What are adhesions?
Adhesions are scars that form abnormal connections between tissue surfaces. Post-surgical adhesion formation is a
natural consequence of surgery, resulting when tissue repairs itself following incision, cauterization, suturing, or other
means of trauma.
Post-surgical adhesions are very common2. Research indicates that adhesions occur in up to 90% of major gynecologic
surgeries.1
Complications associated with adhesions are high,1,3 and may include:
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Small bowel obstruction - 49% to 74%
Infertility - 15% to 20%
Chronic pelvic pain - 20% to 50%
About Seprafilm
Seprafilm is a sterile, bioresorbable adhesion barrier that helps reduce the incidence, extent, and severity of postoperative
adhesions between the abdominal wall and the viscera surrounding the omentum, small bowel, bladder, and stomach,
and between the uterus and the fallopian tubes, ovaries, large bowel, and bladder.
Seprafilm is applied directly to specific sites of surgical trauma to provide a physical barrier that separates traumatized
tissue from other tissues during normal healing. Composed of sodium hyaluronate and carboxymethylcellulose, Seprafilm
remains at the sites of placement for up to seven days, maintaining a barrier effect while the body's normal tissue repair
takes place. As the repairs occur, Seprafilm is slowly resorbed into the body.
Sites of tissue trauma in the abdomen and pelvis are vulnerable to adhesion formation1. Following surgery, surgeons
apply Seprafilm directly on sites of tissue trauma, isolating them from adhesion formation.
Seprafilm is approved for use in open abdominal and pelvic procedures. It can be used in abdominal and pelvic surgeries,
including colorectal, obstetric, and gynecologic, bariatric, and vascular procedures. There are no known contraindications
for the use of Seprafilm.
Safety and efficacy
Seprafilm provides a well established safety and efficacy profile, as demonstrated in two large, multi-center studies
evaluating its use in pelvic and abdominal surgical procedures. No other adhesion prevention barrier has a safety and
efficacy profile based on a broader base of patients and procedures.
Safety and efficacy in abdominal surgery1
In a randomized, double-blind controlled trial of Seprafilm in major abdominal surgical procedures (colectomy and ileal
pouch-anal anastomosis with diverting-loop ileostomy), 51% of patients who received Seprafilm (n = 85) were adhesionfree vs. 6% of patients who did not (n = 90; P < 0.00000000001). Moreover, dense adhesions were observed in 15% of
patients who received Seprafilm vs. 58% of patients who did not (P < 0.0001). There were no statistically significant
differences in the incidence of adverse events between treatment groups. See "Important safety information" below.
Safety and efficacy in pelvic surgery4
In a randomized, double-blind controlled trial of Seprafilm in myomectomy, the incidence, extent, and average area
affected by adhesions were significantly less in patients who received Seprafilm (n = 59) vs. those who did not (n = 68). In
addition, 48% of Seprafilm-treated patients had at least one adnexa free of adhesions to the uterus. Adverse events were
similar in both treatment groups, see "Important safety information" below.
Important safety information
Seprafilm Adhesion Barrier is indicated for the reduction of post-surgical adhesions in patients undergoing abdominal or
pelvic laparotomy. The most common adverse events in clinical trials, which were not different from untreated controls,
were ileus, anastomotic leak, and abdominal abscess. Seprafilm should not be wrapped around an anastomosis as such
usage may result in increased anastomotic leak related events. Seprafilm has not been studied prospectively in
pregnancies, in the presence of frank infections, or in malignancies.
Please see the Package Insert to the right for full prescribing information.
References
1. Hershlag A, Diamond MP, DeCherney AH. Adhesiolysys. Clin Obstet Gynecol. 1991;34:395-401.
2. Becker JM, Dayton MT, Fazio VM, et al. Prevention of postoperative abdominal adhesions by a sodium hyaluronatebased bioresorbable membrane: a prospective, randomized, double-blind multicenter study. J AM Coll Surg. 1996;
183:297-306.
3. Monk BJ, Berman ML, Montz FJ. Adhesions after extensive gynecologic surgery: clinical significance, etiology, and
preventions. Am J Obstet Gynecol.1994;170:1393-1403.
4. Diamond MP. Reduction of adhesions after uterine myomectomy by Seprafilm Membrane (HAL-F): a blinded,
prospective, randomized, multicenter clinical study. Fertility and Sterility. 1996;66:904-910.