Seprafilm

Acerca de 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 effectiveness of Seprafilm Adhesion Barrier has not been evaluated in clinical studies for the following involving: 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 4 weeks of Seprafilm placement – during anticipated time of peak adhesion formation as is associated with natural progression of healing.

Seprafilm Safety and Efficacy

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.

Important Safety Information

References

  1. Seprafilm® Adhesion Barrier Instructions for Use (IFU); Genzyme Corporation, Cambridge, MA; 2017.
  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.