Device Dossier

Seprafilm - Barrier, absorbable, adhesion prevention

Device Dossier for Seprafilm - Barrier, absorbable, adhesion prevention (Barrier, absorbable, adhesion prevention, Class III, sponsor Baxter Healthcare).…

Intended purpose

Seprafilm is intended as an adjunct in abdominal and pelvic surgery for reducing the incidence, extent and severity of postoperative adhesions at the site of placement, and to reduce adhesive small bowel obstruction when placed in the abdomen.

Functional description

Seprafilm is sterile, bioresorbable translucent membrane that is resorbed within one week and excreted from the body in less than 30 days. Therefore, no procedure is required to remove the membrane and there is no risk of reuse. Seprafilm is applied to sites of potentially adhesiogenic tissue and organ structures in the abdominopelvic cavity to serve as a temporary barrier separating opposing tissue surfaces. Seprafilm is for single use only and must not be resterilised.

TGA Public Summary