Whitehead-Clarke, Thomas; (2025) The development of 3-dimensional in vitro rectus sheath models and their potential role in hernia mesh testing. Doctoral thesis (Ph.D), UCL (University College London).

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Abstract

Over the last 10-15 years, hernia meshes have come under increased scrutiny from various organizations and patient advocacy groups due to potential complications. Institutions such as the European Union have re-described hernia mesh products as a class III or ‘high risk’ device in order to achieve a higher standard of pre-market testing. The vast majority of pre-market mesh testing is undertaken in animal subjects, including a great variety of in vivo models. The advent of cell culture and tissue engineering have given rise to the practice of creating in vitro 3D tissue models - biomimetic tissue equivalents used most commonly for the testing of cancer treatments. Not yet explored, however, is the potential for using such tissue models for the assessment of medical devices such as implants or hernia mesh. This thesis first explores the literature around animal mesh testing to identify the current techniques used and standardization within the field. The scoping review undertaken is the largest of its kind, identifying the variation amongst in vivo models and comparators used. This thesis proceeds in the development of a rectus sheath tissue model by carrying out an analysis of cadaveric samples of human posterior rectus sheath. This work establishes strength, stiffness and thickness values for the tissue that are well supported by the literature. The thesis goes on to develop a protocol for the isolation, culture and cryopreservation of rectus sheath fibroblasts so that the relevant cells may be used to produce such a model. Once established, this cell population is then successfully characterized – establishing the cell population as of fibroblast lineage and capable of contracting collagen. Final experimental chapters develop 2 different rectus sheath tissue models – one to mimic the tissue’s structural characteristics, and another to test different commercial hernia meshes.

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