Safety
The safety of SEPRAFILM® Adhesion Barrier has been demonstrated in five clinical studies involving 2,133 patients, as cited in the Package Insert. In these studies, there were no significant differences in the incidence of adverse events (serious or non-serious) between SEPRAFILM and untreated control patients.
In one of these studies1, a post-market safety study of unrestricted SEPRAFILM placement in major abdominopelvic 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. (See Abdominal Laparotomy Safety below for more detail.)
There are no contraindications for the use of SEPRAFILM.2
Formulation and Preclinical Safety
SEPRAFILM is composed of chemically modified hyaluronic acid and carboxymethylcellulose. Hyaluronic acid (HA) is a naturally occurring polysaccharide found in most tissues in the human body. Carboxymethylcellulose (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.2 SEPRAFILM has been shown in preclinical studies to be nonmutagenic, nonpyrogenic, and nontoxic.2 SEPRAFILM did not affect wound healing or promote bacterial growth in preclinical studies.2
Abdominal Laparotomy Safety
The post-market study evaluated 1,791 patients who underwent colorectal resections or adhesiolysis for treatment of small bowel obstruction.1 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 reaction. 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.
Seprafilm should not be wrapped around a fresh bowel anastomosis but may otherwise be applied safely in abdominal surgery in which an anastomosis has been created.
A pivotal clinical study3 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 non-serious), comparing 91 SEPRAFILM patients and 92 control patients. No adverse event was considered directly attributable to SEPRAFILM.
Pelvic Laparotomy Safety
A pivotal clinical study4 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.