Using biologic mesh for abdominal wall hernia repair provides no benefit over using cheaper synthetic mesh, according to a new study from the UT Southwestern Medical Center that compared the 2 materials.
Findings from the study were reported earlier this week in JAMA Surgery.
“In the absence of evidence demonstrating superiority of biological mesh materials, the expense associated with their use cannot be justified,” study author Dr. Sergio Huerta of UT Southwestern said in a press release.
Meshes are used during abdominal hernia repairs, and biological meshes were introduced in the 1990s in hopes of reducing the rate of infections erosions associated with earlier synthetic meshes. Biologic meshes are derived from biological sources, such as pig or cow tissue, and cost on average 350% more than synthetic mesh, according to a UT Southwestern press release.
The study examined 274 published articles covering the use of biologic mesh in abdominal wall hernia repair, as well as the FDA 510(k) approvals of the devices. FDA clearance for the meshes was based on “substantial equivalence” to synthetic meshes, rather than clinical trials.
Outcomes for 1,033 patients were analyzed during the study, which found that follow-up time, operative technique, meshes used and patient selection criteria varied widely, and outcomes such as infection were inconsistently reported across all studies.
The re-examination analysis found only 3 studies which compared biologic meshes to synthetics, none of which were randomized clinical trials. In addition, 16 of 20 studies did not report conflicts of interest and recurrence rates ranged from 0% to 80%.
“The cost of health care is increasing at a pace much greater than the economy can support. Much of the increase in health care expenses has been attributed to the use of new technologies. It is believed that greater application of evidence-based medicine will help control these increasing costs. The use of biological mesh materials for hernia repair is one of many examples in which significant costs could be avoided by tailoring clinical practice based on careful review of the evidence. These devices were approved on the basis of being equivalent to other devices, which cost as much as one-fourth less than the biological equivalent. Until evidence exists demonstrating superiority of biological mesh materials, the expense associated with their use cannot be justified,” study authors wrote.