An examination of the published evidence on the use of biological mesh materials for the repair of abdominal wall hernia failed to find evidence supporting the use of these more expensive materials relative to low-cost synthetic mesh, according to a study published online by JAMA Surgery.
Abdominal hernia procedures are among the most common operations performed by general surgeons. In 2012, there were 190,000 inpatient abdominal wall hernia repairs performed in the United States. A new class of biological mesh materials was introduced in the 1990s to minimize the risk of complications linked to the use of synthetic mesh material. Because the outcomes for biological mesh materials are perceived to be better than those for polymer-based prosthetic mesh replacement materials, the use of biological grafts increased exponentially without clear clinical evidence of efficacy, according to background information in the article.
Sergio Huerta, M.D., of the University of Texas Southwestern, Dallas and colleagues investigated the evidence base supporting the added expense associated with use of biological mesh materials and also reviewed the U.S. Food and Drug Administration (FDA) approval history of these devices: the 510(k) approval process. The authors conducted a search of the medical literature to identify articles on the use of biological mesh materials used to reinforce abdominal wall hernia repair, and reviewed an FDA online database for 510(k) clearances for all commercially available biological mesh materials.
Of 274 screened articles, 20 met the search criteria. Most were case series that reported results of convenience samples of patients at single institutions with a variety of clinical problems. Only 3 of the 20 were comparative studies. There were no randomized clinical trials. In total, outcomes for 1,033 patients were described. Studies varied widely in follow-up time, operative technique, meshes used, and patient selection criteria. Reported outcomes and clinical outcomes, such as infection, were inconsistently reported across studies. Conflicts of interest were not reported in 16 of the 20 studies. Recurrence rates ranged from 0 percent to 80 percent. All biological mesh devices were approved by the FDA based on substantial equivalence to a group of nonbiological predicate devices that, on average, were one-third less costly.
"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," the authors write.
(JAMA Surgery. Published online January 27, 2016. doi:10.1001/jamasurg.2015.5234. Available pre-embargo to the media at http://media.
Editor's Note: This study was supported by the Hudson-Penn Endowment fund at University of Texas Southwestern. No conflict of interest disclosures were reported.
Commentary: Balancing Innovation and Value of Biological Meshes in Hernia
"The work by Heurta et al in this issue of JAMA Surgery highlights a fundamental problem in surgery: balancing the need for innovation with the practicalities of demonstrating clinical benefit for novel ideas," write Benjamin K. Poulose, M.D., M.P.H., of the Vanderbilt University Medical Center, Nashville, and colleagues in an accompanying commentary.
"It is important for surgeons to understand the limitations of the 510k process and consider that the FDA sees surgeons as the group responsible for understanding and evaluating the data before using expensive medical devices. In fact, if surgeons were trained to ask for and interpret data to substantiate claims before using medical devices, most of these issues would be resolved. Understanding who is in charge of making sure that the devices that we use during surgery are safe and effective is critical. Likely, it will require a collaborative effort of the FDA, medical device companies, and physicians."
(JAMA Surgery. Published online January 27, 2016. doi:10.1001/jamasurg.2015.5236. Available pre-embargo to the media at http://media.
Editor's Note: Please see the article for additional information, including financial disclosures, funding and support, etc.
Media Advisory: To contact Sergio Huerta, M.D., call Cathy Frisinger at 214-648-3404 or email firstname.lastname@example.org. To contact commentary co-author Benjamin K. Poulose, M.D., M.P.H., email Craig Boerner at craig.boerner@Vanderbilt.Edu.