Each gynecological procedure presents unique challenges that can cause complications for the healing process. Here are a few examples.
Bleeding during and/or after a myomectomy can lead to more severe complications such as a return to the operating room or worse yet, a hysterectomy. TISSEEL, Baxter's fibrin sealant, has a wide range of drip and spray applicators and mimics a physiological clot for resorption in 7-14 days2.
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Indications and Important Risk Information
FLOSEAL Hemostatic Matrix Indication
FLOSEAL Matrix is indicated in surgical procedures (other than ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.
Full important risk information
Do not inject or compress FLOSEAL Matrix into blood vessels. Do not apply FLOSEAL Matrix in the absence of active blood flow, e.g., while the vessel is clamped or bypassed, as extensive intravascular clotting and even death may result.
Do not use FLOSEAL Matrix in patients with known allergies to materials of bovine origin. Do not use FLOSEAL Matrix in the closure of skin incisions because it may interfere with the healing of the skin edges.
FLOSEAL Matrix contains Thrombin made from human plasma. It may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
FLOSEAL Matrix is not intended as a substitute for meticulous surgical technique and the proper application of ligatures or other conventional procedures for hemostasis.
Excess FLOSEAL Matrix (material not incorporated in the hemostatic clot) should always be removed by gentle irrigation from the site of application.
FLOSEAL Matrix swells by approximately 10% to 20% after product is applied. Maximum swell volume is achieved within about 10 minutes.
The safety and effectiveness of FLOSEAL Matrix has not been established in children under 2 years of age and pregnant women.
Do not use air to remove residual FLOSEAL Matrix from Applicator tip. The Applicator tips should not be cut. Do not use FLOSEAL Matrix on bone surfaces where adhesives, such as methylmethacrylate or other acrylic adhesives, will be required to attach a prosthetic device.
Rx Only. For safe and proper use of this device, refer to the full Instructions for Use.
FLOSEAL Full Instructions for Use:
TISSEEL [Fibrin Sealant] Indications
Hemostasis: TISSEEL is a fibrin sealant indicated for use as an adjunct to hemostasis in adult and pediatric patients (> 1 month of age) undergoing surgery when control of bleeding by conventional surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. TISSEEL is effective in heparinized patients.
Sealing: TISSEEL is a fibrin sealant indicated as an adjunct to standard surgical techniques (such as suture and ligature) to prevent leakage from colonic anastomoses following the reversal of temporary colostomies.
Important Risk Information for TISSEEL [Fibrin Sealant]
For Topical Use Only. Do not inject TISSEEL directly into the circulatory system or into highly vascularized tissue. Intravascular application of TISSEEL can lead to intravascular coagulation, can result in life- threatening thromboembolic events, and can increase the likelihood and severity of acute hypersensitivity reactions in susceptible patients. To minimize the risk of intravascular application, exercise caution when using TISSEEL in surgery.
Do not use TISSEEL in individuals with a known hypersensitivity to aprotinin.
Do not use TISSEEL for treatment of severe or brisk arterial or venous bleeding. In these situations, TISSEEL will be washed away in the flow of blood before hemostasis can be attained.
Do not spray TISSSEEL where the minimum recommended distance from the applicator tip to the target site cannot be assured.
Hypersensitivity or allergic/anaphylactoid reactions can occur with the use of TISSEEL. Such reactions may especially be seen if TISSEEL is applied repeatedly over time or in the same setting, or if systemic aprotinin has been administered previously.
Aprotonin is known to be associated with anaphylactic reactions. Even in the case of strict local application of aprotinin, there is a risk of anaphylactic reactions to aprotinin, particularly in the case of previous exposure.
Discontinue administration of TISSEEL in the event of hypersensitivity reactions. Remove remaining product from the application site.
Air or gas embolism has occurred when fibrin sealant was administered using pressurized gas. This can occur if a spray device is used at higher than recommended pressures and in closer than recommended proximity to the tissue surface.
When using the EASYSPRAY device, or an equivalent spray device for open surgical procedures cleared by FDA, TISSEEL must not be sprayed in enclosed body areas and must be sprayed onto only visible application sites.
TISSEEL is denatured when exposing to solutions containing alcohol, iodine or heavy metals. If any of these substances have been used to clean the wound area, the area must be thoroughly rinsed before the application of TISSEEL.
Apply TISSEEL as a thin layer by dripping or spraying using cannula or spray set. Excess clot thickness can negatively interfere with wound healing.
The safety and effectiveness of TISSEEL used alone or in combination with biocompatible carriers in neurosurgical procedures or other surgeries involving confined spaces have not been evaluated; its use in this setting is not FDA approved.
TISSEEL is made from human plasma. It may carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
ADEPT® Adhesion Reduction Solution [4% Icodextrin] Indications
ADEPT Adhesion Reduction Solution is indicated for use intraperitoneally as an adjunct to good surgical technique for the reduction of post-surgical adhesions in patients undergoing gynecological laparoscopic adhesiolysis.
Important Risk Information for ADEPT®
ADEPT® is for direct intraperitoneal administration only. NOT for intravenous (IV) administration.
ADEPT® is contraindicated in patients with known or suspected allergy to cornstarch based polymers e.g. icodextrin, or with
maltose or isomaltose intolerance, or with glycogen storage disease.
ADEPT® is contraindicated in laparotomy, in cases involving bowel resection or repair, or appendectomy and in surgical cases with
frank abdomino-pelvic infection.
There have been rare reports of sterile peritonitis following the use of icodextrin.
Leakage of ADEPT® from port sites may lead to wound healing complications; meticulous fascial closure may reduce leakage
through laparoscopic port sites post-operatively.
There have been rare reports of hypersensitivity reactions, pulmonary edema, pulmonary effusion and arrhythmia.
Anaphylaxis has been reported in a few patients.
Maltose metabolites of icodextrin may interfere with blood glucose measurement in diabetic patients who use rapid blood glucose
systems that are not glucose specific.
In the pivotal study, the most frequently occurring treatment related adverse events between surgeries were post procedural
leaking from port sites, labial, vulvar or vaginal swelling and abdominal distention.
Rx Only: For safe and proper use of this device, please refer to full device Instructions For Use.