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Biological Mesh Implants for Abdominal Hernia Repair US Food and Drug Administration Approval Process and Systematic Review of Its Efficacy

Sergio Huerta, MD1,2; Anubodh Varshney, MD3; Prachi M. Patel, BS1; Helen G. Mayo, MLS4; Edward H. Livingston, MD1,2,5,6
[+] Author Affiliations
1School of Medicine, University of Texas Southwestern, Dallas
2Department of Surgery, North Texas Veterans Affairs Health Care System, Dallas
3Department of Medicine, Brigham and Women’s Hospital, Boston, Massachusetts
4Biomedical Library, University of Texas Southwestern, Dallas
5Department of Biomedical Engineering, University of Texas, Arlington
6Deputy Editor, JAMA
JAMA Surg. 2016;151(4):374-381. doi:10.1001/jamasurg.2015.5234.
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Importance  Expensive biological mesh materials are increasingly used to reinforce abdominal wall hernia repairs. The clinical and cost benefit of these materials are unknown.

Objectives  To review the published evidence on the use of biological mesh materials and to examine the US Food and Drug Administration (FDA) approval history for these devices.

Evidence Acquisition  Search of multiple electronic databases (Ovid, MEDLINE, EMBASE, Cochrane Systematic Reviews, Cochrane Database of Abstracts of Reviews of Effects, Cochrane Central Register of Controlled Trials, and Cochrane National Health Service Economic Evaluation Database) to identify articles published between 1948 and June 30, 2015, on the use of biological mesh materials used to reinforce abdominal wall hernia repair. Keywords searched included surgical mesh, abdominal hernia, recurrence, infection, fistula, bioprosthesis, biocompatible materials, absorbable implants, dermis, and collagen. The FDA online database for 510(k) clearances was reviewed for all commercially available biological mesh materials. The median national price for mesh materials was established by a benchmarking query through several Integrated Delivery Network and Group Purchasing Organization tools.

Evidence Synthesis  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 1033 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 fistula formation and infection, were inconsistently reported across studies. Conflicts of interest were not reported in 16 of the 20 studies. Recurrence rates ranged from 0% to 80%. 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.

Conclusions and Relevance  There is insufficient evidence to determine the extra costs associated with or the clinical efficacy of biological mesh materials for the repair of abdominal wall hernia.

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