To order Seprafilm or for more information, call 1-800-261-1570 Instructions for Use (IFU)
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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 [...]  View Full Important Safety Information

For US Healthcare Professionals Only

About Seprafilm

Seprafilm is a mechanical bioresorbable adhesion barrier that is applied to adhesiogenic tissues before surgical closure. It is indicated for the reduction in the incidence, extent, and severity of postoperative adhesions in patients undergoing abdominal or pelvic laparotomy.1

Clinical Trial and Patient Experience

Seprafilm has been FDA approved as an adhesion barrier since 1996. To support approval, Seprafilm Adhesion Barrier was studied in five clinical trials involving 2,133 patients.1

More than 4 million patients have received Seprafilm in clinical use worldwide.2

Mode of Action (MOA)

When placed between traumatized tissue surfaces, Seprafilm acts as a physical barrier preventing the formation of adhesions between opposing tissues while the natural process of tissue wound healing takes place. Seprafilm turns into a gel that is reabsorbed into the body.1,3

  • Composition: Seprafilm is comprised of two anionic polysaccharides: modified hyaluronic acid (HA) and carboxymethylcellulose (CMC). The polymers in Seprafilm are chemically modified to have reduced water solubility and longer in vivo residence time than the unmodified polymers, thereby enhancing its ability to reduce adhesion formation.3
  • Residence time: Seprafilm turns into a gel within 24-48 hours after placement and stays in place for up to seven days—the critical tissue healing period. By day 7, Seprafilm is resorbed from the abdominopelvic cavity and, by day 28, Seprafilm is excreted from the body.1,3
  • Characteristics: Seprafilm is sterile, bioresorbable, translucent, and hydrophilic.1

Seprafilm Safety and Efficacy

For detailed Seprafilm efficacy and safety data, click here.

Seprafilm offers an effective and safe method for reducing postsurgical adhesions:

  • Indicated for the reduction of the incidence, extent, and severity of adhesions1
  • The only FDA-approved adhesion barrier indicated for both abdominal and pelvic laparotomy1
  • Safety and efficacy has been established by prospective randomized trials in abdominal and pelvic surgery3,4

The safety and efficacy of Seprafilm Adhesion Barrier has not been evaluated in clinical studies in the presence of malignancies in the abdominopelvic cavity. Long-term clinical outcomes such as chronic pain and infertility have not been determined in clinical studies.

References

  1. Seprafilm® Adhesion Barrier Instructions for Use (IFU); Genzyme Corporation, Cambridge, MA; 2008.
  2. Data on file. Genzyme Corporation. Cambridge, MA: Genzyme Corp.
  3. 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.
  4. 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(10):1310-1319.