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Risks of CoSeal Sealant

CoSeal is an entirely synthetic polymer used by surgeons to repair areas of potential leakage in the vascular system. CoSeal uses two synthetic polyethylene glycols (PEGs) that, once mixed, can be applied directly to tissue surfaces or used to seal suture lines or synthetic grafts. The sealant works by bonding with the proteins in a patient's tissue. The polymer remains flexible and is resorbed by the body in about four weeks, according to CoSeal's manufacturer, Baxter.

  1. Cardiac Tamponade

    • CoSeal, according to Baxter's product information, can swell to four times its original size. A study conducted by the European Association of Cardio-Thoracic Surgery between February 2005 and September 2007, found that patients who were given too large a dose of CoSeal presented with cardiac tamponade, or compression of the heart.

    Superior Vena Cava Occlusion

    • The superior vena cava is one of two main veins that return blood from the body to the heart. The European Association of Cardio-Thoracic Surgery study found that occlusion, or obstruction, of this vein occurred as a direct result of CoSeal use in one of the 76 trail patients.

    Cardiac Fibrillation

    • The European Association of Cardio-Thoracic Surgery study also reported one case of cardiac fibrillation, or irregular heart beat, that seemed to be directly related to the use of CoSeal.

    Possible Adverse Effects

    • Other adverse effects where documented in the European Association of Cardio-Thoracic Surgery study as being "possible related" to the use of CoSeal. Those effects included pericardial effusion, or excess fluid around the heart, and mediastinitis, or irritation to the area between the lungs.

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