The safety of SEPRAFILM® Adhesion Barrier has been demonstrated in five clinical studies involving 2133 patients, as cited in the prescribing information. In these studies, there were no significant differences in the incidence of adverse events (serious or nonserious) between SEPRAFILM and untreated control patients.1
In one of these studies, a post-market safety and efficacy study of unrestricted SEPRAFILM placement in major abdominal surgery, SEPRAFILM exhibited no significant difference from control in the overall rate of adverse events at 30-day and six-month follow-up. In this study, it was determined that SEPRAFILM should not be wrapped around a fresh bowel anastomosis, as such usage may result in increased anastomotic leak-related events.2 See Abdominal Laparotomy Safety below for more detail.
Formulation and preclinical safety
SEPRAFILM is composed of chemically modified hyaluronic acid (HA) and carboxymethylcellulose (CMC). HA is a naturally occurring polysaccharide found in most tissues in the human body. CMC, also a polysaccharide, is a derivative of cellulose. Together, the HA and CMC in SEPRAFILM are chemically modified to prolong residence time and are slowly resorbed within seven days. SEPRAFILM has been shown in preclinical studies to be nonmutagenic, nonpyrogenic, and nontoxic. SEPRAFILM did not promote bacterial growth in preclinical studies. Please see full prescribing information.
Abdominal laparotomy safety
The post-market study evaluated 1791 patients who underwent colorectal resections or adhesiolysis for treatment of small bowel obstruction. In this study, up to 10 sheets of SEPRAFILM were applied to the organs and tissues that sustained direct surgical trauma or were potentially adhesiogenic. All serious adverse events occurring within the first six months post-surgery were collected. Treatment with SEPRAFILM was well tolerated in this study and no relationship was observed between SEPRAFILM and the incidence of abscess or pulmonary embolus. There were no reports of foreign body reaction2 and when placed under the abdominal wall incision SEPRAFILM did not affect wound healing or surgical site infection rates.
A retrospective subgroup analysis showed that wrapping SEPRAFILM around a fresh bowel anastomosis resulted in a greater number of anastomic leak-related events. However, an increase in leak-related events was not observed when SEPRAFILM was placed elsewhere in the abdomen (including in places other than the midline incision), regardless of the presence of an anastomosis.2
A pivotal clinical study evaluated the safety and efficacy of SEPRAFILM in patients with ulcerative colitis or familial polyposis undergoing colectomy followed by ileal pouch anal anastomosis with temporary ileostomy. No statistically significant differences were observed in the incidence of adverse events (serious or nonserious), comparing 91 SEPRAFILM patients and 92 control patients. No adverse event was considered directly attributable to SEPRAFILM.3
Pelvic laparotomy safety
A pivotal clinical study evaluated the safety and efficacy of SEPRAFILM in patients undergoing myomectomy. No statistically significant differences were observed in the incidence of adverse events, comparing 59 SEPRAFILM patients and 68 control patients. SEPRAFILM was well tolerated and was comparable to control in terms of safety measurements.4
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.