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Vascular Surgery

Sclerotherapy chemical not FDA approved

01/18/2006

Question:

I recently had a vein in my leg (on my ankle) bleed out. I was refered to a vascular specialist. Currently, I have had two appointments with the vascular doctor who has performed a vein test via ultrasound. Tests results confirm that I have one very large, un-named varicose vein in my leg that runs from my groin to below my knee. The vein supplies extra pressure to smaller veins below, causing the bleed in another vein. This large vein needs dissolved. The doctor suggests to perform sclerotheraphy via ultrasound guided method using a drug, Poliodocanol, which is not FDA approved. I would need to sign a waiver for the doctor to use this drug to perform the needed procedure. I am very aprehensive to have a non FDA approved drug used. This vein is not my greater saf and according to this vascular doctor, could not be treated by laser method. I am told this is not a common problem. The vascular doctor I am seeing has performed only 2-3 such procedures. Can you offer any advice as to another option or drug suggestion? Thank you in advance for a second opinion.

Answer:

The sclerosant you refer to has been used "off-label" previously, meaning the FDA did not intend for the product to be used in this fashion. There are other sclerosants available and FDA-approved,  such as hypertonic saline that have been safely used as well. More information can be obtained at the American College of Phlebology web-site if you are interested. Ultimately, if this branch can not be successfully treated with sclerotherapy, stab phlebectomy and removal is always a reasonable option under a local anesthetic. Best of luck!

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Response by:

Amy B Reed, MD Amy B Reed, MD
No longer associated