The collagen-based Permacol surgical implant is safe and feasible for incisional and ventral hernia repair, according to the authors of a study that found hernia recurrence probabilities of 5.8%, 16.6%, and 31.0% at 1, 2, and 3 years, respectively.
Retrospective data from 343 patients with 213 incisional and 130 ventral hernias, treated with the cross-linked porcine collagen product, showed open surgery was associated with a significantly higher rate of recurrence than laparoscopic surgery at 12 months (7.7% vs. 2.5%, P = .047).
Mesh location also affected recurrence rates at 12 months, with onlay (suprafascial) repair associated with an 18.9% recurrence rate, compared with 2.4% for underlay (subfascial, intraperitoneal) repair. But wound classification, wound infection, and seromas did not impact the risk of recurrence at 12 or 24 months (Int. J. Surg. 2014;12:296-303).
Dr. Bipan Chand of the Loyola Center for Metabolic Surgery and Bariatric Care, Loyola University, and colleagues described the study as the largest retrospective multinational study to date evaluating outcomes from hernia repair using Permacol.
"Despite an initially enthusiastic adoption [of collagen-based prosthetics] by the surgical community, clinical data supporting product safety and efficacy and proper indication is needed," the authors wrote.
"The use of biologics is still controversial in class III (contaminated) and IV (infected) wounds and fields with increased collagenase due to potential accelerated breakdown of the collagen-based materials in these more hostile environments and limited evidence of long-term efficacy under those conditions."
At the time of surgery, 8.2% of patients had class III wounds and 6.4% had class IV.
Researchers observed a 1-year hernia recurrence rate of 7.4% in clean wounds and 4.5% in dirty wounds, compared with another study using a non–cross-linked biologic that recorded recurrence rates of 39% in dirty wounds and 5% in clean wounds after 1 year.
There was a 15.2% rate of wound infection and a 19% incidence of seroma. In addition, there was a 3.2% incidence of hematoma and a 0.9% incidence of fistula. One patient required reoperation to remove the mesh, which the authors said was procedure related.
Biologic mesh such as Permacol includes an intact extracellular matrix that supports tissue incorporation, revascularization, and cell repopulation that may also help to clear bacterial contamination, the authors reported.
"Permacol surgical implant was shown to be safe and feasible with low rates of postoperative morbidity even in patients with higher risk of failure," the researchers wrote.
"We recommend optimizing controllable patient conditions, performing these complex operations on an elective basis, reducing the bioburden of the wound, and reapproximating the fascial midline while utilizing Permacol surgical implant as reinforcement."
The study was sponsored and funded by Covidien, who also provided editorial support. Most authors declared a range of honoraria, consultancies, lecture fees, and travel support, including from Covidien.