Seprafilm® has been proven safe and effective.
Seprafilm has been studied in more than 4000 patients, and featured in more than 40 studies.1 Below are summaries of a few studies.
C-Section
In a study of women receiving Seprafilm at their first C-Section, up to 93%* of the patients were adhesion free, resulting in decreased procedure and delivery times at repeat C-Sections.2
Gynecologic surgery
In a study of patients having their ovaries, fallopian tubes, and uterus removed, patients who received Seprafilm had nearly 70% fewer adhesions than patients who did not receive an adhesion barrier.3
In a study of patients receiving Seprafilm at open myomectomy, or fibroid removal, Seprafilm reduced the frequency, severity, and extent of adhesions.4
Colorectal surgery
In a study of patients receiving Seprafilm during two-stage colorectal surgery, Seprafilm reduced the incidence of dense adhesions by 74%* compared with untreated patients. In one particular study, patients that received Seprafilm were 8.5 times more likely to be adhesion free compared to patients who did not receive an adhesion barrier.5
Future surgeries
In a series of studies where Seprafilm was used during the first surgery, Seprafilm was shown to reduce adhesions seen at future surgeries, resulting in fewer complications during surgery,6 less time in surgery,2 and reduced blood loss.2.7 Small bowel obstruction
In a study of patients receiving Seprafilm during open abdominal surgery, Seprafilm was shown to reduce the number of follow-up operations needed for small bowel obstruction due to adhesions by 47% compared with patients who did not receive an adhesion barrier.8
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.
References
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Data on file, Genzyme Corp.
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Fushiki H, Ikoma T, Kobayashi H, Yoshimoto H. Efficacy of Seprafilm as an adhesion prevention barrier in cesarean sections. Obstet Gynecol Treatment. 2005;91(5):557-561.
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Bristow RE, Montz FJ. Prevention of adhesion formation after radical oophorectomy using a sodium hyaluronate-carboxymethylcellulose (HA-CMC) barrier. Gynecol Oncol. 2005;99(2):301-308.
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Diamond MP. Reduction of adhesions after uterine myomectomy by Seprafilm membrane (HAL-F): a blinded, prospective, randomized, multicenter clinical study. Fertil: Steril 1996;66(6);904-910.
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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(4):297-306.
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Tang C-L, Seow-Choen F, Fook-Chong S, Eu K-W. Bioresorbable adhesion barrier facilitates early closure of the defunctioning ileostomy after rectal excision: a prospective randomized trial. Dis Colon Rectum. 2003;46(9):1200-1207.
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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(11):940-945.
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Fazio VW, Cohen Z, Fleshman JW, et al. Reduction in adhesive small-bowel obstruction by Seprafilm Adhesion Barrier after intestinal resection. Dis Colon Rectum. 2005;49(1):1-11