Adhesion Prevention
The little things make a big difference. Our adhesion prevention portfolio can help you make the critical decisions that could mean healthier lives.
SEPRAFILM Adhesion Barrier
SEPRAFILM is an adhesion barrier that reduces the incidence, extent and severity of adhesions following abdominopelvic laparotomy.1
ADEPT Adhesion Reduction Solution
ADEPT is proven to reduce post-surgical adhesions in patients undergoing gynecological laparoscopic surgery.2
The Impact of Adhesions
Up to 93%
of patients develop adhesions following one or more abdominal operations3
Approx 20%
of abdominal surgical patients will return for adhesion-related complications4,5
$2.3 Billion
is the estimated annual economic impact of adhesiolysis procedures6
INDICATIONS AND IMPORTANT SAFETY INFORMATION
SEPRAFILM Indications for Use
SEPRAFILM Adhesion Barrier is indicated for use in patients undergoing abdominal or pelvic laparotomy as an adjunct intended to reduce the incidence, extent and severity of postoperative adhesions between the abdominal wall and the under-lying viscera such as omentum, small bowel, bladder, and stomach, and between the uterus and surrounding structures such as tubes and ovaries, large bowel, and bladder.
SEPRAFILM Important Risk Information
SEPRAFILM Adhesion Barrier is contraindicated in patients with a history of hypersensitivity to Seprafilm and/or to any component of SEPRAFILM. SEPRAFILM Adhesion Barrier is contraindicated for use wrapped directly around a fresh anastomotic suture or staple line; as such use increases the risk of anastomotic leak and related events (fistula, abscess, leak, sepsis, peritonitis). SEPRAFILM Adhesion Barrier must be used according to the instructions for use. SEPRAFILM Adhesion Barrier is for single use only, supplied sterile and must not be re-sterilized. Every opened and unused SEPRAFILM pouch must be discarded. Do not use product if pouch is damaged or opened. The number of sheets used should be just adequate to cover the under surface of the abdominal wall or uterine incision in a single layer.
In patients who have ovarian, primary peritoneal or fallopian tube malignancies, SEPRAFILM use has been reported to have an increased risk of intra-abdominal fluid collection and/or abscess, particularly when extensive debulking surgery was required.
The safety and effectiveness of SEPRAFILM Adhesion Barrier has not been evaluated in clinical studies for the following: Patients with frank infections in the abdominopelvic cavity; patients with abdominopelvic malignancy; device placement in locations other than directly beneath an abdominal wall incision following laparotomy, or directly on the uterus following open myomectomy (not laparoscopic); patients with ongoing local and/or systemic inflammatory cell responses; device use in the presence of other implants, e.g. surgical mesh; patients requiring re-operation within four weeks of SEPRAFILM placement – during anticipated time of peak adhesion formation. Foreign body reactions have occurred with SEPRAFILM Adhesion Barrier.
The safety and effectiveness of SEPRAFILM Adhesion Barrier in combination with other adhesion prevention products and/or in other surgical procedures not within the abdominopelvic cavity have not been established in clinical studies.
The safe and effective use of SEPRAFILM Adhesion Barrier in pregnancy and Cesarean section has not been evaluated. No clinical studies have been conducted in pregnant women or women who have become pregnant within the first month after exposure to SEPRAFILM Adhesion Barrier. Therefore, this product is not recommended for use during pregnancy and avoidance of conception should be considered during the first complete menstrual cycle after use of SEPRAFILM Adhesion Barrier.
Long term clinical outcomes such as chronic pain and infertility have not been determined in clinical studies.
Rx Only. For safe and proper use of this device refer to the complete Instructions for Use.
SEPRAFILM Full Instructions For Use
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.
ADEPT® Important Risk Information
ADEPT® Solution 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 Instructions For Use.