Archives of
`
`Surgery
`
`VOLUME 104
`
`JANUARY THROUGH JUNE 1972
`
`American Medical Association Publication
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`_—_—_———A_
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`ETHICON EXHIBIT 1018
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`ETHICON EXHIBIT 1018
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`

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`Compression of the Brain and
`Spinal Cord Following Use of Gelfoam
`
`James H. Herndon, MD; Hermes C. Grillo, MD; Edward J. Riseborough, MD; and J. Charles Rich, Jr., MD, Boston
`
`Symptomatic compression of the central
`nervous system secondary to the use of Gel-
`foam (absorable gelatin sponge) in a closed
`space occurred in two cases. Absorbable
`gelatin sponge may be used to control bleed-
`ing; but it should be removed from closed
`spaces where vital
`tissues may be com-
`pressed against rigid walls by fluid accumu-
`lation.
`
`(Gel-
`bsorbable gelatin sponge
`foam) used for hemostasis in
`.
`closed spaces of the central nervous
`system has produced in two recent
`cases a sterile accumulation of fluid,
`which resulted in transient neurologic
`damage from pressure. Both cases re—
`quired prompt surgical decompression
`for relief of signs and symptoms.
`
`Report of Cases
`
`CASE 1.—A 44-year—old man with a left
`superior orbital fissure syndrome second-
`ary to an en plaque meningioma of the me-
`dial sphenoid wing and cavernous sinus
`underwent a craniotomy on Nov 3, 1970.
`When the dura was closed a small piece of
`surgical packing was inserted into the su-
`ture line for hemostasis. The patient was
`disharged from the hospital in ten days,
`but one week after discharge he returned
`with confusion and anorexia. He had bilat-
`eral upgoing toes. Carotid angiography re-
`vealed a shift of the midling structures
`and reexploration was done to rule out
`postoperative clot. On opening the dura at
`the site of the packing, tenacious yellow-
`brown fluid gushed out. The result of a
`gram stain of the fluid was negative and
`cultures were negative. The patient had
`not received antibiotics. Postoperatively
`the patient brightened and recovered fully.
`CASE 2.—A 13-year-old girl with con-
`genital kyphosis secondary to a wedged
`fifth dorsal vertebral body (D-5) under-
`Went right transthoracic excision of the
`
`Accepted July 28, 1971.
`From the departments of orthopedic surgery
`(Drs. Herndon and Riseborough), general sur-
`gery (Dr. Grillo), and neurosurgery (Dr. Rich),
`Massachusetts General Hospital, and Harvard
`Medical School, Boston. Drs. Herndon and Rich
`Were teaching fellows. Dr. Herndon is currently
`“1 the Army, stationed at Valley Forge General
`Hospital.
`Reprint requests to 120 Meadowview Lane,
`Phoenixville, Pa 19460 (Dr. Herndon).
`
`vertebral body. The defect was strutted
`with rib grafts. Absorbable gelatin sponge
`was used to control epidural bleeding on
`the right side of the vertebral canal behind
`the posterior longitudinal
`ligament,
`the
`pleura closed over the area, and the lung
`field fully reex-panded. N0 antibiotics were
`used. Postoperatively the patient did well
`and was placed in halo-femoral
`traction
`with increasing weights. On the seventh
`postoperative day she developed a Brown-
`Séquard syndrome with a sensory level on
`the left at D-5 and urinary incontinence.
`Her anal sphincter was relaxed. Reduction
`of weight led to no relief and she was
`promptly reexplored. Upon opening the
`pleura a yellow-white fluid gushed out un-
`der pressure from the area of the sponge
`packing. Gram stain showed a few poly-
`morphonuclear leukocytes, but no bacteria.
`All cultures were negative.
`The patient recovered fully neurologi-
`cally in six days. She was returned to halo-
`femoral traction and later underwent pos-
`terior spine fusion without difficulty.
`
`Comment
`
`Absorbable gelatin sponge is an ef—
`fective hemostatic agent which has
`been in use since 1945."3 Numerous
`papers were published earlier describ-
`ing its hemostatic capabilities, its use
`in different tissues, its antigenicity
`and, later, its absorbability. It is in
`such common usage today that little
`is presently reported about its proper-
`ties.“7
`
`Very little adverse reaction of local
`tissues has been recorded.‘~8 Lind—
`strom cited two cases of brain abscess
`
`and one case of an epileptogenic focus
`that followed implantation of gela-
`tin sponge. Clinical improvement fol-
`lowed promptly after removal of the
`sponges.9 We have found no prior ref-
`erence to events similar
`to those
`
`which occurred in our patients.
`In both cases the surgical packing
`was moistened in saline and com-
`
`pressed before usage. Directions sup-
`plied with the packing state that
`”minimal preliminary compression is
`advised, since too large a volume of
`material may expand to overfill the
`
`”3
`space. Guralnick utilized this prop-
`erty to obliterate and fill large cav-
`ities left by enucleation of cystic
`areas or removal of buccal bone.10
`In the cases described we believe
`
`the sponge initially swelled as it ab-
`sorbed blood. Then as it began to liq-
`uefy it may have exerted an osmotic
`pressure leading to more tissue fluid
`and blood being absorbed in the
`sponge, filling the compressible space
`in which it was enclosed, in very sim-
`ilar fashion to an expanding subdural
`hematoma. This is our clinical impres-
`sion and investigation is needed to
`support it. We could find no informa—
`tion on the osmotic properties of the
`liquefying sponge in the literature.
`We feel that as a precaution the gela-
`tin sponge should not be left in place
`in a closed or rigid space with com-
`pressible vital tissue in close proxim-
`ity. It may be used for hemostasis in
`such a situation, but should be re-
`moved before closing.
`
`References
`
`1. Abbott WD, Coleman FC: The use of
`gelatin sponge in neurosurgery. JAMA
`132:329-330, 1946.
`2. Gyurko G, Erasebet K: Application of
`Gelfoam in experlmental splenic injury.,
`Acta Chir Acad Sci Hung 5287-94, 1965.
`3. Tucker HA: Absorbable gelatin (Gel-
`foam) sponge,
`in An Annotated Bibli-
`ography, 1945-1965. Springfield, 111, Charles
`C Thomas Publisher, 1965.
`4. Doyle-Kelly W: Behavior of absorb-
`able gelatin sponge in the animal middle
`ear. J Laryng 75:152—166, 1961.
`5. Fincher EF: Further uses of gelatin
`foam in neurosurgery. J Neurosurg 4:97—
`104, 1947.
`6. Frantz VK, Clarke HT, Lattes R:
`Hemostasis with absorbable gauze. Ann
`Surg 120:181—198, 1944.
`7. Papen GW, Mikal S: The treatment of
`ruptured liver with absorbable hemo-
`statics, New Eng J Med 239:920-923, 1948.
`8. Huffman JW: The use of gelatin
`sponges
`in gynecologic surgery. Quart
`Bull Northwestern Univ Med School 22:53-
`55, 1948.
`9. Lindstrom PA: Complications from
`the use of absorbable hemostatic sponges.
`Arch Surg 73:133-141, 1956.
`10. Guralnick WC, Berg L: Gelfoam in
`oral surgery: A report of 250 cases. Oral
`Surg 1:632—639, 1948.
`
`Arch Surg/Vol 104, Jan 1972
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`Compression of Brain and Spinal Cord/Herndon et al
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`107
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