Adhesion prevention barriers - approved by the FDA

From: Helen Dynda (olddad66@runestone.net)
Thu Dec 20 11:07:14 2001


The following adhesion prevention barriers have been approved by the US Food and Drug Administration (FDA):

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1.) Seprafilm Bioresorbable Membrane

http://www.genzymebiosurgery.com/

Seprafilm is indicated for use in patients undergoing abdominal or pelvic laparotomy (open abdominal surgery) as an adjunct intended to reduce the incidence , extent and severity of postoperative adhesions between the abdominal wall and the underlying viscera such as omentum, small bowel, bladder, and stomach, and between the uterus and surrounding structures such as tubes and ovaries, large bowel and bladder.

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2.) INTERCEED (TC 7) Absorbable Adhesion Barrier

http://www.adhesions.com/pathogenesis.html

Interceed is the first product indicated as an adjuvant in gynecological pelvic laparotomy surgery for reducing the incidence of postoperative pelvic adhesions after hemostasis is achieved consistent with microsurgical principles. Its use is contraindicated in the presence of frank or ongoing infection. It should be noted that INTERCEED Barrier is not effective in the presence of blood; and thus cannot be used for hemostasis (to terminate bleeding).

Today I discovered that there is an excellent NEW website about Interceed Absorbable Adhesion Barrier. Here is its website address:

http://www.ethiconinc.com/womens_health/product/index.html

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3.) ADCON-L Gel

http://www.gliatech.com/pages/products/adcon-l.html

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.

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4.) Gynecare Intergel adhesion prevention solution

http://www.lifecore.com/

Intergel is the very first gel adhesion prevention product to be market-approved by the FDA for use in laparoscopic surgery. Intergel is indicated for the reduction of the occurrence and severity of adhesions following abdominal/pelvic surgery.

Adhesions start forming within hours following a surgery; and it is known that this process will continue for up to 5-7 days. The instillation of Intergel will help to prevent the formation of adhesions during this time period. The formation of adhesions is a completely natural process. This is how the human body heals itself. Up until now, FDA-approved adhesion barriers have been approved for laparotomy procedures only - and have proven to be less than satisfactory in the prevention of postsurgical adhesions.

Intergel - because it is in a liquid state - can be used laparoscopically. It is the very first adhesion prevention product that will be able to offer protection throughout the abdominal/pelvic cavity. Lifecore Biomedical, Inc. received final clearance for market-approval by the FDA on November 19, 2001. Lifecore expects this adhesion prevention product to be available for surgical use in the first quarter of 2002.

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