Re: INTERGEL: HOT OFF THE PRESS
From: Mary Lou (klischma@plu.edu)
Mon Jan 28 22:27:07 2002
hi ALL ADHESION SUFFERERS,
I just found this site tonight and am not really sure how to use it.
Anyway, I have been at my wit's end for three years because of adhesions
in a very large area (around the entire circumfrance of my trunk) from a
surgery to remove excess skinfolds that resulted from a childhood eating
disorder. Like the rest of you, I have constant chronic pain, and also
a terrible sensation of pulling, tearing, burning, needles, class
cutting inside my skin, etc. THis problem has affected every area of my
life and I have even investigated going on disability (not bad enough to
meet the criteria for disability). I only feel somewaht normal when I
am walking vigourously on a treadmill. I have tried so many different
treatments such as antidepressants, (which did nothing but made me
sedated), massage therapy (somewhat helpful), a tempur-pedic mattress
($1000) (no change in adhesion-caused pain,) NSAIDS for pain, Clonazapam
for the muscle spasm that the adhesions led to (caused daytime sedation
and depression), among other things. Right now I am getting massage
therapy but I do not know if it is vigorous enough to do anything. I
also just started taking the old antidepressant medication Amitryptoline
20 mg before going to sleep which as least lets me get some sleep as it
has a sedative effect. For me, this med also causes dry mouth and
severe constipation, so it is important to take a ton of fiber and many
glasses of water per day to prevent constipation. I use Citracyl,a
fiber product found in any grocery or pharmacy, and just keep a water
bottle at my side all day long. Today I heard about a place in
Gainsville, Florida called "Clear Passages" that specializes in the
"Conservative Treatment for pelvic, abdominal, and chronic pain and
dysfunction". The phone number is 352-336-1433. Has anyone heard of
this place? Does anyone know of spcific massage therapists in the
Seattle-Tacoma area that specialize in work on adhesions?
Mary Lou, age 57, nursing instructer
At Thu, 13 Jan 2000, Gina wrote:
>
>Hi,
>Yes please do post the reasons--I am deeply disappointed in this news as
>it was really my only hope for a future without pelvic pain and pain
>with sex due to adhesions :(
>Gina
>
>At Wed, 12 Jan 2000, Sue Ann Murray wrote:
>>
>>I'm wondering if this might mean Lifecore will extend the clincial trials.
>>It definitely made a difference for me. I'll be interested in hearing more
>>about the spedific reasons why it was rejected.
>>
>>Sue Ann
>>
>>>Dear All
>>>I am sending you this message via the message board becuase I don't have
>>>my computer to send you this personally by email.
>>>I have just come out of the FDA panel meeting on INTERGEL. It was
>>>recommended that the product NOT be approved. This means that it will
>>>not be available any time soon. There are many reasons for the panel's
>>>decisionn which are too length to discuss here. A press release is
>>>copied below. Nonetheless I will give a fuller account about this in
>>>the next week or so.
>>>This dissapoiting news heightens the urgency for us to hget on with our
>>>activities of the Intrenational Adheisons Society especially our metings
>>>in the Philadelphia on Jan 26 and in San Fran on Feb 29(?)
>>>More news to follow.
>>>Regards
>>>Dr. David Wiseman
>>>
>>>FDA panel rejects LifeCore's surgical adhesion gel
>>>
>>>ROCKVILLE, Md. Jan 12 (Reuters) - A federal advisory panel Wednesday
>>>rejected
>>>LifeCore Biomedical Inc.'s (NasdaqNM:LCBM - news) Intergel, a product
>>>designed to
>>>reduce internal scarring after gynecological surgery.
>>>
>>>A Food and Drug Administration advisory committee voted 5 to 2 to
>>>recommend that the agency turn down LifeCore's
>>>application to sell the product in the United States. Panelmembers said
>>>they were not convinced that LifeCore's studies showed
>>>Intergel provided a meaningful benefit.
>>>
>>>``From a clinical standpoint, I think we're hard pressed to say this
>>>device makes a difference,'' said panel member Dr. Barbara
>>>Levy of Yale University School of Medicine.
>>>
>>>Intergel is viewed as a key product for LifeCore's future growth,
>>>company officials and analysts have said. Intergel was
>>>designed to reduce the incidence and severity of post-surgical internal
>>>scars, which can be painful and cause problems years
>>>later.
>>>
>>>The FDA usually follows its panels' advice.
>>>
|
