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!!!!!!!!
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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!!!!!
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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. *