Frequently Asked Embolization Devices Questions

WASHINGTON, D.C., MARYLAND & VIRGINIA

• What is embolization?
• What is an embolization device?
• What are some examples of embolization devices?
• What is the purpose of blocking a blood vessel?
• What are the dangers of glue (cyanoacrylate) as an embolization device?
• What is the potential damage caused by glue spilling onto the brain?
• Is the use of glue as an embolization device legal and approved by the FDA? If so, when did it become legal?
• How is the use of glue (cyanoacrylate) as an embolization device monitored by the government?
• What should you do if you suspect the improper use of glue?

What is embolization?

Embolization is a process intended to "embolize" or seal and close off blood vessels leading to and feeding an abnormal group of blood vessels. These abnormal blood vessels can occur in many areas of the body. including the brain and the digestive track.

What is an embolization device?

An embolization device is the device doctors use to "clog up" the blood vessel that feeds blood directly to the abnormal group of blood vessels.

What are some examples of embolization devices?

Doctors have used coils, lasers, glues, polyvinyl alcohol, and gelatin sponges, among others, to stop the blood flow to abnormal groups of blood vessels. Since the mid 1970s, they have also used cyanoacrylate, which is the generic name of several substances, some of which are sold under the trade names of Superglue® and Krazy Glue.

What is the purpose of blocking a blood vessel?

An embolization device is used to block a normal blood vessel where it is carrying blood to abnormal blood vessels to stop the abnormal vessels from receiving any blood supply. This would make them shrink and reduce the risk of them leaking or bursting.

What are the dangers of glue (cyanoacrylate) as an embolization device?

Immediately before injecting Cyanoacrylate, the chemical sold as Superglue®, the physician will frequently mix it with an oil, like poppyseed oil. The proportions of glue and oil are approximated by the physician, based on your blood flow and other studies that should be performed before this injection.

However, if the catheter used to inject the glue is inserted too deeply, or if the glue and oil mixture polymerizes more quickly than the doctor expected, the catheter could get stuck. (Polymerization is a chemical reaction where smaller molecules combine to form larger ones.)

The glue will harden, so:

• If the catheter is too deeply in, it will likely cause damage when it’s removed, if it can be removed at all. Then the glue could get stuck in the area being injected.
• If the catheter is not in deeply enough, or if the glue and oil mixture polymerizes more slowly than the doctor expected, the mixture could spill onto the brain. It could back up through the catheter or spill in some other way into the area being injected.

Significantly, the precise mixture of glue and oil chosen by the physician had never been previously tested, nor can it be precisely duplicated.

What is the potential damage caused by glue spilling onto the brain?

That damage is permanent and can result in a vegetative state.

Is the use of glue as an embolization device legal and approved by the FDA? If so, when did it become legal?

Prior to September 2000 the government of the United States was so vehemently against the use of glue as an embolization device that it issued what is known as a Trade Alert, advising border guards to seize cyanoacrylate at the border. Indeed, the package insert enclosed by the glue manufacturer contained a specific warning that glue should not be used in, or on, or near the brain, because of the potentially catastrophic consequences.

Nevertheless, doctors developed ways of getting the glue into the United States for internal use as an embolization device in the brain.

In September 2000 the FDA provided "pre-market approval" to the use of glue and oil as an embolization device. This is not final approval, so the government is supposed to carefully monitor adverse consequences.

How is the use of glue (cyanoacrylate) as an embolization device monitored by the government?

When a product has pre-market approval, the FDA rules and regulations require its users to provide reports periodically, regarding the success and/or consequences of the product’s use.

After the horrific experiments done on humans during World War II by the Germans, it was clear that hospitals should have what are known as “Institutional Review Boards” (IRBs). The use of glue as an embolization device was an experiment on a human being, if it was done before the pre-market approval. And even though this product has obtained pre-market approval, it still arguably remains an experiment. Accordingly, one would hope that the Institutional Review Board at the hospital where the procedure took place would have reports regarding its use there.

What should you do if you suspect the improper use of glue?

If you suspect improper use of glue, ask the interventional neuroradiologist (or other physician who attempted to embolize the abnormal area) if glue was in fact used. If the answer is "Yes", the family should request that a full report be submitted to the IRB and/or the FDA.

If the physician states that no such report has been developed or will be developed, then the family should request copies of the films of the injection of the glue, to determine whether the procedure proceeded as planned or whether any adverse events occurred.

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