Safety and Efficacy Studies
Beck DE, Cohen Z, Fleshman JW, Kaufman HS, van Goor H, Wolff BG; for Adhesion Study Group Steering Committee. A prospective, randomized, multicenter, controlled study of the safety of Seprafilm® Adhesion Barrier in abdominopelvic surgery of the intestine. Dis Colon Rectum. 2003;46:1310-1319.
View Abstract
Becker JM, Dayton MT, Fazio VW, et al. Prevention of postoperative abdominal adhesions by a sodium hyaluronate-based bioresorbable membrane: a prospective, randomized, double-blind multicenter study. J Am Coll Surg. 1996;183:297-306.
View Abstract
Bristow RE, Montz FJ. Prevention of adhesion formation after radical oophorectomy using a sodium hyaluronate-carboxymethylcellulose (HA-CMC) barrier. Gynecol Oncol. 2005;99:301-308.
View Abstract
Diamond MP. Reduction of adhesions after uterine myomectomy by Seprafilm membrane (HAL-F): a blinded, prospective, randomized, multicenter clinical study. Fertil Sterility. 1996;66:904-910.
View Abstract
Fazio VW, Cohen Z, Fleshman JW, et al. Reduction in adhesive small-bowel obstruction by Seprafilm Adhesion Barrier after intestinal resection.
Dis Colon Rectum. 2006;49:1-11.
View Abstract Fushiki H, Ikoma T, Kobayashi H, Yoshimoto H. Efficacy of Seprafilm as an adhesion prevention barrier in cesarean sections. Obstet Gynecol Treatment. 2005;91:557-561.
Kusunoki M, Ikeuchi H, Yanagi H, et al. Bioresorbable hyaluronate-carboxymethylcellulose membrane (Seprafilm) in surgery for rectal carcinoma: a prospective randomized clinical trial.
Surg Today. 2005;35:940-945.
View Abstract
Indication
Seprafilm® Adhesion Barrier is indicated for the reduction of post-surgical adhesions in patients undergoing abdominal or pelvic laparotomy.
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 cases of pregnancy, malignancy, or frank infection. The type and frequency of adverse events reported are consistent with events typically seen following abdominopelvic surgery when used as directed.
Please see full prescribing information.