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Gelfoam Sponge

Last reviewed on RxList: 8/15/2019
Gelfoam Sponge Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 8/15/2019

Gelfoam Sponge (absorbable gelatin sponge) is a medical device intended for application to bleeding surfaces is indicated in surgical procedures as a hemostatic device, when control of capillary, venous, and arteriolar bleeding by pressure, ligature, and other conventional procedures is either ineffective or impractical. Although not necessary, Gelfoam Sponge can be used either with or without thrombin to obtain hemostasis. Common side effects of Gelfoam Sponge include: 

  • fever,
  • infection,
  • abscess formation,
  • foreign body reactions,
  • “encapsulation” of fluid, and
  • blood clots.

The minimum amount of Gelfoam Sponge of appropriate size and shape should be applied dry or wet to the bleeding site and held firmly in place until hemostasis is observed. Gelfoam Sponge may interact with other drugs or topical agents. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or breastfeeding before receiving Gelfoam Sponge.

Our Gelfoam Sponge (absorbable gelatin sponge) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Gelfoam Sponge Professional Information

SIDE EFFECTS

There have been reports of fever associated with the use of GELFOAM, without demonstrable infection. GELFOAM Sterile Sponge may serve as a nidus of infection and abscess formation1, and has been reported to potentiate bacterial growth. Giantcell granuloma has been reported at the implantation site of absorbable gelatin product in the brain,2 as has compression of the brain and spinal cord resulting from the accumulation of sterile fluid.3

Foreign body reactions, encapsulation of fluid and hematoma have also been reported.

When GELFOAM was used in laminectomy operations, multiple neurologic events were reported, including but not limited to cauda equina syndrome, spinal stenosis, meningitis, arachnoiditis, headaches, paresthesias, pain, bladder and bowel dysfunction, and impotence.

Excessive fibrosis and prolonged fixation of a tendon have been reported when absorbable gelatin products were used in severed tendon repair.

Toxic shock syndrome has been reported in association with the use of GELFOAM in nasal surgery.

Fever, failure of absorption, and hearing loss have been reported in association with the use of GELFOAM during tympanoplasty.

Adverse Reactions Reported From Unapproved Uses

GELFOAM is not recommended for use other than as an adjunct for hemostasis.

While some adverse medical events following the unapproved use of GELFOAM have been reported to Pharmacia & Upjohn Company (see ADVERSE REACTIONS above), other hazards associated with such use may not have been reported.

When GELFOAM has been used during intravascular catheterization for the purpose of producing vessel occlusion, the following adverse events have been reported; fever, duodenal and pancreatic infarct, embolization of lower extremity vessels, pulmonary embolization, splenic abscess, necrosis of specific anatomic areas, asterixis, and death.

The following adverse medical events have been associated with the use of GELFOAM for repair of dural defects encountered during laminectomy and craniotomy operations: fever, infection, leg paresthesias, neck and back pain, bladder and bowel incontinence, cauda equine syndrome, neurogenic bladder, impotence, and paresis.

Read the entire FDA prescribing information for Gelfoam Sponge (Absorbable Gelatin Sponge, USP)

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© Gelfoam Sponge Patient Information is supplied by Cerner Multum, Inc. and Gelfoam Sponge Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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