Re: Adhesions...Adhesion barriers...and...Pain Management

From: Marla (onery1@soltec.net)
Sat Jul 8 18:41:58 2000


Then I don't understand how ADCON can make this claim:

ADCON®-L Gel is the first FDA approved product for the inhibition of postsurgical scarring and adhesions following laminectomy spine surgery. The proprietary, carbohydrate polymer gel provides a barrier between the spinal cord and nerve roots and the surrounding muscle and bone. http://www.gliatech.com/pages/products/adcon-l.html

And Hylagel- Nuro has been approved for clinical trial in US and Europe. http://pharmalicensing.com/news/headlines/945128009_385582499efda

I find it promising that there is at least some movement in the US towards a positive attitude to gels. Granted these are not gels designed for use in the abdominal area but a step at a time is better than none.

--
Marla

-----Original Message----- From: Helen Dynda <olddad66@runestone.net> To: Multiple recipients of list ADHESIONS <adhesions@forum.obgyn.net> Date: Friday, July 07, 2000 6:25 PM Subject: Adhesions...Adhesion barriers...and...Pain Management

There are two adhesion barriers ( Interceed and Seprafilm ) which a surgeon can use at the conclusion of a surgical procedure. However, the best surgeons in the United States have made a conscious decision NOT to use them; because each of these adhesion barriers presents problems for the surgeon - and neither barrier is 100% effective!!

Both Interceed and Seprafilm have been approved by the FDA for use ONLY in open abdominal surgery ( laparotomy ). Seprafilm is very difficult for surgeons to use because it tends to be brittle and, when moistened, Seprafilm can cause a sticky problem as the surgeon tries to apply it. Interceed is NOT effective if there is any blood left in the abdominal/pelvic cavity! Although some surgeons have found a way to introduce Interceed laparoscopically, Interceed has NOT been approved by the FDA for use in laparoscopic surgery.

Currently there are several gel adhesion barriers, which are involved in clinical research trials throughout the United States. None of these gel adhesion barriers have been approved by the FDA for use in surgical procedures in the United States!!!

Lifecore Biomedical's application for Premarket Approval ( PMA ) for Intergel Adhesion Prevention Solution was NOT approved by the FDA in January 2000. Here are the Press Release web sites for Lifecore:

1.) Lifecore - Latest Press Releases...

http://216.160.5.34/latest%5Fpress%5Freleases.htm

2.) Lifecore - Press Release Archives...

http://216.160.5.34/press%5Frelease%5Farchive.htm

Intergel has been approved for surgical use in the following countries: Canada, Europe, South Africa, Middle East, and Japan. Just knowing that other countries are currently using Intergel, does give us some hope - HOPE that one day Intergel will be approved by the FDA for use in the United States too.

There are no guarantees with any kind of surgery - even with the use of one of the currently available adhesion barriers: Interceed and Seprafilm. Only you will know if you will be able to "tough it out" until the FDA gives its approval to one of the new gel adhesion barriers; however, when and if the FDA approves Intergel, there will be no way of knowing the long-term success rate of this product - so again there are no guarantees!!

There are very few surgeons who will attempt an adhesiolysis unless a person presents with an impending bowel obstruction - which, of course, is an emergency situation. I was told this by a colon-rectal surgeon at my January 1998 appointment at the Mayo Clinic at Rochester, MN. For people who are adhesion-formers ( as we are ), each surgery tends to increase the rate of adhesion-formation; and, as a result, the patient experiences more pain - rather than less pain. This has been a very common experience for many of us who read or post messages at the International Adhesions Society Message Board and the Adhesions Quilt.

Adhesions, which are lysed ( cut ) at the time of surgery have a tendency to reform; and there is always a chance that de nova (new) adhesions may form away from the surgical site. Each successive surgical procedure also increases the risks for the patient; and also creates a very difficult, dangerous, and lengthy surgical procedure for the surgeon. I have actually viewed videos of some of these surgeries. One surgery took 5 hours for the surgeon to complete. The other surgery took 10 hours!!! How many surgeons have that kind of patience? How costly that surgery must be - in terms of the surgeon's time and the use of the hospital operating room!!! Perhaps now many of you will understand why there are so very few surgeons, who even want to consider doing surgery for adhesions.

Until a gel adhesion barrier has been approved by the FDA, a doctor usually suggests pain management to the patient as the best and only alternative. Has a pain management at a pain clinic ever been suggested to you? Here is a web site which will provide you with information about pain clinics:

1.) A World of Information About Pain - click: Consumer Information

http://www.pain.com/

2.) Do you need to find a pain specialist or pain clinic in your area?

http://www.pain.com/painclinics/default.cfm

At the above web site the the Dannemiller Foundation has compiled for your use a list of hundreds of pain specialists and pain clinics from all over the globe. To access this free service, simply click on the state or province where you want to find a pain specialist or pain clinic. Each specialist and/or clinic is listed in postal code order with the complete mailing address.


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