem?

>

> Jim

>

>

No.

I have heard nothing from my Os who did my resurfacing with the

Conserve Plus.

Diane

[Guest guest]

> Good point , how is it that all the surgeons are out at the same

> time? They have to have a stock on hand, in case you can't use a 49

> mm, you use a smaller or a larger one. It must be with itself.

My wife Anne was scheduled for resurfacing on June 14 with Dr. Mont.

When his office called to give her the news, they said that the

problem had something to do with the FDA being concerned because a lot

of patients aren't returning for followup visits--perhaps because

they're doing " too " well and don't see the need.

Based on Jeff Cranston's posts and comments from Dr. Mont when we saw

him, he has been pushing hard on followup visits for a while. So

perhaps the FDA has been concerned about followup, and the hiatus is

their way of forcing the issue.

Has anyone else heard about followup being the problem?

Jim

[Guest guest]

If people are coming from far away to see Dr. Mont, that can create a

problem with follow up right there. Isara

> > Good point , how is it that all the surgeons are out at the

same

> > time? They have to have a stock on hand, in case you can't use a

49

> > mm, you use a smaller or a larger one. It must be with

itself.

>

> My wife Anne was scheduled for resurfacing on June 14 with Dr. Mont.

> When his office called to give her the news, they said that the

> problem had something to do with the FDA being concerned because a

lot

> of patients aren't returning for followup visits--perhaps because

> they're doing " too " well and don't see the need.

>

> Based on Jeff Cranston's posts and comments from Dr. Mont when we

saw

> him, he has been pushing hard on followup visits for a while. So

> perhaps the FDA has been concerned about followup, and the hiatus is

> their way of forcing the issue.

>

> Has anyone else heard about followup being the problem?

>

> Jim

[Guest guest]

When I talked to the executive about the FDA, he did not mention that

they expected full FDA approval within 3 months. In fact, I specifically

asked him whether the timeline for full approval that I had heard elsewhere

was correct. He said, yes, as a rule of thumb the FDA wants two years of

follow-up before considering an application. Then they have 180 days to

make a decision. He did say that it was possible for them to petition the

FDA for earlier acceptance, but did not say anything like that was happening

now.

My interpretation of this second hand fax info is that the FDA has 3 months

to approve their request for additional joints under continuing access. But

they have information (maybe because they applied 45 days ago) that they

expect an answer within 45 days (as of May 22).

The FDA allocation covers ALL surgeons, each does not have his own

individual allocation. This is something I had also asked him specifically

about.

He did not mention anything about problems with patients in the trial

following-up. I can imagine that every time they go back to the FDA for

more devices they have to present their current follow-up data, and if any

doctor's followup database was incomplete, maybe he felt bad about it or got

some heat for it.

-

> Re: What could be the root of the

> shortage?

>

>

>

> Hi. I just had resurfacing 5/21. My surgeon, Kennedy

> in Sarasota, Fl. said he received a fax on 5/22 telling him to

> immediately suspend all resurfacing...cancel surgeries he

> had scheduled...and that the apparatus would receive FDA approval

> in 3 months...he's cleared for Corian June 1 but isn't doing any

> surgeries until Sept. anyway because he'll be on vacation in

> Maine, lucky guy! He says it might be because there are no

> negatives now and they don't want any before FDA approval...I

> slid right in under the wire. ann Gronbach

> wrote: At 11:35 PM 5/25/2002 +0000, you wrote:

> >is it that all the surgeons are out at the same

> >time?

>

> I suspect they are not all out. The only ones we have heard from are the

> couple that have used their entire allotment. My best guess anyway....

>

>

[Guest guest]

I was scheduled for June 3rd. with Dr. Mont. When he called to

cancel the operation, he told me about the lack of patient follow-up

as the reason for the 45 day hold. He stated that " only 52% of his

patients were returning for follow-up visits " . He also stated that

" the FDA wants a 90% follow-up rate " . Seems, most of his patients

start feeling too good and don't see the need to travel a 1000 miles

for a follow-up visit.

For me, this is my second set back for hip resurfacing. I was

originally scheduled with Dr. Vail on April 1, 2002. However, I

couldn't get my insurance company to approve the operation. Dr.

Mont's office was able to get the insurance approval.

To make a long story short, I am now scheduled with Dr. De Smet on

June 12 for a hip resurfacing. I feel blessed that he was

available.

I want to thank all of you for your input into this site. Your

comments and links to other web sites have allowed me to make an

educated decision that will effect the rest of my life. I have

laughed and cried as I have read about each of your recoveries. I

have been impressed by the number of people who have offer

assistance and advise to me personally. I want each of you to know

how thankful I am for your help.

Thanks for your help,

Doug

>>> kbrews@... 05/27/02 02:27PM >>>

<html><body>

<tt>

<BR>

When I talked to the executive about the FDA, he did not

mention that<BR>

they expected full FDA approval within 3 months. & nbsp; In fact, I

specifically<BR>

asked him whether the timeline for full approval that I had heard

elsewhere<BR>

was correct. & nbsp; He said, yes, as a rule of thumb the FDA wants

two years of<BR>

follow-up before considering an application. & nbsp; Then they have

180 days to<BR>

make a decision. & nbsp; & nbsp; He did say that it was possible for

them to petition the<BR>

FDA for earlier acceptance, but did not say anything like that was

happening<BR>

now.<BR>

<BR>

My interpretation of this second hand fax info is that the FDA has

3 months<BR>

to approve their request for additional joints under continuing

access. & nbsp; But<BR>

they have information (maybe because they applied 45 days ago) that

they<BR>

expect an answer within 45 days (as of May 22).<BR>

<BR>

The FDA allocation covers ALL surgeons, each does not have his

own<BR>

individual allocation. & nbsp; This is something I had also asked him

specifically<BR>

about.<BR>

<BR>

He did not mention anything about problems with patients in the

trial<BR>

following-up. & nbsp; I can imagine that every time they go back to

the FDA for<BR>

more devices they have to present their current follow-up data, and

if any<BR>

doctor's followup database was incomplete, maybe he felt bad about

it or got<BR>

some heat for it.<BR>

<BR>

-<BR>

<BR>

& gt; Re: What could be the root of the

<BR>

& gt; shortage?<BR>

& gt;<BR>

& gt;<BR>

& gt;<BR>

& gt; & nbsp; Hi. & nbsp; I just had resurfacing 5/21. & nbsp; My surgeon,

Kennedy<BR>

& gt; in Sarasota, Fl. said he received a fax on 5/22 telling him

to<BR>

& gt; immediately suspend all resurfacing...cancel surgeries

he<BR>

& gt; had scheduled...and that the apparatus would receive FDA

approval<BR>

& gt; in 3 months...he's cleared for Corian June 1 but isn't doing

any<BR>

& gt; surgeries until Sept. anyway because he'll be on vacation

in<BR>

& gt; Maine, lucky guy! & nbsp; He says it might be because there are

no<BR>

& gt; negatives now and they don't want any before FDA

approval...I<BR>

& gt; slid right in under the wire. & nbsp; ann Gronbach<BR>

& gt; & lt;cgronbach@... & gt; wrote: At 11:35 PM 5/25/2002

+0000, you wrote:<BR>

& gt; & gt;is it that all the surgeons are out at the same<BR>

& gt; & gt;time?<BR>

& gt;<BR>

& gt; I suspect they are not all out. & nbsp; The only ones we have

heard from are the<BR>

& gt; couple that have used their entire allotment. & nbsp; & nbsp; My

best guess anyway....<BR>

& gt;<BR>

& gt; <BR>

<BR>

<BR>

</tt>

<br>

<tt>

[Guest guest]

Perhaps the docs should to travel to collect follow up info or have local

docs collect it for them. I know he's done a number from Michigan. One

visit by him might allow several patients an easier opportunity to get the

follow up data collection done. Pass that along to Dr. M. (On the other

hand, they knew what they were getting into!).

Re: What could be the root of the

<BR>

& gt; shortage?<BR>

& gt;<BR>

& gt;<BR>

& gt;<BR>

& gt; & nbsp; Hi. & nbsp; I just had resurfacing 5/21. & nbsp; My surgeon,

Kennedy<BR>

& gt; in Sarasota, Fl. said he received a fax on 5/22 telling him

to<BR>

& gt; immediately suspend all resurfacing...cancel surgeries

he<BR>

& gt; had scheduled...and that the apparatus would receive FDA

approval<BR>

& gt; in 3 months...he's cleared for Corian June 1 but isn't doing

any<BR>

& gt; surgeries until Sept. anyway because he'll be on vacation

in<BR>

& gt; Maine, lucky guy! & nbsp; He says it might be because there are

no<BR>

& gt; negatives now and they don't want any before FDA

approval...I<BR>

& gt; slid right in under the wire. & nbsp; ann Gronbach<BR>

& gt; & lt;cgronbach@... & gt; wrote: At 11:35 PM 5/25/2002

+0000, you wrote:<BR>

& gt; & gt;is it that all the surgeons are out at the same<BR>

& gt; & gt;time?<BR>

& gt;<BR>

& gt; I suspect they are not all out. & nbsp; The only ones we have

heard from are the<BR>

& gt; couple that have used their entire allotment. & nbsp; & nbsp; My

best guess anyway....<BR>

& gt;<BR>

& gt; <BR>

<BR>

<BR>

</tt>

<br>

<tt>