Film adhesion barrier Seprafilm

abdominal laparotomycesarean surgerypelvic laparotomy

Overview
Seprafilm Adhesion Barrier reduces the incidence, extent and severity of postoperative adhesions following abdominopelvic laparotomy. Seprafilm is approved in the U.S. for abdominal open procedures and is intended for use as an adjunct during open abdominal and pelvic surgery.

Mechanism of Action
Seprafilm is a sterile, bioresorbable, translucent, hydrophilic sheet composed of modified sodium hyaluronate and carboxymethylcellulose (HA/CMC). It functions as a temporary physical barrier that separates tissues during the critical tissue-healing period (up to about 7 days).

Clinical Evidence (selected)

• Randomized, prospective, double-blinded multicenter study in 183 patients (175 evaluable) undergoing 2-stage intestinal resection: 51% of Seprafilm-treated patients were adhesion-free at 8–12 weeks vs 6% of controls.
• Prospective, randomized, blinded multicenter study in 127 gynecologic surgery patients: Seprafilm reduced the mean number of sites adherent to the uterine surface after myomectomy and significantly reduced extent and severity of adhesions compared with untreated patients.
• Combined results from five clinical studies (n=2,133) demonstrate significant reduction in incidence, extent and severity of adhesions after abdominopelvic laparotomy; over 4 million patients have received Seprafilm in clinical use worldwide.

Key Benefits / Features

• Separates tissues during the critical healing period (up to ~7 days).
• Bioresorbable synthetic formulation (modified sodium hyaluronate and carboxymethylcellulose, HA/CMC).
• Extensive clinical data and broad clinical use internationally.
• Shown to reduce incidence, extent and severity of adhesions in abdominal and pelvic open surgery.

Indications
Indicated as an adjunct to reduce the incidence, extent and severity of postoperative adhesions between the abdominal wall and underlying viscera and between the uterus and surrounding structures in patients undergoing abdominal or pelvic laparotomy (including use on the uterine surface following open myomectomy as indicated).

Important Risk Information / Contraindications

• Contraindicated in patients with known hypersensitivity to Seprafilm or any component of the product.
• Do not wrap Seprafilm directly around a fresh anastomotic suture or staple line; such use increases the risk of anastomotic leak and related events (fistula, abscess, leak, sepsis, peritonitis).
• Use only according to the Instructions for Use. Single use only; supplied sterile and must not be re‑sterilized. Discard any opened or damaged pouches.
• Use only the number of sheets adequate to cover the undersurface of the abdominal wall or uterine incision in a single layer.
• In patients with ovarian, primary peritoneal or fallopian tube malignancies, particularly after extensive debulking, use has been reported with increased risk of intra‑abdominal fluid collection and/or abscess.
• Safety and effectiveness have not been established in patients with frank intra‑abdominopelvic infection, general abdominopelvic malignancy evaluation, device placement outside directly beneath an abdominal wall incision following laparotomy or on the uterus outside indicated use after open myomectomy, ongoing local/systemic inflammatory responses, concurrent implants (e.g., surgical mesh), or when re‑operation is required within four weeks of placement.
• Foreign body reactions have been reported.
• Safety and effectiveness in combination with other adhesion prevention products or in procedures outside the abdominopelvic cavity have not been established.
• Safety and effectiveness in pregnancy and Cesarean section have not been evaluated; product is not recommended during pregnancy and avoidance of conception should be considered during the first complete menstrual cycle after use.
• Long-term outcomes such as chronic pain and infertility have not been determined in clinical studies.
• Rx Only. For safe and proper use refer to the complete Instructions for Use.

Additional Notes
Not indicated for laparoscopic procedures. Seprafilm is intended for application in open (laparotomy) abdominal and pelvic procedures only.

Technical specifications

• Composition: Modified sodium hyaluronate and carboxymethylcellulose (HA/CMC).
• Form: Sterile, bioresorbable, translucent, hydrophilic sheet(s).
• Function: Temporary physical barrier separating tissues during healing (up to ~7 days).
• Indication (summary): Adjunct to reduce incidence, extent and severity of postoperative adhesions after abdominal/pelvic laparotomy; use on uterine surface after open myomectomy as indicated.
• Contraindications summary: Hypersensitivity to product components; do not wrap around fresh anastomoses.
• Regulatory / use notes: Approved in the U.S. for abdominal open procedures; Rx Only; single use, sterile packaging (do not re‑sterilize).