Fibrin Sealant Well Tolerated, Easy to Use in Hernia Repairs

As an alternative to tissue-penetrating devices, Baxter Healthcare’s Tisseel fibrin sealant product was evaluated in a 1,201-subject multicenter observational study throughout France to assess its safety and efficacy for atraumatic mesh fixation in inguinal hernia repair. This highly concentrated preparation of human fibrinogen and thrombin components was used in 526 procedures performed by “open” surgical techniques and 675 using laparoscopic repairs. The objective was to learn if use of this mesh fixation alternative to such tissue-penetrating devices as staples and sutures is associated with reduced postoperative bleeding, pain and other complications.

Local complications occurred in 4.7 percent of patients, including 3.0 percent with hematoma, 1.4 percent with seroma and a 0.3 percent recurrence rate. Patients reported, on average, minimal pain immediately after surgery and at one-month follow-up. Consistent with other studies assessing fibrin sealant, these results suggest that fibrin sealant may yield fewer of these complications than mechanical means of mesh fixation. The study authors concluded that Tisseel appears to be a well-tolerated, easy-to-use alternative to traditional, tissue-penetrating devices for mesh fixation in hernia repair. The results of large randomized trials now in progress are keenly anticipated.