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Cited by 71Hernia repair and managementAbdominal Surgery and ComplicationsCongenital Anomalies and Fetal Surgery

The DOI matches its Crossref record; 24 of the 24 references it cites were found in a registry or an index.

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

Huerta, Sergio, Varshney, Anubodh, Patel, Prachi M., Mayo, Helen G., Livingston, Edward H.·2016·JAMA Surgery
DOI 10.1001/jamasurg.2015.5234
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Abstract

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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Crossref · 10.1001/jamasurg.2015.5234

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  • Most healthcare regulatory bodies, such as the FDA and EMA, still neglect the immunological effects of ECM bioscaffolds and consider them as medical devices or tissue-engineered products.

    “However, most healthcare regulatory bodies, such as the FDA and EMA, still neglect their immunological effects and still consider ECM bioscaffolds as medical devices (FDA) or tissue-engineered products (EMA) [191,211]”

    From Immune Response to Extracellular Matrix Bioscaffolds: A Comprehensive Review (2025) · cites this paper as [211]

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Metadata

Authors
Huerta, S., Varshney, A., Patel, P. M., Mayo, H. G., & Livingston, E. H.
Affiliations
  • VA North Texas Health Care System (US)
  • Brigham and Women's Hospital (US)
  • The University of Texas Southwestern Medical Center (US)
ORCID
Venue
JAMA Surgery
Publisher
American Medical Association (AMA)
Published
2016-04-01
Volume
151
Issue
4
Pages
374
ISSN
2168-6254 (ISSN-L)
DOI
10.1001/jamasurg.2015.5234
OpenAlex
W2256870563
Cited by
71
References
24
Citations by year
2026: 4 · 2025: 5 · 2024: 6 · 2023: 7 · 2022: 4 · 2021: 8 · 2020: 12 · 2019: 5 · 2018: 6 · 2017: 10 · 2016: 4
FWCI
9.24
Type
journal article
Language
en
Open access
closed
Locations
  • JAMA Surgery (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Surgery › Hernia repair and management
  • Health Sciences › Medicine › Surgery › Abdominal Surgery and Complications
  • Health Sciences › Medicine › Surgery › Congenital Anomalies and Fetal Surgery
Keywords
biological mesh, abdominal wall hernia repair, hernia recurrence, mesh infection, fistula formation, bioprosthesis, FDA 510(k) clearance, substantial equivalence, absorbable implants
MeSH terms
Bioprosthesis, Humans, Prosthesis Design, Surgical Mesh, United States, United States Food and Drug Administration, Wound Healing, Hernia, Abdominal, Herniorrhaphy

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