Fiber Embolization, Foreign Body Contamination and Retained Sponges: The Hazards of Interventional and Surgical Procedures

Foreign body embolization and foreign body granuloma have been described as early as 1949 by The American Journal of Pathology where Glahn states that the introduction of cotton fibers through a vein produced foreign body granulomata. A granuloma forms when the immune system attempts to wall off substances it perceives as foreign but is unable to eliminate. Such substances include infectious organisms such as bacteria and fungi as well as other materials, including sterile cotton gauze fibers. An article from the Annals of Surgery, published in 1967, demonstrated that fragments of gauze, introduced at operation, may induce granulomata and deposition of fibrous tissue. Sturdy, et al concluded that foreign body granulomas as a sequellae of surgical operations are of clinical importance. In addition, a review of clinical cases of foreign body granulomata indicated that gauze may be an important etiological factor. More recently, Shannon, in an article from the American Journal of Neuroradiology 2006, concluded that inadvertent foreign body embolization is common in modern cerebral angiography and are probably underappreciated clinically. His article reports a comprehensive 5‐year retrospective study of all postmortem cases of post‐angiographic neurologic complications at Toronto Western Hospital. This required a review of 841 autopsy reports with diagnosis of intracranial hemorrhage, aneurysm, vascular malformation, or multiple infarctions. Of the 60 arteriovenous malformations that were identified, he found particulate embolization, which was usually cotton fiber, to be present in as many as 25% of the malformations studied. All angiographic and cardiovascular procedures are susceptible to these complications. Truscott, with Kimberly‐Clark Health Care in Roswell, Georgia, maintains that complications of interventional cardiac catheterization may be caused or exacerbated by foreign debris deposited on the inside or outside surfaces of the catheter and subsequently co‐inserted into the bloodstream. Because of the direct vascular insertion and extensive surface area exposed, minimally invasive procedures performed through the vascular system actually place the patient at greater risk of particulate related complications. Examiners have found that particulates or “linting” may inadvertently occur during procedural preparation and the actual surgery. The Society of Toxicology and Pathology published a study in May of 2008 where foreign‐body granulomas within the intramyocardial arteries were detected in 3 of the 5 test subjects in a routine transcoronary safety assessment test. The foreign bodies were strongly birefringent by polarized light microscopy. By their morphological features, they were identified as cotton fibers. The study concluded that “this observation emphasizes that foreign‐body embolization can occur during invasive vascular interventions, which may lead to foreign‐body reaction and misinterpretation of drug safety results”.

 

In recent years, the US Food and Drug Administration (FDA) has become concerned about linting. Measures are being considered by the FDA to set performance standards for gauze to contain the problem of linting. In its response to comments received on proposed regulations, classifying 51 general and plastic surgery devices, the FDA stated: “FDA agrees that current literature indicates that there is no ‘safe’ level of particulate exposure for gauze…” 53(122) Fed. Reg. 23,867 (1988). It further states, “FDA believes that a performance standard is necessary to control design and construction of the gauze to reduce particulate matter contamination and to assure adequate radiopacity.” 53(122) Fed. Reg. 23,866 (1988). Thus, there is a recognized need for a lint‐free material. Of the numerous case reports and studies reviewed on foreign body granuloma and adhesions, cotton gauze fibers present with a particle‐associated risk. Sterile gauze/sponges, made of cotton, lose a significant amount of lint, both macro and microscopic, during routine surgical and catheter based procedures. A study concluded by Seri, et al reports “even if macroscopically visible particles were removed, there would be microscopic particles left behind which still have the potential to induce a foreign body inflammatory response”. Various synthetic materials have been suggested as alternatives to cotton but attempts to produce the same “absorptive” qualities have failed.

Chapot R, Wassef M, Bisdorff A, et al Occlusion of the middle cerebral artery due to synthetic fibers  AJNR 27, 2006;148-50

Occlusion of the Middle Cerebral Artery due to Synthetic Fibers. 43-year-old woman with a recent episode of subarachnoid hemorrhage underwent endovascular treatment for 2 intracranial aneurysms located at the right carotid bifurcation and left posterior communicating artery.

Intraoperatively, the patients left internal carotid artery demonstrated an abrupt occlusion of the left middle cerebral artery. After unsuccessful fibrinolysis a mechanical thrombectomy was performed using a 2mm microsnare. Thrombus was removed allowing complete recanalization of the cerebral circulation.

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