Re: just a hello
From: toni welsh (twelsh1@webtv.com)
Sun Nov 14 07:01:35 1999
At Sat, 13 Nov 1999, Helen Dynda wrote:
>
>Toni,
>
>I have heard that sometimes it is possible for a person to qualify for a
>product, such as Intergel, which is still in clinical trials by filing a
>report which is known as a "Compassionate Use" procedure.
>
>Emergency Use of an Unapproved Medical Device
>
>The following conditions should exist for a situation to be considered
>an emergency:
>
>1.) the patient is in a life-threatening condition that needs immediate
>treatment;
>
>2.) no generally accepted alternative for treating the patient is
>available;
>
>3.) because of the immediate need to use the device, there is no time to
>use existing procedures to get FDA approval for the use.
>
>The following information must be obtained prior to consideration of an
>emergency use:
>
>1.) an independent assessment by an uninvolved physician;
>
>2.) informed consent from the patient or legal representative;
>
>3.) institutional clearance as specified by institutional policies;
>
>4.) the IRB chairpersons concurrence.
>
>After this device is used in an emergency you need to:
>
>1.) notify the IRB and otherwise comply with provisions of the IRB
>regulations and the informed consent regulations;
>
>2.) notify Lifecore Biomedical of the emergency use and the outcome;
>
>3.) evaluate the likelihood of a similar need for this device in the
>future.
>
>Also Lifecore's medical director will need to consult with your doctor
>to determine if the risk benefit to you is favorable.
>
>This "Compassionate Use" is only for an emergency situation!!!!!!!!
>
>xxxxxxxxxxxxxxxxxxxxxxxxxx
>
>You need to know that Seprafilm cannot be used to wrap around the
>intestines or bowels!! This product comes in sheets, which look very
>much like waxed paper.
>
>Seprafilm is brittle!!!!!
>
>xxxxxxxxxxxxxxxxxxxxxxxxxxx
>
>At Sat, 13 Nov 1999, toni welsh wrote:
>>
>>Just a hello to all you and to see how your days are going. I am
>>looking forward to seeing the general surgeon this week, I do not now if
>>he will wait for interger, or decide on seprafilm. I have been havig
>>alot different pain and it is so low it is down as close to the private
>>area you can get, and that pain is getting harder and it is not the same
>>pain I was having, then today the burning pain up higher seemed to be
>>along the whole incision, was pretty bad too. The meds I take even
>>oxycotin does not take it all away. I tod my husband today, I am so
>>scared to back into surgery. The incision they do all of my surgeries
>>is fron my nave all the way down to the private area , and I had about
>>50 staples. What do you think I should do? I will hear from my gyn, he
>>thinks I have already made my mind up to have the surgery, with he and a
>>general surgeon, but we have to talk first. He said there was alot of
>>bowel issues, and other things we have to discuss. If I do, I want my
>>gyn to lyse adhesions, and he had said the general surgeon could be
>>there in case a problem came up with the bowel. And he would wrap the
>>whole bowel with seprafilm, he said he does not know but he ma use
>>something else. He will talk to the surgeon on Monday, so I have to
>>explain the whole story to anther dr. Today I have had alot of hard
>>pain very low in the pelvis the ttransverse colon was stuck to pelvic
>>floor at the last laparotomy. And i know it is stuck to the abdomenal
>>wall, Ican feel that! Sorry so long, supposed to he hello. Guess I was
>>down and confused!
>
>--
>The 15th century proverb which summarizes the purpose of medicine is:
>* To cure sometimes, to relieve often, to comfort always. *
>
hanks Helen,I knw I may have to wait for Integel, bt they also have aid
that seprafilm work betterthan Interceed, the dr you snt me his name
awhile ago fronOhio, I did see him ad he uses seprafilm. But he was the
suron tat does alot of surgries on one perso, he had done 25 on one
patient, and he does a painful test through he nose befor EACH one,
scary guy!
One moe surgry is enough!