Product Description.:
GELFILM Sterile Film and GELFILM Sterile Ophthalmic Film are absorbable gelatin film approximately 0.075 mm in thickness, designed for use as an absorbable gelatin implant in neurosurgery and thoracic and ocular surgery.
To prepare for use, immerse absorbable gelatin film in sterile saline solution and allow it to soak until it becomes quite pliable it may then be cut to desired size and shape without difficulty.
Neurosurgery: Nonconducive to undue inflammatory reaction and absorbable at a rate sufficiently slow to permit dural regeneration and healing of the arachnoid layer, GELFILM Sterile Film favorably meets requisites for dural substitute. Use in patients undergoing craniotomies has been reported to prevent development of meningocerebral adhesions and thereby reduce risk of postoperative sequelae.
Thoracic Surgery: In repair of pleural defects in connection with thoracotomies, thoracoplasties, and extrapleural procedures, implantation of GELFILM Sterile Film has been observed to be followed by minimal tissue reaction and closure of the defect by ingrowth of regenerating pleural and fibrous tissue across the gradually resorbed GELFILM implant.
Ocular Surgery: Various ocular surgical procedures in which GELFILM Sterile Ophthalmic Film has been used include glaucoma filtration operations (ie, iridencleisis and trephination), extraocular muscle surgery, and diathermy or scleral buckling operations for retinal detachment. Experimental studies in rabbits and clinical trials in patients have shown a remarkable lack of cellular reaction to GELFILM implanted subconjunctivally or used as a seton into the anterior chamber. Objective evidence that GELFILM implants aid in preventing formation of adhesions between contiguous ocular structures has been reported as follows: in iridencleisis in which GELFILM was employed as a seton, the resultant filtrating areas were large and there was no postoperative rise in intraocular tension in extraocular muscle surgery and operations for retinal detachment, insertion of GELFILM implants between contiguous tissue layers was found to enhance the ease of secondary operations.
Important Safety Information
GELFILM Sterile Film and GELFILM Sterile Ophthalmic Film should not be implanted in grossly contaminated or infected surgical wounds because the rate of absorption is likely to be increased in the presence of purulent exudation.
GELFILM should be used immediately after removal from its envelope.
