Cerebral spinal fluid (CSF) leaks are a complication of spinal surgery that is the result of accidental tears or cuts through the dura mater that serves as a watertight tissue layer that functions to prevent the CSF from leaking out of the central nervous system. This complication is nearly unavoidable and occurs in approximately fourteen percent of lumbar spine surgeries and two percent of cervical spine surgeries. A durotomy is a cut or tear in the dura matter that may be intended by the surgeon or an accidental consequence of a difficult surgery. A durotomy regardless of the cause will result in a CSF leak if the defect is not repaired or if it persists despite attempted repair.
The complications of a durotomy are directly related to the resulting CSF leak. This may include impaired wound healing, a pseudomeningocele, which is an enlargement of a CSF collection within the soft tissues of the back, or the dreaded ‘spinal headache’, which causes the patient to suffer with positional headaches limiting any mobility.
During surgery on the spine a durotomy that is identified will be repaired by the surgeon with suture closure of the dura mater defect. Despite attempted repair it is sometimes not possible to produce the watertight seal required to prevent CSF leaks and its related complications.
The Federal Drug Administration in 2009 approved the apparent answer to this elusive problem, a synthetic nontoxic bioabsorbable hydrogel sealant (DuraSeal), that when applied over a sutured dura mater defect will seal the defect shut within seconds of application. The approved sealant was determined to be strong, safe, and 100% effective in stopping CSF leaks for both an intended and accidental durotomy.
Unfortunately DuraSeal has been proven not to be the ideal CSF sealant because it has the propensity to absorb bodily fluid and swell up to 50% of its size after application. This increase in size may produce a ‘DuraSeal Mass’ in the surgical field that may develop slowly after application, peaking in size between three and fourteen days. Complications related to DuraSeal are related to the ‘DuraSeal Mass’ that may compress either the spinal cord or the spinal nerves running along the tight spaces of the spinal canal producing progressive neurological symptoms of weakness and potentially bowel and bladder dysfunction. Catastrophic complications include quadriplegia and cauda equina syndrome.
In any post-operative patient with a new or developing neurological deficit a neurosurgeons will emergently order an MRI. In the case of an expanding hydrogel sealant, the radiological interpretation may describe the mass as being consistent with an epidural hematoma (blood collection) or a epidural seroma (fluid collection) but in fact represents a mixed mass composed of DuraSeal, blood products, and bodily fluid. As with any progressive neurological deficit directly attributed to a compressive mass these patients will undergo emergent neurosurgical intervention in attempts to improve or preserve neurological function.
A neurosurgeon, who is also an Academic Physician Life Care Planner, is essential in a product liability action against a manufacturer that involves a catastrophic neurological complication potentially related to a hydrogel dural sealant. Not only will the neurosurgeon be able to assist with the foundation for all the necessary and appropriate future medical care related to the injured person’s spine, but he will also be allowed to testify to the questions of causation. He can enter his opinion on the record if the cause of the neurological deficits is related to an epidural hematoma or a ‘DuraSeal Mass’. Epidural hematomas are an expected complication of all spinal surgeries that every patient consents to, but an expanding compressive mass related to a defective product is not.
ftp://ftp.barrowmedia.com/Public2/George/Preul/Neomend/Safety%20and%20efficacy%20of%20a%20novel%20polyethylene%20glycol%20hydrogel.pdf
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3348307/
http://medicine.missouri.edu/ortho/docs/spine/Cammisa%202000.pdf
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