NEW YORK (Reuters Health) – At a fraction of the cost, synthetic mesh appears to be as safe as biological mesh for ventral hernia repair and leads to significantly fewer recurrences, according to results of a clinical trial.
“Synthetic mesh demonstrated superior 2-year hernia recurrence risk compared with biologic mesh in patients undergoing single-stage repair of contaminated ventral hernias, and both meshes demonstrated similar safety profiles,” researchers write in JAMA Surgery.
“The price of biologic mesh was over 200 times that of synthetic mesh for these outcomes,” they add.
Dr. Michael J. Rosen of Cleveland Clinic Foundation in Ohio and his colleagues conducted the single-blinded randomized trial at five academic medical centers in the U.S. that had specialized units for abdominal-wall reconstruction.
Over more than six years, the research team enrolled 253 adult ranging in age from 55 to 70 years. The patients underwent elective single-stage retromuscular repair for clean-contaminated or contaminated ventral hernias, with 126 receiving synthetic mesh and 127 receiving biologic mesh.
The two groups had similar baseline medical comorbidities and hernia characteristics. The follow-up rate at 2 years was 92%.
Compared with biologic mesh, synthetic mesh significantly decreased hernia recurrence risk (hazard ratio, 0.31; P<0.001).
At two years, hernias recurred in 26 (20.5%) of patients who received biologic mesh compared with 7 (5.6%) of those who received synthetic mesh (P=0.001).
The overall two-year risk of surgical site occurrence requiring surgical intervention was not significantly different (odds ratio, 1.22; P=0.58).
The median price difference between the mesh categories was dramatic: $21,539 for biologic vs. $105 for synthetic (P<0.001). Likewise, the median 30-day hospital direct costs were $44,936 in the biologic group compared with $17,289 in the synthetic group (P<0.001).
In an editorial accompanying the study, Drs. Allan E. Stolarski and Kamal M. F. Itani of Boston University write, “Surgeons should feel more comfortable using polypropylene mesh for ventral hernia repair in contaminated or clean-contaminated fields based on the study results. We applaud Rosen and colleagues on undertaking a long-awaited study.”
“Knowing that mesh infection can continue to occur beyond 2 years after surgery, we encourage the authors to continue to follow up their patients and for other authors to confirm these results in trials with follow-up beyond 2 years,” they add. “With the results of this trial, we are edging closer to the demise of biologics in ventral hernia repair and nailing the coffin on a very costly practice.”
The study did not receive commercial funding.
SOURCES: https://bit.ly/3o6ih0H and https://bit.ly/3KwJyTi JAMA Surgery, online January 19, 2022.
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