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 underlying 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.
Important Safety Information
Seprafilm should not be wrapped around an intestinal anastomosis as such usage may result in increased anastomotic leak-related events, such as abscess or peritonitis. The safety and effectiveness of Seprafilm has not been established in combination with other adhesion prevention products and/or in surgical procedures not within the abdominopelvic cavity. The safety and effectiveness of Seprafilm has also not been evaluated in pregnancy; in the presence of frank infection; or malignancies in the abdominopelvic cavity. The product is not recommended for use in pregnant women and conception should be avoided during the first complete menstrual cycle after Seprafilm Adhesion Barrier usage.
Long term clinical outcomes such as chronic pain and infertility have not been determined in clinical studies. Foreign body reactions may occur with Seprafilm Adhesion Barrier, as with any implanted material. The type and frequency of adverse events reported are consistent with events typically seen following abdominopelvic surgery when used as directed.