SIDE EFFECTS
There have been reports of fever associated with the useof GELFOAM, without demonstrable infection. GELFOAM Sterile Sponge may serve asa nidus of infection and abscess formation1, and has been reportedto potentiate bacterial growth. Giantcell granuloma has been reported at the implantation site of absorbable gelatin product in the brain,2 ashas compression of the brain and spinal cord resulting from the accumulation ofsterile fluid.3
Foreign body reactions, encapsulation of fluid and hematoma have also been reported.
When GELFOAM was used in laminectomy operations, multipleneurologic 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 tendonrepair.
Toxic shock syndrome has been reported in associationwith the use of GELFOAM in nasal surgery.
Fever, failure of absorption, and hearing loss have beenreported in association with the use of GELFOAM during tympanoplasty.
Adverse Reactions Reported From Unapproved Uses
GELFOAM is not recommended for use other than as anadjunct for hemostasis.
While some adverse medical events following theunapproved use of GELFOAM have been reported to Pharmacia & Upjohn Company(see ADVERSE REACTIONS above), other hazards associated with such use may nothave been reported.
When GELFOAM has been used during intravascular catheterizationfor the purpose of producing vessel occlusion, the following adverse eventshave been reported; fever, duodenal and pancreatic infarct, embolization oflower extremity vessels, pulmonary embolization, splenic abscess, necrosis ofspecific anatomic areas, asterixis, and death.
The following adverse medical events have been associatedwith the use of GELFOAM for repair of dural defects encountered duringlaminectomy and craniotomy operations: fever, infection, leg paresthesias, neckand 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)
FAQs
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 ...
What are the side effects of gelatin sponges? ›
The use of gelatin sponge may cause various adverse effects, including acute or chronic hypersensitivity reactions, granuloma formation, foreign body reactions, or brain/spinal cord pressure.
What precautions should be taken when using Gelfoam? ›
As a precaution, GELFOAM should not be used in conjunction with such adhesives. GELFOAM is not recommended for the primary treatment of coagulation disorders. It is not recommended that GELFOAM be saturated with an antibiotic solution or dusted with antibiotic powder.
What are the side effects of Gelfoam dental sponges? ›
ADVERSE REACTIONS
Life-threatening anaphylactic reactions, including death, have been reported after exposure to absorbable gelatin (see WARNINGS). Although sterile, GELFOAM Dental Sponges may form a nidus of infection and abscess.
Can Gelfoam be left in the body? ›
The GELFOAM may be left in place at the bleeding site, when necessary. Since GELFOAM causes little more cellular reaction than does the blood clot, the wound may be closed over it.
What are the side effects of gelatin jelly? ›
When taken by mouth: Gelatin is commonly consumed in foods. It is possibly safe when used in larger amounts as medicine, short-term. But taking high doses of 15 grams daily might increase the risk for side effects, including sore throat, swollen gums, and mouth sores.
Who should avoid gelatin? ›
Because gelatin typically comes from animals, it is not appropriate for use by people who are vegan or vegetarian. Vegans and vegetarians should look for plant-based gelatin.
Does Gelfoam need to be removed? ›
Whenever possible, it should be removed after use in laminectomy procedures and from foramina in bone, once hemostasis is achieved. This is because GELFOAM may swell on absorbing fluids, and produce nerve damage by pressure within confined bony spaces.
What is absorbable gelatin sponge Gelfoam? ›
GELFOAM Sterile Sponge is a medical device intended for application to bleeding surfaces as a hemostatic. It is a water-insoluble, off-white, nonelastic, porous, pliable product prepared from purified pork Skin Gelatin USP Granules and Water for Injection, USP.
When should you not apply a hemostatic dressing? ›
Contraindications: 1. Wounds of the abdomen, chest, or open skull fractures.
Gelfoam Dental Sponge (absorbable gelatin dental sponge) is a medical device indicated in oral and dental surgery as an aid in providing hemostasis. Common side effects of Gelfoam Dental Sponge include: infection and. abscess formation.
How long does dental sponge take to dissolve? ›
It is utilized in a wide-range of oral surgical processes, where traditional hemostatic measures are irrelevant, or unsuitable. When embedded, it is absorbed entirely within 3-4 weeks.
What is gel foam used for in dentistry? ›
In dentistry, Gelfoam is used to help hemostasis after extraction by helping to keep the formed blood clot in place.
How often are sponges left in body after surgery? ›
Medical errors may be third leading cause of death in the U.S. In the United States, about a dozen sponges and other surgical instruments are left inside patients' bodies every day, resulting in around 4,500 to 6,000 cases per year, according to the American Society of Anesthesiologists.
Does Surgifoam need to be removed? ›
SURGIFOAM should be removed from the site of application when used in, around, or in proximity to foramina in bone, areas of bony confine, the spinal cord, and/or the optic nerve and chiasm.
What are the side effects of Surgifoam? ›
In a clinical study, 142 patients received SURGIFOAM gelatin sponge and 139 patients received another legally marketed absorbable gelatin sponge. The most common adverse events recorded during and after the application of the device were fever, tachycardia, and asthenia (a general feeling of weakness).
What are the disadvantages of soft gelatin capsules? ›
Soft gelatin capsules have certain disadvantages compared to liquid-filled hard gelatin capsules. Due to the relatively higher water content in soft gela-tin shell (20–30% w/w) compared to hard gelatin capsules (13–16% w/w) moisture-sensitive drugs may not be stable in soft gelatin capsules.
What is a gelatin sponge made of? ›
The gelatin sponge is made from purified animal gelatin. It binds well to tissue and exerts a hemostatic effect by swelling as it is soaked with blood. Gelatin sponges can be soaked in thrombin to help promote coagulation directly.
What are the advantages of absorbable gelatin sponge? ›
SURGISPON® Absorbable Hemostatic Gelatin Sponge is a quick and effective hemostatic which stops bleeding fast. It reduces intra operative bleeding and surgery time. SURGISPON® is non-toxic, non-allergenic, non-immunogenic, and non- pyrogenic.
How long should Surgifoam stay on? ›
When used in appropriate amounts, SURGIFOAM™ is absorbed completely within 4 to 6 weeks. When applied to bleeding mucosal regions, it liquefies within 2 to 5 days.
