Medical conditions like tumors, fibroids, ulcers, internal lesions and abnormal blood flow patterns are being approached with a relatively new technique known as embolization. Previously, these abnormal tissue growths were treated surgically. Now, the medical community is trying the less invasive procedure of embolization, which blocks blood flow to the abnormal tissues, thus stopping their growth. You will hear of such treatments as uterine fibroid embolization, uterine artery embolization, fibroid embolization, uterine embolization, arterial embolization, and chemo embolization.
It sounds good, medical science finding alternatives to surgery in treating age-old ailments. But just how does this technology work? Is it FDA approved? And what are the risks? Several methods have been used to stop the blood flow to abnormal growths in the body, from chemicals to mechanical devices to heat from lasers. An experimental technique for nearly 40 years in embolization uses a substance called cyanoacrylate. You may not recognize the chemical name of this compound, but it is also known as Superglue®, and works by polymerization, cementing molecules together. Being insoluble in water and long lasting, it seems a perfect choice for blocking blood flow in the body.
If you have ever used Superglue®, you know that it dries quickly, and can bond your skin to glued surfaces. These same qualities that make it durable can also make it lethal when used in embolization. Physicians must work fast with these characteristics, and a lot can go wrong. It is not a precise science, and medical malpractice claims are not uncommon.
How it works
Studies of each individual patient dictate how the glue is combined with a carrier, usually poppy seed oil, and what method is used to apply it to the target area for embolization. The amount of oil used determines how fluid the substance will be, and the time it will take to harden. The mixture must be correct, as a second embolization is rarely possible.
The glue mixture is directed to the target embolization zone by using a catheter. Insertion of this device must be very accurate for a successful outcome. If the oil to glue mixture is not optimal, it may set up too soon. This could cement the catheter into the patient’s body, and require surgical removal, if it can indeed be removed. Another possibility of improper oil to glue ratios is that the mixture may not set up at all and spill over onto non-target organs, causing irreversible damage. When this technique is used near the brain, risk of brain damage is very high.
The FDA did not approve the procedure of embolization using cyanoacrylate until the year 2000. At this time, FDA assigned it “pre-market approval,” meaning that its use was to be carefully monitored. All outcomes, good and bad, were to be studied and evaluated for final approval. In other words, the medical community was given permission to experiment on humans during the testing phase of the technique. To insure that pre-market procedures are reviewed, every hospital has an IRB, Institutional Review Board, which is responsible for evaluating the results of all pre-market procedures, and reporting findings to the FDA.
Precautions: What you can do
If you or a loved one is scheduled for an embolization procedure, talk to the surgeon and find out as much as you can about what he or she plans to do. In the event that glue will be used, request that complete results of the outcome are sent to the hospital’s IRB and the FDA. You may also contact a malpractice lawyer to discuss your options in case of a poor outcome.
In the absence of a detailed report, you may request to view the operating room video and films of the injection. Operating rooms are under constant surveillance, and a video copy of the procedure should be made available to your legal representative by the hospital. Any irregularities during the procedure can be determined by medical experts from this evidence.
If you find yourself faced with an unsuccessful embolization outcome, you do not have to face the tragedy alone. You can call us twenty-four hours a day, seven days a week. After hours, you can call our offices to get the name and phone number of the medical malpractice lawyer on call, and you can also email O’Connor, Acciani & Levy to request a free and confidential consultation.
One of our experienced malpractice attorneys will hear your story, answer your questions, and evaluate your situation. If we determine that your case is valid and we can help you obtain justice, we will investigate further and construct a case to win your malpractice claim. Waste not one minute in pursuing your case, as passing time makes evidence harder to collect. Those of you in Cincinnati Ohio or neighboring areas can contact a malpractice lawyer at O’Connor, Acciani & Levy today for a free and confidential consultation.
Court costs and case expenses by law are responsibility of the client.